Category Archives: Immunology

Immunology

VBI Vaccines Announces FDA Approval of PreHevbrio for the Prevention of Hepatitis B in Adults – Yahoo Finance

- PreHevbrio is the only approved 3-antigen hepatitis B vaccine for adults in the U.S.

- Shareholder conference call to be held today, December 1, at 8:30 AM ET

CAMBRIDGE, Mass., December 01, 2021--(BUSINESS WIRE)--VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the U.S. Food and Drug Administration (FDA) has approved PreHevbrio [Hepatitis B Vaccine (Recombinant)] for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older. PreHevbrio contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the U.S.

"As we work to implement the ACIPs new universal hepatitis B vaccine recommendation for all adults ages 19-59, as voted on in November, we benefit from having more tools, including this newly approved 3-antigen hepatitis B vaccine," said Chari Cohen, DrPH, MPH, Senior Vice President of the Hepatitis B Foundation. "Having more vaccine options will help us effectively expand vaccine uptake, ensure more people are protected from hepatitis B infection, and reach the 2030 goal of eliminating hepatitis B in the U.S."

Jeff Baxter, VBIs President and CEO, commented: "We are proud to announce the approval of PreHevbrio, VBIs first FDA-approved vaccine. This is a substantial achievement that demonstrates the VBI teams ability to progress vaccine candidates from the clinic through to approval. This approval, however, is just the first step in our mission to provide broad access to our vaccine and to help strengthen the public health effort to put an end to adult HBV infections. We would like to thank the study participants, clinical site investigators, our employees, and all who contributed to this achievement, and we look forward to working with public health and advocacy organizations as we join the fight against hepatitis B."

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The approval of PreHevbrio was based on the results from two Phase 3 clinical studies, PROTECT and CONSTANT, data from which were published, respectively, in The Lancet Infectious Diseases in May 2021 and The Journal of the American Medical Association Network Open in October 2021. The pivotal studies compared PreHevbrio to Engerix-B, a single-antigen HBV vaccine. Data from the PROTECT study showed that PreHevbrio elicited higher rates of seroprotection in all subjects age 18+ (91.4% vs. 76.5%), including in adults age 45+ (89.4% vs. 73.1%). The integrated safety analysis of both studies demonstrated good tolerability with no unexpected reactogenicity. The most common adverse events in all age groups were injection site pain and tenderness, myalgia, and fatigue, all which generally resolved without intervention in 1-2 days.

VBI expects to make PreHevbrio available in the U.S. in the first quarter of 2022, and has partnered with Syneos Health for the past two years to ensure commercial readiness.

Outside of the U.S., VBI continues to support the European Medicines Agencys (EMA) ongoing review of the marketing authorization application for VBIs 3-antigen HBV vaccine. VBI expects to complete regulatory submissions to the United Kingdoms Medicines and Healthcare products Regulatory Agency (MHRA) and to Health Canada in 2022.

Conference Call Details

VBI Vaccines will host a conference call on Wednesday, December 1 at 8:30 AM ET. The live call can be accessed via the Events/Presentations page in the Investors section of the Companys website, or by clicking this link: https://viavid.webcasts.com/starthere.jsp?ei=1517423&tp_key=00a076a769.

A replay of the conference call will be archived on the Companys website following the live call.

To listen to the live conference call, please dial:

- Toll-free U.S. & Canada Dial-In: 877-705-6003

- International Dial-In: 201-493-6725

- Conference ID: 13725342

Indication and Use

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

Important Safety Information (ISI)

Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.

Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.

PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).

To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or http://www.vaers.hhs.gov

Please see full Prescribing Information.

About Hepatitis B

Hepatitis B is one of the worlds most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.

Earlier in November 2021, the U.S. Centers for Disease Control and Preventions (CDC) Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend universal HBV vaccination for adults age 18 to 59, and for adults age 60+ with risk factors for infection, expanding the addressable adult population that should be vaccinated.

About PreHevbrio

PreHevbrio is an adult hepatitis B vaccine that contains the three hepatitis B surface antigens of the hepatitis B virus S, pre-S1, and pre-S2. PreHevbrio is also approved for use and commercially available in Israel under the brand name Sci-B-Vac.

About VBI Vaccines Inc.

VBI Vaccines Inc. ("VBI") is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles ("VLPs"), including a proprietary enveloped VLP ("eVLP") platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.

Website Home: http://www.vbivaccines.com/

News and Resources: http://www.vbivaccines.com/news-and-resources/

Investors: http://www.vbivaccines.com/investors/

Cautionary Statement on Forward-looking Information

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). The Company cautions that such statements involve risks and uncertainties that may materially affect the Companys results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Companys ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Companys products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Companys filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, as may be supplemented or amended by the Companys Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211201005387/en/

Contacts

VBINicole AndersonDirector, Corporate Communications & IRPhone: (617) 830-3031 x124Email: IR@vbivaccines.com

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VBI Vaccines Announces FDA Approval of PreHevbrio for the Prevention of Hepatitis B in Adults - Yahoo Finance

Immunology

Everything We Know and Don’t Know About the Omicron Variant – WDET

This week, Michigan hit a dreadful milestone. The statehasthe highest numberof adults hospitalized with COVID-19 since the pandemic began, even as vaccines are widelyavailable.

I think its important for everyone to remember that we know so little right now. Adam Lauring, microbiologist at University ofMichigan

Now, many Michiganders and Americans are worried about anew variantthat has emerged and is spreading around theworld.

Adam Lauringis an associate professor of microbiology and immunology, and infectious diseases at the University of Michigan medical school. I think its important for everyone to remember that we know so little right now, hesays.

Laurings lab uploads the second most variant data in Michigan behind the state lab. He says some viral mutations are much more important than others, which is contingent upon how quickly the new virus spreads and the lethality that it brings withit.

WDET strives to make our journalism accessible to everyone. As a public media institution, we maintain our journalistic integrity through independent support from readers like you. If you value WDET as your source of news, music and conversation, please make a gift today.

Donate today

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Everything We Know and Don't Know About the Omicron Variant - WDET

Immunology

Letter to the editor | In support of Hakeem Jefferson and the Early Career Black Faculty Group – The Stanford Daily

To our Stanford Community,

In response to the recent racist attacks on Professor Hakeem Jefferson and the open letter published in The Stanford Daily from the Early Career Black Faculty Group, we, the chairs of the Basic Bioscience Departments in the Stanford Schools of Medicine, Humanities and Sciences, and Engineering, the directors of the Biosciences Institutes and the directors of the Interdisciplinary Biosciences Programs, express our support for Professor Jefferson and the requests made in the open letter. We condemn the coordinated, racist attacks against Professor Jefferson and call on ourselves, our community and our University to help protect and defend our Black colleagues in response to these attacks. We commit to developing proactive strategies, in coordination with our Black faculty, to prevent these attacks in the future, and when we cannot prevent them, to respond to them quickly and to mitigate their negative impacts. We hope that we can help Stanford become a community where all of our members feel safe and included as we pursue our scholarly endeavors and career aspirations.

Chairs of Basic Biomedical Science Departments in the Schools of Medicine, Engineering,and Humanities and Science, directors of the Biosciences Institutes and the directors of the Interdisciplinary Biosciences Programs

Stephen A. Baccus Chair, Department of Neurobiology

Melissa L. Bondy Chair, Department of Epidemiology and Population Health

James K. Chen Chair, Department of Chemical and Systems Biology

Jennifer R. Cochran Chair, Department of Bioengineering

Martha S. Cyert Chair, Department of Biology

Miriam B. Goodman Chair, Department of Molecular and Cellular Physiology

Sherril L. Green Chair, Department of Comparative Medicine

Theodore S. Jardetzky Chair, Department of Structural Biology

Paul S. Mischel Vice Chair for Research, Department of Pathology

Thomas Montine Chair, Department of Pathology

Douglas K. Owens Chair, Department of Health Policy

Sylvia K. Plevritis Chair, Department of Biomedical Data Science

David S. Schneider Chair, Department of Microbiology and Immunology

Michael Snyder Chair, Department of Genetics

AaronF. Straight Chair, Department of Biochemistry

Anne Villeneuve Chair, Department of Developmental Biology

Steven Artandi Director, Stanford Cancer Institute

Carolyn Bertozzi Director, ChEM-H Institute

Mark M. Davis Director, Institute for Immunity, Transplantation, and Infection

Mary Leonard Director, Maternal and Child Health Research Institute

Crystal Mackall Director, Parker Institute for Cancer Immunotherapy

William Newsome Director, Wu Tsai Neuroscience Institute

Carla Shatz Director, Bio-X Program

Irving Weissman Director, Institute for Stem Cell Biology and Regenerative Medicine

Joseph C. Wu Director, Cardiovascular Institute

Olivia Martinez Director, Immunology Interdisciplinary Graduate Program

K.C. Huang Director, Biophysics Interdisciplinary Graduate Program

Tushar Desai Co-Director, Stem Cell Biology and Regenerative Medicine Interdisciplinary Graduate Program

Gerald Spangrude Co-Director, Stem Cell Biology and Regenerative Medicine Interdisciplinary Graduate Program

Julien Sage Co-Director, Cancer Biology Interdisciplinary Graduate Program

Laura Attardi Co-Director, Cancer Biology Interdisciplinary Graduate Program

Justin Gardner Co-Director, Neurobiology Interdisciplinary Graduate Program

Merritt Maduke Co-Director, Neurobiology Interdisciplinary Graduate Program

Link:
Letter to the editor | In support of Hakeem Jefferson and the Early Career Black Faculty Group - The Stanford Daily

Immunology

Robert Koch Prize in Microbiology and Immunology Goes to Andreas Bumler – UC Davis

Microbiologist Andreas Bumler of the School of Medicine and the College of Biological Sciences has been named a recipient of the 2021 Robert Koch Prize, given by Germanys Robert Koch Foundation for achievement in microbiology and immunology a prize that is considered one of the most prestigious awards in science.

Bumler is a professor and vice chair of research in the Department of Medical Microbiology and Immunology, and also affiliated with four graduate groups: Microbiology; Immunology; Integrative Pathobiology; and Biochemistry, Molecular, Cellular and Developmental Biology.

He shares the prize with Yasmine Belkaid, immunologist and senior investigator at the National Institute of Allergy and Infectious Diseases, and adjunct professor at the University of Pennsylvania.

The Robert Koch Prize is shared this year to recognize groundbreaking research that shows how, on the one hand, our microflora train our immune system, and on the other hand, our intestinal epithelium determines the composition of our microflora, and what role disruptions of this dialogue between microflora and us play in infectious and inflammatory diseases, the foundation said in a news release.

UC Davis Professor Satya Dandekar, chair of the Department of Medical Microbiology and Immunology, said: Dr. Bumler has made seminal contributions for advancing our knowledge of the microbial dysbiosis during gut inflammatory infections. He is an exceptional scientist and a great mentor to junior researchers.

The award ceremony is scheduled for Nov. 19 in Berlin. As of today (Nov. 8), the prize of 120,000 euros is the equivalent of $139,075.

Wolfgang Plischke, chair of the Robert Koch Foundation, said: At a time when science and research are constantly at the center of public interest and are often the subject of unfiltered discussion on social networks, it is more important than ever to honor the hard work, unwavering diligence and thirst for knowledge of all the men and women who have dedicated their lives to medicine and biology.

Robert Koch (18431910), after whom the prize is named, founded modern bacteriology. For this he received the Nobel Prize for Medicine and Physiology in 1905. Koch headed the Institute for Infectious Diseases in Berlin from 1891 until his retirement in 1904.

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Robert Koch Prize in Microbiology and Immunology Goes to Andreas Bumler - UC Davis

Immunology

Oncology meets immunology: the cancer-immunity cycle

The genetic and cellular alterations that define cancer provide the immune system with the means to generate T cell responses that recognize and eradicate cancer cells. However, elimination of cancer by T cells is only one step in the Cancer-Immunity Cycle, which manages the delicate balance between the recognition of nonself and the prevention of autoimmunity. Identification of cancer cell T cell inhibitory signals, including PD-L1, has prompted the development of a new class of cancer immunotherapy that specifically hinders immune effector inhibition, reinvigorating and potentially expanding preexisting anticancer immune responses. The presence of suppressive factors in the tumor microenvironment may explain the limited activity observed with previous immune-based therapies and why these therapies may be more effective in combination with agents that target other steps of the cycle. Emerging clinical data suggest that cancer immunotherapy is likely to become a key part of the clinical management of cancer.

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Oncology meets immunology: the cancer-immunity cycle

Immunology

Biovaxys says CoviDTH shows safety and tolerability in pathology and immunology evaluations – Proactive Investors USA & Canada

BioVaxys Technology Corp Chief Medical Officer David Berd joined Proactive to discuss results from its in vivo animal research study support the safety and tolerability of CoviDTH at two intradermal dose levels across a battery of clinical pathology, immunology, and histopathology evaluations.

CoviDTH is the world's first and only low-cost, disposable, point-of-care diagnostic tool that screens for a T-cell response to SARS-CoV-2, the virus that causes coronavirus, according to BioVaxys.

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Biovaxys says CoviDTH shows safety and tolerability in pathology and immunology evaluations - Proactive Investors USA & Canada

Immunology

The Science Behind COVID-19 Vaccines & Immunology – News | University Communication | Nebraska

Increase your understanding of the science behind biology and immunology, along with how scientists use that information to develop vaccines and how these vaccines work in our bodies. Plan to attend this interesting and informal educational session with Dr. Angie Pannier, a biomedical engineer and expert in nucleic acid vaccines, and Dr. Amanda Ramer-Tait, an immunologist and expert on host-microbe interactions.

Whether youre a budding researcher yourself or youd like to increase your scientific knowledge to share with family and friends, this session will break down the basics of how vaccines work. The first 45 minutes will provide an overview and the second half of the session will offer time for Q&A.

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The Science Behind COVID-19 Vaccines & Immunology - News | University Communication | Nebraska

Immunology

Correction for Wolfsberger et al., TAp73 represses NF-Bmediated recruitment of tumor-associated macrophages in breast cancer – pnas.org

IMMUNOLOGY AND INFLAMMATION Correction for TAp73 represses NF-Bmediated recruitment of tumor-associated macrophages in breast cancer, by Johanna Wolfsberger, Habib A. M. Sakil, Leilei Zhou, Niek van Bree, Elena Baldisseri, Sabrina de Souza Ferreira, Veronica Zubillaga, Marina Stantic, Nicolas Fritz, Johan Hartman, Charlotte Rolny, and Margareta T. Wilhelm, which published March 1, 2021; 10.1073/pnas.2017089118 (Proc. Natl. Acad. Sci. U.S.A. 118, e2017089118).

The authors note that Supporting Table S2 in the SI Appendix appeared incorrectly. Regarding this error, the authors note, Sanger sequencing primers for the mouse and human Ccl2 gene have mistakenly been entered in the qPCR primer table (SI Appendix, Table S2) instead of the qPCR primer sequences for Ccl2 that were used in this study.

The authors also note that an error appeared in Fig. 3 and Fig. S3 in the SI Appendix. In both figures, the histograms are labeled DMSO but should instead be labeled siCtrl. The corrected figure and its legend appear below. The online version has been corrected, including the SI Appendix with the corrected Table S2 and Fig. S3.

TAp73 represses NF-Bmediated regulation of Ccl2 expression. (A) qRT-PCR analysis of Ccl2 mRNA levels in (A) TAp73 WT and KO MEFE1A/Ras (n = 3) and (B) PyMT/TAp73 WT or KO cells (n = 4) after 16-h treatment with NF-B inhibitor SC-514 (100 g/mL). ELISA analysis of Ccl2 protein secretion in conditioned media from (C) TAp73 WT and KO MEFE1A/Ras (n = 3) and (D) PyMT/TAp73 WT or KO cells (n = 4) after 16-h treatment with SC-514 (100 g/mL). (E and F) qRT-PCR analysis of Ccl2 mRNA levels in (E) TAp73 WT and KO MEFE1A/Ras (n = 3) and (F) PyMT/TAp73 WT or KO cells (n = 3) after 48-h treatment with sip65/RELA. (G and H) ELISA analysis of Ccl2 protein secretion in conditioned media from (G) TAp73 WT and KO MEFE1A/Ras (n = 3) and (H) PyMT/TAp73 WT or KO cells (n = 3) after 48-h treatment with sip65/RELA. (I) Schematics showing the murine Ccl2 promoter including NF-B response elements, of which the distal BSs 3 and 4 were deleted either individually or simultaneously. (J) WT or mutated Ccl2 promoter luciferase reporter was cotransfected with TAp73 in HEK293 cells. Luciferase activity was measured 24 h after transfection and normalized to mock control (n = 6). All data are shown as mean SD *P < 0.05, **P < 0.01, ****P < 0.0001.

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Correction for Wolfsberger et al., TAp73 represses NF-Bmediated recruitment of tumor-associated macrophages in breast cancer - pnas.org

Immunology

Fight Misinformation With Anticipation, Facts, and Curiosity – Medscape

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

With the Delta variant taking hold and COVID cases on the rise in mid-July, US Surgeon General Vivek Murthy, MD, MBA, released an advisory declaring that misinformation was a serious health threat and urging Americans to help slow its spread during the pandemic and beyond.

Last weekend, speakers at the American College of Allergy, Asthma, and Immunology (ACAAI) 2021 Annual Meeting, in New Orleans, Louisiana, issued a similar call to arms. "We have to take advantage of the very special role that we all play in the lives of our patients," said David Stukus, MD, an allergist-immunologist and professor of clinical pediatrics at Nationwide Children's Hospital, Columbus, Ohio. "We want to use that trust that we've developed with them to help combat misinformation."

According to a poll conducted by the Kaiser Family Foundation, personal doctors and pediatricians topped the list of trusted sources for reliable COVID-19 vaccine information, Gerald Lee, MD, associate professor of pediatrics at Emory University School of Medicine, Atlanta, Georgia, told attendees.

Social media usage has soared over the past decade. Today, 7 in 10 Facebook users say they visit the site daily, and nearly 80% of Americans who regularly get news on Snapchat and TikTok view social media as an important source of vaccine news, according to Pew Research Center data that Lee presented at the meeting.

Although research shows that most people do a decent job discriminating truth from fake news, when it comes to sharing news on social media platforms, that discernment drops considerably. "Users share misinformation without considering accuracy," said Lee, citing a March 2021 study published in Nature. Social media algorithms tend to promote content that is emotionally engaging. This amplification allows "a small number of activists to achieve influence," Lee said. Their continued, repetitive messaging "perpetuates misinformation to being accepted by the public," he said.

Anne Ellis, MD, chair of allergy and immunology at Queen's University, in Kingston, Ontario, Canada, called for vigilance among allergy practitioners to fight the cycle of misinformation and not let fake news shape medical decision making. "Make facts your hook when you're talking to patients" and explain that "science is an evolving process," Ellis said at ACAAI.

"Providing facts not only helps patients trust and value their provider's input, but facts also help patients challenge anxiety-provoking information they may have learned via social media," Tamara Hubbard, LCPC, told Medscape Medical News. Hubbard, a licensed counselor in the Chicago area, works with food-allergy families and maintains a resource website that includes an international directory of allergy-informed clinical therapists.

Stukus encouraged physicians to anticipate patients' confusion and to be proactive about engaging people on these topics. "Ask questions," he said. "See if they have any concerns about health-related information or about things impacting their allergic conditions." Observe nonverbal cues, he said. For example, when asking patients whether they have concerns about the COVID vaccine, "they may say no, but their body may say something different." Then, he said, take time "to dive into the nuance."

In addition, he advised clinicians to bear in mind the fact that many patients have trouble comprehending risk and to seek different ways to convey health information. "It's one thing to say only five out of a million people have anaphylaxis to COVID vaccines," Stukus said. "You can also state that 999,995 people out of the million didn't have anaphylaxis when they got a COVID vaccine. Some people need to hear that."

He advised that when conversations wander into unfamiliar territory, one should be humble and transparent. If a patient throws a stumper, "I say, 'I honestly don't know. But you've given me an assignment that I'll happily take on, so I can give you the right information about that particular question you just asked,' " Ellis said.

Stukus has consulted for Before Brands, Integrity CE, and Kaleo; works as social media editor for the American Academy of Allergy, Asthma and Immunology (AAAAI) and is associate editor for Annals of Allergy, Asthma and Immunology; and receives honoraria from the American College of Allergy, Asthma and Immunology (ACAAI), the American Academy of Pediatrics, and AAAAI. Ellis has received an honorarium from AstraZeneca to give webinars on managing allergic and adverse reactions to COVID-19 vaccines. Lee reports no relevant financial relationships. Hubbard is an allied health member of ACAAI and AAAAI and completed a paid project for the nonprofit organization Food Allergy Research and Education.

American College of Allergy, Asthma, and Immunology (ACAAI) 2021 Annual Meeting: Presented November 6, 2021.

Esther Landhuis is a freelance science journalist in the San Francisco Bay Area. She can be found on Twitter @elandhuis.

For more news, follow Medscape on Facebook, Twitter, Instagram, and YouTube.

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Fight Misinformation With Anticipation, Facts, and Curiosity - Medscape

Immunology

OSE Immunotherapeutics Presented the First Positive Preclinical Efficacy Data on CLEC-1, a Novel Myeloid Immune Checkpoint Target For Cancer…

Data presented at the 36th Annual Society for Immunotherapy of Cancer (SITC) Meeting

NANTES, France, November 15, 2021--(BUSINESS WIRE)--Regulatory News:

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) (Paris:OSE) presented the first positive preclinical efficacy data on its novel myeloid cell immune checkpoint target, CLEC-1 (a C-type lectin receptor), at the Society for Immunotherapy of Cancer (SITC) 36 th Annual Meeting in Washington D.C. held in-person and virtually on November 10 14, 2021.

In the poster entitled: "Preclinical efficacy of CLEC-1 antagonist as novel myeloid immune checkpoint therapy for oncology", OSE Immunotherapeutics and Dr Elise Chiffoleaus research team* reported results from their collaborative program, and for the first time highlighted significant preclinical efficacy of CLEC-1 antagonist antibodies in vivo and in monotherapy in an hepatocarcinoma tumor model in immunocompetent mice.

Nicolas Poirier, Chief Scientific Officer of OSE Immunotherapeutics, commented: "The identification of CLEC-1 and its antagonists is an exciting innovation in cancer immunotherapy, as already presented in recent immuno-oncology events. The latest preclinical efficacy data generated from our teams collaboration opens the development pathway for monoclonal antagonist antibodies targeting CLEC-1 and for further translational clinical development in the coming years as a new myeloid immune checkpoint therapy releasing the breaks on macrophages and dendritic cells. CLEC-1 is a new myeloid checkpoint inhibitor identified and validated for cancer immunotherapy after the CD47-SIRP pathway, which is now a competitive drug development focus."

CLEC-1 is a C-type lectin receptor with demonstrated potential to inhibit the functions of myeloid cells and to block anti-tumor responsiveness of T-lymphocytes. Myeloid cells have the ability to accumulate in the tumor microenvironment and deregulate the immune activation of T-lymphocytes.

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Previous presentations (AACR 2020 and 2021, SITC 2020) ** featured CLEC-1 antagonist monoclonal antibodies identified as an innovative immunotherapy that releases the brakes on macrophage phagocytosis and dendritic cells and demonstrates synergistic anti-cancer effects, in particular when paired with chemotherapy.

*Center for Research in Transplantation and Immunology, UMR1064, INSERM, Nantes University at Nantes University Hospital (CHU).

** AACR 2020 Virtual Annual Meeting II oral presentation details CLEC-1 suppress dendritic cell antigen presentation and is a novel myeloid immune checkpoint target for cancer immunotherapy.Drouin M, Saenz J, Evrard B, Gauttier V, Teppaz G, Lopez-Robles MD, Louvet C, Poirier N, Chiffoleau E

AACR 2020 Virtual Annual Meeting II poster details CLEC-1 is a novel myeloid immune checkpoint for cancer immunotherapy controlling damaged and tumor cells phagocytosis.Gauttier V, Drouin M, Saenz J, Evrard B, Mary C,, Teppaz G, Desalle A, Thpenier V, Wilhelm E , Poirier N, Chiffoleau E

SITC 2020 Virtual Annual Meeting poster details CLEC-1 is a novel myeloid immune checkpoint controlling damaged and tumor cells phagocytosis.Gauttier V, Pengam S, Drouin M, Saenz J, Evrard B, Biteau K, Mary C,, Teppaz G, Desalle A, Thpenier V, Wilhelm E , Poirier N, Chiffoleau E

AACR 2021 Virtual Annual Meeting II CLEC-1 is a novel myeloid immune checkpoint for cancer immunotherapy limiting tumor cells phagocytosis and tumor antigen cross-presentation.Gauttier V., Pengam S., Drouin M., Saenz J., Evrard B., Mary C., Teppaz G., Desselle A., Thpenier V., Wilhelm E., Poirier N., Chiffoleau E.

ABOUT OSE ImmunotherapeuticsOSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The companys immunology research and development platform is focused on three areas: T-cell-based vaccination, Immuno-Oncology (focus on myeloid targets), Auto-immunity & Inflammation. Its balanced first-in-class clinical and preclinical portfolio has a diversified risk profile:

Vaccine platform

- Tedopi (innovative combination of neoepitopes): the companys most advanced product; positive results for Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients after secondary resistance to checkpoint inhibitors.

In Phase 2 in pancreatic cancer (TEDOPaM), sponsor GERCOR.

In Phase 2 in ovary cancer, in combination with pembrolizumab (TEDOVA), sponsor ARCAGY-GINECO.

In Phase 2 in non-small cell lung cancer in combination with nivolumab, sponsor Italian foundation FoRT.

- CoVepiT: a prophylactic second-generation vaccine against COVID-19, developed using SARS-CoV-2 optimized epitopes against multi variants. Positive preclinical and human ex vivo results. Voluntary and temporary Phase 1 enrollment suspension on-going (July 2021).

Immuno-oncology platform

- BI 765063 (OSE-172, anti-SIRP mAb on CD47/SIRP pathway): developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 dose escalation results of BI 765063 in monotherapy or in combination with ezabenlimab (PD-1 antagonist); Expansion Phase 1 open for screening.

- CLEC-1 (novel myeloid checkpoint target): identification of mAb antagonists of CLEC-1 blocking the "Dont Eat Me" signal that increase both tumor cell phagocytosis by macrophages and antigen capture by dendritic cells.

- BiCKI: bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) combined with new immunotherapy targets; 2nd generation of PD-(L)1 inhibitors to increase antitumor efficacity.

Auto-immunity and inflammation platform

- FR104 (anti-CD28 monoclonal antibody): Licensing partnership agreement with Veloxis in the organ transplant market; ongoing Phase 1/2 in renal transplant (sponsored by the Nantes University Hospital); Phase 2-ready asset in an autoimmune disease indication.

- OSE-127/S95011 (humanized monoclonal antibody targeting IL-7 receptor): developed in partnership with Servier; positive Phase 1 results; in Phase 2 in ulcerative colitis (OSE sponsor) and an independent Phase 2a ongoing in Sjgrens syndrome (Servier sponsor).

- OSE-230 (ChemR23 agonist mAb): first-in-class therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.

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Forward-looking statementsThis press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.These forward-looking statements include statements typically using conditional and containing verbs such as "expect", "anticipate", "believe", "target", "plan", or "estimate", their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on 15 April 2021, including the annual financial report for the fiscal year 2020, available on the OSE Immunotherapeutics website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211114005024/en/

Contacts

OSE Immunotherapeutics Sylvie Dtrysylvie.detry@ose-immuno.com +33 153 198 757

Investor Relations Thomas Guillotthomas.guillot@ose-immuno.com +33 607 380 431

Media U.S. Media: LifeSci Communications Darren Opland, Ph.D.darren@lifescicomms.com +1 646 627 8387

French Media: FP2COM Florence Portejoiefportejoie@fp2com.fr +33 607 768 283

Guillaume van Renterghem LifeSci Advisorsgvanrenterghem@lifesciadvisors.com +41 76 735 01 31

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OSE Immunotherapeutics Presented the First Positive Preclinical Efficacy Data on CLEC-1, a Novel Myeloid Immune Checkpoint Target For Cancer...