Axalimogene filolisbac is under clinical development by Ayala Pharmaceuticals and currently in Phase II for Oropharyngeal Cancer. According to GlobalData, Phase II drugs for Oropharyngeal Cancer have a 61% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Axalimogene filolisbac’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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.

Axalimogene filolisbac overview

Axalimogene filolisbac (ADXS-HPV, ADXS11-001, human papillomavirus (HPV) vaccine) is under development for the treatment of cervical squamous cell carcinoma, rectal cancer, HPV-Positive oropharyngeal squamous cell carcinoma and non-squamous, HPV associated cancers such as head and neck squamous cell carcinoma and cervical cancer in combination with durvalumab. The vaccine candidate is administered intravenously. It is a live attenuated Listeria cancer vaccine which specifically contains HPV-16-E7 antigen specific for cervical carcinoma. It is based on Listeria technology platform which uses modified Listeria monocytogenes to deliver a tumor-specific antigen fusion protein. It was under development for the treatment of anal cancer and  HPV associated cancers such as non-small cell lung carcinoma.

Ayala Pharmaceuticals overview

Ayala Pharmaceuticals Inc (Ayala Pharmaceuticals) is a clinical-stage bio-pharmaceutical company which develops novel drugs for defined cancers. Its lead product candidate AL101 and AL102 to treat cancers. The products render different cancers like desmoid tumors, adenoid cystic carcinoma (ACC), triple negative breast cancer (TNBC) and T-cell acute lymphoblastic leukemia (T-ALL). Ayala Pharmaceuticals desmoid tumors arise in upper and lower extremities, abdominal wall, head and neck area, mesenteric root and chest wall of the body. In addition, it also focuses on inhibiting the Notch activating pathway with best-in-class gamma secretase inhibitors (GSIs). The company has operations in Israel and the US. Ayala Pharmaceuticals is headquartered in Wilmington, Delaware, the US.

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


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.