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Curadev Pharma bags ‘Study May Proceed’ letter from US FDA

The study will be performed at a leading US cancer centre

Curadev Pharma, a small molecule drug discovery and development company focussed 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 centre.

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Successful clearance of tumours by the immune system requires the action of Type I IFNs. When activated in cells of the tumour 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 per cent of the population.

CRD3874 is a potent allosteric activator of all major human STING variants covering 98.8 per cent of the population and is differentiated from the CDN class of STING agonists. CRD3874 displays strong T cell-dependent anti-tumour activity when dosed through either the IV or IT routes in a range of syngeneic tumour models as a single agent or combination with checkpoint inhibitors. As would be anticipated for an immune-modulated mechanism of action, mice that experienced complete tumour regression on treatment were refractory to challenge from re-engrafted tumour 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 tumour clearance,” says Dr Arjun Surya, CEO & CSO, Curadev.

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