M-9241 is under clinical development by Merck and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect M-9241’s likelihood of approval (LoA) and phase transition for Pancreatic Cancer took place on 19 May 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their M-9241 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

M-9241 overview

M-9241(MSB-0010360) (NHS-Interleukin-12) is under development for the treatment of metastatic solid tumors including epithelial tumor, mesenchymal tumor, pancreatic adenocarcinoma, small intestine cancer (small bowel cancer), metastatic breast cancer, metastatic castration-resistant prostate cancer (CRPC), kaposi sarcoma, transitional cell carcinoma (urothelial cell carcinoma), colorectal cancer, metastatic renal cell carcinoma, non-small cell lung cancer, metastatic non-prostate genitourinary malignancies including bladder cancer, kidney cancer, genital cancer, urinary tract cancer, HPV associated vulvar cancer, vaginal cancer, penile cancer, anal cancer, cervical cancer, oropharyngeal cancer, squamous cell rectal cancers, lung cancer, Metastatic Colorectal Cancer, cholangiocarcinoma and esophageal cancer. The drug candidate is administered by subcutaneous route. It is a new biological entity. M9241 is an immunocytokine composed of 2 heterodimers of IL-12 fused to the heavy chains of a human antibody targeting DNA released from necrotic tumor cells.

Merck overview

Merck, a subsidiary of E. Merck KG, is a science and technology company. It discovers, develops and manufactures prescription drugs to treat cancer, multiple sclerosis and infertility; and develops liquid crystal mixtures, organic light-emitting diode (OLED) materials, cosmetic active ingredients, pigments for coatings, and high-tech materials. Merck also provides a wide range of products including lab water systems, gene editing tools, cell lines, antibodies and end-to-end systems. The company serves healthcare, performance materials, and life sciences markets. It has presence in Europe, North America, Asia-Pacific, Latin America and Middle East and Africa. Merck is headquartered in Darmstadt, Hesse, Germany.

Quick View M-9241 LOA Data

Report Segments
  • Innovator
Drug Name
  • M-9241
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Infectious Disease
  • Oncology
Key Developers
  • Sponsor Company: Merck
  • Originator: EMD Serono
Highest Development Stage
  • Phase II

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.