Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, is pleased to announce its MAST (Metastatic Advanced Solid Tumours) clinical program evaluating the safety and efficacy of novel cancer-killing virus CF33-hNIS (VAXINIA), has been granted Fast Track designation from the US Food and Drug Administration (FDA).
The Fast Track process of drug development is designed to facilitate the development, and the review of drugs to treat serious conditions and fill an unmet medical need, with Fast Track status often leading to earlier drug approval and access by patients,” Imugene CEO and MD Leslie Chong, said.
Benefits of Fast Track designation include:
- Increased frequency of meetings with the FDA to discuss the drug’s development plan;
- Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and
- Regular dialogue with the FDA known as a Rolling Review in support of a New Drug Application or Biologic License Application.
Imugene CMO Dr Paul Woodard said the company has received a high level of interest from clinicians in the emerging data from the difficult to treat bile duct cancer patient population.
FDA Fast Track was granted based on the promising data package from Imugene detailing Phase 1 efficacy and tolerability data in patients suffering with bile duct cancer. Bile duct cancer is a rare disease in which malignant (cancer) cells form in the bile ducts. Bile duct cancer is also called cholangiocarcinoma. Bile duct cancers are difficult to treat and typically respond poorly to immunotherapy drugs.
The multicentre Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models1. Overall, the study aims to recruit cancer patients across approximately 12 trial sites in the United States and Australia.
The clinical trial is titled “A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33- hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST).” The trial commenced in May 2022 and is anticipated to run for approximately 24 months while being funded from existing budgets and resources.
