Poly-ICLC is under clinical development by Oncovir and currently in the Phase I and 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 Poly-ICLC’s likelihood of approval (LoA) and phase transition for Peritoneal Cancer took place on 17 Nov 2021, 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.

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

Poly-ICLC overview

Poly-ICLC (Hiltonol) is under development for the treatment of severe acute respiratory syndrome (SARS), Coronavirus disease 2019 (COVID-19), colorectal cancer, pancreatic ductal adenocarcinoma, melanoma, squamous head and neck cancer, sarcoma, malignant pleural mesothelioma, triple negative breast cancer, lymphomas including cutaneous T-cell lymphoma, B-cell lymphoma, merkel cell carcinoma, MMR-p colorectal cancer, metastatic pancreatic cancer and colon cancer. The drug candidate is also under development as adjuvant therapy for the treatment of HIV-1 infection,ovarian cancer, fallopian tube cancer and primary peritoneal cancer (first line therapy). It is administered intramuscularly, intradermally, intratumorally and subcutaneously. The drug candidate is a synthetic complex of carboxymethylcellulose, polyinosinic-polycytidylic acid and poly-L-lysine double-stranded RNA. Poly-ICLC is a viral mimic and broad activator of innate immunity. Poly ICLC may stimulate the release of cytotoxic cytokines and by inducing interferon-gamma production, may increase the tumoricidal activities of various immunohematopoietic cells. It activates the oligoadenylate synthetase (OAS) and the p68 protein kinase. It is also acts as TLR3 agonist. The drug was also under development for the treatment of brain tumor, anaplastic astrocytoma, anaplastic oligoastrocytoma, oligodendroglioma, glioblastoma multiforme, prostate cancer, poxviridae infections, west nile virus infections, japanese encephalitis, dengue fever, yellow fever, st louis encephalitis, murray valley, orthopox virus infections, banzai viruses, smallpox and influenza.

Oncovir overview

Oncovir is a pharmaceutical company that develops and markets nucleic-acid-based clinical therapies. The company offers clinical trials such as hiltonol plus dendritic cell vaccine, hiltonol (Poly-ICLC) plus temodar, and hiltonol (Poly-ICLC). Its hiltonol vaccines have biological effects in humans, which include antiviral, immune activating, vaccine adjuvant and antitumor actions. Oncovir’s clinical trials are used in the treatment of brain tumor antigens in patients with recurrent glioblastoma, diagnosed glioblastoma, malignant brain tumors and smallpox. It offers clinical therapies for cancer, infectious, immune and degenerative disorders. The company provides products under the brand name Hiltonol. Oncovir is headquartered in Washington, the US.

Quick View Poly-ICLC LOA Data

Report Segments
  • Innovator
Drug Name
  • Poly-ICLC
Administration Pathway
  • Intradermal
  • Intramuscular
  • Intratumor
  • Subcutaneous
Therapeutic Areas
  • Infectious Disease
  • 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.