On December 8, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, reported that it will focus its resources in two strategic areas: (i) treating colorectal cancer using IgM death receptor 5 (DR5) agonist antibodies, and (ii) treating autoimmune diseases using IgM T cell engager antibodies (Press release, IGM Biosciences, DEC 8, 2023, View Source [SID1234638326]). As an expansion of its autoimmune efforts, the Company also announced today that it plans to file an Investigational New Drug (IND) application to begin the clinical development of IGM-2644, its CD38 x CD3 T cell engager antibody, for the treatment of autoimmune diseases. As part of its strategic refocus, the Company is halting all hematologic oncology clinical development as well as the clinical development of its targeted cytokine product candidate. The Company will continue to focus on the development of oncology and immunology and inflammation product candidates under its collaboration with Sanofi. In conjunction with this strategic refocusing, the Company will be reducing its workforce by approximately 22 percent. As a result of these actions, IGM expects to extend its cash runway into the second quarter of 2026.

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"IGM continues to have a tremendous opportunity to transform a variety of disease areas using an entirely new class of antibody medicines," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "Although we are very encouraged by the clinical and preclinical data that we have generated for the programs we are halting, given the difficult conditions in the capital markets for our industry, we have decided to focus our capital resources on those opportunities that we believe have the most potential to produce significant near-term value. We are very sorry that some of our dedicated and talented employees will be leaving IGM as part of this strategic refocusing, and we wish to extend our sincere thanks and assistance to them in this difficult transition."

Pipeline Update:

Aplitabart (DR5 agonist)

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Clinical development of aplitabart in colorectal cancer prioritized.
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Enrollment continues in randomized colorectal cancer clinical trial. The Company continues to enroll patients in a randomized clinical trial of aplitabart, a death receptor 5 agonist, plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer, with a goal of enrolling approximately 110 patients by the end of the first quarter of 2024. In addition to clinical trial sites in the United States, this trial includes multiple clinical trial sites in Asia and Europe.
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Treatment at 10 mg/kg ongoing in the single arm colorectal cancer clinical trial continues. The Company also continues to treat later line colorectal cancer patients in its single arm combination clinical trial of 10 mg/kg of aplitabart and FOLFIRI. The Company expects to complete enrollment of patients in this 10 mg/kg single arm combination study in the first half of 2024.

Imvotamab (CD20 x CD3)

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Clinical development of imvotamab in autoimmune diseases prioritized. The Company is prioritizing the clinical development of imvotamab, an IgM-based CD20 x CD3 bispecific T cell engaging antibody in autoimmune diseases. The Company currently has two Phase 1b clinical trials underway, one in severe systemic lupus erythematosus (SLE) and one in severe rheumatoid arthritis (RA). These clinical trials are being expanded to include multiple U.S. and international clinical trial sites. The Company also recently received clearance from the FDA of its IND application for the use of imvotamab in treating idiopathic inflammatory myopathies (myositis), and preparations are underway to move this clinical trial forward.

IGM-2644 (CD38 x CD3)

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Clinical development of IGM-2644 in autoimmune diseases prioritized. The Company is prioritizing the clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, in the treatment of autoimmune diseases, and it plans to file an IND for these purposes in 2024.

As a part of this strategic refocusing, the Company will halt the following clinical development activities:

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Aplitabart in acute myeloid leukemia and in combination with birinapant
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IGM-2644 (CD38 x CD3) in multiple myeloma
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IGM-2537 (CD123 x CD3)
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IGM-7354 (IL-15 x PD-L1)