DAEJEON, South Korea, July 26, 2023 /PRNewswire/ — PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics, announced today that the first patient has been dosed in the Phase I clinical trial of PMC-403, the Company’s novel TIE2 agonistic antibody, in nAMD (neovascular age-related macular degeneration).
The study, consisting of single ascending-dose cohort and multiple ascending-dose cohort, has dosed the first of 36 planned study subjects. The Phase I clinical trial, an open-label, multi-center, single and multiple ascending-dose study, is currently enrolling patients at multiple hospitals in South Korea, including Seoul National University Bundang Hospital.
The goal of the study is to assess safety, tolerability, MTD (maximum tolerated dose), RP2D (recommended phase 2 dose), as well as clinical efficacy and pharmacokinetics of PMC-403 in subjects with nAMD,an advanced form of macular degeneration, that results in significant central vision loss due to neovascular and non-neovascular damages.
PMC-403 is a potential first-in-class antibody that activates TIE2, a receptor specifically expressed in vascular endothelial cells. Once the molecule binds to the receptors, it promotes the normalization and stabilization of pathologically leaky blood vessels. PharmAbcine has been developing this asset to treat not just AMD (Age-related Macular Degeneration), but also DME (Diabetic Macular Edema), and DR (Diabetic Retinopathy). The Company also plans to further expand therapeutic scopes of PMC-403 to other systemic vessel-related diseases.
“This clinical trial is the world’s first ophthalmology trial using Tie2 activation antibodies.”, said Dr. Sagong Min, Professor of Yeungnam University Hospital, who conducted the first patient administration. He further added,”Tie2 activation antibody ‘PMC-403,’ developed by PharmAbcine, stabilizes abnormal blood vessels and reduces leakage, providing a new treatment option for patients who do not respond or have become relapsed to the existing anti-VEGF drugs.”
“The initiation of the clinical trial to evaluate PMC-403’s performance in nAMD is a significant step to unlocking its full potential,” said Dr. Jin-San Yoo, CEO of PharmAbcine. “There are significant unmet needs in ophthalmology field as patients, who do not respond or have become relapsed to the existing anti-VEGF drugs, have no alternative therapeutic options. Our team believes that once PMC-403 shows positive therapeutic effects in one of the most prevalent vessel-related ocular diseases, it would surely be a new game-changer in the market.”
For more information about the study, visit clinicaltrials.gov and search for the reference identifier NCT05953012.
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 assets include olinvacimab, the lead asset in clinical stage, and IND-ready preclinical assets with first-in-class potential such as PMC-309 and PMC-403.
Olinvacimab, the Company’s lead asset, is undergoing a Phase II trial in combination with MSD’s pembrolizumab for mTNBC patients in Australia. The Company entered the Phase II study to reconfirm the encouraging result from Phase Ib olinvacimab-pembrolizumab trial, delivering 50% ORR, 67% DCR, and clean safety profile.
PMC-309, a novel anti-VISTA-antagonizing IgG in pan pH, 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-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).
One of other early-stage assets, 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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