Pharma Focus Asia

PharmAbcine Gains Safety Approval for First Dose Group in Phase 1a/b Study of PMC-309 in Advanced or Metastatic Solid Tumors

Monday, July 08, 2024

PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on innovative antibody therapeutics, has announced that their VISTA-targeting immuno-oncology candidate, PMC-309, received safety approval for the first dose cohort (0.2mg/kg) in a Phase 1a/b clinical trial for patients with advanced or metastatic solid tumors in Australia. The trial is now progressing to the second dose cohort (0.5mg/kg).

The initial dose of PMC-309 was administered in January 2024, with safety approval granted in April 2024. Currently, the second dose cohort has been administered to two patients, with a third patient scheduled for treatment soon.

PMC-309 is an IgG1 monoclonal antibody designed to target VISTA on immunosuppressive cells. It demonstrates strong binding affinity across various pH conditions within the tumor microenvironment (TME). By inhibiting VISTA, PMC-309 activates T cells, monocytes, and M1 macrophages, thereby enhancing anti-cancer effects.

This open-label Phase 1a/b clinical trial involves 67 patients and consists of two phases: Phase 1a and Phase 1b. Phase 1a will evaluate PMC-309 both as a monotherapy and in combination with KEYTRUDA® (pembrolizumab) to establish the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Phase 1b will assess the safety and tolerability of PMC-309 monotherapy and its combination with KEYTRUDA® at the RP2D. The trial is being conducted across four institutions in Australia.

PharmAbcine Australia Pty, the Australian arm of PharmAbcine Inc., stated, "Over the past decade, first-generation immuno-oncology drugs have shown benefits to some patients. However, many have developed resistance, and others have not survived. The demand for next-generation immuno-oncology drugs is high. The initial safety approval of PMC-309 is a significant milestone. We are eager to further test its safety and efficacy at higher doses and to commence combination trials with KEYTRUDA® in collaboration with MSD."

He added, "Our goal is to deliver new treatment options to patients facing the limitations of existing immuno-oncology therapies."

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.



magazine-slider-imageHexagon - Expert Insights WebinarMFA + MMA 20244th Annual Cleaning Validation 20242nd Annual Pharma Impurity Conclave 2024CPHI Korea 2024CHEMICAL INDONESIA 2024World Orphan Drug Congress Europe 2024INALAB 2024Thermo Fisher - Drug Discovery and the impact of mAbsAdvanced Therapies USA 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals Conference