CAL-1 is under clinical development by CSL 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 CAL-1’s likelihood of approval (LoA) and phase transition for Human Immunodeficiency Virus (HIV) Infections (AIDS) took place on 14 Nov 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their CAL-1 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

CAL-1 overview

Cal-1 is under development for the treatment of HIV-1 Infection and HIV associated Non-Hodgkin and Hodgkin lymphoma. It is administered by intravenous route. It is a RNA-based gene therapy in which CCR5 gene is silenced by using lentiviral vector-modified CD34+ cells. The drug candidate is developed based on DNA-directed RNA interference (ddRNAi) technology. The technology utilizes a DNA construct to continually express shRNA molecules which silence the target gene.

CSL overview

CSL discovers, develops, manufactures, commercializes and distributes biopharmaceuticals and related products. Its portfolio encompasses plasma-derived products for the treatment of hemophilia, hereditary angioedema, von Willebrand disease, inherited primary and secondary immune deficiencies, respiratory disease, neurological disorders and protein-based medicines for treating serious human illnesses. The company also provides products for the prevention of hemolytic disease in newborns, infection in solid organ transplant recipients and to treat specific infections for victims of trauma and burns. CSL markets an array of vaccines, anti-venoms and pharmaceutical products of various other manufacturers. The company sells its products in Australia, Germany, Switzerland, the US, the UK and other countries. CSL is headquartered in Parkville, Victoria, Australia.

Quick View CAL-1 LOA Data

Report Segments
  • Innovator
Drug Name
  • CAL-1
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Infectious Disease
  • Oncology
Key Developers
  • Sponsor Company: CSL
  • Originator: Calimmune
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.