Approval for Initial Dose Cohort in PMC-309 Phase 1a/b Trial for Advanced Solid Tumors

July 8, 2024, PharmAbcine Inc., a clinical-stage biotechnology company, announced significant progress regarding their PMC-309 immuno-oncology program. PMC-309, a VISTA-targeting monoclonal antibody, received safety approval for the initial dose cohort of 0.2mg/kg during its Phase 1a/b clinical trial, which is aimed at patients with advanced or metastatic solid tumors in Australia. Following the initial approval, the second dose cohort of 0.5mg/kg has now commenced, with two patients already having received treatment and a third set to be treated shortly.

PMC-309, an IgG1 monoclonal antibody, exhibits specific binding to VISTA on immunosuppressive cells. It demonstrates excellent binding affinity across various pH levels within the tumor microenvironment. By inhibiting VISTA, PMC-309 activates T cells and monocytes and promotes the proliferation of M1 macrophages, offering a unique anti-cancer mechanism of action.

The Phase 1a/b clinical trial involves 67 patients and is divided into two stages: Phase 1a and Phase 1b. Phase 1a focuses on PMC-309 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 alone and in combination with KEYTRUDA at RP2D. This trial is being conducted across four institutions in Australia.

Dr. Jin-San Yoo, CEO of PharmAbcine Australia Pty, an Australian subsidiary of PharmAbcine Inc., remarked that the past decade has seen the introduction of first-generation immuno-oncology drugs, which have been administered to numerous cancer patients. He noted that while some patients have benefited, others have developed resistance or succumbed to their illnesses, underscoring the need for next-generation immuno-oncology treatments. The safety confirmation of the first dose cohort of PMC-309 marks the beginning of this trial, and there is anticipation for the continued safety and efficacy assessments through higher dose cohorts. Furthermore, preparations are underway for a combination trial of PMC-309 with KEYTRUDA in collaboration with MSD.

PharmAbcine is dedicated to offering new treatment options to patients who face limitations with current first-generation immuno-oncology drugs.

PharmAbcine Inc. is a clinical-stage public company focused on developing next-generation IgG-based therapeutics for cancer, neovascular eye diseases, and other vascular-related unmet medical needs. The company’s primary pipeline includes several clinical assets such as olinvacimab, PMC-403, and PMC-309.

Olinvacimab, the company’s leading asset, is undergoing a Phase 2 trial combined with MSD's pembrolizumab for patients with metastatic triple-negative breast cancer (mTNBC) in Australia. This trial aims to validate the promising results observed in the Phase 1b olinvacimab plus pembrolizumab trial, which reported a 50% objective response rate (ORR) and a 67% disease control rate (DCR) with a favorable safety profile.

PMC-403 is another innovative TIE2-activating antibody that stabilizes dysfunctional and pathological blood vessels, potentially offering solutions for vascular-related eye diseases like wet age-related macular degeneration (AMD). It is currently in Phase 1 trials for neovascular AMD patients in Korea and is being considered for broader therapeutic applications involving pathological vessels.

PMC-309, the novel anti-VISTA-antagonizing IgG, functions as an immune checkpoint regulator targeting myeloid-derived suppressor cells (MDSC) and M2 macrophages, key players in sustaining the immunosuppressive tumor microenvironment. The Phase 1a trial is ongoing at multiple centers in Australia, with plans for a Phase 1b trial in combination with MSD’s pembrolizumab.

Additionally, PharmAbcine is developing PMC-005, an anti-EGFRviii IgG that specifically targets EGFRviii on cancer cells and has potential applications across multiple modalities, including CAR-T, CAR-NK, CAR-Macrophage, T cell/NK cell engager, and radio-immunotherapy.

PharmAbcine continues to innovate and advance its pipeline to address unmet medical needs in oncology and other therapeutic areas.

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