PharmAbcine Receives Safety Review Committee Approval to Advance to Dose Level 2 of Clinical Trial of PMC-403 with Neovascular Age-related Macular Degeneration following Dose Level 1 Safety Data
- Safety Review Committee evaluated dose level 1 safety data of PMC-403 and approved advancing to the higher dose treatment.
- The starting dose (0.7mg) of PMC-403 showed potential in improving eyesight for neovascular age-related macular degeneration patients with suboptimal response to currently available therapies.
DAEJEON, South Korea, Nov. 9, 2023 /PRNewswire/ -- PharmAbcine, Inc. ("PharmAbcine" or the "Company") (KOSDAQ: 208340), a clinical-stage public company focused on developing novel antibody therapies for patients, today announced that the Safety Review Committee (SRC) has approved advancing to dose level 2 of the PMC-403 Phase 1 clinical study in neovascular age-related macular degeneration patients following completion of dose level 1 safety data evaluation.
In this clinical study, a maximum of 36 patients with neovascular age-related macular degeneration with suboptimal response to currently available therapy will be evaluated for safety and maximum tolerated dose (MTD) of PMC-403. The SRC reviewed the clinical data for dose level 1, and all of the SRC members agreed to advance to the dose level 2.
The secondary endpoint for this clinical study is efficacy data which includes changes in best corrected visual acuity (BCVA), central retinal thickness, and intraocular fluid leakage. All of the patients who received the dose level 1 treatment of PMC-403 showed improvement in BVCA in the first month, suggesting the potential for promising efficacy data.
PMC-403 is an antibody therapeutic candidate with a novel mechanism of action in which it activates the TIE2 receptor and normalizes the leaky pathological blood vessels. PMC-403 offers a new treatment option for patients with unmet needs in vascular ophthalmic diseases who do not respond to current marketed treatments which target vascular endothelial growth factor (VEGF).
Dr. Jin-San Yoo, President and CEO of PharmAbcine, commented "As the safety of the starting dose of PMC-403 has been confirmed and the dose escalation has been approved, as well as improvements in the patients' vision, PMC-403 will most likely be the new treatment option for age-related ophthalmic diseases. In addition, the MoA of PMC-403 has potential to treat various systemic vascular diseases which enables expansion of indications and maximizing the value of PMC-403."
Age-related macular degeneration is a vision-threatening condition caused by abnormal blood vessels in the macula due to retinal aging. While the aging population has led to a significant increase in the number of patients, the current standard treatment, VEGF inhibitors, still show non-responders and do not guarantee optimal treatment. Therefore, there is a high demand for a new treatment option with novel MoA that can complement existing therapies.
According to the global market research agency Market Research Future (MRF), the global age-related macular degeneration market was estimated to be US$9.6 billion in 2021 and is expected to grow at an average annual rate of 8.09% (2018-2027), reaching US$15.3 billion in 2027.
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 includes clinical assets olinvacimab and PMC-403, and an IND-approved potential first-in-class asset 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-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).
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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