Wellmarker Bio Co., Ltd.

Wellmarker Bio Co., Ltd, a company committed to discovering and developing first-in-class anti-cancer drugs with predictive biomarkers, announced on April 4th 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%).

Wellmarker Bio is pleased to sign a clinical collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA) to evaluate a first-in-class treatment with a novel mechanism in combination with KEYTRUDA® (pembrolizumab), MSD's anti-PD-1 therapy. SEOUL, South Korea , Feb. 7, 2023 /PRNewswire/ -- 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, today announced the company has entered a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA) on 7th Feb. 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]) About Wellmarker Bio Wellmarker Bio Co., Ltd (WMBIO) is the first company to be spun out from the renowned Asan Medical Center, Korea's largest hospital. It focuses on the development of novel anticancer drugs derived from comprehensive biomarker analysis. Since it was founded in 2016, WMBIO has developed 9 first-in-class drugs for solid tumor indications. Having access to a wide array of patient samples from Asia and using predictive biomarkers to guide therapeutic development in innovative ways have allowed WMBIO to rapidly move its assets from exploratory to preclinical and then into early clinical stages. WMBIO's R&D strategy is to focus mainly on drug discovery and early-stage development of lead compounds to build a deep and wide pipeline of products, with the most advanced assets in phase 1 clinical trials. Once a drug candidate is at that stage, WMBIO would seek to find global pharmaceutical companies to partner with for co-development or licensing. For further information, visit: About WM-A1-3389 WM-A1-3389 is a novel therapeutic antibody targeting a new immune checkpoint protein discovered by Wellmarker Bio. WM-A1-3389's novel target is abundantly expressed in a variety of cancer types 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. About PharmaVentures PharmaVentures is a premier transaction advisory firm and a leading international company in partnering, M&A deals and strategic alliances. For the past 30 years, PharmaVentures has acted as advisor on over 1,000 deal related projects covering licensing, mergers, acquisitions, divestments, and joint venture activities for companies worldwide. We are regulated through PharmaVentures Capital Ltd. Find out more SOURCE Wellmarker Bio

Since its foundation in 2016, WellmarkerBio("WMBIO") has been developing 9 predictive-biomarker driven first-in-class anticancer pipelines. With predictive biomarkers, development programs with trials employing patient preselection biomarkers are said to have three-fold higher LOA by the FDA and could reduce the cost and the risk of administrating ineffective drugs to the patients. Over the past 5 years, WMBIO made outstanding operation progress, marked by the advancement of WM-S1-030 in the phase 1a clinical study and progression of WM-A1 preclinical program. The company has raised a total of $55 million closing series C round in August 2021 and completed 3 KDDF government projects successfully. Accredited by the Ministry of Science and ICT of Korea(MIST) as an ‘Excellent Corporation R&D Center’ and acquiring Inno-Biz certification by the Ministry of SMEs and Startups(a certification conferred to SMEs equipped with competitive edge based on the company’s innovate technology), WMBIO is rapidly advancing its robust pipeline of early stage assets. “2022 is going to be a vital year for WellmarkerBio to set in motion an ambitious-yet-achievable plan of developing a blockbuster drug” said, Dong-Hoon Jin, CEO of Wellmarker Bio. “We are planning to submit the application for preliminary review in mid-2022. After the IPO, our priority is to execute on our strategy aimed at out-licensing 2-3 candidate pipelines to global top pharmaceuticals and develop a portfolio of clinical-stage products that could address significant unmet medical need in oncology” he added. M&A is also on the list of WMBIO’s business plan. To reinforce core technology and strengthen manpower, Wellmarker is considering to geographically expand, advance new discoveries through collaborations with leading companies and institutions worldwide. “We believe we are well-positioned to realize our mission of becoming a global pharmaceutical company and advance precision medicines by positively impacting many patients through our competitive edge”.