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Highlights
- In the Phase 1 MAST trial for VAXINIA, a bile tract cancer patient has maintained a complete response for over two years.
- The Bile Tract Cancer Expansion phase has cleared its first cohort with no dose limiting toxicities, and is now open for enrolment targeting up to 10 patients.
- FDA Fast Track Designation was secured in November 2023 for the MAST clinical program and its treatment of bile tract cancer.
- Orphan Drug Designation was secured in September 2024, offering incentives and seven years of market exclusivity upon FDA approval.
Shares of Imugene Limited (ASX:IMU) rose after the company’s positive update on its Phase 1 MAST (Metastatic Advanced Solid Tumours) trial. This study is evaluating the safety and efficacy of the novel cancer-killing virus CF33-hNIS, VAXINIA.
A major highlight from the trial is that a bile tract cancer patient has maintained a complete response for more than two years.
In addition, the company reported that the Bile Tract Cancer Expansion part of the study has successfully cleared its first cohort. The first three participants were assessed for safety, and none experienced dose-limiting toxicities. With this milestone achieved, the company has now opened full enrollment, with plans to include up to 10 patients.
IMU shares jump
IMU shares were trading 6.82% higher at the time of writing on 5 November 2024 with a market cap of AU$327.28 million.
