IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company dedicated to the development of IgM antibodies, today shared an update on its clinical development program for IGM-8444, a potent novel multivalent DR5 agonist. The company also announced plans for a groundbreaking randomized combination trial in patients with metastatic colorectal cancer, aiming to improve treatments and outcomes for individuals diagnosed with this deadly disease.
The initial Phase 1 data from a cohort of patients who received a combination of IGM-8444 and FOLFIRI showed an encouraging safety profile that was similar to what is expected from chemotherapy alone in this setting. Notably, there were no serious drug-related hepatotoxicity events, only minor grade 1 and 2 transient liver enzyme elevations.
IGM-8444 and FOLFIRI showed promising activity in patients with metastatic colorectal cancer, with four confirmed responses and one additional patient having substantial tumor shrinkage for complete surgical resection. Even those who had previously progressed on FOLFIRI saw results, as 10 of the 13 patients had been treated with it. Of the nine 3L+ patients, median progression free survival (PFS) was 5.5 months, with the longest observed PFS extending beyond 12 months. The combination of IGM-8444 and FOLFIRI did not discriminate between KRAS wild type and mutated tumors or between those with or without liver metastases.
The Company is launching a randomized trial in the second-line of patients with metastatic colorectal cancer to evaluate the additional benefits of IGM-8444 in combination with FOLFIRI and bevacizumab, the current standard of care regimen. This open-label trial is scheduled to start in the first quarter of 2023.
We are delighted with the initial results of IGM-8444 in patients with colorectal cancer, which show an excellent safety profile with no significant hepatotoxicity. The responses observed, especially in patients who had previously failed chemotherapy, are very encouraging and give us confidence to keep exploring the potential of IGM-8444 in further clinical development. Our upcoming randomized trial with FOLFIRI will help us gain a better understanding of the activity of IGM-8444 and its potential to help patients with colorectal cancer.
At IGM Biosciences, we are thrilled to announce the successful initial clinical results of our IgM antibody platform targeting DR5. These results offer a promising indication of the potential of our IgM antibodies to overcome the long-standing challenge of using conventional IgG antibodies. Moreover, these results further reinforce our vision of creating a new class of agonist antibody medicines, and we are eager to continue our partnership with Sanofi to make these treatments a reality.
IGM-8444 is an IgM antibody with a revolutionary difference: it has 10 binding units, allowing it to target Death Receptor 5 (DR5) on the surface of cancer cells with a stronger signal than traditional IgG antibodies. By cross-linking multiple receptors at the same time, IGM-8444 can send an apoptotic death signal to cancer cells, providing hope for patients with solid and hematologic malignancies. As a member of the tumor necrosis factor receptor superfamily, DR5 has been identified as a key player in the fight against cancer – and IGM-8444 may be a game-changer.
About IGM Biosciences, Inc.
IGM Biosciences is a clinical-stage biotechnology company on a mission to revolutionize the world of medicine. Our groundbreaking pipeline of clinical and preclinical assets is based on IgM antibodies, which have 10 binding sites compared to the conventional IgG antibodies’ two. We have an exclusive worldwide collaboration with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists for oncology, immunology, and inflammation targets, and together, we are committed to delivering innovative treatments to patients with cancer, infectious diseases, and autoimmune and inflammatory diseases.
Cautionary Note Regarding Forward-Looking Statements
IGM is excited to share its plans, expectations and forecasts regarding its technology platform and IgM antibodies, as well as its product candidate IGM-8444. IGM is committed to advancing IGM-8444 through clinical development, with the goal of initiating a randomized clinical trial as soon as possible. However, the potential delays and disruptions caused by the COVID-19 pandemic may have an impact on IGM’s operations, the manufacture of its product candidates, and the progression of its clinical trials. Additionally, IGM must demonstrate the safety and efficacy of its product candidates, successfully advance them through preclinical studies and clinical trials, and manufacture and supply them for clinical trials. IGM also faces competition from alternative therapies and must protect its intellectual property rights. IGM is hopeful that all necessary regulatory approvals can be obtained and that the potential market for its product candidates can be realized.