CDX-301 is under clinical development by Celldex Therapeutics and currently in the 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 CDX-301’s likelihood of approval (LoA) and phase transition for Follicular Lymphoma took place on 26 Sep 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.

In addition, the same event on 26 Sep 2022 increased CDX-301’s LoA and decreased Phase Transition Success Rate (PTSR) for Marginal Zone B-cell Lymphoma.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their CDX-301 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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.

Quick View CDX-301 LOA Data

Report Segments
  • Innovator
Drug Name
  • CDX-301
Administration Pathway
  • Intratumor
  • Subcutaneous
Therapeutic Areas
  • Immunology
  • Oncology
Key Developers
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.