IGM Biosciences Announces Leadership Appointments and Formation of IGM Infectious Diseases and IGM Autoimmunity and Inflammation Business Units

– John Shiver, Ph.D., and Tong-Ming Fu, M.D., Ph.D., Appointed as Chief Strategy Officer and Chief Scientific Officer, Respectively, of IGM Infectious Diseases –

– Mary Beth Harler, M.D., Appointed as President of IGM Autoimmunity and Inflammation –

MOUNTAIN VIEW, Calif., Oct. 11, 2021 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced the formation of two business units: IGM Infectious Diseases and IGM Autoimmunity and Inflammation. These new business units will utilize and build upon IGM’s platform technology to create and develop novel IgM and IgA antibodies to address infectious diseases, autoimmunity and inflammation. Both business units will be headquartered in the greater Philadelphia area of Pennsylvania.

“We believe the successes we have achieved clinically and preclinically this year, together with our successes with engineering and manufacturing IgM antibodies, provide a strong basis for the expansion of our research and development efforts beyond oncology,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “We are very excited that Drs. Shiver, Fu and Harler have decided to bring their decades of experience as successful drug developers and thought leaders in infectious diseases, autoimmunity and inflammation to help develop the potential of the IGM technology across a broad range of disease areas that may be transformed by therapeutic IgM and IgA antibodies.”

To lead the IGM Autoimmunity and Inflammation business unit, IGM today announced the appointment of Mary Beth Harler, M.D., as President. Dr. Harler served most recently as Senior Vice President, Head of Immunology and Fibrosis Development at Bristol Myers Squibb, where she oversaw late-stage development of assets with the potential to become approved treatment options for patients with diseases such as psoriasis, inflammatory bowel disease (IBD) and nonalcoholic steatohepatitis (NASH), among others. Dr. Harler also oversaw approved medicines that sit within the immunology and fibrosis portfolios, such as Orencia and Zeposia. Prior to being appointed to that position, Dr. Harler served in positions of increasing responsibility at Bristol Myers Squibb for almost 10 years. Notably, Dr. Harler served as Head of Innovative Medicines Development and Head of Innovative Clinical Development in the cardiovascular, fibrosis, immunoscience and genetically-defined diseases group.

Prior to joining Bristol Myers Squibb, Dr. Harler worked in both medical affairs and clinical research at Wyeth Pharmaceuticals (now part of Pfizer). Dr. Harler received a B.S. from Wheeling University in West Virginia and an M.D. from Marshall University. She then went on to complete training as a general surgeon at Brown University’s Rhode Island Hospital, where she was also a research fellow with a focus on the role of immune cells in wound healing.  

“As the global leader in the development of engineered IgM antibodies, I believe IGM Biosciences has the potential to create exciting new therapies for patients with autoimmune and inflammatory diseases,” said Dr. Harler. “The IGM Autoimmunity and Inflammation business unit will be dedicated to rapidly and efficiently establishing our platform’s full potential in these therapeutic areas, and I look forward to building and leading the team in these efforts.”

To lead the IGM Infectious Diseases business unit, IGM today also announced the appointments of John Shiver, Ph.D. and Tong-Ming Fu, M.D., Ph.D., as Chief Strategy Officer and Chief Scientific Officer, respectively.

Dr. Shiver was most recently Senior Vice President, Vaccine Research and Development at Sanofi Pasteur. Prior to joining Sanofi, Dr. Shiver held positions of increasing responsibility at Merck & Co., most recently as Vice President, Vaccine and Biologics Basic Research and Global Vaccine Research Franchise Head. He has also served as an Adjunct Professor at the University of Pennsylvania College of Medicine for ten years. Over the course of his career, he has contributed leadership towards the approval of ten novel pharmaceutical products and has worked on product candidates addressing more than forty infectious and noninfectious diseases. He received a Ph.D. in Chemistry from the University of Florida and a B.S. in Chemistry and Mathematics from Wofford College.

“IgM antibodies are nature’s first line of defense against pathogens, and the preclinical data to date suggest that engineered IgM antibodies could be very helpful in treating and preventing COVID-19 and other infectious diseases,” said Dr. Shiver. “Following the expansion of the IgM platform into infectious diseases with our intranasally delivered IgM antibody, IGM-6268, for the treatment and prevention of COVID-19, as described in a recent Nature publication, IGM has been advancing its understanding of the potential of IgM antibodies in other infectious diseases. I am very excited that the IGM Infectious Diseases business unit has been established, and I look forward to helping to build and lead the team working to broadly develop this potential in infectious diseases.”

Dr. Fu served most recently as Head of Vaccine Research, North America, at Sanofi Pasteur, where he led a group of over 40 scientists working on multiple vaccine projects, including respiratory syncytial virus, influenza virus, SARS-CoV-2, chlamydia and pertussis, and novel vaccine or technology platforms including mRNA and recombinant human antibodies. Prior to his time at Sanofi, Dr. Fu was a research scientist in vaccines and biologics at Merck & Co. Dr. Fu is also an Adjunct Professor at the Texas Therapeutic Institute, Texas Health Science Center. Dr. Fu received a Ph.D. from the Milton S. Hershey Medical Center at the Pennsylvania State University College of Medicine and an M.D. from Peking University Health Science Center, formerly Beijing Medical University.

“Based on IGM’s preclinical work demonstrating that IgM antibodies can be more effective at neutralizing viruses, including SARS-CoV-2, as compared with traditional IgG antibodies, we feel it is important to expand the scope of research and development to explore the use of IgM antibodies in a variety of infectious diseases where there is unmet need,” said Dr. Fu. “I am very excited to help build the team and lead the work at IGM Infectious Diseases to develop new antibody therapies that can provide exciting new medicines to treat and prevent infectious diseases.”

About IGM Biosciences, Inc.

Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including statements relating to IGM’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to: the potential of, and expectations regarding IGM’s technology platform, its IgM and IgA antibodies and product candidates, its expansion into infectious diseases and autoimmunity and inflammation, and its newly created infectious diseases and autoimmunity and inflammation business units; the Company’s research and development strategy and statements by the Chief Executive Officer of IGM, the Chief Strategy Officer and Chief Scientific Officer of IGM’s Infectious Diseases business unit and the President of IGM’s Autoimmunity and Inflammation business unit. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: potential delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including any future impacts to IGM’s operations, the manufacturing of its product candidates, the progression of its clinical trials, enrollment in its current and future clinical trials and progression of its collaborations and related efforts; IGM’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM’s ability to demonstrate the safety and efficacy of its product candidates; IGM’s ability to successfully and timely advance its product candidates through preclinical studies and clinical trials; IGM’s ability to enroll patients in its clinical trials; the potential for the results of clinical trials to differ from preclinical, preliminary or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; IGM’s ability to successfully manufacture and supply its product candidates for clinical trials; the potential impact of continuing or worsening supply chain constraints; the risk that all necessary regulatory approvals cannot be obtained; the potential market for IGM’s product candidates, the potential diminishing need for therapeutics to address COVID-19, particularly in the United States and other major markets, and the progress and success of alternative therapeutics currently available or in development; IGM’s ability to obtain additional capital to finance its operations, if needed; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM is targeting; IGM’s ability to obtain, maintain and protect its intellectual property rights; developments relating to IGM’s competitors and its industry, including competing product candidates and therapies; risks related to collaborations with third parties, including the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of any such collaboration; general economic and market conditions; and other risks and uncertainties, including those more fully described in IGM’s filings with the Securities and Exchange Commission (SEC), including IGM’s Annual Report on Form 10-K filed with the SEC on March 30, 2021, IGM’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2021 and in IGM’s future reports to be filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM specifically disclaims any obligation to update any forward-looking statement, except as required by law.

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