PharmAbcine’s 스피드 바카라 사이트309 successfully passed Safety Review Committee for 2mg/kg Cohort in Phase 1 Trial for advanced or metastatic solid tumors
- 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, 스피드 바카라 사이트309, 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 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.
스피드 바카라 사이트309 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. 스피드 바카라 사이트309 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, 스피드 바카라 사이트309 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 스피드 바카라 사이트309 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 스피드 바카라 사이트309, 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 스피드 바카라 사이트309 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 스피드 바카라 사이트309 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 스피드 바카라 사이트309, 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.”