Curadev Pharma Receives FDA '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
BOSTON, Mass. and NOIDA, India, Dec. 6, 2022 /PRNewswire/ -- Curadev Pharma, a small molecule drug discovery and development company focused on the generation of novel therapeutics for the treatment of intractable diseases such as cancer 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-?B activated cytokines. The human STING gene is polymorphic, with five major variants covering 98.8% of the population.
CRD3874 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.
Curadev is a small molecule drug discovery and development biotech with an exciting portfolio of research programs that have yielded patent protected drug candidates. Founded in 2010, Curadev has created a premier translational research organization known for prescient target selection and high quality, data-driven program execution. Programs at Curadev seek to ameliorate disease by translating cutting edge discoveries into new medicines. To know more about Curadev, visit our website www.curadev.in.
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