Curadev Pharma receives FDA 'Study May Proceed' Letter for its Investigational New Drug Application of CRD3874

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-kB 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 .

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( With inputs from ANI )

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