GRC 54276 / Glenmark - LARVOL DELTA

A Study of GRC 54276 in Participants With Advanced Solid Tumors and Lymphomas. (clinicaltrials.gov) - P1 | N=320 | Active, not recruiting | Sponsor: Glenmark Specialty S.A. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Lymphoma • Oncology • Solid Tumor

Ichnos and Glenmark take a collaborative leap to accelerate innovation in Cancer Treatment with their alliance - 'Ichnos Glenmark Innovation' (PRNewswire) - "This alliance brings together drug innovation capabilities of Ichnos and Glenmark to develop cutting-edge therapies for the treatment of hematological malignancies and solid tumors; IGI harnesses the collective expertise of over 150 scientists, operating through its three centers of innovation across the USA, Switzerland and India; There are currently three oncology molecules in clinical trials, with two having received orphan drug designation from the U.S. FDA; The synergies derived from this alliance will substantially reduce Glenmark's investment in innovative research."

Licensing / partnership • Acute Lymphocytic Leukemia • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor

PHASE 1 FIRST IN HUMAN STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF GRC54276, A NOVEL HPK1 THRONINE- KINASE INHIBITOR, IN ADVANCED SOLID TUMOURS AND LYMPHOMAS. (EHA 2023) - "GRC54276 has been well tolerated at the dose levels tested and has shown antitumor activity when administered as monotherapy to Hodgkin's lymphoma, colon carcinoma and buccal mucosal carcinoma patients. GRC54276 will be further tested in select patients as monotherapy and in combination with pembrolizumab or atezolizumab. Lymphoma, Targeted therapy, Hodgkin's lymphoma, Cancer immunotherapy"

Clinical • Metastases • P1 data • PK/PD data • Biliary Cancer • Breast Cancer • Cervical Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Hepatology • Hodgkin Lymphoma • Immune Modulation • Lymphoma • Oncology • Ovarian Cancer • Solid Tumor • BLNK • LCP2

A Study of GRC 54276 in Participants With Advanced Solid Tumors and Lymphomas. (clinicaltrials.gov) - P1 | N=320 | Recruiting | Sponsor: Glenmark Specialty S.A.

Combination therapy • Metastases • New P1 trial • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Lymphoma • Oncology • Solid Tumor

GRC 54276, a novel small molecule inhibitor of HPK1 has entered phase 1/2 clinical trial insolid malignancies and Hodgkin’s/non Hodgkin’s lymphoma (AACR 2023) - "Enhanced efficacy was demonstrated by combining GRC 54276 with check-point blocking antibodies anti-CTLA4 and Atezolizumab in the CT26 and MC38-hPD-L1 models, respectively. GRC 54276 is a novel HPK1 inhibtitor with acceptable pre-clincial profile and is currently undergoing a Phase 1/2 clinical trial."

Clinical • IO biomarker • P1/2 data • Colon Cancer • Gastrointestinal Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Glenmark receives acceptance from U.S. FDA on its IND application for GRC 54276 to proceed with a Phase 1/2, first-in-human clinical study of the molecule for the treatment of patients with advanced solid tumors and lymphomas (PRNewswire) - "Glenmark Specialty SA...received acceptance from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application for GRC 54276 to proceed with a Phase 1/2, first-in-human, clinical study of GRC 54276 for the treatment of patients with advanced solid tumors and lymphomas....A Phase 1/2 multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of GRC 54276 is currently underway in India."

IND • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

IND-ready clinical candidate for HPK1 developed with excellent efficacy and safety profile (AACR 2022) - "In vivo efficacy was demonstrated in syngeneic mouse tumor models, both as a single agent and combination with immune check-point blockers (ICB), mouse anti-CTLA4 antibody or Atezolizumab (human anti-PD-L1 antibody). The no observed adverse effect levels in the 14-day and 17-day exploratory studies in mice and monkeys were 50 and 15 mg/kg/day, respectively.Conclusions GRC 54276, our clinical candidate is potent, selective, orally bioavailable HPK1 inhibitor demonstrating strong single-agent and combination efficacy, low DDI liability accompanied by acceptable early safety profile in mice and monkeys. GRC 54276 is undergoing IND enabling studies to advance to Phase 1 clinical trial."

Clinical • Oncology • Solid Tumor • CYP3A4 • IFNG • IL2

Glenmark Specialty S.A. receives approval for conducting Phase 1 Clinical Trial of its Novel Molecule GRC 54276 in patients with Advanced Solid Tumors and Hodgkin’s Lymphoma (PRNewswire) - "Glenmark Pharmaceuticals Limited...announced that its subsidiary Glenmark Specialty S.A. (Glenmark) received approval from the Indian drug regulator, Drug Controller General of India (DCGI), to conduct a Phase 1 clinical trial of its novel small-molecule, GRC 54276, a hematopoietic progenitor kinase 1 (HPK1) inhibitor....The study will evaluate the safety and tolerability of GRC 54276 as a monotherapy, and also in combination with checkpoint inhibitors in patients with advanced solid tumors and Hodgkin's lymphoma. Glenmark will initiate Phase 1 clinical trial in India by June 2022, and also plans to file an IND in the US and Clinical Trial Applications in Europe to kick-off a fully global clinical study program."

European regulatory • IND • New P1 trial • Hematological Malignancies • Hodgkin Lymphoma • Oncology • Solid Tumor