Wellmarker Bio Co., Ltd, a company committed to discovering and developing first-in-class anti-cancer drugs with predictive biomarkers, announced on April 4^th that it has received approval from the Ministry of Food and Drug Safety(MFDS) to initiate Phase 1 clinical study for its novel therapeutic antibody, ‘WM-A1-3389’, for the treatment of Non-Small Cell Lung Cancer (NSCLC).

The company plans to enroll 54 solid tumor patients for the clinical trial, which will be conducted in two phases; Phase 1a and 1b. Phase 1a will involve treatment of ‘WM-A1-3389’ as a monotherapy while Phase 1b will involve treatment of ‘WM-A1-3389’ in combination with KEYTRUDA® (pembrolizumab), MSD's anti-PD-1 therapy. Safety, tolerability, and biomarker validation will be evaluated to assess efficacy and optimal dosage.

WM-A1-3389 demonstrated high immunotherapeutic efficacy in an in vivo humanized mouse model using NSCLC cell lines that are resistant to existing anti-PD(L)1 antibody (with low or no PD-L1 expression) as well as in co-culture conditions using peripheral blood mononuclear cells (PBMC) derived from lung cancer patients. Furthermore, the novel therapeutic antibody is widely expected to address the limitations of existing immunotherapeutic drugs, via a distinct mechanism of action. This allows for potential synergistic efficacy in combination with anti-PD1 antibody, leading to maximal efficacy in clinical trial.

According to the company, WM-A1-3389 has attracted high interest from global pharmaceutical companies due to its potential to address the limitations of KEYTRUDA® (pembrolizumab), which is considered as the mostly widely sold anti-cancer drug but has limited responses in NSCLC patients with low or no PD-L1 expression (response rate of 20~30%).