Dear David
On behalf of the Imugene team we wanted to take the time to wish you and your families a safe and happy holiday season and new year.
In our recent newsletter we reflected on what has recently been another period of highly significant progress at Imugene.
Our journey over the past few months has been marked by several important advancements, ultimately bringing us closer to our goal of revolutionising cancer treatment.
Positive early data and Fast Track Designation for VAXINIA
Our Phase 1 CF33-hNIS (VAXINIA) MAST study has been our headline act recently, showing promising early results, particularly in patients with challenging gastrointestinal cancers. This paved the way for our receipt of Fast Track designation awarded by the FDA for VAXINIA, underscoring its potential in addressing the urgent treatment need for bile duct cancer.
This designation significantly streamlines the development and review process, enabling more frequent and strategic discussions with the FDA regarding VAXINIA’s development plan.
It opens avenues for Accelerated Approval and Priority Review if certain criteria are met and supports a Rolling Review for our New Drug Application or Biologic License Application. We remain pleased by the progress of the multicentre Phase 1 MAST trial as it continues to successfully clear the various cohorts and arms in the study.
Azer-cel hits Phase 1b initiation milestone
Following our acquisition of the technology in August, we’ve seen strong progress in our azer-cel program. The initiation of the Phase 1b clinical trial, with the first patient being dosed, marks a step forward in evaluating this promising therapy for non-Hodgkin’s lymphoma, especially Diffuse-Large B-cell lymphoma. The Phase 1a trial’s findings, involving multiple US centres, laid a foundation for further exploration of azer-cel’s safety and efficacy. Our goal for 2024 includes potentially initiating a Phase 2 registrational study, subject to FDA agreement, which could help us understand azer-cel’s broader impact in cancer treatment. Additionally, we are continuing to explore opportunities to integrate azer-cel with our onCARlytics platform for solid tumour treatments, which aligns with Imugene’s strategic vision for comprehensive cancer care.
Initiation of onCARlytics CD19 Virus Technology Trial
Entering the clinic for the first time, the initiation of our Phase 1 clinical trial for CD19 oncolytic virotherapy onCARlytics was another major piece of news. This trial represents a novel approach to treating solid tumours, combining our innovative therapy with approved CD19 drugs. The world-first clinical trial of a CD19 oncolytic virus in combination with a CD19 drug opens new treatment avenues for patients with solid tumours, historically challenging to treat with CD19-targeting biological drugs.
Outlook for 2024
Looking ahead to 2024, Imugene is well positioned to continue to deliver further key newsflow and milestones with five clinical studies ongoing. A critical focus will be advancing azer-cel through its clinical trials, with the aim of initiating a Phase 2 registrational study. This move is pivotal, as it could position azer-cel as the potential first approved allogeneic CAR T cell therapy for cancer, a remarkable achievement in our industry.
We’re eager to see what the onCARlytics Phase 1 program delivers, both in the recently initiated clinical trial as well as the synergistic potential with azer-cel in treating solid tumours, thus broadening our impact across the oncology spectrum. The progress in the now expanded MAST study, buoyed by Fast Track designation, will be crucial as we expedite our clinical program.
We also anticipate fostering closer cooperation with regulatory bodies and exploring new partnerships to expand our reach and enhance our capabilities. Financially, our balance sheet remains strong, and we remain well funded to continue the advancement of our ongoing programs. As always, our strategy will be guided by our commitment to making a tangible difference in the lives of cancer patients worldwide.
Leslie Chong
CEO & Managing Director
Paul Hopper
Executive Chairman |
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