CDX-301 is under clinical development by Celldex Therapeutics and currently in Phase I for Triple-Negative Breast Cancer (TNBC). According to GlobalData, Phase I drugs for Triple-Negative Breast Cancer (TNBC) have an 81% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how CDX-301’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.
CDX-301 overview
CDX-301 is under development for the treatment of low-grade B-cell lymphomas, marginal zone lymphoma, follicular lymphoma, cutaneous T-cell lymphoma, mycosis fungoides, non-small cell lung cancer, metastatic or unresectable triple negative breast cancer, small lymphocytic lymphoma, head and neck squamous cell carcinoma and cutaneous melanoma (skin cancer). The drug candidate is a recombinant FMS-like tyrosine kinase 3 ligand, or Flt3L is a hematopoietic cytokine administered subcutaneously and intratumorally. It acts by targeting receptor-type tyrosine-protein kinase FLT3. CDX-301 is a soluble, recombinant human Fms-like tyrosine kinase-3 ligand (Flt3L).
It was also under development for the treatment of autoimmune diseases and pancreatic ductal adenocarcinoma, mucosal melanoma or ocular melanoma and malignant melanoma.
Celldex Therapeutics overview
Celldex Therapeutics (Celldex) is a biopharmaceutical company. It focuses on advancing mast cell biology and developing therapeutic antibodies to treat severe inflammatory, allergic, autoimmune, and other debilitating diseases. The company’s primary candidate, barzolvolimab (CDX-0159), targets the KIT receptor and is under evaluation for multiple mast cell-related conditions. An ongoing Phase 2 study in chronic spontaneous urticaria has achieved its primary efficacy endpoint, with additional Phase 2 studies in chronic inducible urticaria, prurigo nodularis, and eosinophilic esophagitis underway. The company is also expanding its pipeline with a bispecific antibody, CDX-585, which combines PD-1 and anti-ILT4 blockade to enhance anti-tumor immunity, currently in a Phase 1 study for advanced solid tumors. Celldex is headquartered in Hampton, New Jersey, the US.
For a complete picture of CDX-301’s drug-specific PTSR and LoA scores, buy the report here.
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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.
