On December 12, 2022 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics, reported that the Company has entered into a clinical collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ., USA), to initiate a Phase I combination trial of PMC-309, a novel anti-VISTA (V-domain Ig suppressor of T cell activation) antibody, in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy (Press release, PharmAbcine, DEC 12, 2022, View Source [SID1234625156]).
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Under the terms of the agreement, PharmAbcine will sponsor a Phase I study in Australia to evaluate the safety and clinical efficacy of the combination therapy for the treatment of multiple advanced solid tumors, and MSD will supply KEYTRUDA.
"We are excited to announce another pipeline combination project in collaboration with MSD besides olinvacimab, our lead anti-VEGFR2 antibody, undergoing a Phase II study in combination with KEYTRUDA in mTNBC (metastatic Triple Negative Breast Cancer) patients," said Dr. Jin-San Yoo, CEO of PharmAbcine. "In preclinical studies, PMC-309 demonstrated significantly enhanced tumor growth reduction when used with an anti-PD-1 drug in in vivo mouse model compared to both monotherapies of PMC-309 and an anti-PD-1 drug. We look forward to the opportunity to investigate this approach in a clinical setting."
Dr. Yoo also added, "In comparison to the existing immuno-oncology drugs that directly activate T cells, PMC-309’s distinct mechanism of indirectly activating T cells by inhibiting immunosuppressive cells may represent a novel strategy for patients who do not respond well or have become resistant to the existing treatments and are in need of new therapies. "We are optimistic about PMC-309’s best-in-class potential, and we are particularly excited to continue to evaluate it in combination with KEYTRUDA, one of the key leading molecules in cancer immunotherapy."
Further details of agreement and clinical protocols were not disclosed.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About PMC-309
PMC-309 is a novel IgG1 anti-VISTA (V-domain Ig Suppressor of T cell Activation) antagonizing antibody that can be used for the treatment of various tumor types. By inhibiting VISTA, an immune checkpoint receptor mainly expressed on MDSC (Myeloid-Derived Suppressor Cells) and Tregs (regulatory T cells), it can play a pivotal role in maintaining the immunosuppressive environment around the tumor cells.
In the nonclinical studies, it has been discovered that PMC-309 can promote both innate immunity (monocyte activation, M1 macrophage proliferation) and adaptive immunity (T cell activation) unlike the existing drugs which show significant changes only in adaptive immunity. In addition, the in vivo data showed that PMC-309 demonstrated significantly improved tumor growth inhibition when used in combination with an anti-PD-1 drug compared to both monotherapies of PMC-309 and an anti-PD-1 drug. These findings suggest that PMC-309 can offer a new treatment strategy in immuno-oncology area as it can be used in combination with other drugs to improve their low-response rates.
The GLP-Toxicology studies were already completed, and no serious safety issues were observed. The Company plans to submit Clinical Trial Application in early 2023.