- Safety Review Committee (SRC) approves single 3mg dose for the third cohort in Phase 1 trial of PMC-403
DAEJEON, South Korea, July 2, 2024 /PRNewswire/ -- PharmAbcine, Inc. ("PharmAbcine" or the "Company") (KOSDAQ: 208340), a clinical-stage public company developing next generation therapeutics to treat medical unmet needs, announced today the decision to advance PMC-403, its candidate treatment for neovascular age-related macular degeneration (nAMD), to the fourth single-dose group of 4mg and first multiple-dose group of 3mg in Phase 1 clinical trial.
PMC-403 is a novel TIE2-activating antibody with the mechanism of stabilizing pathological and leaky blood vessels. TIE2 receptors, expressed on endothelial cells, are involved in vessel normalization processes such as angiogenesis and intercellular adhesion.
This Phase 1 trial targets patients with neovascular age-related macular degeneration who are no longer responding to anti-VEGF standard therapeutics. With the SRC's decision, the trial will advance to the highest single dose cohort (4mg) and the first multiple ascending dose cohort (3mg), potentially providing more advanced data from this Phase 1 study.
Dr. Weon Sup Lee, Head of R&D and Chief Technology Officer at PharmAbcine, stated, "Despite standard anti-VEGF treatments, many patients with neovascular age-related macular degeneration continue to experience vision loss and retinal vascular leakage. We are committed to delivering an innovative new drug with differentiated mode of action for these patients." He added, "If final safety is confirmed in this Phase 1 trial, the likelihood of advancing to Phase 2 will increase, paving the way for the commercialization of this treatment."
Macular degeneration is a leading cause of blindness caused by aging-related damage to the retina, particularly due to abnormal blood vessels in the macula. The global aging population has led to a rapid increase in macular degeneration cases, and current standard treatments with anti-VEGF inhibitors are insufficient for complete treatment. Consequently, there is a growing demand for new mechanism therapies.
Once PharmAbcine's PMC-403 secures safety at the highest dose cohort (4mg), it could play a crucial role in treating macular degeneration. As the likelihood of moving to Phase 2 clinical trials increases, PMC-403 is expected to provide a new treatment option for macular degeneration patients worldwide.
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 ongoing a Phase II trial in combination with MSD's pembrolizumab for mTNBC patients in Australia to reconfirm the encouraging result from Phase Ib olinvacimab plus 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 diseases and non-rare diseases.
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). Phase I is ongoing at multicenter in Australia and Phase Ib/II in combination with MSD's pembrolizumab PMC-309 + Pembrolizumab combo is in plan.
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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