PharmAbcine Announces First Patient Dosed in Phase 1a/b Clinical Trial of PMC-309 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Advanced or Metastatic Solid Tumors

• nitiation of Phase 1a/b clinical trial exploring MTD, RP2D, safety and tolerability of PMC-309 monotherapy and combination therapy with KEYTRUDA®
• The clinical trial aims to enroll a total of 67 patients across four institutions in Australia

 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on next-generation antibody therapeutics, announced today the initiation of patient dosing in the Phase 1a/b clinical trial of PMC-309 in patients with advanced or metastatic solid tumors.PMC-309 is an IgG1 monoclonal antibody with specific binding to VISTA in immunosuppressive cells, exhibiting excellent binding affinity at various pH conditions within the tumor microenvironment (TME). By inhibiting VISTA, PMC-309 presents a differentiated mechanism of action contributing to anti-cancer effects through activation of T cells, activation of monocytes, and proliferation of M1 macrophages.

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

Dr. Jin-San Yoo, President and Chief Executive Officer of PharmAbcine, stated, "This clinical trial aims to assess the human safety of PMC-309 and explore the potential of both monotherapy and combination therapy with KEYTRUDA®. We are committed to developing new therapeutic options for cancer patients facing high unmet needs, emphasizing our dedication to advancing oncology treatments."

For more information on the clinical trial, please visit clinicaltrials.gov, identifier NCT 05957081.

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

About PharmAbcine Inc.

PharmAbcine is a clinical stage public company developing next generation IgG based therapeutics to treat cancer, neovascular eye diseases, and vascular related unmet needs. 

The Company's main pipeline include clinical assets olinvacimab, PMC-403, and PMC-309.

Olinvacimab, the Company's lead asset, is undergoing a Phase 2 trial in combination with MSD's pembrolizumab for mTNBC patients in Australia. The Company entered the Phase 2 study to reconfirm the encouraging result from Phase 1b olinvacimab-pembrolizumab trial, delivering 50% ORR, 67% DCR, and clean safety profile.

PMC-403 is a novel TIE2-activating antibody that stabilizes dysfunctional leaky disorganized pathological vessels and can be used for vascular-related eye disease, including wet AMD (Age-related Macular Degeneration). PMC-403 is currently undergoing Phase 1 trial for neovascular AMD patients in Korea. PMC-403 is also being explored to expand into wider therapeutic areas related to pathological vessels including vessel-related rare disease and chronic kidney disease.

PMC-309, a novel anti-VISTA-antagonizing IgG in pan pH conditions, is an immune checkpoint regulator that targets MDSC (myeloid derived suppressor cells) and M2 macrophages which play pivotal role in maintaining immunosuppressive TME (Tumor Microenvironment).

PMC-005, is an anti-EGFRviii IgG that only binds to EGFRviii expressed on cancer cells and can be applied to various modalities including CAR-T, CAR-NK, CAR-Macrophage, T cell/NK cell engager, and Radio-Immunotherapy.

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