IGM-7354 / IGM Biosciences - LARVOL DELTA

Evaluation of IGM-7354 in Adults With Relapsed and/or Refractory Cancer (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: IGM Biosciences, Inc. | Active, not recruiting ➔ Completed | N=50 ➔ 14 | Trial completion date: Mar 2026 ➔ May 2024 | Trial primary completion date: Feb 2026 ➔ May 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Evaluation of IGM-7354 in Adults With Relapsed and/or Refractory Cancer (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: IGM Biosciences, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor

Evaluation of IGM-7354 in Adults With Relapsed and/or Refractory Cancer (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: IGM Biosciences, Inc.

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

IGM-7354, an immunocytokine with IL-15 fused to an anti-PD-L1 IgM, induces NK and CD8+ T cell mediated cytotoxicity of PD-L1-positive tumor cells (AACR 2023) - "The strong avidity of IGM-7354 for PD-L1 may enhance IL-15 delivery to tumors and antigen-presenting cells and thus provide a more favorable safety profile. A Phase 1 clinical trial is planned."

IO biomarker • Tumor cell • Oncology • CD34 • CD8 • GZMB • IL15

IGM Biosciences Announces Six Presentations at the American Society for Cancer Research Annual Meeting 2023 (GlobeNewswire) - "IGM Biosciences...announced the presentation of six posters at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2023....'We are proud to show the breadth and depth of our oncology pipeline at this year’s AACR meeting, as the emerging data from our clinical and pre-clinical efforts on IGM-8444, IGM-7354, IGM-2644, IGM-2537 and imvotamab continue to demonstrate the potential for encouraging anticancer activity coupled with favorable safety profiles'..."

Preclinical • Trial status • Acute Myelogenous Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

IGM Biosciences Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "IGM-7354 (IL-15 x PD-L1): The Company announced today that it has successfully dosed two patients in its clinical trial of IGM-7354 without any drug related safety issues to date."

Trial status • Oncology • Solid Tumor

Evaluation of IGM-7354 in Adults With Relapsed and/or Refractory Cancer (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: IGM Biosciences, Inc.

New P1 trial • Oncology • Solid Tumor

IGM Biosciences Initiates First-in-Human Clinical Trial of IGM-7354 in Solid Tumors (GlobeNewswire) - "IGM Biosciences, Inc...announced that the first patient has been dosed in its Phase 1 clinical trial evaluating IGM-7354, a targeted IL-15/IL-15R IgM antibody which could potentially be used for the treatment of patients with solid and hematologic malignancies....The multicenter, open-label, dose escalation Phase 1 clinical trial will evaluate IGM-7354 intravenously administered as a monotherapy in patients with relapsed and/or refractory solid tumor cancers....If IGM-7354 shows an encouraging safety profile and significant increases in T cells and natural killer (NK) cells in this clinical trial, the Company may begin combination studies of IGM-7354 with T cell engaging antibodies in 2024. The Company may also decide to pursue combination studies with CAR-T or CAR-NK cells with a partner."

Trial status • Hematological Malignancies • Oncology • Solid Tumor

IGM-7354, an anti-PD-L1/IL-15 IgM immunocytokine, activates and expands NK cells and effector memory CD8+ T cells in vivo (SITC 2022) - "This approach may enhance targeted delivery of the immunostimulatory cytokine IL-15 through high affinity and high avidity binding to PD-L1 potentially improving anti-tumor responses and minimizing toxicity. Ethics Approval The animal studies were approved by the Testing Facilities’ IACUC."

IO biomarker • Preclinical • Oncology • CD34 • CD8 • ENTPD1 • GZMB • IL15 • IL2RA

IGM Biosciences Announces Third Quarter 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "Pipeline Updates: IGM-7354 (IL-15 x PD-L1): (i) Phase 1 trial to initiate in the first quarter of 2023: IGM today announced that it expects to dose the first patient in the Phase 1 trial for IGM-7354, IGM’s targeted IL-15 IgM antibody for the treatment of patients with solid and hematologic malignancies, in the first quarter of 2023, subject to IND clearance; (ii) Preclinical data to be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting: The poster, titled 'IGM-7354, an anti-PD-L1/IL-15 IgM immunocytokine, activates and expands NK cells and effector memory CD8+ T cells in vivo' will be made available beginning at 9:00 a.m. ET on Thursday, November 10, 2022..."

New P1 trial • Preclinical • Hematological Malignancies • Oncology • Solid Tumor

Enhanced NK and CD8+ T cell proliferation, tumor cytotoxicity and reversal of T cell exhaustion with IGM-7354, an anti-PD-L1 IgM antibody and IL-15 cytokine fusion (AACR 2022) - "IGM-7354 stimulates NK and CD8+ T cell expansion in vitro and in vivo plus induces tumor regressions in mouse tumor models in monotherapy or combination with various agents. This approach may enhance tumor localization of the immunostimulatory cytokine IL-15 through high affinity and high avidity binding to PD-L1 thereby improving anti-tumor responses and minimizing toxicity."

Oncology • CD8 • IL15

IGM Biosciences Announces Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "IND filing expected in 2022. IGM expects to file an Investigational New Drug Application (IND) for IGM-7354, the Company’s IL-15 x PD-L1 bispecific IgM antibody, in solid tumors in 2022."

IND • Oncology • Solid Tumor

IGM-7354 is an anti-PD-L1 IgM antibody and IL-15 cytokine fusion that enhances NK and CD8+ T cell proliferation and tumor cytotoxicity plus potently reverses T cell exhaustion (SITC 2021) - "Conclusions IGM-7354 stimulates NK and CD8+ T cell expansion in vitro and in vivo plus induces tumor regressions in mouse tumor models. This approach may enhance tumor localization of the immunostimulatory cytokine IL-15 through high affinity and high avidity binding to PD-L1 thereby improving anti-tumor responses and minimizing toxicity."

Breast Cancer • Oncology • Solid Tumor • CD8 • IL15

IGM Biosciences Announces Third Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "Plans to Initiate Phase 2 Studies of IGM-2323 in Diffuse Large B-cell Lymphoma and Follicular Lymphoma; Data from IGM-2323 Selected for Oral Presentation at 2021 ASH Annual Meeting; IGM-2644 (CD38 x CD3) Expected to Enter Clinical Testing for Multiple Myeloma in 2022; Phase 1 clinical testing expected to initiate in 2022. IGM plans to initiate a Phase 1 study of IGM-7354, the Company’s IL-15 x PD-L1 bispecific IgM antibody, in solid tumors in 2022; Phase 1 clinical testing expected to initiate in 2022. IGM announced today that it plans to initiate a Phase 1 study of IGM-2644, the Company’s CD38 x CD3 bispecific IgM antibody, in multiple myeloma in 2022...'We hope to file an investigational new drug (IND) application with the FDA and begin the Phase 1 clinical development of IGM-2644 next year.'"

IND • New P1 trial • New P2 trial • P1 data • Diffuse Large B Cell Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

IGM Biosciences Announces First Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "Pipeline Updates:IGM-7354 - Investigational New Drug (IND) application expected to be filed this year. IGM also plans to file an IND application with the U.S. Food and Drug Administration (FDA) for IGM-7354, the Company’s IL-15 x PD-L1 bispecific IgM antibody, before the end of 2021 in order to begin clinical testing initially in solid tumors, followed by hematologic malignancies."

IND • Hematological Malignancies • Oncology • Solid Tumor

IGM Biosciences Announces Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update (GlobeNewswire) - "'We also expect to file an IND for our IL-15 x PD-L1 antibody, IGM-7354, in 2021.' IGM-2323: IGM expects to complete enrollment in the Phase 1 dose escalation study and establish a recommended Phase 2 dose in 2021. IGM-8444: IGM expects to report initial data in solid tumors from the dose escalation portion of this Phase 1 trial in the second half of 2021....IGM plans to begin clinical testing of birinapant in combination with IGM-8444 this year."

Clinical • Enrollment status • New trial • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

IGM Biosciences Announces Third Quarter 2020 Financial Results and Provides Corporate Update (GlobeNewswire) - “IGM will report initial data from its Phase 1 clinical trial evaluating IGM-2323 in patients with relapsed/refractory Non-Hodgkin’s Lymphoma (NHL), the first-in-human application of IGM’s engineered IgM antibody technology, at the ASH Annual Meeting being held virtually December 5-8, 2020; IGM announced that the first patient has been dosed in its Phase 1 clinical trial evaluating IGM-8444 in patients with solid cancers and NHL. IGM expects to report initial data from this Phase 1 trial in 2021; IGM-7354 preclinical data to be presented at Society for Immunotherapy of Cancer (SITC) Annual Meeting.”

P1 data • Preclinical • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology