FDA Accepts IND for GRC 54276 in Advanced Solid Tumors and Lymphomas

A phase 1/2 trial investigating GRC 54276 for the treatment of patients with advanced solid tumors and lymphomas will begin following the acceptance of an investigational new drug application for the agent.

The FDA accepted an investigational new drug (IND) application for GRC 54276 and the start of a phase 1/2, first-in-human, clinical study of GRC 54276 for the treatment of patients with advanced solid tumors and lymphomas, according to Glenmark Specialty SA.1

"Now that the FDA has accepted our IND application, we look forward to initiating the ongoing phase 1/2 study at the [United States] sites. This is an important milestone for Glenmark as we continue to advance our oncology pipeline,” Nikhil Amin, MD, chief scientific officer and president of innovative Medicine Group, Glenmark Pharmaceuticals Ltd, said in a press release.

The orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor, GRC 54276, is currently being developed by Glenmark.

HPK1-regulated functions are involved in the cancer-immunity cycle. This in turn makes it an attractive target for immuno-oncology. Through the inhibition of HPK1, investigators are hopeful that treatment with GRC 54276 can potentially enhance the patient's own immune system to fight against cancers.

GRC 54276 previously has demonstrated good stand-alone efficacy and has enhanced current immunotherapy efficacy.2

With the IND, a phase 1/2 multicenter, open-label study will examine the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of treatment with GRC 54276 in patients with advanced solid tumors and lymphomas. The study is currently taking place in India where GRC 54276 is being evaluated alone or in combination with anti–PD-1 or anti–PD-L1 therapies for the treatment of this patient population.

A total of 16 patients with various types of advanced cancers have already been enrolled in this ongoing study. According to the company, the trial is expected to expand at other research sites in the coming months.

“We are excited about the prospects of what this new class of immune-oncology medicines may mean for patients in need," added Amin.

1. 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. News release. Glenmark Specialty SA. March 16, 2023. Accessed March 29, 2023. https://prn.to/40oE4BE
2. R&D pipeline. Glenmark. Accessed March 30, 2023. https://bit.ly/42ShTW5
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