On November 4, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that it expects the first clinical data from its Phase 1 trial evaluating IGM-2323 will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, which will be held virtually. IGM-2323 is a bispecific IgM antibody targeting the CD20 protein on the surface of lymphoma cells and the CD3 protein on(Press release, IGM Biosciences, NOV 4, 2020, View Source [SID1234569842]) the surface of T cells in order to kill lymphoma cells in patients with non-Hodgkin’s lymphoma (NHL). The Company’s multicenter, open-label Phase 1 clinical trial is intended to assess the safety, pharmacokinetics and preliminary efficacy of intravenous IGM-2323 in patients with relapsed/refractory B cell NHL.
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The preliminary results are expected to be presented on Saturday, December 5, 2020, at 7:00 a.m. PT, in an oral poster presentation titled "Preliminary Results of a Phase 1 Dose Escalation Study of the First-in-Class IgM Based Bispecific Antibody IGM-2323 (anti-CD20 x anti-CD3) in Patients with Advanced B-Cell Malignancies." At the time of the ASH (Free ASH Whitepaper) Annual Meeting, IGM plans to present additional safety, pharmacokinetic, biomarker and efficacy data from the eight patients described in the abstract released today (Budde et. al., abstract #134983) and from additional patients treated subsequent to the data cut-off for the abstract. IGM is currently enrolling patients for treatment with 300 mg, but data from this dose cohort will not be available by the time of the ASH (Free ASH Whitepaper) Annual Meeting.
As described in the abstract, as of June 12, 2020, eight patients had been treated at 4 dose levels (0.5, 2.5, 10, and 30 mg). The eight patients had received an average of four prior therapies before treatment with IGM-2323. Six of the eight patients remained on active treatment as of the data cut-off for the abstract. No dose limiting toxicities (DLTs) or drug related serious adverse events (SAEs) had been observed among the eight patients. Two patients had experienced low-grade transient fevers, but no grade 2 or higher cytokine release syndrome had been observed among the eight patients. When cytokines were detectable following dosing, they were transient and had returned to baseline at less than 6-12 hours. Interferon-gamma (IFNg) was the primary cytokine observed, with significant levels of IL-6 detected in only one patient. Preliminary results from this first-in-human T cell engaging antibody study show an improved safety and tolerability profile. There is also evidence of a novel mechanism of action based on repeatable T cell activation and preservation of T cell function compared with other T cell engaging antibodies.
"We are very pleased with the clinical data described in the abstract from the first-in-human clinical testing of an engineered IgM antibody," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We believe that these data provide an important initial validation of the IGM T cell engaging bispecific technology and the broader IGM antibody technology platform. We look forward to the continued development of IGM-2323, IGM-8444 and our extensive pipeline of IgM antibodies."
"It is very encouraging to see evidence of a repeatable immune activation of T cells," said Daniel Chen M.D., Ph.D., Chief Medical Officer of IGM Biosciences. "This is in contrast to the T cell activation profile of other T cell engagers and CAR-T cells and suggests that IGM-2323 is activating T cells in a manner which is different from IgG and fragment-based T cell engagers and which preserves T cell function and repeatable T cell activation. We look forward to presenting our initial clinical results at ASH (Free ASH Whitepaper), continuing the development of IGM-2323 and applying this novel T cell engager technology to additional hematologic and solid tumor targets and indications."