IGM Biosciences Initiates First-in-Human Clinical Trial of IGM-8444 for the Treatment of Solid Cancers and Non-Hodgkin’s Lymphoma
IGM Biosciences (Nasdaq: IGMS) has announced the dosing of its first patient in a Phase 1 clinical trial for IGM-8444, an IgM antibody targeting DR5 in patients with solid tumors and non-Hodgkin’s lymphoma. The trial aims to assess pharmacokinetics, safety, and preliminary efficacy of IGM-8444, both alone and with chemotherapy. Initial data is expected in 2021. CEO Fred Schwarzer noted the trial's significance as part of IGM's strategy utilizing its proprietary IgM technology platform.
- First patient dosed in Phase 1 trial of IGM-8444.
- Trial aims to evaluate both monotherapy and chemotherapy combination.
- Initial data from the trial is expected in 2021.
- Highlights IGM's strategy to develop IgM antibodies offering therapeutic advantages.
- Clinical trials are subject to delays, especially amid COVID-19.
- The use of engineered IgM antibodies remains a novel and unproven approach.
- Risks associated with meeting regulatory approval requirements.
MOUNTAIN VIEW, Calif., Sept. 30, 2020 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced that the first patient has been dosed in its Phase 1 clinical trial evaluating IGM-8444, an IgM antibody targeting the Death Receptor 5 (DR5) protein, in patients with solid cancers and non-Hodgkin’s lymphoma.
The multicenter, open-label Phase 1 clinical trial will evaluate IGM-8444 intravenously administered as a monotherapy and in combination with chemotherapy in patients with relapsed and/or refractory solid cancers and non-Hodgkin’s lymphoma. The key objectives of this trial are to provide an initial assessment of the pharmacokinetics, safety, biomarkers and preliminary efficacy of IGM-8444 both as a single agent and in combination with standard of care chemotherapy. IGM expects to report initial data from this Phase 1 trial in 2021.
“The initiation of this clinical trial is another significant milestone in IGM’s development, as it marks the second program from our proprietary IgM antibody platform to begin clinical development,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “We believe that IgM antibodies have the potential to overcome some of the limitations of current IgG-based medicines and deliver new therapeutic options to patients with cancer and other serious diseases, and we hope to pursue a broad clinical development strategy for IGM-8444, including in combination with other targeted oncology drugs.”
“DR5 IgM antibodies have the capacity for multivalent binding of DR5 and are designed to more efficiently send an apoptotic signal to the cancer cell and enhance in vitro potency in killing cancer cells compared to IgG antibodies with the same binding units,” said Johanna Bendell, M.D., Chief Development Officer, Director, Drug Development Program, Sarah Cannon Research Institute at Tennessee Oncology. “I look forward to working with the IGM team in their pursuit to fully elucidate the potential of this novel therapy.”
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 Statements
This press release contains forward-looking statements, including statements relating to IGM’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to, the potential of, and expectations regarding, the Company’s IgM technology platform, its IgM antibodies and IGM-8444, statements regarding the Company’s Phase 1 clinical trial of IGM-8444, statements regarding the Company’s development strategy for IGM-8444, and statements by IGM’s 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 IGM’s operations, the manufacturing of its product candidates, the progression of its clinical trials, enrollment in its current and future clinical trials and on its collaborations and related efforts; IGM’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM’s ability to advance product candidates into, and successfully complete, clinical trials on the timelines it projects; the risk that all necessary regulatory approvals cannot be obtained; IGM’s ability to adequately demonstrate sufficient safety and efficacy of its product candidates; IGM’s ability to enroll patients in its ongoing and future clinical trials; IGM’s ability to successfully manufacture and supply its product candidates for clinical trials; IGM’s 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; 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; general economic and market conditions; and other risks and uncertainties, including those more fully described in IGM’s filings with the Securities and Exchange Commission (“SEC”), including IGM’s Annual Report on Form 10-K filed with the SEC on March 26, 2020, IGM’s Quarterly Report on Form 10-Q filed with the SEC on August 6, 2020 and in IGM’s 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.
Contact:
Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com
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