Glenmark Pharmaceuticals on Monday said the Drug Controller General of India (DCGI) has given nod to the firm’s unit to conduct Phase 1 clinical trials of its novels molecule on patients with advanced solid tumors.
Glenmark Specialty SA has received approval from DCGI to conduct a Phase 1 clinical trial of its novel small molecule, GRC 54276, a hematopoietic progenitor kinase 1 (HPK1) inhibitor. This molecule is one of the many novel molecules from Innovative Medicines Group of the pharmaceutical firm focused on the development of novel molecular entities for critical unmet medical needs. Glenmark has said GRC 54276 has shown tumor cell killing ability in preclinical studies as a single agent and also in combination with checkpoint inhibitors, thus making it a high-priority target in immune-oncology.
Glenmark has said it will begin Phase 1 clinical trial in India by June 2022. Moreover, it is also planning to file an Investigational New Drug (IND) application in the US and clinical trial applications in Europe to start with a fully global clinical study programme.
