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.

Regulatory Advancements and Approvals

The VAXINIA MAST clinical program for treating bile tract cancer had received FDA Fast Track Designation in November 2023. This designation facilitates closer collaboration with the FDA and may accelerate the development and approval process, offering opportunities for priority review and potentially faster approval.

Furthermore, in September 2024, Imugene secured Orphan Drug Designation from the FDA for VAXINIA. This status provides various incentives, including seven years of market exclusivity upon FDA approval.

Patent Extension

In a recent development, the company was granted a patent extension from the United States Patent and Trademark Office (USPTO). The patent extends the protection for its oncolytic virotherapy CF33, including both VAXINIA (CF33-hNIS) and CHECKVacc (CF33-hNIS-antiPDL1) from 2037 to 2040.  

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.