On January 23, 2024 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on next-generation antibody therapeutics, reported the initiation of patient dosing in the Phase 1a/b clinical trial of PMC-309 in patients with advanced or metastatic solid tumors (Press release, PharmAbcine, JAN 23, 2024, View Source [SID1234639435]).
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PMC-309 is an IgG1 monoclonal antibody with specific binding to VISTA in immunosuppressive cells, exhibiting excellent binding affinity at various pH conditions within the tumor microenvironment (TME). By inhibiting VISTA, PMC-309 presents a differentiated mechanism of action contributing to anti-cancer effects through activation of T cells, activation of monocytes, and proliferation of M1 macrophages.
This open-label clinical trial comprises two phases, Phase 1a and Phase 1b. Phase 1a involves PMC-309 monotherapy and combination therapy with KEYTRUDA (pembrolizumab), determining the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). In Phase 1b, safety and tolerability of PMC-309 monotherapy and combination therapy with KEYTRUDA at the RP2D will be evaluated. The clinical trial, spanning four institutions in Australia, aims to enroll a total of 67 patients.
Dr. Jin-San Yoo, President and Chief Executive Officer of PharmAbcine, stated, "This clinical trial aims to assess the human safety of PMC-309 and explore the potential of both monotherapy and combination therapy with KEYTRUDA. We are committed to developing new therapeutic options for cancer patients facing high unmet needs, emphasizing our dedication to advancing oncology treatments."
For more information on the clinical trial, please visit clinicaltrials.gov, identifier NCT 05957081.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.