IMT-009 / Immunitas Therap, Lonza - LARVOL DELTA

Abundance of KLRB1+ (CD161) T cells in anti-PD1 non responders coupled with enhanced tumor cytotoxicity of anti-CD161 (IMT-009) with anti-PD1 makes it a rational target for combination with anti-PD-(L)1 immunotherapy (AACR 2024) - "Combining anti-PD1 and IMT-009 significantly enhanced cytotoxic benefit compared to individual monotherapy in both Raji and MDA-MB-231 target cell line models. IFNγ levels in supernatants of DTCs treated with this combination were elevated as compared to individual monotherapy. Together with scRNAseq data of increased abundance of KLRB1 (CD161) expressing T cells in anti PD1 non-responder patients, our data provide rationale for testing combination of IMT-009 with anti-PD1 in patients that may not respond to anti PD1 alone."

IO biomarker • Breast Cancer • Burkitt Lymphoma • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Kidney Cancer • Lymphoma • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Triple Negative Breast Cancer • CD4 • CD8 • CLEC2D • GZMB • IFNG • IL2 • KLRB1 • TNFA

Immunitas Therapeutics Presents Preclinical Data Supporting Combination of IMT-009 with Anti-PD1 Immunotherapy at the AACR 2024 Annual Meeting (PRNewswire) - "Immunitas Therapeutics...presented preclinical data supporting the combination potential of IMT-009 with anti-PD1 immunotherapy at the American Association for Cancer Research Annual Meeting (AACR 2024)....Preclinical data expand potential of IMT-009, confirming presence of CD161 expressing T cells in anti-PD1 non-responder tumors and demonstrating enhanced T cell mediated cytotoxicity with combination treatment of IMT-009 and anti-PD1. Results support clinical evaluation of IMT-009-anti-PD1 combination treatment approaches."

Preclinical • Oncology

Immunitas Therapeutics to Present Preclinical Data Supporting Combination of IMT-009 with Anti-PD1 Immunotherapy at the AACR 2024 Annual Meeting (PRNewswire) - "Immunitas Therapeutics...announced it will present preclinical data supporting the combination potential of IMT-009...with anti-PD1 immunotherapy at the American Association for Cancer Research Annual Meeting (AACR 2024)....Preclinical data demonstrate presence of CD161 expressing T cells in anti-PD1 non-responder tumors and enhanced T cell mediated cytotoxicity with combination treatment of IMT-009 and anti-PD1, providing rationale for clinical studies assessing combination treatment approaches."

Preclinical • Oncology

Anti CD161 Antibody IMT-009 Is a Novel Immunotherapeutic Agent That Effectively Blocks the Inhibitory CLEC2D/CD161 Axis in CLEC2D+ B Cell Hematological Malignancies Reinvigorating T and NK Cell Function Leading to Anti-Tumor Benefit (ASH 2023) - "Results showed CD161+ cells infiltrated in Hodgkin Lymphoma, and post-R-CHOP treated DLBCL, highlighting the potential sensitivity of these malignancies to IMT-009 treatment. B cell malignancies tend to respond poorly to anti-PD-1 therapy4,5. This lack of efficacy could be driven by a highly immunosuppressive environment mediated by the CLEC2D/CD161 axis. Our results support evaluation of IMT-009 as a novel cancer immunotherapy to disrupt CLEC2D/CD161 signaling, with strong therapeutic potential in lymphomas."

IO biomarker • Burkitt Lymphoma • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • CD34 • CD8 • CLEC2D • IFNG • KLRB1 • TNFA

Immunitas Therapeutics Announces First Patient Dosed in Phase 1/2a Study of IMT-009 (PRNewswire) - P1/2a | N=NA | NCT05565417 | Sponsor: Immunitas Therapeutics | "Despite significant therapeutic advancements, there are still a substantial number of patients who remain unresponsive to standard treatments and would benefit from more effective cancer immunotherapies,' said Melissa L. Johnson....'IMT-009 inhibits the CD161/CLEC2D axis, a novel cancer immunotherapeutic target, and has been shown to re-stimulate the anti-cancer activity of key immune cell populations with a reasonable safety profile in preclinical studies. We look forward to further investigation of IMT-009 and its potential for patients awaiting improved treatment options.'"

Media quote • P1/2 data

Immunitas Therapeutics Announces First Patient Dosed in Phase 1/2a Study of IMT-009 (PRNewswire) - "Immunitas Therapeutics...announced the first patient has been dosed in a Phase 1/2a clinical trial evaluating use of novel cancer immunotherapeutic IMT-009 in solid tumors and hematologic malignancies....The Phase 1 study (NCT05565417) is designed to evaluate the safety, tolerability, pharmacodynamic biomarkers, and preliminary efficacy of IMT-009 as well as identify the Recommended Phase 2 Dose (RP2D) for treatment of patients with advanced solid tumors or lymphomas."

Trial status • Breast Cancer • Burkitt Lymphoma • Colorectal Cancer • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Hormone Receptor Positive Breast Cancer • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Triple Negative Breast Cancer

Anti-CD161 antibody IMT-009 is a novel immunotherapeutic agent that reinvigorates T and NK cell function and anti-tumor efficacy through blocking interaction of CD161 with its ligand CLEC2D (SITC 2022) - "Finally, multiplexed immunofluorescence data of over 30 solid tumor types showed the highest density of CLEC2D+ and CD161+ cells in the following indications: NSCLC-squamous cell carcinoma, NSCLC- adenocarcinoma, Head and Neck squamous cell carcinoma (HNSCC), Triple negative breast cancer (TNBC), Cutaneous squamous cell carcinoma and Colorectal carcinoma. Conclusions These results support the development of IMT-009 as a novel cancer immunotherapy for application in several solid tumor indications."

Clinical • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Triple Negative Breast Cancer • CD4 • CD8 • IFNG • KLRB1 • TNFA

Immunitas Therapeutics Presents Preclinical Data Demonstrating Potential of Novel Cancer Immunotherapy IMT-009 at the 2022 Society for Immunotherapy of Cancer (SITC) Annual Meeting (PRNewswire) - "Preclinical data confirm that IMT-009 binds with high affinity and selectivity to CD161, a cell surface inhibitory receptor that is broadly expressed on NK and a subset of memory CD4+ and CD8+ T cells. Upon binding, IMT-009 disrupts CD161 interaction with its ligand, CLEC2D, restoring activation of effector functions of both CD161+ T and NK cells and thus enhancing cytotoxicity towards target tumor cells."

Preclinical • Oncology • Solid Tumor

Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas (clinicaltrials.gov) - P1/2 | N=119 | Recruiting | Sponsor: Immunitas Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Burkitt Lymphoma • Colorectal Cancer • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • HER2 Breast Cancer • Hodgkin Lymphoma • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Small Intestinal Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • T Cell Non-Hodgkin Lymphoma • Triple Negative Breast Cancer • ALK • BRAF • KRAS • MET • MSI • PIK3CA

"ERX-41 making local news. @gr8straj Could we combine ERX-41 with TTX-MC138, Bria-IMT, IMT-009 etc for a super mbc cocktail? @RNAoncology @BriaCell @ImmunitasTx https://t.co/1NUakSOxze" (@rushmorealum)

Oncology

Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas (clinicaltrials.gov) - P1/2 | N=119 | Not yet recruiting | Sponsor: Immunitas Therapeutics

New P1/2 trial • Breast Cancer • Burkitt Lymphoma • Colorectal Cancer • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • HER2 Breast Cancer • Hodgkin Lymphoma • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Small Intestinal Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • T Cell Non-Hodgkin Lymphoma • Triple Negative Breast Cancer • ALK • BRAF • KRAS • MET • MSI • PIK3CA

Immunitas Therapeutics to Present Preclinical Data on IMT-009 at the 2022 Society for Immunotherapy of Cancer (SITC) Annual Meeting (PRNewswire) - "Immunitas Therapeutics...announced they will present preclinical data on lead program IMT-009, a fully human monoclonal antibody against a novel immuno-oncology target CD161, at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, held both virtually and in Boston from November 8-12, 2022....The SITC presentation will demonstrate the potential of IMT-009 as a novel cancer immunotherapy to treat solid tumors and hematological malignancies....IMT-009 is anticipated to begin enrollment for a Phase 1/2a clinical trial in Q4 2022 for use as a monotherapy and combination treatment for solid tumor and hematological malignancies. The Phase 1 study is designed to evaluate the safety, tolerability, pharmacodynamic biomarkers, and preliminary efficacy of IMT-009 as well as identify the Recommended Phase 2 Dose (RP2D). "

Preclinical • Trial status • Hematological Malignancies • Oncology • Solid Tumor

"#ImmunitasTherapeutics Receives #FDA Clearance of #IND Application for #IMT009 in #SolidTumors and #HematologicalMalignancies https://t.co/0m88LIreeq" (@1stOncology)

FDA event • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor

Immunitas Therapeutics Receives FDA Clearance of IND Application for IMT-009 in Solid Tumors and Hematological Malignancies (PRNewswire) - "Immunitas Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for IMT-009, a fully human monoclonal antibody against a novel immuno-oncology target CD161. The Phase 1 study is designed to evaluate the safety, tolerability, pharmacodynamic biomarkers, and preliminary efficacy of IMT-009 as well as identify the Recommended Phase 2 Dose (RP2D). The trial will then transition into Phase 2 with multiple expansion cohorts to assess the safety and efficacy of IMT-009 alone or in combination with another antineoplastic agent....The IMT-009 Phase 1/2 clinical trial is anticipated to begin enrollment in Q4 2022."

Enrollment status • IND • Hematological Malignancies • Oncology • Solid Tumor

Immunitas Therapeutics Completes $58 Million Series B Financing to Advance Pipeline into the Clinic and Expand Single Cell Analysis Drug Development Platform for Immuno-Oncology and Other Diseases (PRNewswire) - “The Series B funding will be used to advance Immunitas' lead program, IMT-009, a CD161 inhibitor, into the clinic to treat both solid tumors and hematological malignancies….The company expects to file its first Investigational New Drug application (IND) in 1H 2022 for IMT-009.”

Commercial • IND • Hematological Malignancies • Oncology • Solid Tumor