On February 27, 2024 Curadev, a drug discovery and development company, reported a significant milestone in its development of drugs targeting the immune system to treat cancer (Press release, Curadev, FEB 27, 2024, View Source [SID1234640552]). The dosing of patients with advanced sarcoma and Merkel cell carcinoma by intravenous infusion of Curadev’s systemic allosteric STING agonist, CRD3874-SI, has been initiated in a Phase 1a/b dose escalation and expansion clinical trial (NCT06021626) currently underway at Memorial Sloan Kettering Cancer Center (MSKCC) in New York. The first 4-week treatment cycle for the first patient is complete without adverse events. The primary objective for the dose escalation is to evaluate the safety and tolerability of CRD3874-SI and to establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).

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"This is an important milestone in the development of CRD3874-SI," said Dr. Arjun Surya, CEO and Chief Scientific Officer at Curadev. "It is the lead compound from an extensive small molecule drug discovery campaign that led to the discovery of our allosteric STING agonists which are clearly differentiated from agonists that bind to the orthosteric CDN site".

Data that formed the basis for CRD3874’s successful US-FDA application to support FIH trials was presented at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2023. These included single agent efficacy of CRD3874 delivered intravenously in a range of tumors seeded in human STING knock-in mice and safety studies in non-human primates that supported the systemic delivery of CRD3874-SI by intravenous infusion in the clinic. Evidence presented indicated that CRD3874’s distinct pharmacological features could arise from its allosteric binding mode which promotes pro-inflammatory Type I IFN signals while simultaneously blocking STING’s proton channel-mediated toxicity and autophagy driven actions. The initiation and progression of cancers hinges on their ability to evade clearance by the immune system. The goal of intravenous administration of CRD3874-SI to patients with advanced cancer is to systemically activate STING to revive dormant or disrupted immune mechanisms to clear primary and metastatic tumors.

Dr. Ciara Kelly, the Principal Investigator for this clinical trial and an expert in treating and researching bone and soft tissue sarcomas and Merkel cell carcinomas said, "CRD3874-SI demonstrated promising pre-clinical safety and anti-tumor efficacy. It has unique properties that differentiate it from other STING agonists under investigation and has the potential to harness and augment innate and adaptive immunity. We are excited to evaluate this novel immunotherapeutic in the clinical setting and provide this option to patients with advanced cancers including sarcoma and Merkel cell carcinoma."

"We are very pleased that Dr. Kelly and the expert team at MSKCC are investigating the clinical performance of CRD3874-SI with the hope of establishing a potentially important new treatment for advanced cancer to those most in need of it. This first clinical trial of a compound discovered and developed by Curadev underscores our commitment to advancing life changing therapies for cancer patients," added Dr. Surya.