Curadev Pharma gets FDA nod for phase-1 study of its cancer drug candidate

The company has received US-FDA's 'Study May Proceed' letter for its Investigational New Drug Application of CRD3874, an IV-Administered STING Agonist for the treatment of advanced/metastatic solid cancers

New Delhi: Curadev Pharma, a molecule drug discovery and development company, has received a Study May Proceed letter from the United States Food and Drug Administration (FDA) to begin a Phase 1 study of its lead STING agonist CRD3874 in advanced/metastatic solid cancers. The study will be performed at a leading US cancer center.
Successful clearance of tumors by the immune system requires the action of Type I IFNs. When activated in cells of the tumor microenvironment and lymph nodes, the immune adaptor protein STING coordinates proinflammatory immune responses by generating Type I IFNs and NF-κB activated cytokines. The human STING gene is polymorphic, with five major variants covering 98.8% of the population.
BioVoice Special IssueCRD3874 is a potent allosteric activator of all major human STING variants covering 98.8% of the population and is differentiated from the CDN class of STING agonists. CRD3874 displays strong T cell dependent anti-tumor activity when dosed through either the IV or IT routes in a range of syngeneic tumor models as a single agent or in combination with checkpoint inhibitors. As would be anticipated for an immune-modulated mechanism of action, mice that experienced complete tumor regression on treatment were refractory to challenge from re-engrafted tumor cells.
“Immune evasion is an absolute requirement for the establishment of cancers. The systemic activation of STING by intravenous infusion of CRD3874-SI in patients with cancer is an attempt to re-activate dormant or disrupted immune mechanisms of tumor clearance,” says Dr. Arjun Surya, CEO & CSO of Curadev.