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Curadev Completes First Treatment Cycle of Phase 1a/b Trial of CRD3874-SI at Memorial Sloan Kettering

Wednesday, February 28, 2024

Curadev, a pharmaceutical company specializing in drug discovery and development, has announced a significant milestone today in its efforts to develop drugs targeting the immune system for cancer treatment. The company has initiated the dosing of patients with advanced sarcoma and Merkel cell carcinoma through intravenous infusion of its systemic allosteric STING agonist, CRD3874-SI, as part of a Phase 1a/b dose escalation and expansion clinical trial (NCT06021626) currently underway at Memorial Sloan Kettering Cancer Center (MSKCC) in New York. The initial 4-week treatment cycle for the first patient has been completed without any adverse events. The primary objective of the dose escalation phase is to assess the safety and tolerability of CRD3874-SI, determine the maximum tolerated dose (MTD), and establish the recommended Phase 2 dose (RP2D).

Curadev, highlighted the importance of this milestone, stating, "This marks a significant step forward in the development of CRD3874-SI. It represents the culmination of extensive small molecule drug discovery efforts, leading to the identification of our allosteric STING agonists, which offer distinct advantages over orthosteric CDN site agonists."

The successful application of CRD3874-SI to support First-in-Human (FIH) trials by the US-FDA was based on data presented at the annual meeting of the Society for Immunotherapy of Cancer (SITC) in November 2023. These data included the efficacy of CRD3874 as a single agent delivered intravenously in various tumors implanted in human STING knock-in mice, as well as safety studies in non-human primates, supporting the intravenous delivery of CRD3874-SI in clinical settings. Evidence presented indicated that CRD3874's unique pharmacological features stem from its allosteric binding mode, promoting pro-inflammatory Type I IFN signals while concurrently blocking STING's proton channel-mediated toxicity and autophagy-driven actions. The aim 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, commented on the promising pre-clinical safety and anti-tumor efficacy of CRD3874-SI. She highlighted its unique properties and potential to enhance both innate and adaptive immunity, expressing excitement about evaluating this novel immunotherapeutic in clinical settings and offering it as an option to patients with advanced cancers.

Dr. Surya reiterated the company's commitment to advancing life-changing therapies for cancer patients, expressing gratitude for the investigation of CRD3874-SI's clinical performance by Dr. Kelly and the expert team at MSKCC. He emphasized that this first clinical trial of a Curadev-developed compound underscores their dedication to addressing the critical needs of cancer patients through innovative treatments.



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