| Title | PharmAbcine’s PMC-309 successfully completes 1mg/kg Cohort in Phase 1 Trial for Advanced or Metastatic Solid Tumors |
| Category | Press Release |
- Safety Review Committee (SRC) Approval in Australia Following 0.2mg/kg and 0.5mg/kg Cohorts
- Total of 67 Patients Enrolled for Monotherapy and Combination Therapy with MSD
Daejeon, May 19, 2025 – PharmAbcine Inc. (KOSDAQ: 203840), a clinical-stage biotech company specializing in next-generation antibody therapeutics, announced today that its anti-VISTA immuno-oncology antibody, PMC-309, has successfully completed the 1mg/kg cohort of the Phase 1 clinical trial in Australia. The Safety Review Committee (SRC) unanimously approved the advancement following the successful review of previous 0.2mg/kg and 0.5mg/kg cohorts.
This ongoing Phase 1 trial is targeting patients with advanced or metastatic solid tumors. The trial includes both monotherapy and combination therapy with pembrolizumab (Keytruda®), provided by MSD, PharmAbcine’s clinical partner.
PMC-309 is a fully human IgG1 monoclonal antibody that specifically binds to VISTA (V-domain Immunoglobulin Suppressor of T-cell Activation), a key immune checkpoint expressed on suppressive myeloid cells. It demonstrates stable and high binding affinity regardless of pH changes in the tumor microenvironment (TME).
VISTA interacts with ligands such as VISTA-VISTA (pH 7.2), VISTA-VSIG3 (pH 7.2), and VISTA-PSGL1 (pH 6.2), contributing to the activation and maintenance of myeloid-derived suppressor cells (MDSCs) in the immunosuppressive TME. PMC-309 inhibits these interactions, thereby blocking MDSC activation, suppressing Treg function, and reducing M2 macrophage activity. Beyond the classical T-cell activation pathway of current immunotherapies, PMC-309 also promotes monocyte activation, M1 macrophage proliferation, and increased T-cell infiltration, resulting in a distinct and complementary anti-tumor immune response.
This multicenter Phase 1 trial in Australia is being conducted in two parts:
- Phase 1a involves PMC-309 as monotherapy and in combination with Keytruda®, evaluating maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).
- Phase 1b will assess the safety and tolerability of PMC-309, both alone and in combination with Keytruda®, at the RP2D.
The study is enrolling a total of 67 patients across four Australian sites and is progressing smoothly.
Preclinical studies have consistently shown that PMC-309 combined with anti-PD-1 therapy is more effective in inhibiting tumor growth than monotherapy. MSD is supplying Keytruda® free of charge for the combination arm of this study under the clinical collaboration.
Dr. Jin-San Yoo, founder of PharmAbcine’s Australian subsidiary and current Executive Vice President of PharmAbcine Korea, commented,
“We aim to validate the safety and efficacy of PMC-309 in humans and demonstrate the therapeutic potential of monotherapy and combination with Keytruda®. Our ultimate goal is to provide a new treatment option for cancer patients in need.” He further noted, “To ensure the clinical success of PMC-309, we must identify predictive biomarkers to stratify responders from non-responders. We also need to address immune-related adverse events (irAEs) arising from excessive immune activation, as is common with all immunotherapies. Additionally, selecting the optimal combination partner and dosing regimen will be critical.”
The Distinct Value of Anti-VISTA Immunotherapy Compared to Conventional Checkpoint Inhibitors
(Anti-PD-1, Anti-PD-L1, Anti-CTLA-4)
Key Anti-VISTA Antibodies in Development
PharmAbcine Inc. is a clinical-stage biotech company specializing in the development of novel antibody therapeutics. Based on its proprietary next-generation IgG antibody platform, PharmAbcine is focused on addressing unmet medical needs in oncology, vascular eye diseases, and other vascular-related conditions.
PharmAbcine's pipeline includes:
- Olinvacimab: a VEGFR2-neutralizing human IgG antibody currently in clinical development,
- PMC-403: a novel TIE2-activating antibody, and
- PMC-309: a first-in-class VISTA-targeting immune checkpoint inhibitor, which has received IND approval.
Olinvacimab, the company’s lead asset, was evaluated in a Phase 1b/2 trial in combination with MSD’s checkpoint inhibitor for metastatic triple-negative breast cancer (mTNBC) in Australia. Based on the favorable safety profile and clinical activity demonstrated in Phase 1b—an objective response rate (ORR) of 50% and clinical benefit in 67% of patients—the program advanced into Phase 2.
PMC-403 is a first-in-class antibody that restores abnormal neovasculature to a normalized state by activating the TIE2 receptor, representing a novel mechanism of action. It demonstrated strong preclinical efficacy in inhibiting angiogenesis and vascular leakage in models of age-related macular degeneration (AMD) and diabetic retinopathy (DR). The compound entered Phase 1 trials in AMD patients in Korea but has since been suspended.
PMC-309 is an innovative immune-oncology candidate that targets VISTA, an immune checkpoint molecule highly expressed on immunosuppressive myeloid-derived suppressor cells (MDSCs). By binding to VISTA, PMC-309 blocks MDSC function, reactivates T cells, and modulates the tumor microenvironment (TME) to an immune-active state.
For more information, please visit our website: http://www.pharmabcine.com
You can also follow us on YouTube and LinkedIn.
For inquiries regarding licensing, joint ventures, co-development, or antibody platform collaborations, please contact our Business Development Team:
Business Development Team
๐ง Email: bd@pharmabcine.com
๐ Phone: +82-70-4279-5100
- Safety Review Committee (SRC) Approval in Australia Following 0.2mg/kg and 0.5mg/kg Cohorts
- Total of 67 Patients Enrolled for Monotherapy and Combination Therapy with MSD
Daejeon, May 19, 2025 – PharmAbcine Inc. (KOSDAQ: 203840), a clinical-stage biotech company specializing in next-generation antibody therapeutics, announced today that its anti-VISTA immuno-oncology antibody, PMC-309, has successfully completed the 1mg/kg cohort of the Phase 1 clinical trial in Australia. The Safety Review Committee (SRC) unanimously approved the advancement following the successful review of previous 0.2mg/kg and 0.5mg/kg cohorts.
This ongoing Phase 1 trial is targeting patients with advanced or metastatic solid tumors. The trial includes both monotherapy and combination therapy with pembrolizumab (Keytruda®), provided by MSD, PharmAbcine’s clinical partner.
PMC-309 is a fully human IgG1 monoclonal antibody that specifically binds to VISTA (V-domain Immunoglobulin Suppressor of T-cell Activation), a key immune checkpoint expressed on suppressive myeloid cells. It demonstrates stable and high binding affinity regardless of pH changes in the tumor microenvironment (TME).
VISTA interacts with ligands such as VISTA-VISTA (pH 7.2), VISTA-VSIG3 (pH 7.2), and VISTA-PSGL1 (pH 6.2), contributing to the activation and maintenance of myeloid-derived suppressor cells (MDSCs) in the immunosuppressive TME. PMC-309 inhibits these interactions, thereby blocking MDSC activation, suppressing Treg function, and reducing M2 macrophage activity. Beyond the classical T-cell activation pathway of current immunotherapies, PMC-309 also promotes monocyte activation, M1 macrophage proliferation, and increased T-cell infiltration, resulting in a distinct and complementary anti-tumor immune response.
This multicenter Phase 1 trial in Australia is being conducted in two parts:
- Phase 1a involves PMC-309 as monotherapy and in combination with Keytruda®, evaluating maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).
- Phase 1b will assess the safety and tolerability of PMC-309, both alone and in combination with Keytruda®, at the RP2D.
The study is enrolling a total of 67 patients across four Australian sites and is progressing smoothly.
Preclinical studies have consistently shown that PMC-309 combined with anti-PD-1 therapy is more effective in inhibiting tumor growth than monotherapy. MSD is supplying Keytruda® free of charge for the combination arm of this study under the clinical collaboration.
Dr. Jin-San Yoo, founder of PharmAbcine’s Australian subsidiary and current Executive Vice President of PharmAbcine Korea, commented,
“We aim to validate the safety and efficacy of PMC-309 in humans and demonstrate the therapeutic potential of monotherapy and combination with Keytruda®. Our ultimate goal is to provide a new treatment option for cancer patients in need.” He further noted, “To ensure the clinical success of PMC-309, we must identify predictive biomarkers to stratify responders from non-responders. We also need to address immune-related adverse events (irAEs) arising from excessive immune activation, as is common with all immunotherapies. Additionally, selecting the optimal combination partner and dosing regimen will be critical.”
The Distinct Value of Anti-VISTA Immunotherapy Compared to Conventional Checkpoint Inhibitors
(Anti-PD-1, Anti-PD-L1, Anti-CTLA-4)
Key Anti-VISTA Antibodies in Development
PharmAbcine Inc. is a clinical-stage biotech company specializing in the development of novel antibody therapeutics. Based on its proprietary next-generation IgG antibody platform, PharmAbcine is focused on addressing unmet medical needs in oncology, vascular eye diseases, and other vascular-related conditions.
PharmAbcine's pipeline includes:
Olinvacimab, the company’s lead asset, was evaluated in a Phase 1b/2 trial in combination with MSD’s checkpoint inhibitor for metastatic triple-negative breast cancer (mTNBC) in Australia. Based on the favorable safety profile and clinical activity demonstrated in Phase 1b—an objective response rate (ORR) of 50% and clinical benefit in 67% of patients—the program advanced into Phase 2.
PMC-403 is a first-in-class antibody that restores abnormal neovasculature to a normalized state by activating the TIE2 receptor, representing a novel mechanism of action. It demonstrated strong preclinical efficacy in inhibiting angiogenesis and vascular leakage in models of age-related macular degeneration (AMD) and diabetic retinopathy (DR). The compound entered Phase 1 trials in AMD patients in Korea but has since been suspended.
PMC-309 is an innovative immune-oncology candidate that targets VISTA, an immune checkpoint molecule highly expressed on immunosuppressive myeloid-derived suppressor cells (MDSCs). By binding to VISTA, PMC-309 blocks MDSC function, reactivates T cells, and modulates the tumor microenvironment (TME) to an immune-active state.
For more information, please visit our website: http://www.pharmabcine.com
You can also follow us on YouTube and LinkedIn.
For inquiries regarding licensing, joint ventures, co-development, or antibody platform collaborations, please contact our Business Development Team:
Business Development Team
๐ง Email: bd@pharmabcine.com
๐ Phone: +82-70-4279-5100