ISA-201 is under clinical development by ISA Pharmaceuticals 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 ISA-201’s likelihood of approval (LoA) and phase transition for Head And Neck Cancer took place on 10 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.

In addition, the same event on 10 Nov 2022 increased ISA-201’s LoA and PTSR for Human Papillomavirus (HPV) Associated Cancer, and increased LoA and PTSR for Oropharyngeal Cancer.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their ISA-201 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

ISA-201 overview

ISA-201 (SLP-Amplivant conjugate) is under development for the treatment of human papilloma virus (HPV)-positive head and neck cancer,  oropharyngeal cancer and cervical cancer. The vaccine candidate is administered intradermally. The drug candidate is a conjugate of two HPV16 E6 Synthetic Long Peptides (SLPs) covalently linked to AMPLIVANT (a synthetic Toll-like receptor (TLR) 1/2 ligand).

ISA Pharmaceuticals overview

ISA Pharmaceuticals is a developer of synthetic therapeutic vaccines for the treatment of cancer and persistent viral infections. The company’s pipeline products include ISA101, an immunotherapeutic vaccine for cervical cancer, MyISA, a personalized immunotherapy based on neoantigens to eradicate cancer; ISA203, preferentially expressed antigen in melanoma for treating different types of cancers; and ISA204 for the treatment of hepatitis B. It also develops synthetic long peptides technology used in the applications of viral and non-viral targets and provides multiple products for persistent virus infections. The company also provides amplivant technology, which is based on a proprietary and synthetic toll-like receptor agonist and is used in new generation immunotherapeutic for treating various diseases. ISA Pharmaceuticals is headquartered in Leiden, the Netherlands.

Quick View ISA-201 LOA Data

Report Segments
  • Innovator
Drug Name
  • ISA-201
Administration Pathway
  • Intradermal
Therapeutic Areas
  • 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.