GlobeNewswire Inc | Dec 8, 2021 07:00AM EST

December 08, 2021

Grant Agreement with the Bill & Melinda Gates Foundation Aims to Leverage IGMs Engineered IgM and IgA Antibodies to Address a Significant Driver of Morbidity and Mortality in Low- and Middle-Income Countries

MOUNTAIN VIEW, Calif., Dec. 08, 2021 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced a grant agreement with the Bill & Melinda Gates Foundation to fund the design, production, and evaluation of IgM and IgA antibodies for the potential prevention of malaria.

Despite recent advances in prevention and treatment, malaria continues to be one of the developing worlds deadliest human pathogens. The World Health Organization estimates that there are more than 200 million cases and over 400,000 deaths annually worldwide.

Studies suggest that anti-CSP (circumsporozoite protein) monoclonal antibodies (mAbs) may be useful in protecting against infection and disease. Because of their multimeric format, IgM and IgA antibodies directed against CSP could potentially exhibit significantly improved potency, thereby providing benefits at lower doses.

IGM Biosciences is the leader in the development of engineered IgM antibodies, which may be more effective than comparable IgG antibodies in the treatment and prevention of a broad range of infectious diseases, said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. We are honored that the Bill & Melinda Gates Foundation, one of the most significant forces for positive change in global public health, is supporting our efforts to evaluate the potential of IgM and IgA antibodies in the battle against malaria.

A recent publication in Nature, which showed in preclinical studies that engineered IgM antibodies capable of neutralizing SARS-CoV-2 had potencies 50- to more than 500-fold greater than corresponding IgG antibodies, illustrated the promise of IgM antibodies for potential treatment and prevention of infectious diseases. Under the agreement with the Bill & Melinda Gates Foundation, IGM and its subsidiary, IGM Infectious Diseases, will engineer and produce novel anti-CSP IgM and IgA antibodies, which will enable the assessment of their efficacy against infection in animal models of malaria, as compared to IgG antibodies.

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 StatementsThis press release contains forward-looking statements, including statements relating to IGMs plans, expectations, and forecasts and to future events. Such forward-looking statements include, but are not limited to, the potential of and expectations regarding IGMs technology platform and its IgM and IgA antibodies, including the potential of engineered IgM antibodies to be more effective than comparable IgG antibodies in the treatment and prevention of a broad range of infectious diseases and the potential ofIgM and IgA antibodies to provide significantly improved potency; IGMs plans and expectations regarding its development efforts and activities, including activities under the grant agreement with the Bill & Melinda Gates Foundation; plans by IGM and its subsidiary, IGM Infectious Diseases, to engineer and produce novel anti-CSP IgM and IgA antibodies to enable the assessment of their efficacy against infection in animal models of malaria, as compared to IgG antibodies; statements regarding IgM and IgA antibodies for the potential novel prevention and treatment of malaria; and statements by IGMs Chief Executive Officer. 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 IGMs 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; IGMs early stages of clinical drug development; risks related to the use of engineered IgM and IgA antibodies, which is a novel and unproven therapeutic approach; IGMs ability to demonstrate the safety and efficacy of its product candidates; IGMs ability to successfully and timely advance its product candidates through preclinical studies and clinical trials; IGMs 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; IGMs 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; IGMs 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; IGMs ability to obtain, maintain and protect its intellectual property rights; developments relating to IGMs 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 IGMs filings with the Securities and Exchange Commission (SEC), including IGMs Annual Report on Form 10-K filed with the SEC on March 30, 2021, IGMs Quarterly Report on Form 10-Q filed with the SEC on November 4, 2021 and in IGMs 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.

ContactArgot PartnersDavid Pitts212-600-1902igmbio@argotpartners.com