Poly-ICLC is under clinical development by Oncovir and currently in Phase II for Low-Grade Glioma. According to GlobalData, Phase II drugs for Low-Grade Glioma have a 64% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Poly-ICLC’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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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.

Poly-ICLC overview

Poly-ICLC (Hiltonol) is under development for the treatment of colorectal cancer, pancreatic ductal adenocarcinoma, melanoma, squamous head and neck cancer, human papillomavirus (HPV)-associated HNSCC, sarcoma, malignant pleural mesothelioma, lymphomas including cutaneous T-cell lymphoma, B-cell lymphoma, merkel cell carcinoma, metastatic adenocarcinoma of pancreas, MMR-p colorectal cancer, metastatic pancreatic cancer, colon cancer, prostate cancer, epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer (first line therapy), recurrent or metastatic breast cancer, non-small cell lung cancer, solid tumors, bladder cancer, kidney cancer, pediatric diffuse intrinsic pontine glioma and low-grade glioma. 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, poxviridae infections, west nile virus infections, japanese encephalitis, dengue fever, yellow fever, st louis encephalitis, murray valley, orthopox virus infections, banzai viruses, smallpox, severe acute respiratory syndrome (SARS),  acute myeloid leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia (CMML) and influenza.

Oncovir overview

Oncovir is a research-based pharmaceutical company that develops drugs for oncology and other immune diseases. The company’s pipeline products include hiltonol plus dendritic cell vaccine and hiltonol (Poly-ICLC) plus temodar. 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.

For a complete picture of Poly-ICLC’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.