| Title | PharmAbcine Successfully Completes Phase 1 Clinical Trial of TIE2-Targeting Antibody PMC-403 |
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PharmAbcine Successfully Completes Phase 1 Clinical Trial of TIE2-Targeting Antibody PMC-403
Safety, tolerability, and exploratory efficacy signals observed in chronic, treatment-resistant wet AMD patients
<Daejeon, South Korea, December 18, 2025> — PharmAbcine Inc. (CEO: Peter Shim) announced today that it has successfully completed a Phase 1 clinical trial of PMC-403, a TIE2-targeting antibody therapeutic.
Unlike conventional early-stage clinical trials conducted in healthy volunteers or treatment-naïve patients, this Phase 1 study was conducted in chronic wet age-related macular degeneration (AMD) patients, with a mean age in the 70s. Enrolled patients represented a highly refractory population, having been diagnosed approximately 10 years prior and treated repeatedly with standard anti-VEGF therapies, often switching agents due to inadequate response or treatment resistance.
PharmAbcine confirmed receipt of the final Clinical Study Report (CSR) on December 17, 2025. Based on the integrated analysis, PMC-403 demonstrated favorable tolerability and a predictable safety profile, with no dose-limiting toxicities (DLTs) or major safety concerns observed up to the maximum planned dose, following both single and multiple administrations. In addition, functional and anatomical efficacy-related endpoints were generally maintained relative to baseline across most dose levels and assessment time points, with modest improvement trends observed in selected dose cohorts. Given that the enrolled patients had shown insufficient responses to prior standard therapies, these findings should be interpreted as exploratory signals, taking into account the advanced and treatment-resistant nature of the study population. Pharmacokinetic (PK) analyses showed low systemic exposure, with dose- and dosing-frequency-dependent increases in exposure, as well as drug accumulation and achievement of steady state following repeated dosing. Non-linear PK behavior observed at higher dose levels was considered consistent with target-mediated drug disposition (TMDD). Immunogenicity assessment demonstrated no detectable anti-drug antibodies (ADA) in the majority of subjects, indicating an overall favorable immunogenicity profile.
PMC-403 is a fully human monoclonal antibody discovered using PharmAbcine’s proprietary HuPhage Display human antibody library and its in-house screening platform. The antibody is designed to stabilize disrupted endothelial tight junctions and recruit detached pericytes, thereby structurally and functionally normalizing pathological blood vessels through a differentiated mechanism of action. This approach distinguishes PMC-403 from existing TIE2-activating candidates that rely on Angiopoietin-1 mimetics or TIE2 receptor multimerization. By addressing vascular instability at its structural level, PMC-403 is designed to fundamentally suppress vascular leakage and inflammation, potentially overcoming limitations of anti-VEGF therapies that do not repair underlying vascular damage.
The Phase 1 trial was conducted following Investigational New Drug (IND) approval from the Korean Ministry of Food and Drug Safety (MFDS) in May 2023. A total of 27 chronic wet AMD patients were enrolled across four clinical sites in South Korea: Seoul National University Bundang Hospital, Seoul Asan Medical Center, Severance Hospital (Yonsei University), and Yeungnam University Medical Center. The study received partial financial support through a clinical development grant from the Korea Drug Development Fund (KDDF). The trial was designed as a dose-escalation study, comprising single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, to evaluate safety, local tolerability, pharmacokinetics, and exploratory efficacy-related endpoints.
Based on the Phase 1 results, PharmAbcine believes PMC-403 has the potential to demonstrate differentiated therapeutic value not only in chronic wet AMD, but also in newly diagnosed AMD, diabetic retinopathy (DR), and diabetic macular edema (DME). The company plans to advance PMC-403 into subsequent stages of clinical development. Peter Shim, CEO of PharmAbcine, stated, “The Phase 1 trial of PMC-403 clearly confirmed its safety and tolerability. We believe further clinical development may establish PMC-403 as a new therapeutic option not only for wet AMD, but also for diabetic macular edema and diabetic retinopathy.” Jin-San Yoo, Ph.D., President of R&BD at PharmAbcine, added, “PMC-403 represents more than a single drug candidate—it is the foundation of our vascular normalization platform. The mechanism validated in this study may be broadly applicable beyond ophthalmology to diseases driven by vascular leakage and inflammation, including those associated with aging, cancer, diabetes, obesity, infectious diseases, and genetic disorders.”
About PharmAbcine
PharmAbcine Inc. is a clinical-stage biotechnology company developing innovative antibody-based therapeutics focused on vascular normalization and immune modulation. The company leverages its proprietary HuPhage Display fully human antibody platform to generate differentiated biologics for ophthalmology, oncology, and vascular-related diseases.
Forward-Looking Statements
This press release contains forward-looking statements regarding the development, potential benefits, and future clinical progress of PMC-403. Actual results may differ materially due to various risks and uncertainties inherent in drug development and regulatory processes.
PharmAbcine Successfully Completes Phase 1 Clinical Trial of TIE2-Targeting Antibody PMC-403
Safety, tolerability, and exploratory efficacy signals observed in chronic, treatment-resistant wet AMD patients
<Daejeon, South Korea, December 18, 2025> — PharmAbcine Inc. (CEO: Peter Shim) announced today that it has successfully completed a Phase 1 clinical trial of PMC-403, a TIE2-targeting antibody therapeutic.
Unlike conventional early-stage clinical trials conducted in healthy volunteers or treatment-naïve patients, this Phase 1 study was conducted in chronic wet age-related macular degeneration (AMD) patients, with a mean age in the 70s. Enrolled patients represented a highly refractory population, having been diagnosed approximately 10 years prior and treated repeatedly with standard anti-VEGF therapies, often switching agents due to inadequate response or treatment resistance.
PharmAbcine confirmed receipt of the final Clinical Study Report (CSR) on December 17, 2025. Based on the integrated analysis, PMC-403 demonstrated favorable tolerability and a predictable safety profile, with no dose-limiting toxicities (DLTs) or major safety concerns observed up to the maximum planned dose, following both single and multiple administrations. In addition, functional and anatomical efficacy-related endpoints were generally maintained relative to baseline across most dose levels and assessment time points, with modest improvement trends observed in selected dose cohorts. Given that the enrolled patients had shown insufficient responses to prior standard therapies, these findings should be interpreted as exploratory signals, taking into account the advanced and treatment-resistant nature of the study population. Pharmacokinetic (PK) analyses showed low systemic exposure, with dose- and dosing-frequency-dependent increases in exposure, as well as drug accumulation and achievement of steady state following repeated dosing. Non-linear PK behavior observed at higher dose levels was considered consistent with target-mediated drug disposition (TMDD). Immunogenicity assessment demonstrated no detectable anti-drug antibodies (ADA) in the majority of subjects, indicating an overall favorable immunogenicity profile.
PMC-403 is a fully human monoclonal antibody discovered using PharmAbcine’s proprietary HuPhage Display human antibody library and its in-house screening platform. The antibody is designed to stabilize disrupted endothelial tight junctions and recruit detached pericytes, thereby structurally and functionally normalizing pathological blood vessels through a differentiated mechanism of action. This approach distinguishes PMC-403 from existing TIE2-activating candidates that rely on Angiopoietin-1 mimetics or TIE2 receptor multimerization. By addressing vascular instability at its structural level, PMC-403 is designed to fundamentally suppress vascular leakage and inflammation, potentially overcoming limitations of anti-VEGF therapies that do not repair underlying vascular damage.
The Phase 1 trial was conducted following Investigational New Drug (IND) approval from the Korean Ministry of Food and Drug Safety (MFDS) in May 2023. A total of 27 chronic wet AMD patients were enrolled across four clinical sites in South Korea: Seoul National University Bundang Hospital, Seoul Asan Medical Center, Severance Hospital (Yonsei University), and Yeungnam University Medical Center. The study received partial financial support through a clinical development grant from the Korea Drug Development Fund (KDDF). The trial was designed as a dose-escalation study, comprising single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, to evaluate safety, local tolerability, pharmacokinetics, and exploratory efficacy-related endpoints.
Based on the Phase 1 results, PharmAbcine believes PMC-403 has the potential to demonstrate differentiated therapeutic value not only in chronic wet AMD, but also in newly diagnosed AMD, diabetic retinopathy (DR), and diabetic macular edema (DME). The company plans to advance PMC-403 into subsequent stages of clinical development. Peter Shim, CEO of PharmAbcine, stated, “The Phase 1 trial of PMC-403 clearly confirmed its safety and tolerability. We believe further clinical development may establish PMC-403 as a new therapeutic option not only for wet AMD, but also for diabetic macular edema and diabetic retinopathy.” Jin-San Yoo, Ph.D., President of R&BD at PharmAbcine, added, “PMC-403 represents more than a single drug candidate—it is the foundation of our vascular normalization platform. The mechanism validated in this study may be broadly applicable beyond ophthalmology to diseases driven by vascular leakage and inflammation, including those associated with aging, cancer, diabetes, obesity, infectious diseases, and genetic disorders.”
About PharmAbcine
PharmAbcine Inc. is a clinical-stage biotechnology company developing innovative antibody-based therapeutics focused on vascular normalization and immune modulation. The company leverages its proprietary HuPhage Display fully human antibody platform to generate differentiated biologics for ophthalmology, oncology, and vascular-related diseases.
Forward-Looking Statements
This press release contains forward-looking statements regarding the development, potential benefits, and future clinical progress of PMC-403. Actual results may differ materially due to various risks and uncertainties inherent in drug development and regulatory processes.