PDS-0301 is under clinical development by PDS Biotechnology and currently in Phase II for Human Papillomavirus (HPV) Associated Cancer. According to GlobalData, Phase II drugs for Human Papillomavirus (HPV) Associated Cancer have a 16% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how PDS-0301’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.
PDS-0301 (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 (mCRPC), 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, intrahepatic 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.
PDS Biotechnology overview
PDS Biotechnology is a biopharmaceutical company that develops vaccines and immunotherapies for cancer and infectious disease. It is investigating PDS0101 for the treatment of head and neck, HPV-positive anal, cervical, penile, vaginal, vulvar cancers and pre-metastatic HPV-associated oropharyngeal cancer (OPSCC); PDS-0201 to prevent tuberculosis; PDS0202 targeting influenza; and PDS0203 against COVID-19. The company is also evaluating PDS0102 for TARP-associated AML (acute myeloid leukemia), prostate and breast cancers; PDS0103 against MUC1-associated breast, colon, lung, ovarian and other cancers; and PDS0104 to treat melanoma. It utilizes Versamune and Infectimune, T-cell immune activating platform technologies. PDS Biotechnology is headquartered in Princeton, New Jersey, the US.
For a complete picture of PDS-0301’s drug-specific PTSR and LoA scores, buy the report here.