Imugene (ASX:IMU) VAXINIA achieves major milestone in bile tract cancer treatment

Imugene (ASX:IMU) has made a significant breakthrough with its VAXINIA treatment in a Phase 1 clinical trial, delivering an exceptional outcome for a bile tract cancer patient who has maintained a complete response (CR) for over two years.

This achievement within the MAST (Metastatic Advanced Solid Tumours) trial highlights the potential of Imugene’s oncolytic virus CF33-hNIS (VAXINIA) to revolutionise cancer treatment.

Key Highlights:

• Complete Response: A bile tract cancer patient remains in remission, with CR maintained for over two years.
• Trial Progress: The Bile Tract Cancer Expansion has cleared its first cohort, paving the way for full enrolment of up to 10 patients.
• Regulatory Milestones: VAXINIA has earned FDA Fast Track Designation and Orphan Drug Designation, accelerating its pathway through the regulatory process.
• Patent Extension: U.S. patent protection for CF33 VAXINIA extended to 2040, reinforcing Imugene’s position in the oncology space.

The remarkable stability of the patient’s condition underscores the potential of CF33-hNIS as a cancer-killing agent.

According to Imugene CEO Leslie Chong, “We’re very pleased to see the two-year milestone reached for the bile tract cancer patient who has maintained a complete response in our MAST study. Most importantly, this is an outstanding result for the patient given the limited treatment options available, but also demonstrates the excellent potential of the CF33 oncolytic virus for this and other cancer types.”​

The trial’s progress is underpinned by robust regulatory support, with FDA Fast Track and Orphan Drug Designation offering expedited review benefits that potentially accelerate the route to market for VAXINIA and grant seven years of market exclusivity upon FDA approval.

These designations not only boost the drug’s market potential but affirm its innovative approach in an area where treatment options are sparse​.

Furthermore, Imugene’s recent patent extension in the U.S. to 2040 signals confidence in the CF33 platform’s long-term relevance.

Chong highlighted the milestone, saying, “Receiving this patent extension to 2040 from the US patent office is a significant milestone for the CF33 family of oncolytic viruses. The US is the core healthcare market, and we are delighted to strengthen the patent life.”

This protection ensures that Imugene remains well-positioned to capture the evolving oncology market as it pioneers immuno-oncology solutions.

The MAST trial’s expansion into bile tract cancer reflects Imugene’s targeted approach to addressing unmet medical needs.

With no dose-limiting toxicities (DLTs) observed in the initial cohort, the trial’s extension opens new possibilities for patient enrolment and underscores CF33’s tolerability, a critical factor in immuno-oncology treatments.

As Imugene continues to harness the immune system’s power against cancer, its progress in the MAST trial serves as a beacon of hope for patients and a testament to the possibilities of virotherapy in oncology.

The journey forward may be as promising as the landmark moment achieved here.

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