On February 7, 2023 Wellmarker Bio Co., Ltd (WMBIO) (CEO: Dong-Hoon Jin, Department of Convergence Medicine, Ulsan College of Medicine and Asan Medical Center,), a predictive biomarker-driven biotech company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer, reported the company has entered a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA) on 7th Feb (Press release, Merck & Co, FEB 7, 2023, View Source [SID1234626945]).

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Under the agreement, WMBIO will sponsor the Phase 1 (or Phase 1b) clinical trial for WM-A1-3389, a novel therapeutic antibody for Non-Small Cell Lung Cancer (NSCLC) patients with low or no PD-L1 expression, in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy. Some NSCLC patients with low or no PD-L1 expression have shown limited response to treatment with immunotherapies alone and there is a high unmet need in these patient populations. WMBIO is also planning to expand the target patient group to other solid tumor indications.

WM-A1-3389 is a novel therapeutic antibody targeting a new immune checkpoint protein discovered by Wellmarker Bio and has demonstrated efficacy across different PBMC humanized models. An additive benefit of WM-A1-3389 and anti-PD-1 antibody was evidenced in preclinical mouse models including PD-1-resistant CT26 and LLC-1 mouse models.

"This clinical trial collaboration with MSD holds great significance for WMBIO as it allows us to evaluate a first-in-class drug with a novel mechanism in combination with KEYTRUDA," said Dong-Hoon Jin, CEO of Wellmarker Bio. "Now that we have seen WM-A1-3389 demonstrates a favorable safety margin in combination with immunotherapies in preclinical studies, we are excited to collaborate with MSD to further investigate the therapeutic potential of an additive benefit when combining WM-A1-3389 with KEYTRUDA."

WM-A1-3389 development was funded by Korea Drug Development Fund (KDDF). In eary 2022, this study was selected by the follow-up project of Korea Drug Development Fund (KDDF, Director. Muk, Hyunsang) in the preclinical stage.In addition, Wellmarker Bio is co-developing liquid biopsy companion diagnostics (CDx) with Cytogen. PharmaVentures Ltd., a UK-based premier transaction advisory firm, acted as the exclusive advisor for this collaboration and the ongoing partnering efforts for WM-A1-3389.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

For further information, please contact:
Jai-Hee Moon
Strategy planning manager (email: [email protected])