IGM Biosciences Announces Expansion of IgM Platform in
MOUNTAIN VIEW, Calif., June 03, 2021 (GLOBE NEWSWIRE) – IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on the creation and development of modified IgM antibodies, today announced expanding its IgM antibody platform in infectious diseases, with the expected advancement of a new pipeline candidate, IGM-6268, in the clinic in the third quarter of 2021. IGM-6268 is an IgM version of an anti-SARS-CoV-2 IgG monoclonal antibody under development as an intranasally administered agent for the treatment and prevention of COVID-19. The announcement coincides with the publication in Nature of an article titled “Nasal IgM Administration Offers Broad Protection Against SARS-CoV-2 Variants,” which is now available online and will be published in a future print issue of Nature. The article describes the results of preclinical studies demonstrating a significantly greater neutralization of SARS-CoV-2 with an IgM antibody compared to IgG antibodies, the potent neutralization of all mutant variants of concern (VoC) and variants of interest ( VoI) evaluated, and the ability to provide effective preventive and therapeutic protection when administered intranasally in mice. The work described in the article was carried out in collaboration with the medical branch of the University of Texas at Galveston (UTMB) and the University of Texas at Houston Health Sciences Center (UTHealth). IGM has exclusively licensed the rights to the antibodies used to generate IGM-6268 and related intellectual property of the University of Texas system.
“A high viral load in the respiratory tract correlates with severe illness and mortality in patients with COVID-19,” said Dr. Zhiqiang An, director of 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 essential in clearing SARS-CoV-2 infection and reducing viral transmission, and IgM antibodies are nature’s first line of defense against pathogens such as viruses. Current EUA antibodies, all of which are IgG antibodies, are administered intravenously in high doses and do not directly target major sites of infection. Additionally, SARS-CoV-2 has developed mutations that severely compromise the neutralizing activities of several IgG monoclonal antibodies, including those undergoing clinical trials and cleared for emergency use. Therefore, the development of new antibody therapies capable of overcoming these challenges is an urgent unmet need, and we are pleased with the data published today. “
The results of the study published in Nature found that, among the anti-SARS-CoV-2 IgG, IgA and IgM antibodies screened, the IgM antibodies were in all cases significantly more potent than the IgG and IgA antibodies in the neutralizing virus. IGM-6268, described as IgM-14 in the publication, has been shown to be effective for prophylaxis and treatment in animal models when administered intranasally, and has also demonstrated significantly increased potency against SARS -Wild-type CoV-2 and emerging natural viral variants, such as current VoC strains from UK, South Africa and Brazil, VoIs, as well as antibody escape mutants for current antibodies allowed for emergency use.
“The ability to transform IgG antibodies into neutralizing IgM antibodies for possible prevention and treatment of COVID-19 with broad coverage of VoCs, VoIs and viral escape mutants is a very interesting application of our IgM platform that could respond to 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 launch a clinical study in the third quarter of this year, marking the expansion of our IgM antibody platform from oncology to infectious diseases. . We thank our collaborators from UTMB and UTHealth and our scientists from IGM for the exceptional work described in Nature today.”
IGM-6268, a human IgM monoclonal antibody designed for the treatment and prevention of COVID-19, has been shown in preclinical studies to be very effective in preventing and treating COVID-19 after intranasal administration. Due to its ability to bind to SARS-CoV-2 with greater strength, IGM-6268 offers advantages over current IgG treatments, including neutralizing potency 100 times to 1,000 times greater than that of antibodies. Comparable IgGs, and the ability to effectively neutralize variants of concern and variants of interest. In our in vivo models, IGM-6286 appears to be well tolerated, does not appear to present unwanted safety signals, and demonstrates good persistence in the sinuses after intranasal administration.
About IGM Biosciences, Inc.
Based in Mountain View, Calif., IGM Biosciences is a clinical-stage biotechnology company focused on the creation and development of modified IgM antibodies. Since 2010, IGM Biosciences has been working to overcome barriers to protein manufacturing and engineering 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 clinical indications where their inherent properties may offer advantages over IgG antibodies.
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements, including statements relating to IGM’s plans, expectations and forecasts and about future events. These forward-looking statements include, without limitation, the potential and expectations regarding IGM-6268, the Company’s IgM technology platform and its expansion into infectious diseases, statements regarding the schedule of clinical trials planned by the Company for IGM-6268, the Company’s Development Strategy for IGM-6268, and the statements of Dr. An and Mr. Schwarzer. Such statements are subject to many important factors, risks and uncertainties that may cause actual events or results to differ materially, including, but not limited to: the early stages of clinical development of IGM’s drugs; the risks associated with the use of modified IgM antibodies, which is a new and unproven therapeutic approach; IGM’s ability to demonstrate the safety and efficacy of IGM-6268; IGM’s ability to advance IGM-6268 successfully and in a timely manner through clinical studies; the risk that all necessary regulatory approvals may not be obtained; the ability of the IGM to enroll patients in clinical studies; the possibility that the results of clinical studies with IGM-6268 may differ from preclinical, preliminary or expected results; the potential for IGM-6268 to cause significant adverse events, toxicities or other unwanted side effects; the risk that initial, interim, baseline or preliminary data from IGM’s clinical studies may change as more patient data becomes available, and be subject to audit and verification procedures that may result in changes important subsequent or final data; IGM’s ability to successfully manufacture and supply IGM-6268 for clinical studies; delays and potential disruptions resulting from the COVID-19 pandemic and government responses to the pandemic, including any future impact on IGM’s operations, the manufacturing of its product candidates, the progress of its clinical studies, recruitment into its current and future clinical studies and the progress of its related collaborations and efforts; the potential market for IGM-6268, the potential decrease in the therapeutic need to combat COVID-19, particularly in the United States and other major markets, and the advancement and success of currently available alternative therapies or in development ; IGM’s ability to raise additional capital to finance its operations, if required; uncertainties associated with projections of the size of patient populations suffering from the diseases targeted by the IGM; 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 associated with collaborations, licenses or agreements with third parties, including the risk of any event, change or other circumstance occurring that could result in the termination of such collaborations, licenses or agreements; general economic and market conditions; and other risks and uncertainties, including those described in more detail in documents filed by IGM 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 May 6, 2021 and in future IGM reports that will be filed with the SEC. All forward-looking statements contained in this press release speak only as of the date hereof, and IGM expressly disclaims any obligation to update any forward-looking statement, except as required by law.