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Highlights
- Imugene achieves significant milestone in bile tract cancer treatment.
- Patient in VAXINIA Phase 1 trial maintains complete response after two years.
- U.S. patent extended to 2040, boosting longevity of CF33 oncolytic virotherapy.
Imugene Ltd (ASX:IMU) has made noteworthy progress with its CF33 MAST VAXINIA study, achieving a key milestone in the treatment of bile tract cancer. The Phase 1 MAST trial, which explores the efficacy of Imugene's CF33 oncolytic virus platform, reported that a patient in the study has surpassed two years in remission, maintaining a complete response. This development underscores the potential of CF33 oncolytic viruses, such as VAXINIA, in providing durable treatment options for patients with limited alternatives.
The bile tract cancer expansion phase of the MAST trial has successfully cleared its first cohort. Three patients in this segment of the trial were evaluated for safety, and results indicated no dose-limiting toxicities (DLTs), marking a positive outcome in terms of patient safety. With this achievement, the expansion portion is now open for full enrolment, aiming to include up to 10 patients to further examine VAXINIA’s potential.
Further solidifying its position, Imugene recently received an extension of its patent for CF33, including the VAXINIA (CF33-hNIS) and CHECKVacc (CF33-hNIS-antiPDL1) variants. The U.S. Patent and Trademark Office granted a patent extension to 2040 for application number 16/324,541. This long-term patent protection will enable Imugene to maximize the impact of CF33 oncolytic viruses in addressing cancer needs. According to Imugene’s CEO Leslie Chong, the extension strengthens the company’s position in the critical U.S. healthcare market.
In addition to the patent extension, Imugene’s work with the VAXINIA program has garnered recognition from regulatory bodies. Last year, the company received FDA Fast Track Designation for the VAXINIA MAST clinical program targeting bile tract cancer. This designation enables a more streamlined approval process, allowing for closer collaboration with the FDA. The expedited path provided by this status facilitates quicker access to potential treatments for patients with limited options.
Additionally, in September, Imugene secured Orphan Drug Designation for VAXINIA’s application in bile tract cancer. This designation grants seven years of market exclusivity in the U.S. for this particular use, along with a range of incentives aimed at fostering the development of treatments for rare conditions.
As Imugene continues to enroll patients in the bile tract cancer expansion of the MAST trial, these recent accomplishments highlight the company's commitment to advancing innovative cancer therapies and reflect the promising outlook for CF33 oncolytic viruses in providing effective cancer treatment options.
