Embryology

UVA and the History of Race: Eugenics, the Racial Integrity Act, Health Disparities – UVA Today

According to Barringer, rigid hereditary determinism predetermined the absolute limit of African Americans biological and social advancement. He argued that with emancipation came reversion of African Americans to savage status, creating a new, degenerate black generation that could not possibly survive in contact with civilized white society.

Barringer believed that under the conditions of slavery, blacks had advanced beyond their natural selection through selective breeding by slave owners. With emancipation came reversion of African Americans to their original savage nature, which put them on a path toward extinction, accelerated by an irrational procreation which further exacerbated their genetic inferiority and susceptibility to disease and criminality.4

The drastically high incidence of tuberculosis, syphilis and typhoid fever among African Americans (locally and in cities around the country) indicated nothing to Barringer about overcrowded housing or lack of clean water, sanitation or safe meats and pasteurized milk. Instead the high morbidity and mortality rates of African Americans proved the genetic unfitness of a markedly criminal race. Without white intervention, Barringer condemned blacks to a life of barbarism and death. To Barringer, the Negro Problem was more than a political problem; it was a huge public health threat to whites.

Barringers tripartite solution to the Negro Problem was political disfranchisement, transferring responsibility for African American education from black to white teachers, and training blacks to be law-abiding laborers and artisans. As he wrote, Every Negro doctor, lawyer, teacher or other leader in excess of the immediate needs of his own people is an antisocial produce, a social menace.5

Eugenics flourished under the leadership of President Edwin Alderman (1903-27) as he set out to build the research base of the University with recruitment of leading men of eugenic science into schools across Grounds: These included Harvey Jordan, Robert Bean and Lawrence Royster in the medical school; George Ferguson in education; Orlando White as director of UVAs biological station; and Ivey Lewis as chair of biology.

Together these faculty created eugenics research and education programs at UVA and throughout the state, and in doing so, trained UVA students as well as high school and college teachers in eugenic racism. They also collaborated with nationally renowned eugenics investigators, and presented their work at international eugenics meetings. Fully immersed in race science, these men contributed directly and indirectly to ethically contemptuous laws and policies designed to maintain a culture of white supremacy, and exclusionary white privilege.

Jordan, a professor of embryology, genetics and histology, was one of Aldermans early recruits. Joining the faculty in 1907, he served as dean of the medical school from 1939 to 1949. Believing that blacks inherited a susceptibility to contracting diseases such as syphilis and tuberculosis, Jordan called for compulsory registration of all who were ill. He argued that proposed eugenic marriage, segregation and sterilization laws, were public and racial health measures that should form part of the health code, to be administered under the State Police powers.6 The promise of eugenics as a solution to societys ills, and the power of physicians in solving such problems was best summed up when Jordan declared at the 1st International Congress of Eugenics in 1912 that the future physician must also take a more active part in helping to shape legislation in the interest of race welfare.7

Chair of Anatomy Dr. Robert Bean argued that the physical features of African Americans confirmed their inferiority when compared to whites. Furthermore, he advanced human types that represent different degrees of susceptibility of disease may be segregated and given differential treatment.8 Through medical school core courses, Jordan and Bean, combined, taught about 20% of the medical school curriculum.

Along similar lines, George Oscar Ferguson, a professor in the education school, in his use of intelligence testing among blacks, mixed-race and white children concluded, It does not seem possible to raise the scholastic attainment of the Negro to an equality with that of the white. [N]o expenditure of time or money would accomplish this end, since education cannot create mental power, but can only develop that which is innate.9

Eugenics began to shape public policy nationally as early as 1907, when Indiana passed a sterilization law. Two Virginia eugenics laws, both passed in 1924, had a profound impact in the commonwealth and throughout the country. The Virginia Sterilization Act and the Racial Integrity Act not only legalized sterilization of the mentally ill and persons of low literacy, but also cemented discrimination against marginalized and vulnerable populations, including African Americans. These laws codified Jim Crow into every aspect of community life, and in doing so, denied African Americans access to medical care, jobs and fair wages, as well as higher education and professional training. Simply put, eugenic laws created the one drop rule, where one drop of African American blood restricted a person of color to life behind the veil.10

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UVA and the History of Race: Eugenics, the Racial Integrity Act, Health Disparities - UVA Today

Embryology

Cheryl Tweedy is considering sperm donation to have more children but how does it work? – Yahoo Style

Cheryl Tweedy has revealedplans to have more children by sperm donor.

The pop singer, 36, explained that she wants to provide more than one sibling for two-year-old son Bear, who she shares with ex-boyfriend Liam Payne, 26.

Speaking to The Times Magazine, the star, who is currently single, said that the thought of potential solo fertility treatment makes me very happy.

She continued: If time was on my side and I was in my twenties, yeah, I would wait and consider more options, or wait for somebody I felt was right, but

You could meet somebody and for that year it feels incredible, but there is never a guarantee because there are so many variables that can happen.

Life is a funny old game.

Cheryl, went on to confirm that she is considering having a second and possibly third child with the help of a sperm donor from out of town.

She explained: You can get it from abroad.

Do you imagine some guy from Newcastle saying, Thats my child!?

Theres a lot to choose from and a lot to think about, she added.

READ MORE: What is spurgling and why do experts have concerns about the sperm stealing practice?

More women are choosing sperm donation as a method of having a family [Photo: Getty]

Cheryl Tweedy certainly isnt alone in considering fertility treatment without a father.

Latest figures from the Human Fertilisation and Embryology Authority (HFEA) showthe number of women attempting to start a family without a father increased by more than a third (35%) in two years; 1,272 women registered to have fertility treatment without a partner in 2016 up from 942 in 2014.

Likewise, there has been a rise in the use of sperm donation to start or grow a family. In 2016, 4,306 treatment cycles involved a patient using their own eggs and donor sperm, up 15% from 3,749 in 2015.

So why is sperm donation becoming more popular?

Some experts believe women are feeling more empowered to make that choice, while Dr Geetha Venkat director ofHarley Street Fertility Clinic believes the fact that many women are waiting until they are older to have children, and the changing circumstances surrounding starting a family are both contributing to the process becoming a more popular option.

Of course sperm donation is also considered by some couples where the male partner has sperm abnormalities, poor sperm production or no sperm at all.

Some men carry inherited genetic diseases and are thus seeking donated sperm so as not to transmit the disease to their children, Dr Venkat continues.

Sperm donors can change lives and make families a reality.

READ MORE: Single mum, 39, who used sperm donor, explains choice to her baby boy in moving video

According to Dr Venkat there is a shortage of sperm donors in the UK and many people have to wait to benefit from donated sperm.

Some couples are fortunate enough to have friends and family willing to donate sperm as a known donor, she explains.

However, most are not so fortunate and thus they are likely to be in the queue waiting for around one year on average for sufficient donors to volunteer to donate their sperm.

Dr Venkat says that to meet the demand, over 500 sperm donors are needed every year from all nationalities, religions, ethnicities and cultures.

UK fertility clinics are able to import sperm from overseas, but only under certain conditions, she adds.

Dr Venkat says the person/people who receive a sperm donation will be the childs legal and social parent(s) the donor will not be named on the birth certificate.

The donor has no legal, financial or social obligations to any child created from the donation either now or in 18 years time, she explains.

Donors are asked to complete an HFEA form and this details personal details about them that could be handed to the donor-conceived person when they reach age 18 or older.

Story continues

This information enables the childs parents to talk to them about their origins as they grow up and helps them build a mental picture of the donor, but they cannot meet them, she adds.

Its worth nothing that if youre having treatment at a licensed fertility clinic in the UK, the donor will have no legal rights or responsibilities to any children born with their sperm.

This is a personal choice, says Dr Venkat. But the most important thing is that donor procedures are carried out and that only healthy, safe sperm is used for your health and that of any child you have.

If you use a donor through a fertility clinic can find out:

height, weight, eye and hair colour

the year and country of birth

their ethnicity

whether they had any children at the time of donation, how many and gender

their marital status and medical history

they may choose to write a message at the time of their donation but you wont be able to find out any information that might reveal who the donor is.

READ MORE:Woman considers divorcing husband who fathered 47 children through sperm donations

IUI with donor insemination is a relatively quick and painless process [Photo: Getty]

When fertility treatment involves directly inserting sperm into a woman's womb, it is called Intrauterineinsemination (IUI).

The donor sperm is prepared in the laboratory to separate fast moving sperm from more sluggish or non-moving sperm, advises Dr Venkat.

The sperm is washed in the laboratory before insemination in order to concentrate the best sperm into a small amount of fluid.

Dr Venkat explains that using a catheter, your doctor will place the concentrated sperm directly into your uterus through your cervix, under ultrasound guidance.

The insemination procedure is relatively painless and is performed in a few minutes, although some women may experience some temporary, menstrual-like, cramping, she says.

IUI treatment can be performed in a natural cycle without fertility medicines or in a stimulated cycle with fertility drugs.

Though the treatment is available on the NHS, the waiting list can be very long in some areas and there are strict rules.

Dr Venkat advises speaking to your GP about your personal situation.

To give you an idea of costings, prices for IUI start at 1,100 per cycle with the HSFC.

Though you can go abroad for sperm donor treatment, like Cheryl Tweedy seems to hint shes considering, Dr Venkat says suggests remaining in the UK for the safest option.

The success rate with IUI treatment depends on your partner fertility status and your age.

Most couples who opt to undergo IUI have a 5 to 20%chance of becoming pregnant with each attempt, Dr Venkat says.

The chances are higher for stimulated IUI cycles in younger women using good quality sperm. However, it is not uncommon for multiple IUI cycles to be attemptedduethe poor success rate with a single cycle.

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Cheryl Tweedy is considering sperm donation to have more children but how does it work? - Yahoo Style

Genetics

Genetics | Science | The Guardian

Requiring minimal amounts of sleep is sometimes seen as a badge of honour. But for many of us, being able to actually function is a different matter altogether. So why is it that some people seem to need more or less sleep? And what are some of the ramifications if we dont get enough? Hannah Devlin speaks to two experts whose work is bringing new understanding to our sleeping behaviours

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Genetics | Science | The Guardian

Genetics

Empirico Announces Strategic Collaboration to Harness Human Genetics for the Discovery and Development of Novel Antisense Oligonucleotide Therapeutics…

Empirico Inc. announced today that it has entered into a strategic collaboration with Ionis Pharmaceuticals. During the three-year collaboration, Empirico will utilize its Precision Insights Platform, which incorporates huge biological data sets, human genetics and advanced algorithmic approaches, to identify therapeutic targets for indications and tissues that are amenable to Ionis industry-leading antisense technology. Under the terms of the agreement, Ionis can advance up to ten targets identified by Empirico and assume responsibility for all preclinical and clinical development activities. Empirico and Ionis will also work together to incorporate human genetics evidence into ongoing efforts with existing Ionis programs, including work on target validation, indication and biomarker selection, and patient stratification.

Empiricos Precision Insights Platform was purpose-built for therapeutic target discovery and incorporates one of the largest datasets of its kind in the world to interrogate the role of genes and proteins in health and disease and find opportunities for novel therapeutic interventions. By combining expert data curation, customized data models, and statistical and machine learning algorithms, the platform enables Empiricos scientists to systematically generate, interrogate, and prioritize high-confidence therapeutic hypotheses that are then validated experimentally.

"Empiricos approach to human genetics provides a much-needed opportunity to improve the success rate of drug discovery and development by leveraging experiments of nature," said Omri Gottesman, M.D., CEO of Empirico. "Antisense oligonucleotides are an ideal translational partner for human genetics-focused target discovery, allowing us to precisely mimic or interfere with the mechanisms by which functional genetic variants influence health and disease. We are excited to work with Ionis, the leader in RNA-targeted drug discovery and development, in discovering new medicines for patients in need."

As part of this new collaboration, Ionis has made a $10 million equity investment in Empirico, with additional near-term commitments of up to $30 million based on operational and preclinical milestones. Empirico will be eligible to receive in excess of $620 million for the achievement of clinical development, regulatory and commercial milestones, and royalties on net sales. Empirico also has the option to license, develop, and commercialize an Ionis development candidate directed toward a collaboration target for which Ionis will receive milestone payments and royalties on net sales.

In connection with this new collaboration, Empirico also announced today the closing of its $17 million Series A-2 financing, led by Ionis and with participation by DCVC Bio and Neotribe Ventures. This was a follow-on round to Empiricos $12.5 million Series A financing, co-led by DCVC Bio and Neotribe Ventures and completed In November 2018.

About Empirico

Empirico is a next-generation therapeutics company founded on utilizing human genetics, data science and programmable biology to power novel target discovery and development. Empiricos Precision Insights Platform, a proprietary human genetics-focused discovery platform, leverages a world-leading dataset and advanced algorithmic approaches to identify and prioritize therapeutic targets with a higher probability of translational success. All potential therapeutic targets are subjected to rigorous experimental validation to elucidate the mechanism by which genetic variation impacts disease risk and provide insights about which therapeutic modality could be programmed to mimic or interfere with that mechanism. Empirico has active preclinical development programs across several immune, dermatological, cardiometabolic, and ophthalmic indications based on targets identified with the Precision Insights Platform. Empirico is headquartered in San Diego, Calif. with laboratories in Madison, Wis. To learn more about Empirico, visit http://www.empiricotx.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200109005091/en/

Contacts

Media Contact: Jessica Yingling Ph.D.Little Dog Communications Inc. jessica@litldog.com +1-858-344-8091

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Empirico Announces Strategic Collaboration to Harness Human Genetics for the Discovery and Development of Novel Antisense Oligonucleotide Therapeutics...

Immunology

OncoMyx Therapeutics Announces Formation of Scientific Advisory Board – Business Wire

PHOENIX--(BUSINESS WIRE)--OncoMyx Therapeutics, a privately-held oncolytic immunotherapy company, announced today the formation of its Scientific Advisory Board (SAB), comprised of experts in tumor immunology, oncology drug discovery and development, and oncolytic viruses. The SAB will work closely with the OncoMyx leadership team as the company advances a therapeutic pipeline of oncolytic immunotherapies based on the myxoma virus (MYXV) platform. The companys pipeline includes both monotherapies and therapies to be used in combination with immune checkpoint blockade and other immuno-modulatory approaches, offering significant therapeutic promise to a wide range of cancer targets.

This is a group of highly-accomplished scientists and drug hunters, some whom I have known for many years, said Leslie Sharp, Ph.D., chief scientific officer (CSO) of OncoMyx. We are thrilled to welcome Tobias, Neil, Grant, Ronan, and Dominic to our SAB, and I look forward to working with the team to develop new therapeutic options for cancer patients.

The SAB will be comprised of the following members:

Tobias Bald, Ph.D. is the Head of the Oncology and Cellular Immunology Laboratory at QIMR Berghofer Medical Research Institute. He is a leading expert in tumor immunology with a strong focus on the role of the innate immune system during tumor development, progression and cancer immunotherapy.

Neil Gibson, Ph.D. is President and CEO of PDI Therapeutics and Senior Vice President of COI Pharmaceuticals. Dr. Gibson has more than 30 years of drug development experience and has been involved in the successful discovery, development and commercialization of four approved oncology drugs (including temozolomide, sorafenib, erlotnib, and crizotinib). Dr Gibsons extensive oncology experience includes being CSO of Pfizer Oncology Research Unit, CSO of Regulus Therapeutics and CSO of OSI Pharmaceuticals. Dr. Gibson also serves on the board of TCR2, a new public company focused on T-cell therapies.

Grant McFadden, Ph.D. is founder, research advisor, and director at OncoMyx. He is one of the top global leaders in oncolytic viruses with a specialization in pox viruses, including myxoma. The McFadden lab pioneered the field of viral immune subversion (also called anti-immunology) and is credited with the discovery of a wide spectrum of virus-derived inhibitors of the immune system.

Ronan OHagan, Ph.D. is Senior Vice President of Research and Translational Sciences at Akrevia Therapeutics. Prior to Akrevia, Ronan served as Executive Director, Oncology Discovery at Merck Research Laboratories. In this role he led the oncology discovery program at Merck with a particular emphasis on approaches to enable and enhance immune-modulatory therapies in cancer. Earlier at Merck, he led target identification and validation for oncology and generated an early-discovery pipeline including both biologics and small-molecule programs. He has helped to bring multiple small-molecule and biologics programs into clinical development during his time in industry. His academic career included undergraduate and graduate work in Canada followed by post-doctoral work at the Dana Farber Cancer Institute (DFCI). In Dr. Ron DePinhos laboratory at DFCI, he focused on genetically engineered mouse models of cancer and novel approaches to target discovery.

Dominic Spinella, Ph.D. has over 25 years of experience in drug research and development and the discipline of Translational Medicine. He has been an executive leader at Chugai Biopharmaceuticals USA, where he was Vice President of Exploratory Research; at Pfizer where he served as head of Translational Medicine for the Oncology division; and at Amgen where he was Executive Director of Medical Sciences and head of Biomarkers and Diagnostics. A former professor of Medicine and Immunology at the University of Tennessee College of Medicine and Howard Hughes postdoctoral fellow at Washington University School of Medicine in St. Louis, he also served on several national and international cancer biomarker development bodies.

We are assembling a world-class team with deep expertise in developing and commercializing innovative therapeutics, said Steve Potts, Ph.D., MBA, founder and chief executive officer of OncoMyx. Our SABs collective strategic, scientific, and clinical experience, together with our existing team, will help transform OncoMyx into a high growth clinical-stage therapeutics company.

About OncoMyx Therapeutics

OncoMyx Therapeutics, a startup launched from Arizona State University (ASU), develops oncolytic immunotherapies based on the myxoma virus (MYXV) platform to orchestrate an immune response and treat cancer. Successful immuno-oncology (IO) cancer treatment generally requires combination therapy, and oncolytic viruses (OVs) have emerged as a safe and effective IO complement. The companys MYXV platform, spun out from ASU, is poised to be a best-in-class OV approach, and the top OV team has assembled around MYXV to create important new therapeutic options for cancer patients. For more information, please visit http://www.oncomyx.com.

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OncoMyx Therapeutics Announces Formation of Scientific Advisory Board - Business Wire

Immunology

AbbVie Sets up Allergan Aesthetics Ahead of Finalizing its $63 Billion Acquisition – BioSpace

While Allergan and AbbVie prepare to complete their $63 billion merger later this year, plans are being laid out for a new, stand-alone company called Allergan Aesthetics that will include Botox as a tent pole.

AbbVie announced the proposed company Wednesday, along with a dedicated leadership team. The new division of AbbVie will include Botox, as well as the Juvederm collection of dermal fillers, the CoolSculpting body contouring treatments and other aesthetic products. It will also have its own research and development functions to continue to build out its aesthetics programs, AbbVie said.

The new division will be headquartered in Irvine, Calif. and will be helmed by Carrie Strom, who is currently senior vice president of U.S. Medical Aesthetics at Allergan. When the merger of the two companies is completed this quarter, Strom will be named senior vice president of AbbVie and president of Global Allergan Aesthetics. She will oversee the worldwide operations of the new company and will be assisted with an experienced team of other Allergan aesthetics veterans. As a division of AbbVie, Strom will report directly to AbbVie Chief Executive Officer Richard Gonzales.

Allergans eye care and specialty businesses, which include the use of Botox as a therapeutic for migraine headaches and other indications, as well as treatments of the central nervous system, womens health and gastrointestinal diseases, will be integrated into the current AbbVie pipeline. The combined companies will have several strong franchises across immunology, hematologic oncology, medical aesthetics, neuroscience, women's health, eye care and virology.

Gonzales said they are enthusiastic about the changes coming to AbbVie due to the Allergan acquisition. At the time the deal was announced, Gonzales said it would be transformational for the company. The announcement of the new aesthetics division, as well as the leadership changes, marks an important step forward for the company.

We are fortunate to have a leadership team with a deep breadth of both industry and company experience and we are excited to welcome the new Allergan leaders to our company, Gonzales said in a statement.

The new executive leadership team of AbbVie includes:

The new leadership team will certainly be tasked with integrating a number of pipeline-boosting therapeutics that AbbVie could gain from a number of collaborative deals over the past several months. In December, AbbVie and The Scripps Research Institute entered into a research collaboration focused on oncology, immunology, neurology and fibrosis. In November, AbbVie and Dragonfly Therapeutics struck a deal to advance new treatment options for autoimmune and oncology indications. At the center of the agreement are Dragonflys novel NK cell engager-based immunotherapies. AbbVie also entered into a collaboration with Idera Pharmaceuticals targeting metastatic head and neck squamous cell carcinoma. AbbVie snapped up Seattle-based Mavupharma and its STING (STimulator of INterferon Genes) pathway-focused treatments in July. The STING pathway plays an important role in the innate immune system, which is the bodys first line of defense against various pathogens, including the development of cancerous tumors.

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AbbVie Sets up Allergan Aesthetics Ahead of Finalizing its $63 Billion Acquisition - BioSpace

Immunology

Friend of Winnipeg plane crash victim shocked by news the jet may have been shot down – CTV News

WINNIPEG -- A Winnipegger who knows one of the victims aboard Ukraine International Airlines Flight 752 is reacting to new information the plane may have mistakenly been shot down by an Iranian missile.

Prime Minister Justin Trudeau told reporters Thursday afternoon the Canadian government has intelligence from multiple sources, including its allies and its own intelligence.

The evidence indicates that the plane was shot down by an Iranian surface-to-air missile, said Trudeau. This may have been unintentional.

The news left Jude Uzonna shaken. The University of Manitoba professor advised Forough Khadem when she was completing her PhD in immunology -- Khadem was among the 176 people on board the plane.

How could that happen, said Uzonna. Thats terrible. Thats terrible. And it makes me so upset if this is really true.

Uzonna said he had exchanged text messages with Khadem just before her flight and she expressed concern about the tensions between Iran and the U.S.

(Source: Jude Uzonna)

Uzonna is remembering Khadem for her affable personality and knowledge in the field of immunology.

This is somebody with an infectious smile and infectious optimism, he said. There is nobody that Forough crosses his or her path that would never want to know who is this lady.

Humanity has lost one of its greatest, one of its finest,

Counsellors are meeting with students, faculty and staff to help everyone cope with the loss.

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Friend of Winnipeg plane crash victim shocked by news the jet may have been shot down - CTV News

Immunology

Not enough parents in Lancashire are vaccinating their babies – Lancashire Post

Babies in Lancashire could be at risk of catching potentially deadly illnesses as uptake rates for important jabs fall below safe levels.

The British Society for Immunology has urged the new government to deliver on its promise to develop the UKs first vaccine strategy to protect communities against nasty diseases.

Young children should get the so-called six-in-one jab, which protects against six serious infections including polio, whooping cough and diphtheria, in the first few months of their lives.

But new Public Health England data shows that just 93.2 per cent of those in Lancashire who had their first birthday in the six months to September were vaccinated.

It means 400 children missed out, with the area falling slightly short of the 95 per cent rate recommended by the World Health Organisation to prevent outbreaks.

The uptake rate for the North West over the period was 92.2 per cent, while the figure across England stood at 92.1 per cent.

The British Society for Immunology said the uptake rate across England for the six-in-one vaccine among one year olds has averaged around 92 per cent over the past year.

Low levels of vaccination coverage matter as it means these diseases have the potential to spread within our communities, infecting unvaccinated people, with young babies and people with compromised immune systems particularly at risk, said Dr Doug Brown, the groups chief executive.

We urge the new government to deliver on its promise to develop the UKs first vaccine strategy and to fully fund immunisation services to ensure our communities are protected against these preventable diseases.

But he also urged parents to make sure their children get the jabs.

He added: If you are worried your child hasnt received all the doses of the six-in-one vaccine, do make an appointment at your GP surgery.

Its much better to get your child vaccinated than risk them catching one of these nasty diseases.

Babies should have three rounds of the six-in-one vaccination at eight, 12 and 16 weeks of age.

It helps them develop a strong immunity to diphtheria, hepatitis B, haemophilus influenza type b, polio, tetanus and whopping cough all described by the NHS as serious childhood diseases.

Health minister Nicola Blackwood said: Every child must be vaccinated against dangerous and potentially fatal diseases. Vaccine uptake is very high, at around 90 per cent, for most childhood vaccines, but we are determined to drive rates up even further.

"Our new vaccination strategy, published in the new year, will consider a range of approaches to improve uptake.

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Not enough parents in Lancashire are vaccinating their babies - Lancashire Post

Immunology

DBV Technologies Reports Positive Three-Year, Long-Term Data from the PEOPLE Phase III Open-Label Extension Study of Viaskin Peanut in Children with…

Montrouge, France, January 8, 2020

DBV Technologies Reports Positive Three-Year, Long-Term Data from the PEOPLE Phase III Open-Label Extension Study of Viaskin Peanut in Children with Peanut Allergy

Patients demonstrated durable, long-term clinical benefit with an additional two years of treatment

Low discontinuations due to adverse events observed

Study represents the largest long-term peanut allergy immunotherapy trial to date, with high compliance enabling extended study participation

DBV Technologies (the Company) (Euronext: DBV ISIN: FR0010417345 Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced positive topline results of the three-year, open-label extension of the Phase III PEPITES trial (PEOPLE) evaluating the long-term efficacy and safety of investigational Viaskin Peanut in peanut-allergic children ages 4 to 11 years. The results demonstrate long-term clinical benefit as shown by an increase in eliciting dose (ED), which may decrease the chance of reacting to an accidental peanut exposure. After three years, 75.9% (107/141) of patients had increased their ED from baseline, and 51.8% (73/141) of patients reached an ED of at least 1,000 mg peanut protein by year three.

These new long-term data support the overall clinical benefit of Viaskin Peanut that weve observed to date in Phase II and III clinical trials. We are particularly pleased to see that approximately three out of four patients showed an increase in their eliciting dose over three years, regardless of their individual baseline, with roughly 1 in 7 patients able to consume 5,444 mg peanut protein without reacting during the Month 36 oral food challenge, said Dr. David Fleischer, Principal Investigator of PEPITES and PEOPLE, Director, Allergy and Immunology Center and Section Head, Childrens Hospital Colorado. Most peanut-allergic children react to a single peanut (300 mg of peanut protein) or less, with some reacting to as little as 1 mg, leading many children and families to experience constant fear of accidental exposure, loss of normalcy and decreased quality of life. These new data provide further evidence that Viaskin Peanut may reduce the risk of reaction from accidental exposure by increasing threshold reactivity through a treatment option that could be safe and convenient.

The PEOPLE study is an ongoing open-label extension study evaluating the long-term safety, tolerability and efficacy of Viaskin Peanut 250 g in patients who have completed the Phase III PEPITES trial. Of the 213 patients who were randomized in the active treatment arm of PEPITES and completed the 12-month trial, 198 patients opted to enter the PEOPLE study (safety population). Of these patients, 148 were considered completers after 36 months and 141 patients completed all treatment according to the study protocol without major deviations. Efficacy data were analyzed from these 141 patients (per-protocol).

Topline results from PEOPLE support the long-term tolerability and clinical benefit of Viaskin Peanut, demonstrating desensitization over 36 months of treatment. After 36 months, 51.8% (73/141) of patients reached an ED of at least 1,000 mg peanut protein, an increase relative to Month 12, 40.4% (57/141). In addition, 13.5% (19/141) of patients completed the food challenge without meeting stopping criteria at 36 months (cumulative dose of 5,444 mg). At Month 36, the mean cumulative reactive dose (CRD) was 1,768.8 mg (median 944 mg) compared to 223.8 mg (median 144 mg) at baseline.

The safety profile of Viaskin Peanut was consistent with that observed in the clinical program to date in over 1,000 patients. During PEOPLE, the most common adverse events were mild to moderate skin reactions localized to the administration site and there was no epinephrine use deemed related to treatment. No treatment related serious adverse events (SAEs) were reported. One patient experienced one case of mild anaphylaxis that was determined by the investigator to be possibly related to treatment and resolved without treatment. Treatment compliance remained high throughout the study at a mean of 98% over three years of treatment.

Exploratory analyses suggest Viaskin Peanut may offer sustained effect even after a period without treatment. All participants who reached an ED 1,000 mg at Month 36 were eligible to continue the study for two additional months without treatment while maintaining a peanut-free diet. A further double-blind placebo-controlled food challenge to determine ED was administered at the end of this period (Month 38). The analysis showed that 77.8% (14/18) of the children who completed the oral food challenge at Month 38 maintained desensitization with an ED 1,000 mg.

Harnessing the important immune properties of the skin, epicutaneous immunotherapy represents a potentially unique mechanism of action that may support the sustained desensitization observed in this study even after a period without treatment. These data further advance our understanding of the profile of Viaskin Peanut, which is currently under review by the U.S. Food and Drug Administration and may offer a simple, once daily, non-invasive treatment option for children living with peanut allergy in the second half of 2020, if approved, said Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies. Importantly, we would like to thank the children, families and investigators for participating in this study, the largest long-term trial in this underserved disease.

The Company plans to present full study results at future medical congresses as well as submit for publication in a peer-reviewed journal.

About PEOPLEThe PEOPLE study is an open-label extension of the Phase III PEPITES trial designed to evaluate the long-term safety, tolerability and efficacy of Viaskin Peanut 250 g (NCT03013517). Participants who completed the 12-month study period of PEPITES were eligible to enroll in PEOPLE. Patients who were randomized to active treatment in PEPITES are eligible to receive up to four additional years of treatment, and those previously receiving placebo are eligible to receive up to five years of treatment.

The study evaluates the eliciting dose after three years (Month 36) of active treatment using a double-blind, placebo-controlled food challenge (DBPCFC). The starting dose of each challenge is 1 mg of peanut protein and escalates to the highest dose of 2,000 mg peanut protein; possibly repeated once to reach a maximum total cumulative dose of 5,444 mg peanut protein. For the next DBPCFCs after four and five years, the starting dose of each challenge is 10 mg of peanut protein and escalates to the highest dose of 3,000 mg peanut protein; possibly repeated once to reach a maximum total cumulative dose of 6,440 mg peanut protein.

The analysis also includes exploratory assessments of safety parameters, immune biomarkers such as immunoglobulin E (IgE) and immunoglobulin G4 (IgG4), and sustained desensitization following a two-month period without treatment.

About PEPITESThePeanutEPIT Efficacy andSafety Study (PEPITES) was a global, double-blind, placebo-controlled Phase III trial designed to evaluate the safety and efficacy of Viaskin Peanut 250 g in children ages 4 to 11 years (NCT02636699). PEPITES was conducted in 31 centers across North America (Canada and the United States), Germany, Ireland and Australia.

Eligible patients were aged 4-11 years at screening with physician-diagnosed peanut allergy, currently following a strict peanut-free diet. Other key inclusion criteria were peanut-specific IgE >0.7 kUA/L, a peanut skin prick test with a largest wheal diameter 6 mm (children 4-5 years) or 8 mm (children 6 years) at screening, and an ED (the single highest dose at which a patient exhibited objective signs/symptoms of an immediate hypersensitivity reaction) of 300 mg peanut protein based on a DBPCFC.

PRACTALL,the joint American Academy of Allergy, Asthma & Immunology (AAAAI) and European Academy of Allergy and Clinical Immunology (EAACI) published food challenge methodology that defines strict, 30-minute intervals for peanut protein dosing, was used to evaluate sensitivity to peanut at baseline and exit.Challenges were stopped when patients exhibited clear, objective symptoms based on a pre-specified symptom scoring scale. A Good Manufacturing Practice food challenge matrix was used for all peanut protein and placebo food challenges.

During PEPITES, patients responses were assessed using DBPCFCs. Patients were randomized 2:1 to receive either Viaskin Peanut 250 g or placebo for 12 months. The primary endpoint was based on a responder analysis after 12 months of treatment with Viaskin Peanut 250 g. For patients with a baseline peanut protein ED equal to or less than 10 mg, a responder was defined as a patient with a peanut protein ED equal to or greater than 300 mg of peanut protein after 12 months of treatment. For patients with a baseline ED greater than 10 mg, a responder was defined as a patient with a peanut protein ED equal to or greater than 1,000 mg of peanut protein after 12 months of treatment.

As a secondary efficacy endpoint, CRD was also evaluated in PEPITES to establish the total quantity of peanut protein that triggers patient reactions at Month 12 of active treatment versus placebo. Serological markers were also measured at baseline, 3, 6, and 12 months in order to characterize the immunological changes in patients.

During the study, investigators relied on the commonly used National Institute of Allergy and Infectious Diseases (NIAID) definition of anaphylaxis, which has been shown to be highly sensitive but only moderately specific in diagnosing anaphylaxis, in an attempt to capture as many potential reactions as possible.

Two hundred thirteen of the 238 patients randomized to the peanut-patch and 107 of the 118 patients randomized to the placebo-patch completed the study. After 12 months of therapy, patients treated with Viaskin Peanut showed a statistically significant improvement in the ED of peanut required to provoke an allergic reaction at food challenge compared with placebo. After 12 months of treatment, we observed that 35.3% of patients on Viaskin Peanut 250 g were responders, compared to 13.6% of patients in the placebo group (treatment difference = 21.7%; 95% CI = 12.4% - 29.8%; p<0.001). An increase in the CRD was also observed between the treatment and placebo groups (nominal p-value<0.001) after 12 months. The median CRD of patients in the treatment group increased from 144 mg at baseline to 444 mg at Month 12, compared with no improvement in the placebo group.

There were no cases of severe anaphylaxis, and only four of 238 patients (1.7%) dropped out due to treatment-emergent adverse events. A low rate of treatment-related epinephrine use was reported (2.9% treatment group vs. 0.8% placebo group). Ten cases in eight Viaskin Peanut patients (3.4%) of possibly or probably treatment-related anaphylaxis occurred; all were classified as mild or moderate without evidence of cardiovascular, neurologic, or respiratory compromise. Six of these ten cases were treated with epinephrine, and five of the eight patients continued on Viaskin Peanut in the study.

About DBV TechnologiesDBV Technologies is developing Viaskin, an investigational proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT, DBVs method of delivering biologically active compounds to the immune system through intact skin. With this new class of self-administered and non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients, for whom there are no approved treatments. DBVs food allergies programs include ongoing clinical trials of Viaskin Peanut and Viaskin Milk, and preclinical development of Viaskin Egg. DBV is also pursuing a human proof-of-concept clinical trial of Viaskin Milk for the treatment of Eosinophilic Esophagitis, and exploring potential applications of its platform in vaccines and other immune diseases. DBV Technologies has global headquarters in Montrouge, France and offices in Bagneux, France, and North American operations in Summit, NJ and New York, NY. The Companys ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345), part of the SBF120 index, and the Companys ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).

Forward Looking StatementsThis press release contains forward-looking statements, including statements about the potential of the EPIT platform and Viaskin Peanut as a treatment for peanut-allergic children. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Factors that could cause actual results to differ materially from those described or projected herein include risk associated with uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals. A further list and description of these risks, uncertainties and other risks can be found in the Companys regulatory filings with the French Autorit des Marchs Financiers and U.S. Securities and Exchange Commission, including in the Companys Annual Report on Form 20-F for the year ended December 31, 2018. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise forward-looking statements as a result of new information, future events or circumstances, or otherwise, except as required by law.

DBV Investor Relations Contact Sara Blum ShermanSenior Director, Investor Relations & Strategy+1212-271-0740sara.sherman@dbv-technologies.com

DBV Media Contact Joe BeckerVP, Global Corporate Communications +1646-650-3912joseph.becker@dbv-technologies.com

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DBV Technologies Reports Positive Three-Year, Long-Term Data from the PEOPLE Phase III Open-Label Extension Study of Viaskin Peanut in Children with...

Cell Biology

CYTOVIA Therapeutics and the New York Stem Cell Foundation Research Institute enter into a partnership to develop iPSC derived CAR NK Therapeutics -…

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NEW YORK, Jan. 09, 2020 (GLOBE NEWSWIRE) -- The New York Stem Cell Foundation (NYSCF) Research Institute today announced a partnership with Cytovia Therapeutics Inc. (Cytovia) to develop new disease treatments that leverage human stem cell research and novel gene editing techniques. NYSCF will be a key partner to Cytovia in using stem cells to advance novel therapeutic targets for cancer.

Cytovia leverages NK cells to make these novel therapeutics more specific to cancer cells. NK or natural killer cells are immune cells that scan the body and attack infected or abnormal cells, often serving as a first line of defense against cancer. CAR (chimeric antigen receptor) NK cells are genetically engineered to better locate and attack tumors. CAR NK-based treatments are currently showing promise in clinical trials and could serve as a potent and cost-efficient alternative to current immunotherapies. Establishing high-quality, stem-cell-derived NKs and CAR NKs will help improve these treatments and accelerate their path to the clinic.

The NYSCF Research Institute is a pioneer and acknowledged leader in stem cell technology, having developed the NYSCF Global Stem Cell Array, the premier automated robotic platform for reprogramming adult cells into induced pluripotent stem cells (iPSCs). These iPSCs carry the genetic blueprint of the person from whom they are derived and can be turned into any cell type in the body, allowing scientists to study disease mechanisms in affected cells or modify them for use in therapeutics.

Our mission is to bring lifesaving treatments to patients around the world and we are excited to further this goal in partnership with Cytovia, says NYSCF CEO and founder Susan L. Solomon. It is critical that we collaborate with partners using our technology and expertise to bring innovative treatments to the market.

We are delighted to collaborate with the NYSCF Research Institute to develop iPSC-derived NK and CAR NK therapeutics, says Dr. Daniel Teper, CEO of Cytovia. By integrating NYSCFs world-class stem cell know-how and the precision gene-editing research conducted at the University of California San Francisco, Cytovia aims to become a leader in NK cell therapeutics for the treatment of cancer.

About The New York Stem Cell Foundation Research Institute The New York Stem Cell Foundation (NYSCF) Research Institute is an independent non-profit organization accelerating cures and better treatments for patients through stem cell research. The NYSCF global community includes over 190 researchers at leading institutions worldwide, including the NYSCF Druckenmiller Fellows, the NYSCF Robertson Investigators, the NYSCF Robertson Stem Cell Prize Recipients, and NYSCF Research Institute scientists and engineers. The NYSCF Research Institute is an acknowledged world leader in stem cell research and in the development of pioneering stem cell technologies, including the NYSCF Global Stem Cell Array, which is used to create cell lines for laboratories around the globe. In 2019, NYSCF launched its Womens Reproductive Cancers Initiative, which aims to shift paradigms in the way these cancers are studied and treated, in collaboration with leading cancer experts across the globe. NYSCF focuses on translational research in an accelerator model designed to overcome barriers that slow discovery and replace silos with collaboration. For more information, visit http://www.nyscf.org.

About Cytovia Therapeutics Inc. Cytovia is dedicated to the development of transformational cancer immunotherapies, addressing several of the most challenging unmet medical needs including the prevention of cancer relapse and metastasis. Cytovia focuses on Natural Killer (NK) cell biology and applies precision medicine tools to develop the right therapy for the right patient at the right stage of the disease. Cytovia has secured access to multiple advanced technologies, including allogeneic cell therapy, multispecific antibodies, and cytokines. Cytovia establishes development partnerships to accelerate time-to-market and commercialization alliances in order to optimize rapid adoption of its novel immunotherapies. Learn more at cytoviatx.com

Contact information:CYTOVIA Therapeutics:Anna Baran-DjokovicVP, Corporate Affairs anna@cytoviatx.com

Cytovia Media Contact: Charlotte Tomic charlotte@tomiccommmunications.com Cell: 9178825243

NYSCF Research InstituteDavid McKeonChief of Staff dmckeon@nyscf.org

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CYTOVIA Therapeutics and the New York Stem Cell Foundation Research Institute enter into a partnership to develop iPSC derived CAR NK Therapeutics -...