Benzinga | Jun 3, 2021 07:06AM EDT

IGM Biosciences Highlights Expansion Of IgM Platform Into Infectious Diseases; Co. Also Highlights Publication Of Preclinical Data In Nature

MOUNTAIN VIEW, Calif., June 03, 2021 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (NASDAQ:IGMS) a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced the expansion of its IgM antibody platform into infectious diseases, with the anticipated advancement of a new pipeline candidate, IGM-6268, into the clinic in the third quarter of 2021. IGM-6268 is an IgM version of an anti-SARS-CoV-2 IgG monoclonal antibody being developed as an intranasally administered agent for the treatment and prevention of COVID-19. The announcement coincides with the publication in Nature of an article entitled "Nasal delivery of an IgM offers broad protection from SARS-CoV-2 variants," which is available now online and will be published in a future print issue of Nature. The article describes results from preclinical studies demonstrating significantly greater neutralization of SARS-CoV-2 with an IgM antibody compared to IgG antibodies, the potent neutralization of all evaluated mutant Variants of Concern (VoC) and Variants of Interest (VoI), and the ability to provide effective preventative and therapeutic protection when delivered intranasally in mice. The work described in the paper was performed in collaboration with The University of Texas Medical Branch at Galveston (UTMB), and The University of Texas Health Science Center at Houston (UTHealth). IGM has exclusively licensed the rights to the antibodies used to generate IGM-6268 and related intellectual property from the University of Texas System.



"High viral load in the respiratory tract correlates with severe illness and mortality in patients with COVID-19," said Dr. Zhiqiang An, Director of the UTHealth Texas Therapeutics Institute, Professor of Molecular Medicine at McGovern Medical School at UTHealth, and one of the corresponding authors on the publication. "Respiratory mucosal antibodies are key to clearing SARS-CoV-2 infection and reducing viral transmission and IgM antibodies are nature's first line of defense against pathogens such as viruses. The current EUA antibodies, which are all IgG antibodies, are administered intravenously at high doses and don't directly target the main sites of infection. Moreover, SARS-CoV-2 has evolved mutations that severely compromise the neutralizing activities of multiple IgG monoclonal antibodies, including those under clinical trials and authorized for emergency use. Therefore, developing new antibody therapies that can overcome these challenges is an urgent unmet need, and we are pleased with the data published today."

Results from the study published in Nature found that, among the anti-SARS-CoV-2 IgG, IgA, and IgM antibodies screened, IgM antibodies were in all cases significantly more potent than IgG and IgA antibodies in neutralizing virus. IGM-6268, described as IgM-14 in the publication, was shown to be effective for prophylaxis and treatment in animal models when administered intranasally, and also demonstrated significantly increased potency against wild type SARS-CoV-2 and emerging natural viral variants, such as the current UK, South African and Brazilian VoC strains, VoIs, as well as the antibody escape mutants for the current Emergency Use Authorized antibodies.

"The ability to transform IgG antibodies into potently neutralizing IgM antibodies for the possible prevention and treatment of COVID-19 with broad coverage of VoCs, VoIs and viral escape mutants is a very exciting application of our IgM platform that could address an urgent unmet medical need," said Fred Schwarzer, CEO of IGM Biosciences. "We look forward to advancing IGM-6268 as quickly as possible and plan to initiate a clinical study in the third quarter of this year, marking the expansion of our IgM antibody platform from oncology into infectious diseases. We are grateful to our collaborators at UTMB and UTHealth and our scientists at IGM for the exceptional work described in Nature today."