Clinical Trial Collaboration Will Assess WM-A1-3389/Pembrolizumab in NSCLC

Wellmarker Bio’s novel therapeutic antibody WM-A1-3389 will be tested with Merck’s pembrolizumab in a phase 1b study of patients with non–small cell lung cancer.

Treatment with the novel therapeutic antibody WM-A1-3389 in combination with pembrolizumab (Keytruda) will be evaluated in a phase 1b clinical trial for patients with non–small cell lung cancer (NSCLC) who have low or no PD-L1 expression.1

The study of WM-A1-3389 is commencing as a part of a clinical trial collaboration between Wellmarker Bio and Merck.

WM-A1-3389 is designed to target a new immune checkpoint protein made by Wellmarker Bio (WMBIO). The agent has previously demonstrated efficacy across different humanized models, and in a preclinical model, the additive benefit of WM-A1-3389 and anti-PD-1 antibody was observed.

"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 [pembrolizumab]," said Dong-Hoon Jin, chief executive officer of Wellmarker Bio, in the press release. "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 [Merck] to further investigate the therapeutic potential of an additive benefit when combining WM-A1-3389 with [pembrolizumab]."

Previous studies have shown that patients with no or low-PD-L1-expressing NSCLC typically have poor responses to anti-PD-1 therapies, including treatment with pembrolizumab. With the development of WM-A1-3389, investigators are hopeful that some unmet needs will be addressed for this patient population.

The company also plans to advance the antibody to other cancer types and other solid tumors beyond NSCLC in the future, including gastric and liver cancer.

In addition to WM-A1-2286, other predictive biomarker-based assets in the company’s pipeline include WM-S2 and WM-A2 for patients with colon cancer, WM-P1 for liver cancer, WM-P2 for metastatic breast cancer, and WM-P3 for NSCLC and breast cancer.2

Currently, WM-S1, a small-molecule for colon cancer, is also being evaluated in a phase 1 study in patients with advanced solid tumors (NCT04801095). Preclinical studies have shown WS-S1 to elicit potent in vitro enzyme inhibitor activity, high in vitro anticancer activity, and strong anticancer efficacy. Data suggests that the treatment could be used as a monotherapy for patients with colon cancer who do not respond to treatment with cetuximab (Erbitux) as well as other cancer types.

Wellmarker Bio announces clinical trial collaboration with MSD to evaluate WM-A1-3389 in combination with KEYTRUDA® (pembrolizumab). News release. Wellmarker Bio Co., Ltd. February 7, 2023. Accessed February 7, 2023.
WellMarker Bio-developing fit-for-purpose biomarkers and novel therapies for cancer. News release. Nature news. Accessed February 8, 2023.
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