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Cell Biology

Rockville cell and gene company may have found treatment for HIV – BethesdaMagazine.com

Jeff Galvin believes his Rockville cell and gene technology company has found a breakthrough treatment for people living with HIV

By David Goldstein

| Published: 2020-08-17 08:31

When Jeff Galvin was 13 years old, he came across a lone computer in the basement of Muzzey Junior High School in Lexington, Massachusetts. It was actually a teletype machine attached to a minicomputer. This was, after all, the 1970s.

He doesnt remember why it was there, but he got permission to use it and taught himself how to program. My first love affair, Galvin recalls. My head exploded with the possibility that you had this thing that never got tired. You just fed it electricity.

At 15, he was taking classes at Massachusetts Institute of Technology (MIT) in nearby Cambridge and teaching computer science to high school and college students on weekends. This may be starting to sound like Good Will Hunting, the 1997 film in which actor Matt Damon plays an MIT janitor who secretly solves complex equations on a classroom blackboard, but theres a difference. He was a math genius, Galvin says. I was a highly passionate, excited kid who had just seen the most amazing toy in history.

In his 20s, Galvin was an early recruit to Silicon Valley in those heady nascent days of the 1980s when it was fast becoming the high-tech Xanadu. His time in California included six years at Apple, but it was a visit to the National Institutes of Health in 2007 that took his career in a much different direction.

Now 61, hes the founder and CEO of a Rockville cell and gene technology company, and he believes his company stands on the cusp of a medical breakthrough. Galvins team of molecular biologists at American Gene Technologies (AGT) thinks it has developed a gene therapy procedure that can cure HIV, the virus that leads to AIDS. According to the U.S. Department of Health and Human Services, 1.1 million people are currently living with HIV in this country; the World Health Organization estimates that 75 million people across the globe have been infected with the virus since the AIDS epidemic began in 1981. About 32 million have died.

Galvin says he made HIV his target because a cure for the virus has remained elusive. People with HIV must take a daily regimen of medications that control infections and suppress the virus, but dont eliminate it. Over time, these drugs can cause everything from nausea and fatigue to more serious conditions affecting the kidneys, heart and central nervous system, according to NIH.

He believes the gene therapy procedure AGT has developed, in which genes are transferred to modify cells or tissue through the use of viral vectors, could actually be a platform to cure any number of diseases.

What cant we cure with this? Galvin says during a call to the head of a financial securities firm one afternoon in February. Hes seated at a large oval table in the AGT conference room with the phone on speaker.

Galvin spends much of his time wooing potential investors. What he brings to the task is his salesmans personality: a bit over the top, a healthy dollop of bravado, and an inclination to push the envelope. And his companys HIV treatment is getting a serious lookthe U.S. Food and Drug Administration is determining whether the procedure is safe enough for human testing.

Galvin says the gene and cell therapy industry has been exploding in recent years, causing a slowdown in the regulatory process for those kinds of treatments. But AGT is hopeful that the FDA will approve the human clinical trials by this fall. I cant imagine we cant cure almost everything in the world, he says on the call. Were going to send chemotherapy and radiation the way of bloodletting and leeches.

Galvin is a ball of energy and nonstop talker. Politics. Facebooks troubled relationship with privacy. Hell opine as long as someone will listen and he doesnt have a pressing appointment. He is 6 feet tall, has a genial smile and an eagerness to engage. And he burns with the passion of the committed.

Were down here in Rockville, Maryland. Lots of good opportunities down here, he says during the pitch, which goes on for more than an hour. Right now [we have] the beginnings of what is turning into a revolution in pharmaceuticalswere talking about the creation of probably another $3 to $5 trillion industry over the next 10 to 15 years. I think this is bigger than the dot-com boom. I think it doesnt have quite the same bubble. This isnt the kind of thing that will all go off the cliff simultaneously like dot-com because theres real science behind it. And if it works out, it can be monetized.

Galvin is a cheerleader for Montgomery Countys growth as a hub for health technology. AGT is just off Interstate 270 at Exit 6B in the life sciences corridor, where it percolates among a cluster of tech, biotech and pharmaceutical companies, as well as educational centers. Branches of the University of Maryland and Montgomery College help incubate new startups. Thats the atmosphere that got AGT off the ground in 2008.

In addition to HIV, AGT is developing therapies for several types of cancerous tumors that affect the breasts, lungs and prostate. The company hopes that its work on a treatment for liver cancer will be approved for human clinical trials in 2022. The lab is also working on a gene therapy for phenylketonuria, known as PKU, a rare inherited metabolic disorder.

Theres this great economic engine which is evolving that will make Maryland the next Silicon Valley, Galvin tells the head of the financial securities firm. I call it DNA Valley.

Galvin, it should be noted, is not a scientist. Hes an economist by training, a 1981 graduate of Harvard University. Hes a computer prodigy by pedigreehis mother was one of the rare female computer software experts in the 1960s, and his father is an MIT-trained electrical engineer who did national security work.

Galvin has this thing about disruptive technologies, he says, systems that upend the old way of doing something and change the culture in a significant way. Like how Apple co-founder Steve Jobs simplified and popularized the computer mouse. Or how GPS changed the way we get from here to there. Thats how he sees AGT and gene therapy. Ive been through a lot of technologies: computers, software, the internet, apps, IT, Galvin says.

So I understand how these technologies grow. Gene and cell therapies are bigger than any of those, and its much more emotional because its your health.

He has a fluency in arcane subjects that arent connected to his own skills. This is Galvins explanation for how HIV infects a cell through a protein known as CCR5, located on the surface of white blood cells, and why AGT believes it has developed a defense: One element of our cell product is the removal of CCR5 from the surface of CD4+ T cells. Howeverwe have also added siRNAs against conserved regions of the vif and tat HIV genes for additional protection against R5 viruses as well as extending protection to CXCR4 versions of HIV.

Heres how he puts it in plain English: We have removed thedoor handle (CCR5) that HIV uses to get into cells. Most forms of HIV use that common surface protein in cells to infect the cell, but some forms do not need that handle. AGT has added specially designed genes to our HIV treatment that are capable of producing substances inside the cell that protect against several known mutations of HIV that do not require that handle. AGT is the first company to provide this type of broad protection to the various known versions of HIV.

HIV is an insidious virus that infects a patients T cells, a type of white blood cell that helps the body fight off infection. In Montgomery County, 3,489 people were infected with HIV between 2009 and 2018, with 123 new cases in 2018, according to the Maryland Department of Health. AGTs gene therapy approach modifies the HIV-specific T cells so they can resist infections and do their job of protecting the body from pathogens that cause disease.

AGT does this by using viral vectors; the viruses are cracked open to remove the bad genes and replaced with newly modified genes that will improve the cell. Instead of a virus with the intention of infecting you and going to the next person, its been tamed to do only one part of that process, says C. David Pauza, a molecular biologist and longtime researcher in gene cloning and HIV who serves as AGTs chief science officer. We put things in it we want it to deliver and it makes one infection and stopsand doesnt go any farther. According to Galvin, once HIV T cells are able to carry out their protective work as intended, HIV patients would eventually become permanently immune to the virus and hopefully have no need to continue taking antiretroviral drugs.

AGTs concept is not new, according to Carl Dieffenbach, director of the Division of AIDS at NIHs National Institute of Allergy and Infectious Diseases. What has improved are the vectors, he says. Its reasonable to continue to watch this. Whats unknown, Dieffenbach says, is the human reaction. Once the therapy is tried on people, what you dont know is how this will actually behave.

Tami Howie, an attorney who represents tech and biotech companies, first met Galvin in 2017, when she was CEO of the Maryland Technology Council. He is one of the rare people who epitomizes the convergence in tech and biotech, she says. Hes totally cutting edge.

But messing around with the human genome can be fraught with risk. We know there are viruses out there that get into your body and activate genes that do all kinds of good things and bad things, Pauza says. [One] good thing is a very old virus thats in most of us that controls the efficiency of pregnancy in women. But then you can get other viruses that go in and they stimulate things to be made inappropriately and trigger horrible results.

To Galvin, no risk, no reward. When he made public late last year that AGT was developing a cure for HIV, he was criticized by some in the HIV/AIDS community for peddling false hope. But Galvin has no regrets and is sympathetic to their concerns. Its reasonable to experience a gut reaction to the word cure when humanity has been struggling against HIV for decades, he says. I dont fault anyone for working to protect their community. We are always clear that we will only know for sure once we prove it in a human trial, he says. He calls AGTs work the future of medicine.

Its going to be typical that many of the diseases that strike you are going to be cured by gene and cell therapy, he tells the prospective investor. And we plan to lead that revolution becausewere going to prove were the most efficient competitor in it by curing HIV this year.

If hes right, that would be seismic.

Enormous, Pauza says.

The oldest of three children, Galvin didnt get a lot of attention when he was young so he tended to get into a lot of trouble, he says. I figured out how things worked early, so it was hard to lock me in the house.

As a child, hed come home with a bloody hand, having found a razor blade, or wander into a snowstorm looking for twigs for the fireplace. His father, Aaron, says Galvin was a handful because his mind was so active. We were on a first-name basis with all the emergency wards, he says with a chuckle.

Galvin showed his entrepreneurial spirit early on, his father says. When he was 6 and the familys house in Lexington was under construction, the boy collected dirt from the excavation site and sifted it through a window screen and into plastic bags. Then he pulled his little red wagon up and down the street, selling topsoil for 50 cents a bag.

Harvard didnt offer a degree in computer science when he went there, so Galvin majored in economics and took all the computer classes he could. After graduation, he left for California to take a job with Hewlett-Packard, but he didnt like the corporate culture and went to work for Apple. Apple was more like me, Galvin says. It was in love with what computers could do.

He stayed on the West Coast for parts of the next three decades. Silicon Valley was on fire when I was there, says Galvin, whose sister, Laurie, and brother, Mark, also pursued careers in the tech world. He describes the atmosphere there as a group of people with the right ideas andpushing things at light speed. There was such a clarity of vision and purpose. There was no limit on what we could do there.

It was a fast life, though. As a marketing manager and later director of international marketing for Claris, an Apple spinoff, Galvin was always on the move: Europe, the Middle East, Indonesia, New Zealand. While in Paris on a trip to show clients how to service Apple hardware, he fell asleep at the wheel while driving through a tunnel at 70 mph after having been up for three days. When he brushed a curb, he awoke and was able to right the car. But it was a chilling experience.

How lucky can you get? Galvin says.

In 2001, after nearly two decades of 16-hour workdays, he decided he was done. At 42, hed made investments in startups, real estate, software and internet companies. I looked at my bank account and realized I didnt have to work anymore, Galvin says.

He bought a house on Maui and traveled between there and his home in San Carlos in Silicon Valley. He started dating, thinking he should settle down before he got too old. He and his wife, Cherry, married in 2004.

The couple enjoyed a carefree life in the tropics. But after five years, Galvin was bored out of my mind, so they moved back to California. He decided to tiptoe back into the game by looking for a project where he could become an angel investor, someone who puts money behind a startup often in exchange for ownership equity. The word got out, and Galvin received a proposal from a postdoctoral researcher at a lab at NIH headed by Dr. Roscoe Brady, a renowned biochemist and pioneer in the treatment of enzyme deficiencies. Galvin visited the lab in 2007 and met Brady, who explained the science behind viral vectors. It was Galvins eureka moment.

When I learned that there was a mechanism to update the DNA in a human cell, my head practically exploded, Galvin says. He reasoned that if you look at a cell as the human bodys computer, and the DNA contained in the cell as the operating system, you could employ viral vectors to convert viruses into updates for the human computer and thereby correct defects.

DNA is the instruction set for the cell, Galvin says. Your genes are just instructions to make enzymes and proteins that then react in the cell. Basically, your cell is an organic computer. You change the software, you change the cell.

Brady was retiring and NIH was closing his lab. Galvin says NIH gave him the intellectual property, free of charge, on the condition that he continue the research. I felt like he was close to making major breakthroughs, Galvin says. So he hired two of Bradys research assistants and signed Brady on as a scientific adviser. Thats how AGT was born.

In the early days, Galvin continued to live on the West Coast and funded the work out of his own pocket. His mother, Frayda, was suffering from Stage 4 pancreatic cancer. She died in 2009 after battling the disease for 15 months. Knowing what she went through bolstered Galvins conviction that AGTs work could help people. In 2010, he realized he needed to be in Rockville full time. Over the next few years, he received $1 million in grants from NIH, which was interested in innovative approaches to gene and cell therapies. Galvin says obtaining funding that way was easier than trying to lure investors, and he kicked in an additional $2 million.

AGT began as a small but determined undertaking. An early supporter was Dr. Robert Redfield, a virologist who now heads the Centers for Disease Control and Prevention and became visible during the White House coronavirus briefings in the spring. He served as an adviser to AGT beginning in 2011 and subsequently chaired the companys clinical advisory board for its HIV gene therapy program until 2018. By that time, AGT had been granted patents for its HIV therapy and had enlisted NIH as a research partner in its search for a cure. Fast forward to today, Galvin says, we have curative therapies for HIV.

Galvins day usually begins in my sweats, he says, in the kitchen of his Rockville condo where he has a three-screen computer. He calls it command central. He can work uninterrupted for about three hours, and hes usually at AGT by noon. He presides over a three-story warren of offices where employees handle regulatory affairs, marketing, finance and other administrative business.

Its in the labs, spread over 11,500 square feet on the third floor, where the microbiologists and other scientists do the research and delicate work of separating genes, the link between one generation and the next. Behind glass walls and clad in blue protective gowns and gloves, they employ an array of biological tools as they work with T cells, viral vectors and other microscopic particles. Their findings spill out of white data machines spaced at regular intervals along the work counters.

Talking up AGT requires Galvin to travel a lot. Before the coronavirus pandemic, he was often on trains to Manhattan for meetings and dinners with prospective investors, and flying around the country for conferences and other events. But the world has new rules these days. Video conference calls and Zoom meetings have become the new way of doing business.

To relax, Galvin plays Xbox or watches The Simpsons. He enjoys how the shows writers parody American culture.

I can tell these people feel the same way about the world as I do, he says. He also reads or catches up on the news. On his nightstand in February was Sapiens: A Brief History of Humankind, a New York Times bestseller.

His wife, Cherry, prefers warm weather, so she spends her winters at the couples home in Silicon Valley. They got married late in life, Galvin says, and dont have children. Cherrys sister, a single mother, lived with the couple and in 2004 sent for her daughter, who was 6 years old and staying with her grandmother in Wuhan, China. Now 21, Galvins niece, Jesse, recently graduated from the University of Washington, where she majored in molecular and cellular biology. Interning at AGT during her high school summers might have had something to do with that. I love my niece like a daughter, Galvin says.

Galvin says hes having the most fun hes ever had. Still, securing funding for new therapies and medicines can be a struggle if youre not a pharmaceutical giant. Investors generally want a quick return, and human trials for a new drug or therapy can be costly.

To be a successful entrepreneur and forging new territory, you get a lot of arrows in the back. A lot of people say no way, says Drew Palin, a physician and chief innovation officer of Intellivisit, a Madison, Wisconsin, online medical diagnosis company. Hes also one of Galvins investors. He has had to raise lots of nickels and dimes that allowed him to be a little more patient and persistent. To do that, you have to have a lot [of] drive, a lot of personal passion and a way to survive.

When Galvin isnt pitching AGTs upside to venture capitalists, blue-chip finance houses like JPMorgan Chase, big financial institutions like Citibank, and angel investors like Palin, hes championing the promise of genetic engineering.

Im basically an evangelical person that is spending his entire day either connecting people with our mission and trying to engage them [in] some way to support it or propel it, or inspiring people to achieve greatness within the mission, Galvin says.

Should AGTs experimental HIV treatment work and eventually be approved for commercial sales, Galvin says it would likely be licensed to a large pharmaceutical company with global reach to ensure the products wide availability.

Galvin doesnt have any idea how much the treatment could cost, but predicted it would be less expensive than what insurance companies now pay to cover the costs of daily antiretroviral treatments, medicine for the side effects and appointments with doctors. Hes not chasing the dollar. Hes chasing every life he can save, Tami Howie says. He figures every minute hes not working, people are dying.

Galvins fundraising has pushed investments to $40 million, and his staff has grown to 30. His commitment to AGT, however, put a strain on both his marriage and retirement nest egg. Both have survived and recovered, he says, but it took sustained engagement with high risk and giant potential downfall for me.

Now he weighs the possibility that it all could pay off. If we get a handful of cured HIV patientsI think the [National] Mall is going to look like the days of the AIDS quilt because these people have been suffering for so long, Galvin says, and I think the emotional response is going to be quite profound.

David Goldstein is a former political and investigative reporter in Washington, D.C., for McClatchy Newspapers and The Kansas City Star.

Continued here:
Rockville cell and gene company may have found treatment for HIV - BethesdaMagazine.com

Cell Biology

Scientists hope to find clues about how life emerged by tinkering with its oldest components – News-Medical.net

Reviewed by Emily Henderson, B.Sc.Aug 15 2020

"I'm fascinated with life, and that's why I want to break it."

This is how Betl Kaar, an assistant professor at the University of Arizona with appointments in the Department of Molecular and Cellular Biology, Department of Astronomy and the Lunar and Planetary Laboratory, describes her research. What may sound callous is a legitimate scientific approach in astrobiology. Known as ancestral sequencing, the idea is to "resurrect" genetic sequences from the dawn of life, put them to work in the cellular pathways of modern microbes - think Jurassic Park but with extinct genes in place of dinosaurs, and study how the organism copes.

In a recent paper published in the Proceedings of the National Academy of Sciences, Kaar's research team reports an unexpected discovery: Evolution, it seems, is not very good at multitasking.

Kaar uses ancestral sequencing to find out what makes life tick and how organisms are shaped by evolutionary selection pressure. The insights gained may, in turn, offer clues as to what it takes for organic precursor molecules to give rise to life - be it on Earth or faraway worlds. In her lab, Kaar specializes in designing molecules that act like tiny invisible wrenches, wreaking havoc with the delicate cellular machinery that allows organisms to eat, move and multiply - in short, to live.

Kaar has focused her attention on the translation machinery, a labyrinthine molecular clockwork that translates the information encoded in the bacteria's DNA into proteins. All organisms - from microbes to algae to trees to humans - possess this piece of machinery in their cells.

We approximate everything about the past based on what we have today. All life needs a coding system - something that takes information and turns it into molecules that can perform tasks - and the translational machinery does just that. It creates life's alphabet. That's why we think of it as a fossil that has remained largely unchanged, at least at its core. If we ever find life elsewhere, you bet that the first thing we'll look at is its information processing systems, and the translational machinery is just that."

Betl Kaar, Assistant Professor, University of Arizona

So critical is the translational machinery to life on Earth that even over the course of more than 3.5 billion years of evolution, its parts have undergone little substantial change. Scientists have referred to it as "an evolutionary accident frozen in time."

"I guess I tend to mess with things I'm not supposed to," Kaar said. "Locked in time? Let's unlock it. Breaking it would lead the cell to destruction? Let's break it."

The researchers took six different strains of Escherichia coli bacteria and genetically engineered the cells with mutated components of their translational machinery. They targeted the step that feeds the unit with genetic information by swapping the shuttle protein with evolutionary cousins taken from other microbes, including a reconstructed ancestor from about 700 million years ago.

"We get into the heart of the heart of what we think is one of the earliest machineries of life," Kaar said. "We purposely break it a little, and a lot, to see how the cells deal with this problem. In doing this, we think we create an urgent problem for the cell, and it will fix that."

Next, the team mimicked evolution by having the manipulated bacterial strains compete with each other - like a microbial version of "The Hunger Games." A thousand generations later, some strains fared better than others, as was expected. But when Kaar's team analyzed exactly how the bacteria responded to perturbations in their translational components, they discovered something unexpected: Initially, natural selection improved the compromised translational machinery, but its focus shifted away to other cellular modules before the machinery's performance was fully restored.

To find out why, Kaar enlisted Sandeep Venkataram, a population genetics expert at the University of California, San Diego.

Venkataram likens the process to a game of whack-a-mole, with each mole representing a cellular module. Whenever a module experiences a mutation, it pops up. The hammer smashing it back down is the action of natural selection. Mutations are randomly spread across all modules, so that all moles pop up randomly.

"We expected that the hammer of natural selection also comes down randomly, but that is not what we found," he said. "Rather, it does not act randomly but has a strong bias, favoring those mutations that provide the largest fitness advantage while it smashes down other less beneficial mutations, even though they also provide a benefit to the organism."

In other words, evolution is not a multitasker when it comes to fixing problems.

"It seems that evolution is myopic," Venkataram said. "It focuses on the most immediate problem, puts a Band-Aid on and then it moves on to the next problem, without thoroughly finishing the problem it was working on before."

"It turns out the cells do fix their problems but not in the way we might fix them," Kaar added. "In a way, it's a bit like organizing a delivery truck as it drives down a bumpy road. You can stack and organize only so many boxes at a time before they inevitably get jumbled around. You never really get the chance to make any large, orderly arrangement."

Why natural selection acts in this way remains to be studied, but what the research showed is that, overall, the process results in what the authors call "evolutionary stalling" - while evolution is busy fixing one problem, it does at the expense of all other issues that need fixing. They conclude that at least in rapidly evolving populations, such as bacteria, adaptation in some modules would stall despite the availability of beneficial mutations. This results in a situation in which organisms can never reach a fully optimized state.

"The system has to be capable of being less than optimal so that evolution has something to act on in the face of disturbance - in other words, there needs to be room for improvement," Kaar said.

Kaar believes this feature of evolution may be a signature of any self-organizing system, and she suspects that this principle has counterparts at all levels of biological hierarchy, going back to life's beginnings, possibly even to prebiotic times when life had not yet materialized.

With continued funding from the John Templeton Foundation and NASA, the research group is now working on using ancestral sequencing to go back even further in time, Kaar said.

"We want to strip things down even more and create systems that start out as what we would consider pre-life and then transition into what we consider life."

Source:

Journal reference:

Venkataram, S., et al. (2020) Evolutionary stalling and a limit on the power of natural selection to improve a cellular module. PNAS. doi.org/10.1073/pnas.1921881117.

Original post:
Scientists hope to find clues about how life emerged by tinkering with its oldest components - News-Medical.net

Cell Biology

High Point University Students, Faculty and Staff Recognized for Research and Innovation – Yes! Weekly

HIGH POINT, N.C., Aug. 14, 2020 Members of the High Point University community frequently conduct, publish and share research and creative works in a variety of ways. Below is a recap of recent research initiatives.

HPU Student, Alumna and Faculty Research Featured in National Scientific Journal

Casey Garr, HPU alumna; Candyce Sturgeon, HPU rising senior; Dr. Veronica Segarra, HPU assistant professor of biology; and Noah Franks, student at Penn Griffin School of the Arts in High Point, North Carolina; recently conducted research that was published in Autophagy, a national scientific journal.

Dr. Veronica Segarra, assistant professor of biology, recently co-authored research that was published in Autophagy, a national scientific journal.

The study, titled, Autophagy as an on-ramp to scientific discovery, examines HPUs Cell Art Collaborative program to gain understanding around how the recruitment of highly creative students into STEM fields through connections to art can be a first step in defining a specialized career path that leads to a valuable and unique contribution to science.

In addition to providing experiential learning opportunities for students at HPU to conduct hands-on research and co-author peer-reviewed articles, the Cell Art Collaborative program encourages students in the local community to explore careers that incorporate both science and art, says Segarra. This initiative continues to facilitate conversations around STEAM-based learning environments for educators to take advantage of a wider range of student talents and interests, preparing them to go forth into society as the creative thinkers and problem solvers the world needs.

HPU Students Research Featured in CBE: Life Sciences Education Journal

Clara Primus, a rising junior majoring in biology and Bonner Leader at HPU, recently collaborated with prominent scientists to conduct research that was published in CBE: Life Sciences Education, a quarterly journal published by the American Society for Cell Biology.

Clara Primus, a rising junior majoring in biology and Bonner Leader at HPU, recently collaborated with prominent scientists at the Mayo Clinic, University of California Davis and Northwestern to conduct research that was published in CBE: Life Sciences Education, a quarterly journal published by the American Society for Cell Biology. The article, titled, Scientific Societies Fostering Inclusive Scientific Environments through Travel Awards: Current Practices and Recommendations, examines how scientific societies can contribute to a diverse and inclusive workforce.

The research compares and contrasts the broad approaches that scientific societies within the National Science Foundation-funded Alliance to Catalyze Change for Equity in STEM Success (ACCESS) use to implement and assess their travel award programs for underrepresented minority (URM) trainees. Findings will improve collaboration and better position scientific societies to begin addressing some of these questions and learning from each other.

The recommendations included in this research shed light on how even scientific societies can be allies in furthering inclusion efforts, said Primus. Ive spent nearly two years studying equity and diversity, and I hope that I can take the knowledge Ive learned from all of my research to educate my peers at HPU.

HPU Exercise Science Professor Publishes Statement for the American Heart Association

Dr. Colin Carriker, assistant professor of exercise science in HPUs Congdon School of Health Sciences, recently co-authored a scientific statement for the American Heart Association (AHA).

Dr. Colin Carriker, assistant professor of exercise science in HPUs Congdon School of Health Sciences, recently co-authored an American Heart Association (AHA) scientific statement on medicinal and recreational cannabis use published in Circulation.

The statement critically reviews the use of medicinal and recreational cannabis from a clinical but also a policy and public health perspective by evaluating its safety and efficacy profile, particularly in relation to cardiovascular health. The purpose of this scientific statement was to explore the evidence and science pertaining to medical marijuana, recreational cannabis and cardiovascular health to provide physicians and health care providers with the information available to date. While cannabis may have some therapeutic benefits, these do not appear to be cardiovascular in nature. Health care providers would benefit from increased knowledge, education and training pertaining to various cannabis products and health implications, including recognition that cannabis use may, in fact, exacerbate cardiovascular events or other health problems. In this regard, the negative health implications of cannabis should be formally and consistently emphasized in policy, while aligning with the American Heart Associations commitment to minimizing the smoking and vaping of any products and banning cannabis use for youth.

It was an honor to work alongside such a high-quality team of researchers, says Carriker. I want to especially thank our committee chairs, Dr. Robert L. Page II and Dr. Larry A. Allen, as their extraordinary leadership and organization were integral components in the completion and publication of this AHA scientific statement. We publish these statements to counterbalance and debunk misinformation because the public requires high-quality information about cannabis from reputable organizations such as the American Heart Association.

Carriker is the advocacy ambassador for the American Heart Associations Council on Lifestyle and Cardiometabolic Health and served as a member of the writing committee tasked with writing this AHA Scientific Statement initiated by the AHAs Council on Clinical Cardiology.

At High Point University, every student receives an extraordinary education in an inspiring environment with caring people. HPU, located in the Piedmont Triad region of North Carolina, is a liberal arts institution with 5,400 undergraduate and graduate students. It is ranked No. 1 by U.S. News and World Report for Best Regional Colleges in the South, No. 1 for Most Innovative Regional Colleges in the South and No. 1 for Best Undergraduate Teaching in the South. The Princeton Review named HPU in the 2020 edition of The Best 385 Colleges and on the Best Southeastern Colleges 2020 Best Colleges: Region by Region list. HPU was recognized as a Great School for Business Majors and a Great School for Communication Majors. HPU was also recognized for Most Beautiful Campus (No. 18), Best College Dorms (No. 5) and Best Campus Food (No. 20). For nine years in a row, HPU has been named a College of Distinction with special recognition for business and education programs and career development, and The National Council on Teacher Quality ranks HPUs elementary education program as one of the best in the nation. The university has 60 undergraduate majors, 63 undergraduate minors and 14 graduate degree programs. It is a member of the NCAA, Division I and the Big South Conference. Visit High Point University on the web at highpoint.edu.

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High Point University Students, Faculty and Staff Recognized for Research and Innovation - Yes! Weekly

Cell Biology

Super Resolution – posted by Biophotonics.World at Biophotonics.World – Biophotonics.World

Image source: Leibniz IPHT

By: Sven Dring

When trying to visualize finest details in cells, standard light microscopes reach their limits. As a doctoral student, Rainer Heintzmann discovered a method that can break this barrier. Today, he has improved the technique of super-resolution microscopy to such an extent that it is useful for applications in biology and medicine

In order to observe living cells at work, researchers have to overcome a physical law. One of the fastest techniques to overcome the resolution limit of classical light microscopy is high-resolution structured illumination microscopy.

It makes details in cells visible that are about one hundred nanometers in size, one hundred millionth of a millimeter. However, translating the recorded data back into images used to take a lot of time. Rainer Heintzmann, together with a team of researchers from Bielefeld University, has developed atechnique that allowsthe image data to be reconstructed directly.This allows researchers to watch biologicalprocesses in the cellvirtually live. "It enables completely newimaging workflows that no other high-resolution microscopy method currently allows in this way," says Rainer Heintzmann.

The graphics helps computer gamers to have a great gaming experience. Researchers use it to observe the smallest cell components in action - in real time and at a very high frame rate. "The image data can be reconstructed about twenty times faster than it would take on a PC," explains Rainer Heintzmann, who already laid the foundations for the structured illumination method in high-resolution microscopy as a doctoral student in 1998. In cooperation with the Bielefeld research team led by Thomas Huser, he further developed the technique of Super-Resolved Structured Illumination Microscopy (SR-SIM).

In the fluorescence microscopic SR-SIM method, objects are irradiated with laser light using a special pattern. It excites special fluorescent molecules in the sample so that they emit light at a different wavelength. The microscopic image then shows this emitted light. It is first recorded in several individual images and then reconstructed as a high-resolution image on a computer. "The second step in particular has taken a lot of time so far," says Andreas Markwirth from Bielefeld University, first author of the study, which the research team published in the renowned journal "Nature Communications".

For the new microscope, the research team used parallelcomputer processes on modern graphics and was thus able to significantly accelerate image reconstruction. A minimum delay of 250 milliseconds is hardly noticeable to the hu- man eye. The raw data can also be generated faster with the newly researched microscope.

Structures that are invisible to conventional microscopes

"This makes it possible to measure samples quickly and to immediately adjust test conditions during an experiment instead of having to evaluate them afterwards," says Rainer Heintzmann, describing the practical benefits of the new technology. It is only through the rapid reconstruction of images that "this type of microscopy becomes really useful for applications in biology or medicine," says Thomas Huser. "Because the problem so far is: microscopes that offer sufficiently high resolution cannot display information at the appropriate speed".

For their study, the scientists tested the method on biological cells and recorded the movements of mitochondria, the energy centers of the cells that are about one micrometre in size. "We were able to generate about 60 frames per second that's a higher frame rate than in motion pictures. There are less than 250 milliseconds between measurement and image, so the technology allows real-time recordings," says Andreas Markwirth.

Until now, super-resolution methods have often been combined with conventional methods: A conventional fast microscope is used to find structures first. These structures can then be examined in detail with a super-resolution micro- scope. "However, some structures are so small that they cannot even be found with conventional microscopes, for example special pores in liver cells. Our method provides both high resolution and speed this enables biologists to investigate such structures," said Thomas Huser. Another application for the new microscope is the investigation of virus particles on their way through the cell. "This enables us to understand exactly what happens during infection processes."

Publication: Andreas Markwirth, Rainer Heintzmann et al., Video-rate multi-color structured illumination microscopy with simultaneous real-time reconstruction, Nature Communications 10 (2019), https://doi.org/10.1038/s41467-019-12165-x

Source: Leibniz IPHT

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Cell Biology

Pluristem and Abu Dhabi Stem Cells Center Sign MOU to Collaborate in the Development of Cell Therapies and Regenerative Medicines for the Treatment of…

Agreement comes as United Arab Emirates (UAE) and Israel Reach Historic Agreement to Fully Normalize Diplomatic Relations

HAIFA, Israel, Aug. 17, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today its subsidiary, Pluristem Ltd., has signed a non-binding Memorandum of Understanding (MOU) with the United Arab Emirates-based Abu Dhabi Stem Cells Center (ADSCC), a specialist healthcare center focused on cell therapy and regenerative medicine. Executives from both companies took part in a signing ceremony held via video conference between Israel and the UAE. The aim of the collaboration is to capitalize on each companys respective areas of expertise in cell therapies to deliver regenerative medicine for the benefit not only of the citizens of the UAE and Israel, but for humanity as a whole. The collaboration between the parties was initiated by the Better Alternatives advisory firm.

The parties have agreed to exchange research results, share samples, join usage of equipment and testing, and other essential activities related to advancing the treatment and research of cell therapies for a broad range of medical conditions, including COVID-19.

ADSCC has been treating COVID-19 patients with stem cells sourced from the patients blood, by returning the cells back into the patients lungs as a fine mist through a nebulizer, a machine that helps a patient breathe in medicine through a mask or mouthpiece. Pluristem has treated patients with its placental PLX-PAD allogenic product via compassionate use programs in Israel and the U.S. and is currently conducting phase II studies in the U.S. and EU.

We are extremely proud to partner with our colleagues at the ADSCC by sharing knowledge and expertise that we believe will advance healthcare within and across our borders. We see life science and regenerative medicine as a bridge for building peace, prosperity, and well-being in our region and for the entire world. I believe it is our obligation and privilege as business and scientific leaders to lead the way forward to strengthen collaborations, and promote innovation and education. We are honored to be on the front line of this historical moment, stated Pluristem CEO and President Yaky Yanay.

Dr Yendry Ventura, General Manager of the ADSCC commented, Pluristem is a major player in the cell therapy field with years of experience, a unique platform and a robust clinical pipeline. We are excited to join forces and to promote the research and development of cell therapies for the best of the patients and the human society as a whole.

About Abu Dhabi Stem Cells CenterAbu Dhabi Stem Cells Center (ADSCC) is an Abu Dhabi-based specialist healthcare center focused on cell therapy and regenerative medicine, as well as delivering cutting-edge research on stem cells in the region. The Center was founded in March 2019 to meet growing domestic and regional demand for highly specialized medical services and treatments. Equipped with the latest technologies, medical devices which are unique to the region, and a team of internationally recognized doctors working hand in hand with researchers, ADSCC is the first of its kind in the UAE. ADSCC specialties include immunology, hematology, clinical stem cell therapy, molecular biology, immunotherapy, orthopedics, and urology amongst others.

About Pluristem TherapeuticsPluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses the aim of the collaboration with the ADSCC is to capitalize on each companys respective areas of expertise in cell therapies to deliver regenerative medicine for the benefit not only of the citizens of the UAE and Israel, but for humanity as a whole and the belief that it is its obligation and privilege as business and scientific leaders to lead the way forward to strengthen collaborations, and promote innovation and education. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristems products may not be approved by regulatory agencies, Pluristems technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristems process; Pluristems products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristems patents may not be sufficient; Pluristems products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

Contact:

Dana RubinDirector of Investor Relations972-74-7107194danar@pluristem.com

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Cell Biology

Live-Cell Imaging Market Size and Growth By Leading Vendors, By Types and Application, By End Users and Forecast to 2027 – Bulletin Line

New Jersey, United States,- This detailed market research covers the growth potential of the Live-Cell Imaging Market, which can help stakeholders understand the key trends and prospects of the Live-Cell Imaging market and identify growth opportunities and competitive scenarios. The report also focuses on data from other primary and secondary sources and is analyzed using a variety of tools. This will help investors better understand the growth potential of the market and help investors identify scope and opportunities. This analysis also provides details for each segment of the global Live-Cell Imaging market.

The report was touted as the most recent event hitting the market due to the COVID-19 outbreak. This outbreak brought about a dynamic change in the industry and the overall economic scenario. This report covers the analysis of the impact of the COVID-19 pandemic on market growth and revenue. The report also provides an in-depth analysis of the current and future impacts of the pandemic and post-COVID-19 scenario analysis.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

The market is further segmented on the basis of types and end-user applications. The report also provides an estimation of the segment expected to lead the market in the forecast years. Detailed segmentation of the market based on types and applications along with historical data and forecast estimation is offered in the report.

Furthermore, the report provides an extensive analysis of the regional segmentation of the market. The regional analysis covers product development, sales, consumption trends, regional market share, and size in each region. The market analysis segment covers forecast estimation of the market share and size in the key geographical regions.

The report further studies the segmentation of the market based on product types offered in the market and their end-use/applications.

Global Live-Cell Imaging Market, By Product

Instruments Consumables Software

Global Live-Cell Imaging Market, By Application

Drug Discovery Developmental Biology Cell Biology Stem Cell Biology

Global Live-Cell Imaging Market, By End User

Academic & Research Institutes Pharmaceutical & Biotechnology Companies Academic & Research Institutes

On the basis of regional segmentation, the market is bifurcated into major regions ofNorth America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.The regional analysis further covers country-wise bifurcation of the market and key players.

The research report offered by Verified Market Research provides an updated insight into the global Live-Cell Imaging market. The report covers an in-depth analysis of the key trends and emerging drivers of the market likely to influence industry growth. Additionally, the report covers market characteristics, competitive landscape, market size and growth, regional breakdown, and strategies for this market.

Highlights of the TOC of the Live-Cell Imaging Report:

Overview of the Global Live-Cell Imaging Market

Market competition by Players and Manufacturers

Competitive landscape

Production, revenue estimation by types and applications

Regional analysis

Industry chain analysis

Global Live-Cell Imaging market forecast estimation

This Live-Cell Imaging report umbrellas vital elements such as market trends, share, size, and aspects that facilitate the growth of the companies operating in the market to help readers implement profitable strategies to boost the growth of their business. This report also analyses the expansion, market size, key segments, market share, application, key drivers, and restraints.

Key Questions Addressed in the Report:

What are the key driving and restraining factors of the global Live-Cell Imaging market?

What is the concentration of the market, and is it fragmented or highly concentrated?

What are the major challenges and risks the companies will have to face in the market?

Which segment and region are expected to dominate the market in the forecast period?

What are the latest and emerging trends of the Live-Cell Imaging market?

What is the expected growth rate of the Live-Cell Imaging market in the forecast period?

What are the strategic business plans and steps were taken by key competitors?

Which product type or application segment is expected to grow at a significant rate during the forecast period?

What are the factors restraining the growth of the Live-Cell Imaging market?

Thank you for reading our report. The report is available for customization based on chapters or regions. Please get in touch with us to know more about customization options, and our team will ensure you get the report tailored according to your requirements.

About us:

Verified Market Research is a leading Global Research and Consulting firm servicing over 5000+ customers. Verified Market Research provides advanced analytical research solutions while offering information enriched research studies. We offer insight into strategic and growth analyses, Data necessary to achieve corporate goals, and critical revenue decisions.

Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance use industrial techniques to collect and analyze data on more than 15,000 high impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise, and years of collective experience to produce informative and accurate research.

Contact us:

Mr. Edwyne Fernandes

US: +1 (650)-781-4080UK: +44 (203)-411-9686APAC: +91 (902)-863-5784US Toll-Free: +1 (800)-7821768

Email: [emailprotected]

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Live-Cell Imaging Market Size and Growth By Leading Vendors, By Types and Application, By End Users and Forecast to 2027 - Bulletin Line

Cell Biology

Cell Imagers Market Size and Growth By Leading Vendors, By Types and Application, By End Users and Forecast to 2027 – Bulletin Line

New Jersey, United States,- This detailed market research covers the growth potential of the Cell Imagers Market, which can help stakeholders understand the key trends and prospects of the Cell Imagers market and identify growth opportunities and competitive scenarios. The report also focuses on data from other primary and secondary sources and is analyzed using a variety of tools. This will help investors better understand the growth potential of the market and help investors identify scope and opportunities. This analysis also provides details for each segment of the global Cell Imagers market.

The report was touted as the most recent event hitting the market due to the COVID-19 outbreak. This outbreak brought about a dynamic change in the industry and the overall economic scenario. This report covers the analysis of the impact of the COVID-19 pandemic on market growth and revenue. The report also provides an in-depth analysis of the current and future impacts of the pandemic and post-COVID-19 scenario analysis.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

The market is further segmented on the basis of types and end-user applications. The report also provides an estimation of the segment expected to lead the market in the forecast years. Detailed segmentation of the market based on types and applications along with historical data and forecast estimation is offered in the report.

Furthermore, the report provides an extensive analysis of the regional segmentation of the market. The regional analysis covers product development, sales, consumption trends, regional market share, and size in each region. The market analysis segment covers forecast estimation of the market share and size in the key geographical regions.

The report further studies the segmentation of the market based on product types offered in the market and their end-use/applications.

Global Cell Imagers Market, By Product

Equipment Consumables Software

Global Cell Imagers Market, By Application

Drug Discovery Developmental Biology Cell Biology Stem Cell Biology

Global Cell Imagers Market, By End User

Academic & Research Institutes Pharmaceutical & Biotechnology Companies Academic & Research Institutes

On the basis of regional segmentation, the market is bifurcated into major regions ofNorth America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.The regional analysis further covers country-wise bifurcation of the market and key players.

The research report offered by Verified Market Research provides an updated insight into the global Cell Imagers market. The report covers an in-depth analysis of the key trends and emerging drivers of the market likely to influence industry growth. Additionally, the report covers market characteristics, competitive landscape, market size and growth, regional breakdown, and strategies for this market.

Highlights of the TOC of the Cell Imagers Report:

Overview of the Global Cell Imagers Market

Market competition by Players and Manufacturers

Competitive landscape

Production, revenue estimation by types and applications

Regional analysis

Industry chain analysis

Global Cell Imagers market forecast estimation

This Cell Imagers report umbrellas vital elements such as market trends, share, size, and aspects that facilitate the growth of the companies operating in the market to help readers implement profitable strategies to boost the growth of their business. This report also analyses the expansion, market size, key segments, market share, application, key drivers, and restraints.

Key Questions Addressed in the Report:

What are the key driving and restraining factors of the global Cell Imagers market?

What is the concentration of the market, and is it fragmented or highly concentrated?

What are the major challenges and risks the companies will have to face in the market?

Which segment and region are expected to dominate the market in the forecast period?

What are the latest and emerging trends of the Cell Imagers market?

What is the expected growth rate of the Cell Imagers market in the forecast period?

What are the strategic business plans and steps were taken by key competitors?

Which product type or application segment is expected to grow at a significant rate during the forecast period?

What are the factors restraining the growth of the Cell Imagers market?

Thank you for reading our report. The report is available for customization based on chapters or regions. Please get in touch with us to know more about customization options, and our team will ensure you get the report tailored according to your requirements.

About us:

Verified Market Research is a leading Global Research and Consulting firm servicing over 5000+ customers. Verified Market Research provides advanced analytical research solutions while offering information enriched research studies. We offer insight into strategic and growth analyses, Data necessary to achieve corporate goals, and critical revenue decisions.

Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance use industrial techniques to collect and analyze data on more than 15,000 high impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise, and years of collective experience to produce informative and accurate research.

Contact us:

Mr. Edwyne Fernandes

US: +1 (650)-781-4080UK: +44 (203)-411-9686APAC: +91 (902)-863-5784US Toll-Free: +1 (800)-7821768

Email: [emailprotected]

More here:
Cell Imagers Market Size and Growth By Leading Vendors, By Types and Application, By End Users and Forecast to 2027 - Bulletin Line

Cell Biology

Precigen Announces First Patient Dosed in Phase I/II Study of First-in-Class PRGN-2009 AdenoVerse Immunotherapy to Treat HPV-associated Cancers -…

GERMANTOWN, Md., Aug. 17, 2020 /PRNewswire/ -- Precigen, Inc.(Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced that the first patient has been dosed with Precigen's PRGN-2009, a first-in-class,off-the-shelf (OTS) investigational immunotherapy utilizing the AdenoVerse platform designed to activate the immune system to recognize and target HPV+ solid tumors (clinical trial identifier: NCT04432597). HPV-associatedcancers represent a significant health burden in indications such as head and neck, cervical, vaginal and anal cancer.

ThePhase I portion of the study will use 3+3 dose escalation to evaluate the safety of PRGN-2009 administered as a monotherapy and to determine the recommended Phase II dose (R2PD) followed by an evaluation of the safety of the combination of PRGN-2009 at the R2PD and bintrafusp alfa (M7824), an investigational bifunctional fusion protein, in patients with recurrent or metastatic HPV-associated cancers. The Phase II portion of the study will evaluate PRGN-2009 as a monotherapy or in combination with bintrafusp alfa as a neoadjuvant or induction therapy in patients with newly-diagnosed stage II/III HPV16-positive oropharyngeal cancer.

PRGN-2009 leverages Precigen's proprietary UltraVector and AdenoVerse platforms to optimize HPV antigen design. Such design is differentiated from other therapies due to the gorilla adenovector's large payload capacity and potential for repeat administration due to very low to no seroprevalence in the human population.

PRGN-2009 is under development through a Cooperative Research and Development Agreement, or CRADA, with the laboratory of Dr. Jeffrey Schlom, Chief oftheLaboratory of Tumor Immunology and Biology (LTIB), Center for Cancer Research (CCR),National Cancer Institute (NCI). This CRADA has allowed Precigen to rapidly and cost-effectively advance PRGN-2009.The Phase I/II clinical trial of PRGN-2009 is being conducted at the NIH Clinical Center and will be led by Dr. Julius Strauss, Co-Director of the LTIB's Clinical Trials Group, and Dr. James Gulley, Chief of the Genitourinary Malignancies Branch, CCR, NCI. For patients interested in enrolling in this clinical study, please call NCI's toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email NCIMO_Referrals@mail.nih.gov,and/or visit the website:https://trials.cancer.gov.

"We appreciate working in collaboration with such renowned partners at the NCI to achieve this important milestone in our efforts to develop a new off-the-shelf immunotherapy treatment option for patients with HPV-associated cancers," said Helen Sabzevari, PhD, President and CEO of Precigen. "We are excited to investigate Precigen's proprietary gorilla adenovector platform for the first time in a clinical setting and achieve this milestone during the COVID-19 global pandemic."

About HPV-associated CancersHPV infects the squamous cells that line the inner surfaces of certain organs and, consequently, most HPV-related cancers are a type of cancer called squamous cell carcinoma. Some cervical cancers come from HPV infection of gland cells in the cervix and are referred to as adenocarcinomas.1 HPV-related cancers include cervical, oropharyngeal, anal, penile, vaginal, and vulvar.1 Nearly 44,000 HPV-associated cancers occur in the United States each year. Of these, approximately 25,000 occur in women and 19,000 occur in men.2HPV is considered responsible for more than 90% of analand cervicalcancers, about 70% of vaginal and vulvar cancers, and more than 60% of penile cancers.2 Recent studies indicate that about 70% of cancers of the oropharynxalso may be related to HPV.2

Precigen: Advancing Medicine with PrecisionPrecigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization.

For more information about Precigen, visit http://www.precigen.com or follow us on Twitter @Precigen and LinkedIn.

References1HPV and Cancer, National Institutes of Health. Accessed in July 20202 HPV-Associated Cancer Statistics, Centers for Disease Control and Prevention. Accessed in July 2020

TrademarksPrecigen, AdenoVerse, UltraVector, and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.

Safe Harbor StatementSome of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon the Company's current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of the Company's business, including the timing and progress of preclinical and clinical trials and discovery programs, the promise of the Company's portfolio of therapies, the Company's refocus to a healthcare-oriented business, and its continuing evaluation of options for the Company's non-healthcare businesses. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties, including the possibility that the timeline for the Company's clinical trial might be impacted by the COVID-19 pandemic, and actual future results may be materially different from the plans, objectives and expectations expressed in this press release. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the Company's most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission.

Investor Contact:

Steven Harasym

Vice President, Investor Relations

Tel: +1 (301) 556-9850

investors@precigen.com

Media Contact:

Marie Rossi, PhD

Vice President, Communications

Tel: +1 (301) 556-9850

press@precigen.com

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Cell Biology

What are the Differences Between Small Cell and Non-Small Cell Lung Cancer? – News-Medical.net

Throughout the world, lung cancer is the main cause of cancer-related deaths. Whereas small cell lung cancer (SCLC) accounts for up to 15% of all lung cancer diagnoses, the remaining 85% of lung cancer cases are of the non-small cell lung cancer (NSCLC) subtype.

Image Credit: David A Litman/Shutterstock.com

Non-small cell lung cancer (NSCLC) can be further categorized into several different types, the most common of which include adenocarcinoma, squamous cell carcinoma (SCC), and large cell carcinoma. Other less common types of NSCLC include adenosquamous, pleomorphic, spindle cell, and giant cell carcinomas, as well as pulmonary blastoma, neuroendocrine tumors, and several others.

Recent advancements in molecular biology, particularly due to the discovery of epidermal growth factor (EGFR) mutations and anaplastic lymphoma kinase (ALK) rearrangements, have drastically changed how these NSCLC subtypes are treated. These discoveries have led to the development of EGFR tyrosine kinase inhibitors and ALK inhibitors, both of which are highly effective treatment options for patients with these specific histologic types of lung cancer.

It is estimated that adenocarcinomas comprise approximately 40% of all lung cancers. By definition, adenocarcinoma in the lung is a malignant epithelial neoplasm that can be accompanied by either glandular differentiation or the production of mucin. Typically, an adenocarcinoma will form a peripherally located mass that exhibits both central fibrosis and pleural puckering.

Other gross appearances that can be associated with an adenocarcinoma diagnosis include a centrally located mass, diffuse lobar consolidation, multiple lobes distributed bilaterally, and pleural thickening.

Following a biopsy or tumor resection, an adenocarcinoma can be further characterized as a lepidic, acinar, papillar, micropapillary, solid, invasive mucinous, colloid, fetal, enteric, or minimally invasive carcinoma.

Approximately 20% of all lung cancers are SCC, which can be present in various places throughout the lungs, the most common of which include the central portion, along major airways and in the form of cavities when present in larger sizes.

Some of the notable pathological characteristics of SCC include keratinization and intracellular bridges, as well as a solid nested growth pattern. The possible subtypes of SCCs include keratinizing, nonkeratinizing, and basaloid SCC.

The establishment of an SCC diagnosis plays a determining role in which chemotherapeutic agents are not only ideal in reducing the cancer burden but can also avoid certain life-threatening complications. The use of a vascular endothelial growth factor inhibitor in the treatment of SCC, for example, can increase the likelihood of a pulmonary hemorrhage, thereby indicating the need to avoid this type of drug.

Notably, patients with SCC often have a better survival rate as compared to those diagnosed with adenocarcinoma.

The establishment of a large cell carcinoma diagnosis can only be achieved after the tumor has been resected; therefore, this type of NSCLC should not be applied to small biopsies or cytology results. There are several different subtypes of large cell carcinoma including large cell neuroendocrine carcinoma (LCNEC), basaloid carcinoma, lymphoepithelioma-like carcinoma, clear cell carcinoma, and large cell carcinoma with rhabdoid phenotype.

Recent reports by the World Health Organization (WHO) have found that large cell carcinomas are a heterogeneous group of tumors that can be made up of adenocarcinoma, squamous cell differentiation, or a null immunophenotype and genotype.

Image Credit: Scio21/Shutterstock.com

Over the past twenty years, the incidence of SCLC has decreased, which is most likely related to the global reduction in tobacco use. It is estimated that at least 95% of patients diagnosed with SCLC have a positive smoking history; however, individuals who quit smoking not only have a reduced incidence of the disease but also have a 50% chance of reduced mortality when this type of lung cancer is diagnosed in its early stages.

In addition to a history of smoking, other environmental and occupational hazards that have been associated with causing SCLC to include exposure to chloromethyl ether, which is a chemical that can be used in various industrial settings, as well as high radon levels, which is particularly a concern for uranium miners.

Although SCLC only comprises about 15% of all lung cancer diagnoses, this form of lung cancer is highly aggressive. In addition, since many patients with SCLC also have multiple comorbidities due to previous tobacco use, which can include chronic obstructive pulmonary disease (COPD), ischemic cardiopathy, and hypertension, treatment for this type of lung cancer can be highly complicated.

Whereas patients with limited disease (LD) type of SCLC is often treated with concomitant chemoradiation, those with the extensive disease (ED) type are instead treated with palliative chemotherapy. Many patients with SCLC will respond well to initial treatment; however, it is common for patients with the resistant disease to relapse.

In the event that the cancer relapses, the median survival is typically in the range of 4 to 5 months when second- or third-line chemotherapy is used.

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What are the Differences Between Small Cell and Non-Small Cell Lung Cancer? - News-Medical.net

Cell Biology

HiFiBiO Therapeutics Collaborates with Coronavirus Immunotherapy Consortium in the Fight Against COVID-19 – BioSpace

Aug. 17, 2020 12:05 UTC

Company leverages its unprecedented antibody drug discovery and development engine empowered by proprietary single-cell profiling technology to identify, engineer, and evaluate multiple neutralizing antibodies against SARS-CoV-2

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- HiFiBiO, a multinational biotherapeutics company focused on the development of novel antibodies for immunomodulation, today announced a collaboration with the Coronavirus Immunotherapy Consortium (CoVIC), a global, academic-industry, non-profit research alliance headquartered at the La Jolla Institute for Immunology (LJI). CoVIC was established to accelerate discovery, optimization, and delivery of life-saving antibody-based therapeutics against SARS-CoV-2. It has received support from the COVID-19 Therapeutics Accelerator, which was launched in March 2020 by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard with additional funding from a range of donors.

Using a combination of its proteomics and proprietary single-cell profiling technology, HiFiBiO has developed multiple SARS-CoV-2 neutralizing antibodies with the potential for both therapeutic and prophylactic applications. With an aligned commitment to deliver accessible therapies to vulnerable individuals globally, the company has submitted 10 distinct antibodies in the format of mono- or bispecific antibodies to CoVIC for in vitro and in vivo testing. HiFiBiO will gain a first look into the performance of its antibodies compared to dozens of other submitted antibodies and synergies among them for combinational therapies.

CoVIC is committed to accelerating the product development pipeline to provide immunotherapeutics that protect vulnerable individuals from severe COVID-19 across the globe, especially in regions where health care resources are severely limited, said Erica Ollmann Saphire, PhD, Professor at LJIs Center for Infectious Diseases and Vaccine Research and Director of CoVIC. We are excited to partner with HiFiBiO to include its antibodies against SARS-CoV-2 in the CoVIC panel that will be analyzed side-by-side in multiple tests to identify optimal immunotherapeutics for COVID-19 patients.

We look forward to working with CoVIC to further assess the potential of our neutralizing antibodies against SARS-CoV-2, said Liang Schweizer, PhD, President and CEO of HiFiBiO Therapeutics. This collaboration is another strong validation of our Drug Intelligent Science platform and our ongoing commitment to working with leading research and academic institutions, as well as pharmaceutical and biotech companies to identify and engineer highly potent and durable antibodies that can address unmet medical needs of patients around the world.

Additionally, HiFiBiO Therapeutics is preparing an Investigational New Drug (IND) application with the US Food and Drug Administration for HFB30132A, a novel SARS-CoV-2 neutralizing antibody for the treatment of COVID-19 patients. The highly differentiated antibody has been rapidly identified, engineered, and evaluated in all key preclinical studies, where it has demonstrated outstanding efficacy, exposure, and safety profile. A planned Phase I single-IV administration ascending dose study will assess the safety and tolerability of HFB30132A in healthy volunteers later this summer.

About HiFiBiO Therapeutics

HiFiBiO Therapeutics is transforming the field of immunotherapy by combining proprietary single-cell profiling technologies with advanced data intelligence and deep knowledge of immune system biology. This approach enables the development of novel antibody therapies that are paired with biomarkers to predict patient response. HiFiBiO Therapeutics is working actively to address unmet medical needs around the world through its own innovative pipeline programs and open-innovation partnerships with world-renowned industry and academic researchers. The companys strong global footprint features cutting-edge laboratories on three continents, in Cambridge, Mass., Paris, Shanghai, and Hong Kong. To learn more, please visit http://www.hifibio.com.

HiFiBiO Therapeutics and the HiFiBiO Therapeutics logo are trademarks of HiFiBiO and its affiliates.

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Link:
HiFiBiO Therapeutics Collaborates with Coronavirus Immunotherapy Consortium in the Fight Against COVID-19 - BioSpace