Title | PharmAbcine Announces Safety Approval for 3mg Multiple-dose Cohort in Phase 1 Clinical Trial of PMC-403 for Neovascular Age-related Macular Degeneration |
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• Safety Review Committee (SRC) approves multiple ascending dose 3mg cohort in Phase 1 trial of PMC-403.
• Multiple ascending dose 4mg cohort is ongoing after SRC's prior clearance of single ascending dose 4mg.
• PMC-403 is being explored in broader therapeutic areas, including systemic capillary leak syndrome (SCLS), chronic kidney disease (CKD), cancer, and various unmet needs related to leaky, inflamed, disorganized, pathological, or aged vessels.
Daejeon, South Korea, January 8th, 2025 /-PharmAbcine, Inc. (KOSDAQ: 208340), a clinical-stage public company developing next-generation IgG-based therapeutics to address unmet medical needs, announced today that its novel TIE2-activating antibody, PMC-403, has received unanimous safety approval from the Safety Review Committee (SRC) for the 3mg multiple ascending dose (MAD) cohort in its Phase 1 clinical trial for neovascular age-related macular degeneration (nAMD). In parallel, the company is recruiting patients for the 4mg multiple ascending dose (MAD) cohort and 6mg single ascending dose (SAD).
PMC-403 is a novel TIE2-activating antibody with a unique mechanism that stabilizes pathological, leaky, inflamed blood vessels. TIE2 receptors, expressed on endothelial cells, play a pivotal role in the homeostasis of both blood vessels and lymphatic vessels.
This Phase 1 trial targets patients with neovascular AMD who are no longer responding to anti-VEGF standard therapeutics. The safety and tolerability of the 3mg multiple dose were successfully confirmed.
Dr. Weon Sup Lee, Head of R&D and Chief Technology Officer at PharmAbcine, stated, "The successful completion of the 3mg multiple-dose study is a significant milestone, highlighting the potential of PMC-403 as a breakthrough treatment for nAMD. As the 4mg MAD and 6mg SAD cohorts are ongoing in parallel, we aim to gather additional safety and efficacy data to establish a robust foundation for Phase 2 trials."
Macular degeneration, a leading cause of blindness, results from aging-related damage to the retina, particularly due to the development of abnormal blood vessels in the macula. The global aging population has led to a rapid increase in cases, and current standard treatments with anti-VEGF inhibitors are often insufficient for complete treatment. Consequently, there is a growing demand for therapies with novel mechanisms of action.
PharmAbcine plans to continue its research, with the goal of initiating a Phase 2 trial after confirming the safety and efficacy of the 4mg multiple-dose cohort and 6mg single-dose cohort. The company expects PMC-403 to play a pivotal role in the global market for AMD treatments.
Beyond ophthalmology, PMC-403 is being explored in therapeutic areas including vascular-related rare diseases and kidney diseases. The company has conducted a research collaboration with Dr. Kirk Druey, former Chief of the NIH's Lung and Vascular Inflammation Section, to explore the efficacy of PMC-403 in animal models for a rare disease called systemic capillary leak syndrome (SCLS, also known as Clarkson disease). In a recent interview, Dr. Druey expressed excitement about PMC-403’s potential in treating patients with SCLS. While there is currently no treatment for SCLS, PMC-403 received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of SCLS on February 21st, 2023.
For more information about the Phase 1 clinical trial for neovascular age-related macular degeneration (nAMD), please visit
(https://clinicaltrials.gov/study/NCT05953012)
For more information about PMC-403 in SCLS, please visit Dr. Druey’s interview on the NIH "I am Intramural" Blog
(https://irp.nih.gov/blog/post/2024/03/experimental-antibody-tightens-up-leaky-blood-vessels)
The PMC-403 phase I project is partly funded by KDDF (https://kddf.org//en).
# # # 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, 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 results from the Phase Ib olinvacimab plus pembrolizumab trial, delivering 50% ORR, 67% DCR, and a 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 a 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 a pivotal role in maintaining an immunosuppressive TME (Tumor Microenvironment). Phase I is ongoing at multicenters in Australia, and Phase Ib/II in combination with MSD’s pembrolizumab (PMC-309 + pembrolizumab combo) is planned.
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 engagers, and Radio-Immunotherapy.
For additional information about PharmAbcine, visit http://www.pharmabcine.com or follow on YouTube and LinkedIn.
For licensing deals, joint ventures, co-development, and collaboration in research or antibody discovery inquiries, please contact: Business Development Team E-mail: bd@pharmabcine.com Office line: +82 70 4279 5100
For investor relations and public relations inquiries, please contact: IR/PR Team E-mail: pmc_dis@pharmabcine.com
• Safety Review Committee (SRC) approves multiple ascending dose 3mg cohort in Phase 1 trial of PMC-403.
• Multiple ascending dose 4mg cohort is ongoing after SRC's prior clearance of single ascending dose 4mg.
• PMC-403 is being explored in broader therapeutic areas, including systemic capillary leak syndrome (SCLS), chronic kidney disease (CKD), cancer, and various unmet needs related to leaky, inflamed, disorganized, pathological, or aged vessels.
Daejeon, South Korea, January 8th, 2025 /-PharmAbcine, Inc. (KOSDAQ: 208340), a clinical-stage public company developing next-generation IgG-based therapeutics to address unmet medical needs, announced today that its novel TIE2-activating antibody, PMC-403, has received unanimous safety approval from the Safety Review Committee (SRC) for the 3mg multiple ascending dose (MAD) cohort in its Phase 1 clinical trial for neovascular age-related macular degeneration (nAMD). In parallel, the company is recruiting patients for the 4mg multiple ascending dose (MAD) cohort and 6mg single ascending dose (SAD).
PMC-403 is a novel TIE2-activating antibody with a unique mechanism that stabilizes pathological, leaky, inflamed blood vessels. TIE2 receptors, expressed on endothelial cells, play a pivotal role in the homeostasis of both blood vessels and lymphatic vessels.
This Phase 1 trial targets patients with neovascular AMD who are no longer responding to anti-VEGF standard therapeutics. The safety and tolerability of the 3mg multiple dose were successfully confirmed.
Dr. Weon Sup Lee, Head of R&D and Chief Technology Officer at PharmAbcine, stated, "The successful completion of the 3mg multiple-dose study is a significant milestone, highlighting the potential of PMC-403 as a breakthrough treatment for nAMD. As the 4mg MAD and 6mg SAD cohorts are ongoing in parallel, we aim to gather additional safety and efficacy data to establish a robust foundation for Phase 2 trials."
Macular degeneration, a leading cause of blindness, results from aging-related damage to the retina, particularly due to the development of abnormal blood vessels in the macula. The global aging population has led to a rapid increase in cases, and current standard treatments with anti-VEGF inhibitors are often insufficient for complete treatment. Consequently, there is a growing demand for therapies with novel mechanisms of action.
PharmAbcine plans to continue its research, with the goal of initiating a Phase 2 trial after confirming the safety and efficacy of the 4mg multiple-dose cohort and 6mg single-dose cohort. The company expects PMC-403 to play a pivotal role in the global market for AMD treatments.
Beyond ophthalmology, PMC-403 is being explored in therapeutic areas including vascular-related rare diseases and kidney diseases. The company has conducted a research collaboration with Dr. Kirk Druey, former Chief of the NIH's Lung and Vascular Inflammation Section, to explore the efficacy of PMC-403 in animal models for a rare disease called systemic capillary leak syndrome (SCLS, also known as Clarkson disease). In a recent interview, Dr. Druey expressed excitement about PMC-403’s potential in treating patients with SCLS. While there is currently no treatment for SCLS, PMC-403 received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of SCLS on February 21st, 2023.
For more information about the Phase 1 clinical trial for neovascular age-related macular degeneration (nAMD), please visit
(https://clinicaltrials.gov/study/NCT05953012)
For more information about PMC-403 in SCLS, please visit Dr. Druey’s interview on the NIH "I am Intramural" Blog
(https://irp.nih.gov/blog/post/2024/03/experimental-antibody-tightens-up-leaky-blood-vessels)
The PMC-403 phase I project is partly funded by KDDF (https://kddf.org//en).
# # # 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, 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 results from the Phase Ib olinvacimab plus pembrolizumab trial, delivering 50% ORR, 67% DCR, and a 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 a 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 a pivotal role in maintaining an immunosuppressive TME (Tumor Microenvironment). Phase I is ongoing at multicenters in Australia, and Phase Ib/II in combination with MSD’s pembrolizumab (PMC-309 + pembrolizumab combo) is planned.
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 engagers, and Radio-Immunotherapy.
For additional information about PharmAbcine, visit http://www.pharmabcine.com or follow on YouTube and LinkedIn.
For licensing deals, joint ventures, co-development, and collaboration in research or antibody discovery inquiries, please contact: Business Development Team E-mail: bd@pharmabcine.com Office line: +82 70 4279 5100
For investor relations and public relations inquiries, please contact: IR/PR Team E-mail: pmc_dis@pharmabcine.com