PharmAbcine's PMC-403 Phase 1 Trial for Neovascular AMD Progresses to Single 4mg and Multiple 3mg Doses

PharmAbcine, Inc., a clinical-stage public company based in Daejeon, South Korea, has announced a significant advancement in the clinical trial of its novel treatment, PMC-403, for neovascular age-related macular degeneration (nAMD). The Safety Review Committee (SRC) has approved the administration of a 3mg dose for the third cohort in its ongoing Phase 1 trial. This decision also allows the trial to progress to the fourth single-dose cohort of 4mg and the first multiple-dose cohort of 3mg.

PMC-403 is a TIE2-activating antibody designed to stabilize abnormal and leaky blood vessels. TIE2 receptors, which are found on endothelial cells, play a crucial role in vessel normalization, including processes like angiogenesis and intercellular adhesion. The current Phase 1 trial targets nAMD patients who have not responded to traditional anti-VEGF therapies.

Dr. Weon Sup Lee, Head of Research and Development and Chief Technology Officer at PharmAbcine, emphasized the necessity of innovative treatments: "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 a differentiated mode of action for these patients." He also noted that if the safety of PMC-403 is confirmed in this Phase 1 trial, the chances of advancing to Phase 2 will be higher, facilitating the eventual commercialization of the treatment.

Age-related macular degeneration is a major cause of blindness, primarily resulting from age-related damage to the retina and the formation of abnormal blood vessels in the macula. With the global aging population on the rise, cases of macular degeneration have increased rapidly, highlighting the inadequacy of current anti-VEGF treatments. Consequently, there is an urgent need for new therapeutic mechanisms.

If PMC-403 secures safety at the highest dose cohort (4mg), it could become a crucial treatment for macular degeneration. The likelihood of progressing to Phase 2 clinical trials increases, making PMC-403 a promising new treatment option for macular degeneration patients globally.

PharmAbcine Inc. specializes in developing next-generation IgG-based therapeutics to address unmet medical needs in cancer, neovascular eye diseases, and vascular-related conditions. The company's main pipeline includes olinvacimab, PMC-403, and PMC-309.

Olinvacimab, the company's leading asset, is currently in a Phase II trial in combination with MSD's pembrolizumab for metastatic triple-negative breast cancer (mTNBC) patients in Australia. This trial aims to reconfirm the positive results from a Phase Ib trial, which showed a 50% overall response rate (ORR), a 67% disease control rate (DCR), and a favorable safety profile.

PMC-403 is currently undergoing a Phase 1 trial for neovascular AMD patients in Korea. Besides its potential in treating wet AMD, PMC-403 is also being investigated for broader therapeutic applications related to pathological vessels, including rare and non-rare vascular-related diseases.

PMC-309 is a novel anti-VISTA-antagonizing IgG that functions in various pH conditions. It is an immune checkpoint regulator targeting myeloid-derived suppressor cells (MDSCs) and M2 macrophages, which are crucial for maintaining an immunosuppressive tumor microenvironment. A Phase I trial is ongoing at multiple centers in Australia, with a combined Phase Ib/II trial with MSD's pembrolizumab planned.

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