Imugene Limited (ASX: IMU) has made significant strides in the fight against bile tract cancer, as announced today in an update on its VAXINIA oncolytic virus trial. The highlight: a patient in its Phase 1 MAST (Metastatic Advanced Solid Tumours) study has shown a complete response, remaining cancer-free for over two years. This achievement underlines the potential of Imugene’s innovative immuno-oncology platform, designed to trigger patients’ immune systems to combat and eradicate tumours.
The MAST trial, conducted on the CF33-hNIS (VAXINIA) oncolytic virus, seeks to establish safety and efficacy in patients with advanced solid tumours. Specifically, this milestone patient falls under the study’s bile tract cancer cohort expansion, which has now been greenlit for full enrolment. This next phase will bring up to 10 patients on board, with the initial three participants demonstrating no dose-limiting toxicities, thus fulfilling the safety requirements for further testing.
FDA Fast Track and Orphan Drug Designation
Imugene’s momentum goes beyond clinical milestones. In November 2023, the VAXINIA program was awarded FDA Fast Track Designation, a status that supports faster review processes for drugs addressing serious, unmet medical needs. This designation brings potential perks, such as priority review, rolling submissions, and accelerated approval – all key for speeding up access to new therapies. Furthermore, in September 2024, the program earned Orphan Drug Designation for bile tract cancer. This award adds incentives like market exclusivity for seven years upon FDA approval, positioning Imugene strategically in the US oncology market.
Imugene CEO Leslie Chong
Imugene CEO Leslie Chong shared her excitement over these advancements, saying, “Imugene 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.” She also expressed the company’s enthusiasm about the two-year remission milestone for the bile tract cancer patient, adding, “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.”
Patent Extension for CF33
Adding to its clinical and regulatory wins, Imugene announced a patent extension from the US Patent and Trademark Office (USPTO) for its CF33 technology, including VAXINIA (CF33-hNIS) and CHECKVacc (CF33-hNIS-antiPDL1). This extension pushes the patent expiration out to 2040, providing a substantial runway in the competitive US oncology market. This extended intellectual property protection strengthens Imugene’s position as it advances CF33 as a foundational cancer treatment approach, particularly in the high-stakes oncolytic virotherapy segment.
Imugene’s Strategic Position in Immuno-Oncology
With these recent achievements, Imugene’s pipeline is gaining momentum. Beyond VAXINIA, Imugene’s portfolio spans multiple immunotherapies, including B-cell vaccine candidates and the off-the-shelf cell therapy, azer-cel, for blood cancers. Their holistic approach focuses on not just tumour eradication but on stimulating the immune system to sustain long-term responses. The company's collaboration with international cancer specialists and research into combining their therapies with established treatments underscores a strong commitment to providing patients with new options in a market eager for innovation.
Future Outlook
The completion of the MAST trial’s safety evaluation for the bile tract cancer cohort marks an important step in Imugene’s journey. It signals the potential of VAXINIA as an option for cancers with few effective treatments. With the support of its FDA designations and newly secured patent protections, Imugene has a robust foundation to explore further regulatory pathways in the US.
As Imugene continues its journey, all eyes will be on its trial outcomes and regulatory interactions, both of which will be crucial in turning this early-stage success into an approved, marketable therapy.
