Wellmarker Bio Announces Clinical Trial Collaboration with MSD to evaluate WM-A1-3389 in combination with KEYTRUDA
SEOUL, South Korea , Feb. 7, 2023 /PRNewswire/ -- Wellmarker Bio Co., Ltd, 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.
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.
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.
SOURCE Wellmarker Bio
Posted: February 2023
Related articles
- FDA Approves Pembrolizumab for HER2 Positive Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1 (CPS ≥1) - March 19, 2025
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Pemetrexed and Platinum Chemotherapy as First-Line Treatment for Adult Patients With Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma (MPM) - September 18, 2024
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Carboplatin and Paclitaxel as Treatment for Adult Patients With Primary Advanced or Recurrent Endometrial Carcinoma - June 17, 2024
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer - January 12, 2024
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma - November 16, 2023
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Cancer - November 1, 2023
- FDA Approves Keytruda (pembrolizumab) for Treatment of Patients With Resectable NSCLC in Combination With Chemotherapy as Neoadjuvant Treatment, Then Single Agent as Adjuvant Treatment After Surgery - October 16, 2023
- FDA Approves Merck’s Keytruda (pembrolizumab) in Combination With Padcev (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer - April 3, 2023
- FDA Converts to Full Approval Indication for Keytruda (pembrolizumab) for Certain Adult and Pediatric Patients With Advanced Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors - March 29, 2023
- FDA Approves Keytruda (pembrolizumab) as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB (T2a ≥4 Centimeters), II, or IIIA Non-Small Cell Lung Cancer (NSCLC) - January 27, 2023
- FDA Approves Merck’s Keytruda (pembrolizumab) for Patients With MSI‑H/dMMR Advanced Endometrial Carcinoma, Who Have Disease Progression Following Prior Systemic Therapy in Any Setting and Are Not Candidates for Curative Surgery or Radiation - March 21, 2022
- FDA Approves Merck’s Keytruda (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery - November 18, 2021
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Chemotherapy, With or Without Bevacizumab, as Treatment for Patients With Persistent, Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1 (CPS ≥1) - October 13, 2021
- FDA Approves Keytruda (pembrolizumab) Plus Lenvima (lenvatinib) Combination for First-Line Treatment of Adult Patients With Advanced Renal Cell Carcinoma (RCC) - August 11, 2021
- FDA Approves Keytruda (pembrolizumab) for Treatment of Patients With High-Risk Early-Stage Triple-Negative Breast Cancer in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Single Agent as Adjuvant Treatment After Surgery - July 27, 2021
- FDA Approves Keytruda (pembrolizumab) Plus Lenvima (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma - July 22, 2021
- FDA Approves Expanded Indication for Merck’s Keytruda (pembrolizumab) in Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC) - July 6, 2021
- FDA Approves Merck’s Keytruda (pembrolizumab) Combined With Trastuzumab and Chemotherapy as First-line Treatment in Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma - May 5, 2021
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Platinum- and Fluoropyrimidine-Based Chemotherapy for Treatment of Certain Patients With Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction (GEJ) Carcinoma - March 23, 2021
- FDA Approves Merck’s Keytruda (pembrolizumab) in Combination With Chemotherapy for Patients With Locally Recurrent Unresectable or Metastatic Triple‑Negative Breast Cancer Whose Tumors Express PD-L1 (CPS ≥10) - November 13, 2020
- FDA Approves Expanded Indication for Merck’s Keytruda (pembrolizumab) in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL) - October 15, 2020
- FDA Approves Merck’s Keytruda (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer - June 29, 2020
- FDA Approves Merck’s Keytruda (pembrolizumab) for the Treatment of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) that is Not Curable by Surgery or Radiation - June 24, 2020
- FDA Approves Second Biomarker-Based Indication for Merck’s Keytruda (pembrolizumab), Regardless of Tumor Type - June 17, 2020
- FDA Approves Merck’s Keytruda (pembrolizumab) for Use at an Additional Recommended Dose of 400 mg Every Six Weeks for All Approved Adult Indications - April 28, 2020
- FDA Approves Keytruda (pembrolizumab) for Patients With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer - January 8, 2020
- FDA Approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma - September 17, 2019
- FDA Approves Keytruda (pembrolizumab) for Recurrent Locally Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus - July 31, 2019
- FDA Approves Keytruda (pembrolizumab) for the Treatment of Metastatic Small Cell Lung Cancer (SCLC) - June 18, 2019
- FDA Approves Keytruda (pembrolizumab) for First-Line Treatment of Head and Neck Squamous Cell Carcinoma - June 11, 2019
- FDA Approves Keytruda (pembrolizumab) in Combination With Inlyta (axitinib) as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma (RCC) - April 22, 2019
- FDA Approves Expanded Monotherapy Label for Merck’s Keytruda (pembrolizumab) for First-Line Treatment of NSCLC - April 11, 2019
- FDA Approves Keytruda (pembrolizumab) for the Adjuvant Treatment of Patients with Melanoma with Involvement of Lymph Node(s) Following Complete Resection - February 19, 2019
- FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma - December 19, 2018
- FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Hepatocellular Carcinoma (HCC) Who Have Been Previously Treated with Sorafenib - November 9, 2018
- FDA Approves Keytruda (pembrolizumab) in Combination with Carboplatin and Either Paclitaxel or Nab-Paclitaxel for the First-Line Treatment of Patients with Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) - October 30, 2018
- FDA Approves Expanded Label for Merck’s Keytruda (pembrolizumab) in Patients with Metastatic Nonsquamous NSCLC with No EGFR or ALK Genomic Tumor Aberrations - August 21, 2018
- FDA Approves Keytruda (pembrolizumab) for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma (PMBCL) - June 13, 2018
- FDA Approves Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1 - June 12, 2018
- FDA Approves Merck’s Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Whose Tumors Express PD-L1 - September 22, 2017
- FDA Approves Keytruda (pembrolizumab) as First Cancer Treatment for any Solid Tumor with a Specific Genetic Feature - May 23, 2017
- FDA Approves Merck’s Keytruda (pembrolizumab) for Certain Patients with Locally Advanced or Metastatic Urothelial Carcinoma - May 18, 2017
- FDA Approves Merck’s Keytruda (pembrolizumab) as First-Line Combination Therapy for Patients with Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC), Irrespective of PD-L1 Expression - May 10, 2017
- FDA Approves Merck’s Keytruda (pembrolizumab) for Classical Hodgkin Lymphoma (cHL) - March 15, 2017
- FDA Approves Merck’s Keytruda (pembrolizumab) for First-Line Treatment of Certain Patients with Metastatic Non-Small Cell Lung Cancer - October 24, 2016
- FDA Approves Merck’s Keytruda (pembrolizumab) for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma - August 5, 2016
- FDA Approves Expanded Indication for Keytruda (pembrolizumab) for the Treatment of Patients with Advanced Melanoma - December 18, 2015
- FDA Approves Keytruda (pembrolizumab) for Advanced Non-Small Cell Lung Cancer - October 2, 2015
- FDA Approves Keytruda (pembrolizumab) for Advanced Melanoma - September 4, 2014
- Merck to Present New Data in Five Tumor Types from Studies Evaluating Pembrolizumab - September 2, 2014
- Merck’s Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review in Europe for Advanced Melanoma - June 30, 2014
Keytruda (pembrolizumab) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.