BNT-325 is under clinical development by BioNTech and currently in Phase II for Malignant Mesothelioma. According to GlobalData, Phase II drugs for Malignant Mesothelioma have a 42% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how BNT-325’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
BNT-325 overview
BNT-325 (DB-1305) is under development for the treatment of solid tumor, esophageal cancer, pancreatic cancer, malignant mesothelioma, castration-resistant prostate cancer, human epidermal growth factor receptor 2 negative breast cancer (HER2- breast cancer), non-small cell lung cancer, triple-negative breast cancer (TNBC), colorectal cancer, ovarian cancer, duodenal cancer, gastric cancer, adenocarcinoma of the gastroesophageal junction, platinum-resistant ovarian epithelial cancer, endometrial cancer, cervical cancer, primary peritoneal cancer, fallopian tube cancer. It is humanized anti-TROP2 IgG1 mAb with a cytotoxic payload targeting topisomerase I. The drug candidate is administered through intravenous route as injection. . It is being developed based on Duality Immune Toxin Antibody Conjugates (“DITAC”) platform.
It was also under development for small-cell lung cancer.
BioNTech overview
BioNTech is a biotechnology company that develops immunotherapies for cancer and infectious diseases. The company’s primary activities involve harnessing the immune system to address diseases with unmet medical needs, utilizing a multi-technology innovation engine, GMP manufacturing, translational drug discovery, clinical development, commercial capabilities, computational medicine, data science, and artificial intelligence (AI) and machine learning (ML). BioNTech‘s product portfolio includes investigational mRNA vaccines, protein-based therapeutics, cell therapies, and small molecules. Its first marketed product is Comirnaty. The company’s products are designed to address the needs of cancer patients and combat infectious diseases. BioNTech collaborates with multiple global pharmaceutical companies, including Duality Biologics, Fosun Pharma, Genentech, Genevant, Genmab, OncoC4, Regeneron, and Pfizer. While the company operates globally, it aims to contribute to equitable access to medicine as part of its product strategy. BioNTech is headquartered in Mainz, Rhineland-Palatinate, Germany.
For a complete picture of BNT-325’s drug-specific PTSR and LoA scores, buy the report here.
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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
