IGM Biosciences Shifts Focus to Autoimmunity

IGM Biosciences, Inc., a clinical-stage biotechnology company specializing in engineered IgM antibodies, announced a pivotal shift in its strategy to focus on the development of T cell engaging IgM antibodies aimed at treating autoimmune diseases. This move is intended to strengthen the company’s leadership in this specialized area. The company’s primary candidates in this new focus include imvotamab, a CD20 x CD3 bispecific T cell engager being developed for conditions such as rheumatoid arthritis, systemic lupus erythematosus, and myositis. Another promising candidate, IGM-2644, a CD38 x CD3 bispecific T cell engager, is expected to commence clinical trials for generalized myasthenia gravis towards the end of 2024.

In line with this strategic pivot, IGM Biosciences has appointed Dr. Mary Beth Harler as the new Chief Executive Officer and a member of the Board of Directors. Dr. Harler brings a wealth of experience in autoimmunity, having joined IGM in 2021 as President of Autoimmunity and Inflammation. Prior to her tenure at IGM, she spent 11 years at Bristol Myers Squibb, where she served as Senior Vice President and Head of Immunology and Fibrosis Development. Her notable achievements include overseeing the development of therapies such as SOTYKTU®, ORENCIA®, and ZEPOSIA®.

“Mary Beth’s extensive experience in autoimmune research and her proven track record in clinical development make her the ideal leader for IGM as we transition our focus to T cell engagers for autoimmunity,” stated Felix J. Baker, Ph.D., a director at IGM Biosciences. He expressed confidence in her vision and passion for pioneering new treatments for autoimmune diseases.

Dr. Harler expressed enthusiasm about her new role, highlighting the significant progress in the clinical development of imvotamab for autoimmune conditions. She emphasized the substantial clinical and commercial potential of IGM’s pipeline of T cell engaging antibodies in treating autoimmune diseases. The company plans to share initial clinical data from the imvotamab studies later this year or in early 2025.

In addition to the strategic pivot, IGM Biosciences will minimize future spending on its oncology candidates, including aplitabart, a death receptor 5 agonist. This decision follows emerging data from an ongoing randomized clinical trial of aplitabart in second-line metastatic colorectal cancer and underscores the company’s new direction towards autoimmunity. As a part of this shift, steps will be taken to reduce spending in oncology, including a reduction in workforce. Final data from the aplitabart clinical trial will be shared at a later date. These measures are expected to extend IGM’s cash runway into 2027.

Corporate restructuring will accompany this strategic pivot. Fred Schwarzer, the current Chief Executive Officer, President, and Director, along with Chief Scientific Officer Dr. Bruce Keyt, will step down from their roles. Both are expected to continue as consultants for the company. Additionally, Chris Takimoto, the Chief Medical Officer, will leave his position to pursue other opportunities.

Christina Topsøe, a director at IGM Biosciences, thanked Fred Schwarzer and Bruce Keyt for their vision and contributions to the development of IgM antibodies. She also expressed gratitude to Chris Takimoto for his leadership in expanding the clinical development organization beyond oncology.

IGM Biosciences will host a conference call and live webcast to discuss this strategic shift and provide updates on its developments at 4:30 p.m. EDT today, September 30, 2024.