Category Archives: Immunology

For some cancer patients, a "poop transplant" could boost the positive effects of immunotherapy, a treatment designed to rally the immune system against cancer cells.

Not all cancer patients respond to immunotherapy drugs. For example, only about 40% of patients with advanced melanoma, a type of skin cancer, reap long-term benefit from the drugs, according to recent estimates. In trying to pinpoint the differences between patients who respond well to immunotherapy and those who don't, scientists have zeroed in on a likely suspect: the microorganisms living in their guts.

Now, a new study, published Feb. 4 in the journal Science, adds to the growing evidence that having the right gut bugs can improve a patient's response to immunotherapy, helping to stop disease progression or even shrink tumors.

In the study, scientists collected stool from melanoma patients who responded well to immunotherapy and then transplanted their feces (and microbes) into the guts of 15 patients who had never previously responded to the drugs. After the transplant, six of the 15 patients responded to immunotherapy for the first time, showing either tumor reduction or disease stabilization that lasted more than a year.

Related: 7 odd things that raise your risk of cancer (and 1 that doesn't)

"The microbes really appear to drive the immunological changes we see in patients," said study author Dr. Hassane Zarour, a cancer immunologist, co-leader of the Cancer Immunology and Immunotherapy Program at University of Pittsburgh Medical Center Hillman and a professor of medicine at the University of Pittsburgh. The team linked the changes in gut bugs to changes in both tumor growth and the immune system; for instance, some of the participants showed an increase in specific immune cells and antibodies that appeared in their blood.

Despite the positive changes seen in some patients, fecal transplants likely won't help all patients whose cancer resists immunotherapy, Zarour said. In the new study, for instance, nine of the 15 patients did not benefit from the treatment. As part of their research, the team began to sift through the differences between those who improved after the transplant and those who didn't.

The idea for combining fecal transplants with immunotherapy first came from studies in mice with tumors, in which the rodents responded differently to the drugs depending on which gut microbes they carried, according to Science Magazine. By tweaking the mice's gut microbiomes the collection of bacteria, viruses and other microbes in their digestive tracts scientists found that they could improve this response, but they weren't sure which microbes made the difference.

That said, mice's responses to immunotherapy improved after they were given fecal matter from human cancer patients whose tumors had shrunk under immunotherapy. "When they took non-responding mice and gave them the right bugs they could convert non-responding mice into responding mice," Zarour said.

Other research showed that when human patients took antibiotics, which alter the gut microbiome, they were less likely to respond to immunotherapy, providing more evidence that gut bugs make a big difference in people, too.

Having seen the positive effects of fecal transplants in mice, scientists began testing the treatment in humans, starting with a few small clinical trials.

In two such trials, led by researchers at Sheba Medical Center in Ramat Gan, Israel, patients received both fecal transplants and oral pills containing dried stool. The patients then took immunotherapy drugs called "checkpoint blockades," which essentially rip the brakes off of immune cells and help amplify their activity against tumors. A subset of these patients, who had previously not responded to the drugs, suddenly began responding.

The new study by Zarour and his colleagues echoes these positive results, but it also starts to address a crucial question: How do gut bugs boost the effects of immunotherapy?

To answer this question, the team closely analyzed the microbes present in the donor stool samples and the recipients, before and after fecal transplants. The team also collected blood and tumor cell samples to assess the patients' immune responses over time, and computed tomography (CT) scans, to track tumor growth. They then used artificial intelligence to find connections between all these data points.

Out of the 15 patients, nine still didn't respond to immunotherapy after their transplant. But of the six who did respond, one showed a complete response to checkpoint blockade drugs, meaning their tumors shrunk so much they were no longer detectable; two others showed a partial response, meaning their tumors shrunk but did not disappear, and three have shown no disease progression for over a year. In all six of these patients, the microbes from the donor's stool quickly colonized their guts, and several of the newcomer bugs that were previously linked to positive immunotherapy outcomes increased in number.

Related: 11 surprising facts about your immune system

This change in gut bacteria triggered an immune response in the six patients, as their bodies began building antibodies that recognized the new bugs; these antibodies showed up in their blood. While the link between bacteria-specific antibodies and cancer is not well understood, it's thought that some of these antibodies can help prime the immune system to hunt down tumor cells, Zarour said.

"The bugs that increased in the responders were really correlated with positive immunological changes," he said. These patients also built up a larger arsenal of activated T cells immune cells that can target and kill cancer cells while substances that suppress the immune system decreased. For example, a protein called interleukin-8 (IL-8) can summon immunosuppressive cells to tumor sites and therefore blunt the effects of immunotherapy; but IL-8 decreased in the six responsive patients.

By comparison, cells that secrete IL-8 increased in the nine patients who didn't respond to the fecal transplant. Based on this new data, "IL-8 seems to really play a critical role in regulating patients' responses" to the two-part treatment, Zarour said.

Compared with the six responsive patients, the nine others also showed less pronounced immune responses to the transplant and lower levels of the noted beneficial bacteria; some even had dissimilar gut microbiomes to their fecal donors, suggesting the bacteria didn't take over their guts as seen in responsive patients.

In general, "the gut microbiome may be just one of the many reasons we don't respond to a specific treatment," Zarour said, so fecal transplants wouldn't be expected to work for everyone. That said, the immune changes seen in the six responders, including the decline in IL-8, provide hints as to why it works for some people.

In the future, these results will need to be validated in larger groups of melanoma patients, as well as other cancer patients whose disease resists immunotherapy, Zarour said.

Though small, the new trial provides "firm evidence that manipulating the microbiome can yield benefit when added to immunotherapy for cancer," said Dr. Jeffrey Weber, a medical oncologist and co-director of the Melanoma Research Program at New York University Langone Health, who was not involved in the research. Assuming these results hold up in other patients, though, fecal transplants may not be the best way to deliver helpful microbes into the gut, Weber said in an email.

The future may lie in ingesting the bacteria orally, after they've been freeze-dried, Weber said. This approach could include something similar to the oral pills used in other trials, for example. Either that, or scientists could isolate specific metabolites produced by the helpful bacteria and use those as drugs, Weber said. "The big question is, what metabolites from the 'favorable' bacterial species are actually responsible for benefit," he said.

Originally published on Live Science.

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Cancer patients weren't responding to therapy. Then they got a poop transplant. - Livescience.com

Immunology

A Worcester man was part of the Pfizer COVID vaccine trial, but didnt get the actual shot; His experience an – MassLive.com

February 5, 2021 medical

When Paul Bolton, of Worcester, learned he was part of the placebo-controlled group in Pfizer-BioNTechs COVID vaccine trial, he was anxious to find out how long hed have to wait to actually get immunized.

I wanted to see if I could get the vaccine as soon as possible, Bolton, who is a prosecutor for the Worcester District Attorneys office, said.

Bolton, who is in his late 60s, was one of 131 trial participants enrolled in the study, which began in July 2020, through UMass Medical School. With COVID-19 sweeping across parts of the south and the Midwest, and with several prototype vaccines in production, the Worcester native says he just wanted to help in whatever way possible.

He responded to a call for participants in the trial posted on social media, and UMass Medical School contacted Bolton the same day. After being screened for COVID and having blood drawn, he received an injection that he suspected, not long after, was saline not the real thing.

They say if you got the vaccine, you get a kind of a cold feeling going into your arm, Bolton said. I didnt get that so I was pretty sure I had the placebo.

On Jan. 14, the college reached out to Bolton to let him know he was part of the placebo-controlled group during the trial, meaning he didnt actually receive the Pfizer vaccine. The placebo group is used to measure the results of those who did get the COVID vaccine the difference in, for example, immune system response, and other side effects.

Five days later, he got his first dose of the vaccine, which Bolton surmised was well ahead of schedule, according to the states timeline. He has an appointment scheduled for the second dose on Feb. 12.

Now that hes on the verge of being fully vaccinated, Bolton says he feels like a burdens been lifted. Per the trial, he will continue reporting any symptoms or side effects to the UMass researchers.

There were concerns last year over about the integrity of the vaccines ahead of trials during what was to become an expedited emergency approval process. Health experts had high hopes for the shots which, if effective, would have far-reaching consequences for the U.S. and the rest of the world.

We didnt know if theyd work, and we didnt know if it was safe, Dr. Douglas T. Golenbock, chief of the Division of Infectious Diseases and Immunology at UMass Medical School, said of the Pfizer vaccine. But thats the nature of clinical trials.

The pace of the development of mRNA COVID vaccines (approved on an emergency basis in under a year of the virus taking root in the U.S.) and the sheer scale of their preliminary testing remains an unprecedented public health project. With the trials still ongoing, and with other companies working on their versions of vaccines in the middle of a national rollout, some experts worry about how willingly the public will participate in future trials and studies.

As we get closer to the time when people think they will get their vaccination, some are going to say, Yeah, Ill just wait it out, rather than take the risk, Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine and professor in the Department of Immunology and Infectious Diseases at Harvard University, said. Thats inherent in having a simultaneous testing and rollout strategy.

Rubin says experimental trials typically generate more enthusiasm among those who sign up. That tends to wane over time.

And in the case of COVID vaccine testing, the more people are vaccinated, the harder it may become for other companies to recruit volunteers.

That might limit the development of vaccines that are very late to the game, Rubin said. Youre tapping into groups of people who are less and less excited.

Pfizer recently said it finished enrolling children aged 12 to 15 in a new clinical trial to gauge the efficacy of the shots in children. The Pfizer vaccine is currently approved only for adults over the age of 16. The Moderna vaccine, similarly, is only approved for adults older than 18.

Jnana Therapeutics Expands Leadership Team with Two Experienced Biopharmaceutical Executives – BioSpace

February 5, 2021 medical

Feb. 3, 2021 12:00 UTC

Company appoints Nick Pullen, PhD, as Senior VP, Head of Biology and Brian Danieli as VP, Head of Finance & Operations

BOSTON--(BUSINESS WIRE)-- Jnana Therapeutics, a biotechnology company targeting the solute carrier (SLC) family of metabolite transporters to treat underserved diseases, today announced that it has expanded its leadership team with the appointment of two accomplished biopharmaceutical executives: Nick Pullen, PhD, as Senior Vice President, Head of Biology, and Brian Danieli as Vice President, Head of Finance and Operations. These new executives join Jnana at a significant time in the companys evolution as it advances its first SLC transporter-targeted therapies toward clinical development.

Nick Pullen, PhD, Senior Vice President, Head of Biology

Nick is an experienced and passionate leader in drug discovery and development with deep knowledge in several therapeutic areas, including renal disease and inflammation, that are highly relevant to our R&D work with SLC transporters, said Joel Barrish, PhD, co-founder and Chief Scientific Officer of Jnana Therapeutics. We are delighted to welcome Nick to our team and look forward to his contributions in building our research and development strategy and helping guide our lead programs toward the clinic.

In the role of Senior Vice President, Head of Biology, Dr. Nick Pullen will work to further leverage Jnanas RAPID platform to systematically target SLC transporters and develop novel small molecule drug candidates. Dr. Pullen is an experienced drug discovery and development leader with 20 years of experience and a proven track-record of therapeutic innovation across multiple disease areas. Before joining Jnana, he was Vice President, Integrative Sciences, Inflammation & Immunology, Cardiovascular & Fibrosis, at Bristol Myers Squibb and prior to this, he served as Executive Director, Inflammation & Immunology for Celgene. In both of these roles, Dr. Pullen was responsible for scientific and strategic leadership of externalized drug discovery programs applying novel technologies and scientific insights to the expansion of the Inflammation & Immunology portfolio as well as more broadly. Dr. Pullen brings extensive experience in Inflammation & Fibrosis, following a career at Pfizer which spanned more than 15 years and brought multiple development candidates to clinical evaluation and touched many disease areas including renal disease, IBD and NASH, a breadth of experience with significant pertinence to the emerging Jnana portfolio. Dr. Pullen received his PhD in biochemistry from the University of Southampton in the UK.

The Jnana team have made remarkable progress in the development of technologies that open up the therapeutic opportunity afforded by targeting the SLC gene family. I am thrilled to be joining Jnana at this exciting stage in the companys growth and to help them build a pipeline of small molecules targeting SLC transporters, said Dr. Pullen.

Brian Danieli, Vice President, Head of Finance & Operations

Brians extensive finance background and expertise will be a critical addition to the organization, said Caroline Stark Beer, Jnanas Chief Business Officer. Were very pleased to welcome Brian to Jnana and look forward to Brians financial and operational leadership as we enter a new stage of growth.

As the Head of Finance and Operations of Jnana Therapeutics, Brian Danieli will expand the companys finance and operations infrastructure to allow for growth to a clinical-stage drug developer. Mr. Danieli is an expert finance leader with more than 20 years of global experience with fast-growing biotechnology companies. He joins Jnana from Momenta Pharmaceuticals, where he led Financial Planning & Analysis. Previously, he served for more than 20 years in roles of increasing responsibility at Sanofi Genzyme. His most recent position at Sanofi Genzyme was Head of Finance for North America Rare Disease and Rare Blood Disorders, and he drove all aspects of strategic financial planning and operations for the North American region for two business units representing $2B in combined sales with over 500 employees and 12 products. In his roles at Sanofi Genzyme, Mr. Danieli spearheaded the integration of Bioverativ and Ablynx acquisitions, implemented financial modeling and assembled franchise performance metrics for investor audiences. Earlier in his career, he held financial positions at Blue Cross Blue Shield of Massachusetts and KPMG. He earned a BS in accounting from Boston College.

I am eager to leverage my experience to support Jnanas evolution in the next stage of its business, said Mr. Danieli. I see tremendous potential for Jnanas platform to bring innovation to a range of diseases, and I am excited to be part of a team that is committed to bring novel medicines to make a difference in the lives of patients.

About Jnana Therapeutics

Jnana Therapeutics is a biotechnology company focused on opening the solute carrier (SLC) family of metabolite transporters as a target class to develop transformational therapeutics. Jnana uses its RAPID platform, a proprietary, cell-based drug discovery approach, to systematically target SLC transporters and develop best-in-class therapies to treat a wide range of diseases, including immune-mediated, neurological and metabolite-dependent diseases. Headquartered in Boston, Jnana is founded by world-renowned scientists and backed by leading life science investors. For more information, please visit http://www.jnanatx.com and follow us on Twitter and on LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210203005102/en/

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Immunology

FDA weighs tighter restrictions for Pfizer’s Xeljanz on the heels of safety red flags – FiercePharma

February 5, 2021 medical

The FDA already has restrictions on the use ofPfizers JAK inhibitor Xeljanz at a higher dose because of safety concerns. Now, thanks to new red flags, the agency is weighing a move to tighten those restrictions.

In a post Thursday, the FDAalertedpatients and doctors that a postmarket study has linked Xeljanz to an increased risk of serious heart-related problems and cancer compared with TNF inhibitors, a group that includes such drugs as AbbVies Humira. The problems applied to both the 5-mg twice-daily dose and the higher 10-mg strength.

The agency said itll evaluate the clinical trial results and consider what moves to take. The last time it made that kind of comment, it wound up puttinga boxed warning on the high dose and strippingit of its use in previously untreated ulcerative colitis.

In the meantime, the FDA asks patients not to stop taking Xeljanz without first consulting with their doctors.

The FDAs announcement came days after Pfizer unveiled the data from the postmarket trial, which were required by the FDA in granting Xeljanz its first go-ahead in rheumatoid arthritis in 2012.

In the trial ofabout 4,400 rheumatoid arthritis patients who were at least 50 years old and had at least one cardiovascular risk factor, the rate of major cardiovascular events was higher for Xeljanz takers at 3.37%, versus 2.55% for the TNF group. Cancers developed in 4.19% of Xeljanz patients, also higher than the 2.89% among TNF receivers.

RELATED:Pfizer's Xeljanz fails RA safety study, making a tough rivalry with AbbVie's Rinvoq even tougher

Pfizer first warned of heart-related safety issues tied to the trials 10-mg Xeljanz dose in 2019. The FDA took note, slappinga warning label on the drugpointing to an increased risk of blood clots and death. The European Medicines Agency followed with a similar but slightly different restriction.

But the regulatory red alert doesnt affect Xeljanzs larger rheumatoid arthritis indication, because the high dosing regimen is only meant for ulcerative colitis patients. In fact, Xeljanz, as Pfizers cornerstone immunology product, managed to grow sales by 9% at constant currencies to $2.4 billion in 2020, with U.S. prescription volume rising 12% year over year, Pfizer CEO Albert Bourla, Ph.D., said on the companys fourth-quarter earnings call Tuesday.

But its different this time. As the trials raised red flags for both those doses, all three existing Xeljanz indicationswhich also include psoriatic arthritisas well as a potential nod in ankylosing spondylitis could be under threat.

RELATED:Pfizer may have a lot going on in immunology, but all its drugs could be beaten by rivals: analyst

During the call, Pfizer management defended Xeljanzs place in those markets. Pfizer R&D chief Mikael Dolsten, M.D., Ph.D., said the postmarket trial participants belong to a unique population with increased severe risk, pointing to other clinical trial and real-world data it had accrued in larger patient groups.

As for the implications of the study on Xeljanz's label, Pfizer said its still too early to call. We still have a lot of work to do in terms of secondary endpoints, subpopulations and bringing all of this together to discuss this with regulators. So I think were still a ways off in terms of really understanding what impact it will be to our label, Angela Hwang, Pfizers biopharma president, said during the call.

Xeljanzs problems could hand fellow JAK inhibitors,such as AbbVies newly launched Rinvoq, an advantage. Although there are some concerns over potential scrutiny across the entire class, Rinvoq hasnt shown any imbalanced cardiovascular safety signals in the clinic. Pfizer also argued against reading Xeljanzs data into other JAK programs, mainly from the standpoint of its own follow-on programs such as abrocitinib, which is under FDA priority review in atopic dermatitis.

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FDA weighs tighter restrictions for Pfizer's Xeljanz on the heels of safety red flags - FiercePharma

Immunology

The COVID vaccines are not rushed and they’re safe – here’s why – WWLTV.com

February 4, 2021 medical

NEW ORLEANS Most of us know someone who is hesitant to be first in line for the COVID-19 vaccine. In fact, last week we heard the head of Ochsner say some of the medical staff were hesitant as well.

Why? It seems to come down to trust.

We're hearing some ask, How do I know I can trust the vaccine, especially since it came out in about a year, instead of four or five years? It turns out, there's a good answer for that.

Tulane microbiology and immunology expert, Dr. Lisa Morici, says the COVID vaccines were not rushed and there were no corners cut. In fact, the way it tells your immune system to make fighter cells has been studied for 30 years.

It took many years of scientists and engineers making small advances, incremental advances over the years to get the technology to a point where it works terrific. said Dr. Morici.

These are not traditional vaccines. They are called 'plug and play' and are perfectly designed for a pandemic because they can be quickly changed depending on the virus endangering the community.

We already knew these platforms were effective and safe. They've been in tens of thousands, If not hundreds of thousands of people for other diseases.

As for the speed of the clinical trials: For scientists worldwide it was all hands on deck. It was easy to get thousands of volunteers because people wanted to help, and the phases could overlap because pharmaceutical companies did not have the huge financial investment and risk.

The federal government and other agencies committed more than $26 billion towards these vaccines and that's unprecedented,she added.

Data on how well the vaccines worked came out fast, because so many people were infected in the community around those vaccine volunteers.

And so we were able to get the information lightning fast, as opposed to what would typically take us years,said Dr. Morici.

To people who don't want to be first to get vaccinated, you're not.

Tens of millions of doses of these vaccine have been administered to people. They are extremely safe. They are some of the safest vaccines that have ever been developed.

For those worried about long term side effects, Dr. Morici says throughout vaccine history, complications have shown up within two months.

We are well beyond the two month period with these vaccines. Millions, millions of folks, many months have passed. There's no reason to wait,she said.

And the doctor says there are no toxic preservatives in the vaccines. All the ingredients are natural ones that are found in the body.

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The COVID vaccines are not rushed and they're safe - here's why - WWLTV.com

Immunology

New treatment could fight cancer by teaching the body to detect and fight mutated cells – Columbia Missourian

February 4, 2021 medical

Immunotherapy may be the alternative treatment that revolutionizes cancer treatment working with the body instead of against it.

Treatments such as surgery and chemotherapy may not always permanently remove the cancer, depending on its location, type and stage.

Such treatments are designed to eliminate the mutated cancer cells that have already developed and formed tumors, but they dont always stop the body from continuing to produce more cancer cells.

So what if the body could learn to detect and fight mutated cells that fly under the radar?

A study by MU scientist Diana Gil Pags, PhD, about melanoma tumors in mice has shown that altering immune cells can lead to better results with cancer treatment.

Were trying to add to the arsenal of tools from the immune system that you can use against cancer, Gil Pags said. She emphasized the importance of having multiple treatment options for patients with cancer.

Why is it important to have another way? Because not everyone responds to these types of immunotherapies, Gil Pags said.

In fact, our preliminary research shows that if we combine the immunotherapies that are already in the clinic with our approach, there is an added benefit of mice survival and getting control over the tumor.

Immunology is becoming more foundational for cancer research and treatments. MU research technologist Megan Abergel learned about its expanded applications while working alongside Gil Pags.

I really hadnt realized how much immunology is ingrained in cancer research now, Abergel said.

Its really the hot topic and has been for the last couple years at least. I think its really interesting and promising.

Abergel explained the distinctions in cancer as opposed to other illnesses in terms of the bodys response.

When we get cancer, why is our body not able to mount a response? she said. Because its much more complicated, its using our own cells, so our body doesnt necessarily recognize that its foreign.

Gil Pags has been working on an immunotherapy treatment since 2002. She began by studying exactly how specific immune cells, called T-cells, function. She found a structural part of T-cells that allows the cells to identify diseases.

If it (the T-cell) encounters a healthy cell, there wont be a recognition, and the cell will just go around and do nothing, Gil Pags said. But when there is a positive recognition, the T-cell gets reprogrammed and acquires new capabilities that include being cytotoxic, which means killing cells.

By 2007, the study pointed to the possibility that, if their structure could be manipulated, the T-cells threshold for disease detection could be lowered. This means it would be easier for the body to detect mutated cells or any sort of infection.

These mutations also generate signals that make them easily recognized by the immune system, Gil Pags said. But sometimes those signals are subtle, and they are not enough to turn on the mechanism on the T-cells.

In October 2019, Gil Pags received a grant to develop drugs that work with mice genetics to enhance their T-cells. The goal for the drugs is to bind to the proteins that make up the receptors of the T-cell to lower its detection threshold, Gil Pags said.

That data proved that altering the T-cells made it easier for the mice to get rid of the melanoma tumors and keep them away.

The mice have now become what Gil Pags describes as humanized in order to test other drugs that are meant to bind to human T-cells.

A human protein is added to the mice proteins on the T-cell receptors, so the drugs developed for humans can be tested.

With just one component, weve made human in the mouse T-cells, our human reagent binds to these mouse cells now, Gil Pags said.

One problem with the immunotherapy approach is the level of toxicity that a person may experience during treatment.

Gil Pags explained that by lowering the T-cells inhibitions, the cells may also mistake healthy cells for disease, and the therapy can mimic the symptoms of an autoimmune disorder.

Part of the grant is to evaluate the toxicity inherited in our approach and compare it with other immunotherapies already out in the clinic that target T-cells, she said.

If the drug candidates are not equal to or less than the toxicity levels of existing treatments, the research she conducts wont move forward, she said.

The positive outcome is that, so far, we have learned that at least one of our candidates reproduces the anti-tumor effects of our approach seen in mice, and then it might be good enough to move into the clinic in the near future, she said.

She mentioned the possibility that none of the candidates measure up after considering their anti-tumor effects and side effects. Sometimes negative data is not valued so much, but it is needed to push you into developing better ideas.

Her lab research was disrupted in early 2020 because of COVID-19, but she said it began to pick back up in early fall of 2020.

Researchers will continue to run trials with the mice until they are able to do human clinical trials, she said.

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New treatment could fight cancer by teaching the body to detect and fight mutated cells - Columbia Missourian

Immunology

In Survey of Those with Uncontrolled Asthma, Half Smoked Cannabis – Newswise

February 4, 2021 medical

Newswise ARLINGTON HEIGHTS, IL (Feb. 2, 2021) As the number of states increase where medical and recreational cannabis use is legal, so does the importance that physicians discuss with patients the effects of cannabis on those with asthma. A new survey in Annals of Allergy, Asthma and Immunology, the scientific journal of the American College of Allergy, Asthma and Immunology, shows that of those who used cannabis, about half smoked it while a third vaped both inhalation routes likely to affect ones lungs.

It surprised me that over half of the cannabis users in this study who have asthma were smoking it, said Joanna Zeiger, PhD, principal investigator for the study. And further, of those with uncontrolled asthma, half reported smoking cannabis. We also found that people with asthma are not routinely being asked or advised by their physician about cannabis and how they are consuming it.

Eighty-eight (18%) of the 489 adults with allergy/asthma who completed the survey reported current cannabis use. The majority of those responding were younger than 50 years, female, and White. Among non-cannabis users, 2.5% reported an allergy to cannabis. Two-thirds of current cannabis users did so for medical or medical/recreational purposes. The anonymous survey, conducted in collaboration with Allergy & Asthma Network, was of those 18 years and older and looked at cannabis knowledge, attitudes, and patterns of use.

Strikingly, among current cannabis users, only about 40% report having their physicians inquire about cannabis use, and about the same number of patients want to discuss cannabis with their physicians, says allergist William Silvers, MD, study co-author, ACAAI member and expert on cannabis allergy. In order to more completely manage their allergy/asthma patients, allergists should increase their knowledge about cannabis and inquire about cannabis use including types of cannabinoid, route of use, reasons for use, and adverse effects, says Dr. Silvers. As with cigarette smoking, efforts should be made to reduce smoking of cannabis, and recommend other potentially safer routes such as edibles and sublingual tinctures.

Positive effects of cannabis use (e.g., reduced pain, calm, improved sleep) were reported significantly more frequently than adverse effects (e.g., cough, increased appetite, anxiety). Of concern, about 20% of survey respondents reported coughing from cannabis, which was significantly related to smoking the cannabis. Almost 60% of the cannabis users in the survey reported current asthma, of whom 40% were uncontrolled by the Asthma Control Test.

Says Dr. Zeiger, We look forward to future studies of larger, more diverse cohorts to better explore more deeply the effect of cannabis use on asthma and other allergic disorders.

Allergists are specially trained to diagnose and treat asthma. To find an allergist near you who can help create a personal plan to deal with your asthma and help you live your best life, use the ACAAI allergist locator.

About ACAAI

The ACAAI is a professional medical organization of more than 6,000 allergists-immunologists and allied health professionals, headquartered in Arlington Heights, Ill. The College fosters a culture of collaboration and congeniality in which its members work together and with others toward the common goals of patient care, education, advocacy, and research. ACAAI allergists are board-certified physicians trained to diagnose allergies and asthma, administer immunotherapy, and provide patients with the best treatment outcomes. For more information and to find relief, visit AllergyandAsthmaRelief.org. Join us on Facebook, Pinterest and Twitter.

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In Survey of Those with Uncontrolled Asthma, Half Smoked Cannabis - Newswise

Immunology

Gossamer Bio to Host Webcast Focused on its Inflammatory Bowel Disease Program, GB004, on February 18, 2021 – Business Wire

February 4, 2021 medical

SAN DIEGO--(BUSINESS WIRE)--Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced that it will host a conference call and webcast for investors and analysts on Thursday, February 18, 2021 at 11:00am ET to discuss GB004, its oral HIF-1 stabilizer for the treatment of inflammatory bowel disease (IBD), including ulcerative colitis (UC).

Gossamer management will present alongside key IBD and HIF biology opinion leaders, including:

As part of the event, Gossamer Bio management and Drs. Sandborn, Danese, and Taylor will be available for questions.

William Sandborn, M.D., is a board-certified gastroenterologist, who is one of the world's top experts in the management of ulcerative colitis and Crohns disease. He directs the Inflammatory Bowel Disease Center at UC San Diego Health. In addition, he is Chief of the Division of Gastroenterology for UC San Diego Health. A Professor in the Department of Medicine at UC San Diego School of Medicine, Dr. Sandborn conducts clinical trials in IBD and leads a team of physicians, research fellows, nurses, and study coordinators. His clinical trials have been instrumental to developing modern treatments for IBD. Dr. Sandborn has published 836 articles in prestigious journals, including the New England Journal of Medicine, The Lancet, JAMA, the Annals of Internal Medicine, and Gastroenterology. Prior to joining UC San Diego Health, Dr. Sandborn worked in the Division of Gastroenterology and Hepatology at the Mayo Clinic in Rochester, Minnesota. Dr. Sandborn completed his fellowship at Mayo Clinic. He did his residency and earned his medical degree at Loma Linda University School of Medicine.

Silvio Danese, M.D., Ph.D., is the Head of the Inflammatory Bowel Disease Center at Humanitas Research Hospital and the group leader of the Gastrointestinal Immunopathology Laboratory at Humanitas Research Center in Milan, Italy. A Professor of Gastroenterology at Humanitas University, his main research area of interest is the investigation of the fundamental mechanisms underlying IBD pathogenesis. He served as President of the European Crohns and Colitis Organization (ECCO) in 2019 and has served as the Principal Investigator on many Phase 1, 2 and 3 clinical trials for the treatment of IBD patients. He is also Member of the Editorial Board of Current Drug Target and Alimentary Pharmacology & Therapeutics and Associate Editor of Gut and Journal of Crohns and Colitis. He has published more than 300 research articles in peer-reviewed journals with high impact factor. He trained in gastroenterology at Policlinico Gemelli, Rome, Italy, and earned his Ph.D. there in 2004. Professor Danese also worked in Professor Claudio Fiocchis laboratory at the Case Western Reserve University, Cleveland, Ohio from 2001 to 2004.

Cormac Taylor, Ph.D., is a Professor of Cellular Physiology at the School of Medicine and Medical Science and the Conway Institute, University College Dublin, Ireland. He leads the Taylor Lab, in which research is directed towards expanding the understanding of the physiological and pathophysiological mechanisms by which changes in micro-environmental oxygen levels regulate gene transcription in cells. A key focus of this work is the identification of new therapeutic targets in inflammatory bowel disease. Dr. Taylor was elected as a Member of the Royal Irish Academy in 2014. He was awarded the 2014 Nature mid-career mentorship award and the 2017 Takeda Distinguished Researcher Award from the American Physiological Society. He has authored over 130 articles in journals including Gastroenterology, Gut, PNAS and Science and is an Editorial Board Member of the American Journal of Physiology and the Journal of Biological Chemistry. Dr. Taylor received his Ph.D. in Pharmacology from UCD in 1996 prior to a postdoctoral fellowship at Harvard Medical school from 1996-2001 and has been running his own independent research group since 2001.

Conference Call and Webcast

Gossamer will host a conference call and live audio webcast at 11:00 am ET on Thursday, February 18. The live audio webcast may be accessed through the Events / Presentations page in the Investors section of the Company's website at http://www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 6135079Domestic Dial-in Number: (833) 640-7726International Dial-in Number: (602) 585-9912Live Webcast: https://edge.media-server.com/mmc/p/9tbs35gb

A replay of the audio webcast will be available for 30 days on the Investors section of the Company's website, http://www.gossamerbio.com.

About Gossamer Bio

Gossamer Bio is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology. Its goal is to be an industry leader in each of these therapeutic areas and to enhance and extend the lives of patients suffering from such diseases.

Excerpt from:
Gossamer Bio to Host Webcast Focused on its Inflammatory Bowel Disease Program, GB004, on February 18, 2021 - Business Wire

Immunology

AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results – BioSpace

February 4, 2021 medical

NORTH CHICAGO,Ill., Feb. 3, 2021 /PRNewswire/ --AbbVie (NYSE: ABBV) announced financial results for the fourth quarter and full year ended December 31, 2020.

"We successfully completed the transformative Allergan acquisition and delivered another year of strong results in 2020, despite the challenges presented by the global pandemic," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Based on our broad portfolio of diversified growth assets and the robust momentum of our business, we expect impressive growth again in 2021."

Fourth-Quarter Results

Note: "Comparable Operational" comparisons include full-quarter current year and prior year results for Allergan, which was acquired on May 8, 2020, as if the acquisition closed on January 1, 2019, and are presented at constant currency rates and reflect comparative local currency net revenues at the prior year's foreign exchange rates. Refer to the Key Product Revenues schedules for further details. "Operational" comparisons are presented at constant currency rates and reflect comparative local currency net revenues at the prior year's foreign exchange rates.

Recent Events

Full-Year 2021 Outlook

AbbVie is issuing its GAAP diluted EPS guidance for the full-year 2021 of $6.69 to $6.89. AbbVie expects to deliver adjusted diluted EPS for the full-year 2021 of $12.32 to $12.52. The company's 2021 adjusted diluted EPS guidance excludes $5.63 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at http://www.abbvie.com. Follow @abbvie on Twitter, Facebookor LinkedIn.

Conference Call

AbbVie will host an investor conference call today at 8:00 a.m. Central time to discuss our fourth-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central time.

Non-GAAP Financial Results

Financial results for 2020 and 2019 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. The company's 2021 financial guidance is also being provided on both a reported and a non-GAAP basis.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, the failure to realize the expected benefits of AbbVie's acquisition of Allergan or to promptly and effectively integrate Allergan's business, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

AbbVie Inc.

Key Product Revenues

Quarter Ended December31, 2020

(Unaudited)

% Change vs. 4Q19

Net Revenues (in millions)

Reported

Comparable Operational a, b

U.S.

Int'l.

Total

U.S.

Int'l.

Total

U.S.

Int'l.

Total

NET REVENUES

$10,665

$3,193

$13,858

65.9%

40.4%

59.2%

9.4%

(1.2)%

6.8%

Immunology

4,988

970

5,958

18.9

(0.1)

15.3

18.9

(2.5)

14.8

Humira

4,293

859

5,152

8.2

(9.4)

4.8

8.2

(11.4)

4.4

Skyrizi

451

525

>100.0

Rinvoq

244

281

>100.0

Hematologic Oncology

1,373

416

1,789

11.7

30.9

15.7

11.7

29.9

15.5

Imbruvicac

1,165

259

1,424

8.6

15.7

Read more from the original source:
AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results - BioSpace

Immunology

Spherix Global Insights Introduces New Service Focusing on Recent Launches in Expanding Immunology, Nephrology, and Neurology Markets – Daily Local…

February 4, 2021 medical

EXTON, Pa., Jan. 29, 2021 /PRNewswire/ --Spherix Global Insights, a leading market intelligence firm specializing in select dermatology, gastroenterology, nephrology, neurology, and rheumatology markets, announces the inaugural publications of their newest service offering, Launch Dynamix. This innovative, independent service provides monthly benchmarking of newly launched products for the first eighteen months of commercial availability.

This is augmented by a quarterly deep dive into promotional activity, messaging, drivers of use, barriers to uptake, patient types, market access landscape, and degree of disruption surrounding the newly launched product including a mix of both quantitative and qualitative feedback. Clients subscribed to this service received their first monthly pulse on January 15, 2021, including data benchmarking the current launch to relevant historical market entrants at similar post-entry timings.

In rheumatology, Spherix is currently tracking the entry of both Novartis' Cosentyx and Eli Lilly's Taltz in non-radiographic axial spondylarthritis (nr-axSpA), which were approved within weeks of each other in June of last year. Data on the key performance indicators (KPIs), provided in the January publication, are compared to the performance of UCB's Cimzia, which was the first biologic/advanced systemic agent to gain FDA approval for nr-axSpA in March of 2019.

With regard to psoriatic arthritis (PsA), Spherix's new service is available for Janssen's Tremfya, with KPIs benchmarked to Cosentyx, Taltz, Amgen's Otezla, and Pfizer's Xeljanz. Pending FDA approval, Spherix also plans to cover AbbVie's Rinvoq in both ankylosing spondylitis (AS) and PsA, Xeljanz for the treatment of AS, and AstraZeneca's anifrolumab for the treatment of systemic lupus erythematosus.

Inaugural Launch Dynamix coverage in gastroenterology includes tracking and trending of Janssen's Stelara for the treatment of ulcerative colitis (UC), benchmarking the entry of the IL-12/23 inhibitor to the respective Crohn's disease launch, as well as the launch of Xeljanz for the treatment of UC.

In neurology, Spherix is currently covering the launches of Novartis' Kesimpta and BMS' Zeposia, with appropriate benchmarked KPIs to Genentech's Ocrevus, Novartis' Mayzent, EMD Serono's Mavenclad, and Biogen's Vumerity. Pending approval, Spherix will also cover the launch of Janssen's ponesimod, which is expected to be available in the Spring of 2021.

In an area of significant unmet need, the lupus nephritis market is poised for a massive shift with recent drug approvals for GSK's Benlysta (also approved for systemic lupus erythematosus) and Aurinia Pharmaceuticals' Lupkynis. The study will include responses from both nephrologists and rheumatologists, with the first pulse available in February.

Other launches on Spherix's radar with planned 2021 coverage (pending approval) include:

"We are really excited to be able to bring this level of launch detail to our clients," says Lynn Price, Vice President of Strategy and Innovation at Spherix. "The rapid turn-around from fielding to publication and the monthly cadence coupled with quarterly deep-dives provides those with assets in this market or with near-term plans to enter it the perfect tool to keep their finger on the pulse."

About Launch Dynamix

Launch Dynamix is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into patient types initiated, brand perceptions, promotional activity, and drivers and barriers to uptake. The service is offered on a brand-by-brand basis.

Learn more about our services here.

About Spherix Global Insights

Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select dermatology, gastroenterology, nephrology, neurology, and rheumatology markets.

All company, brand or product names in this document are trademarks of their respective holders.

For more information contact:

Kristen Henn, Business Development Manager

Email:info@spherixglobalinsights.com

http://www.spherixglobalinsights.com

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SOURCE Spherix Global Insights

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Spherix Global Insights Introduces New Service Focusing on Recent Launches in Expanding Immunology, Nephrology, and Neurology Markets - Daily Local...