- Safety Review Committee (SRC) Approval in Australia Following 0.2mg/kg, 0.5mg/kg, and 1mg/kg Cohorts
- Total of 67 patients enrolled for monotherapy and combination therapy with MSD
[by Ji, Yong Jun]PharmAbcine, a clinical-stage biotech company specializing in next-generation antibody therapeutics, announced on August 21 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, 0.5mg/kg, and 1mg/kg cohorts.
This ongoing 강원 랜드 바카라ase 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, 강원 랜드 바카라armAbcine’s clinical partner.
강원 랜드 바카라309 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. 강원 랜드 바카라309 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, 강원 랜드 바카라309 also promotes monocyte activation, M1 macrophage proliferation, and increased T-cell infiltration, resulting in a distinct and complementary anti-tumor immune response.
This multicenter 강원 랜드 바카라ase 1 trial in Australia is being conducted in two parts:
• Phase 1a involves 강원 랜드 바카라309 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 강원 랜드 바카라309, 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 강원 랜드 바카라309 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 강원 랜드 바카라armAbcine’s Australian subsidiary and current Executive Vice President of 강원 랜드 바카라armAbcine Korea, commented,
“We aim to validate the safety and efficacy of 강원 랜드 바카라309 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 강원 랜드 바카라309, 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.”