IGM Biosciences Presents Data from T cell Engager Portfolio for Hematologic Malignancies at 2022 American Society of Hematology Annual Meeting
IGM Biosciences presented promising preclinical data for IGM-2644 and IGM-2537 at the 2022 ASH Annual Meeting. Both bispecific IgM antibodies showed potential anti-tumor activity with favorable safety profiles. IGM-2644 demonstrated superior cytotoxicity against myeloma cells compared to traditional IgG antibodies and is set for a Phase 1 trial in early 2023. Similarly, IGM-2537 displayed potent activity against acute myeloid leukemia with minimal cytokine release, with IND filing anticipated in 2023. Biomarker data for imvotamab also indicated efficacy in low CD20 expressing tumors.
- IGM-2644 shows greater complement dependent cytotoxicity than conventional IgG antibodies.
- Phase 1 trial for IGM-2644 planned for early 2023, pending IND application clearance.
- IGM-2537 exhibits potent in vitro and in vivo activity against AML with reduced cytokine release.
- IND filing for IGM-2537 expected in 2023.
- Risks associated with early-stage clinical drug development.
- Potential delays in clinical trials due to COVID-19 impacts.
- Unproven therapeutic approaches related to engineered IgM antibodies.
First Preclinical Data for IGM-2644 and IGM-2537 Featured in Poster Presentations
MOUNTAIN VIEW, Calif., Dec. 11, 2022 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing IgM antibodies, today announced the presentation of data from IGM’s expanding portfolio of T cell engagers for hematologic malignancies, including IGM-2644, IGM-2537 and imvotamab, at the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition being held virtually and in-person in New Orleans, Louisiana, December 10-13, 2022.
“As shown today, the preclinical profiles of IGM-2644, our CD38 x CD3 bispecific IgM antibody, and IGM-2537, our CD123 x CD3 bispecific IgM antibody, demonstrate the potential for encouraging antitumor activity coupled with favorable safety profiles,” said Chris Takimoto, M.D., Ph.D., F.A.C.P., Chief Medical Officer of IGM Biosciences. “We are also presenting today biomarker data from the Phase 1 trial of imvotamab, our CD20 x CD3 bispecific IgM antibody, showing its encouraging activity in patients with low CD20 expressing tumors.”
The poster titled “IGM-2644, a Novel CD38 x CD3 Bispecific IgM T Cell Engager Demonstrates Potent Efficacy on Myeloma Cells with an Improved Preclinical Safety Profile” highlights IGM-2644’s greater complement dependent cytotoxicity (CDC) activity as compared to conventional IgG anti-CD38 antibodies. Additionally, IGM-2644 achieved potent T cell dependent cellular cytotoxicity (TDCC) killing of daratumumab-resistant cell lines with minimal cytokine release as well as potent TDCC killing of myeloma patient samples. IGM-2644 was also shown to inhibit CD38+ tumor growth in humanized xenograft models, but it avoids killing immune effector cells as compared to an IgG bispecific T cell engager. IGM plans to initiate a Phase 1 trial of IGM-2644 in multiple myeloma in the first quarter of 2023, subject to Investigational New Drug (IND) application clearance.
The poster titled “CD123 Directed IgM T-cell Engager, IGM-2537, Demonstrates Potent in vitro and in vivo Activity with Minimal Cytokine Release” highlights potent in vitro and in vivo activity with limited cytokine induction consistent with the potential for providing a favorable safety profile for a CD123-directed IgM-based T cell engager. IGM-2537 was shown to bind to human CD123 with high affinity, avidity, and specificity. IGM-2537 co-engaged with both CD123 and CD3 antigens, leading to T cell redirected killing of acute myeloid leukemia (AML) cell lines with concomitant T cell activation, and eliminated AML blast cells at physiologically relevant effector/target ratios in an ex vivo assay. IGM-2537 also showed significantly reduced cytokine release, exemplified by IFN-γ, TNF-α and IL-6, as compared to an IgG T cell engager molecule. IGM expects to file an IND application for IGM-2537 in AML in 2023.
The poster titled “Pharmacodynamics and Biomarker Correlates of Imvotamab (IGM-2323), the First-in-Class CD20xCD3 Bispecific IgM Antibody with Dual Mechanisms of Action, in Patients with Advanced B Cell Malignancies” features biomarker data from the Phase 1 trial evaluating imvotamab, the Company’s IgM T cell engaging bispecific antibody. The poster highlights that complete responses were observed even in patients with low CD20 expressing tumors. Biomarker data obtained from patients in dose escalation cohorts also demonstrated pharmacodynamic changes that support the TDCC and CDC mechanisms of action of imvotamab.
About IGM Biosciences, Inc.
IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, infectious diseases and autoimmune and inflammatory diseases. IGM’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. IGM also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology and inflammation targets. For more information, please visit www.igmbio.com.
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, IGM’s technology platform and its IgM antibodies and product candidates, including imvotamab, IGM-2644 and IGM-2537; IGM’s plans and expectations regarding its clinical development efforts and activities; and statements regarding the clinical development of imvotamab, IGM-2644 and IGM-2537, including the expected timing of initiating a clinical trial for IGM-2644, filing an IND for IGM-2537, and scientific presentations. 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; 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 demonstrate the safety and efficacy of its product candidates; IGM’s ability to successfully and timely advance its product candidates through preclinical studies and clinical trials; IGM’s ability to enroll patients in its clinical trials; the potential for the results of clinical trials to differ from preclinical, preliminary, initial or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; IGM’s 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; the potential market for IGM’s product candidates, and the progress and success of alternative therapeutics currently available or in development; IGM’s ability to obtain additional capital to finance its operations, if needed; 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 Quarterly Report on Form 10-Q filed with the SEC on November 3, 2022 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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