Benzinga | Oct 11, 2021 04:07PM EDT

IGM Biosciences Reports Formation Of 2 Business Units: IGM Infectious Diseases, IGM Autoimmunity And Inflammation

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 andnoninfectious 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."