Pharma Focus Asia

PharmAbcine Initiates Phase 1a/b Trial for PMC-309 with KEYTRUDA in Advanced Solid Tumors; First Dose Administered Successfully

Wednesday, January 24, 2024

PharmAbcine Inc. (KOSDAQ: 208340ks) has officially initiated patient dosing in the Phase 1a/b clinical trial of PMC-309, a novel IgG1 monoclonal antibody designed for next-generation antibody therapeutics. The trial targets patients with advanced or metastatic solid tumors.

PMC-309 specifically binds to VISTA in immunosuppressive cells, demonstrating strong binding affinity under various pH conditions within the tumor microenvironment (TME). Its unique mechanism of action involves inhibiting VISTA, leading to anti-cancer effects by activating T cells, monocytes, and promoting the proliferation of M1 macrophages.

The open-label clinical trial consists of two phases: Phase 1a and Phase 1b. Phase 1a encompasses PMC-309 monotherapy and combination therapy with KEYTRUDA® (pembrolizumab), with a focus on determining the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). In Phase 1b, the safety and tolerability of PMC-309 monotherapy and combination therapy with KEYTRUDA® at the RP2D will be assessed. This multi-institutional trial, spanning four institutions in Australia, aims to enroll a total of 67 patients.

PharmAbcine, expressed the company's commitment to advancing oncology treatments and addressing the unmet needs of cancer patients. The trial's primary objectives include evaluating the safety of PMC-309 in humans and exploring the potential of both monotherapy and combination therapy with KEYTRUDA®.



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