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, announced on July 2, 2024, that it will advance its drug candidate PMC-403 to the fourth single-dose group of 4mg and the first multiple-dose group of 3mg in its ongoing Phase 1 clinical trial for neovascular age-related macular degeneration (nAMD).

PMC-403 is a TIE2-activating antibody designed to stabilize pathological and leaky blood vessels. The TIE2 receptors, located on endothelial cells, play a crucial role in vessel normalization, including processes like angiogenesis and intercellular adhesion. This trial specifically targets patients with nAMD who are no longer responding to the standard anti-VEGF therapies.

The company's Scientific Review Committee (SRC) has decided to move forward with testing the highest single dose cohort (4mg) and the initial multiple ascending dose cohort (3mg). This advancement aims to gather more comprehensive data from the Phase 1 study. Dr. Weon Sup Lee, Head of R&D and Chief Technology Officer at PharmAbcine, emphasized the innovative approach of PMC-403. He noted that despite existing anti-VEGF treatments, many patients continue to suffer from vision loss and retinal vascular leakage. Dr. Lee stated, "If the 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."

Age-related macular degeneration is a leading cause of blindness, primarily resulting from abnormal blood vessels in the macula. The global rise in the aging population has led to an increase in cases of macular degeneration, and current anti-VEGF treatments are not entirely effective. This situation underscores the need for new therapies with different mechanisms of action.

PharmAbcine's PMC-403, upon securing safety in the highest dose cohort, could offer a significant breakthrough in treating macular degeneration. If the drug progresses to Phase 2 clinical trials, it could provide a novel treatment option for patients suffering from this condition worldwide.

PharmAbcine is focused on developing next-generation IgG-based therapeutics aimed at treating cancer, neovascular eye diseases, and other vascular-related medical needs. The company's main pipeline includes several clinical assets: olinvacimab, PMC-403, and PMC-309.

Olinvacimab, PharmAbcine's leading asset, is currently in a Phase II trial in combination with MSD's pembrolizumab for patients with metastatic triple-negative breast cancer (mTNBC) in Australia. The trial aims to reconfirm the promising results from a Phase Ib trial, which demonstrated a 50% Overall Response Rate (ORR), a 67% Disease Control Rate (DCR), and a clean safety profile.

PMC-403, in addition to its ongoing Phase 1 trial for nAMD patients in Korea, is being evaluated for broader applications related to pathological blood vessels, including vascular-related rare and non-rare diseases.

PMC-309, another asset in PharmAbcine's pipeline, is a novel anti-VISTA-antagonizing IgG designed to target myeloid-derived suppressor cells (MDSCs) and M2 macrophages, which play crucial roles in maintaining an immunosuppressive tumor microenvironment. This drug is currently undergoing a Phase I trial at multiple centers in Australia, with plans for a Phase Ib/II trial in combination with MSD's pembrolizumab.

Another promising candidate, PMC-005, is an anti-EGFRviii IgG that binds exclusively to EGFRviii expressed on cancer cells. This asset has potential applications across various modalities, including CAR-T, CAR-NK, CAR-Macrophage, T cell/NK cell engagers, and Radio-Immunotherapy.

PharmAbcine's commitment to developing innovative treatments aims to address significant unmet medical needs, particularly in the areas of cancer and vascular-related diseases. The advancement of PMC-403 to further stages of clinical trials underscores the company's ongoing efforts to bring new, effective therapies to patients worldwide.