CDX-301 is under clinical development by Celldex Therapeutics and currently in Phase II for Metastatic Breast Cancer. According to GlobalData, Phase II drugs for Metastatic Breast Cancer have a 34% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. 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, pancreatic ductal adenocarcinoma, 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 and head and neck squamous cell carcinoma. 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 HSC (hematopoietic stem cell) transplantation, mucosal melanoma or ocular melanoma and malignant melanoma.

Celldex Therapeutics overview

Celldex Therapeutics (Celldex) is a bio-pharmaceutical company that discovers, develops, and commercializes targeted immunotherapy and other biologics for the treatment of various types of cancers. The company’s developmental pipeline comprises therapeutic antibodies, antibody drug conjugates (ADCs), protein-based therapeutics, immune system modulators and vaccine for unmet medical needs. Its key products in development include CDX-1140; CDX-527, CDX-0159. Celldex’s products find application in the treatment of various indications such as brain cancer, triple negative breast cancer, lymphoma/leukemia, melanoma, and renal cell carcinoma. It operates a manufacturing facility in Massachusetts, the US, and research laboratories in Massachusetts, New Jersey, and Connecticut. 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.


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.