Imugene Ltd (ASX:IMU, OTC:IUGNF) has made several important advancements in 2023, bringing the company closer to its goal of “revolutionising” cancer treatment.
Encouraging initial results and accelerated pathway for VAXINIA
The Phase 1 CF33-hNIS (VAXINIA) MAST study has delivered encouraging preliminary outcomes, especially in patients with complex gastrointestinal cancers. These initial successes led to the Fast Track designation for VAXINIA by the FDA, highlighting its prospective impact in treating bile duct cancer, an area with a critical need for new treatments.
The Fast Track status greatly facilitates the development and regulatory review process, allowing for more regular and focused interactions with the FDA concerning the development strategy for VAXINIA.
“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 licence application,” IMU CEO Leslie Chong said.
“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.”
Progress in azer-cel development with Phase 1b trial
Since acquiring the technology in August, IMU’s azer-cel program has made significant strides. The start of the Phase 1b clinical trial, marked by the first patient dosing, represents a significant advancement in assessing this innovative therapy for non-Hodgkin’s lymphoma, particularly Diffuse-Large B-cell lymphoma.
The insights gained from the Phase 1a trial, conducted across multiple US centres, have established a solid groundwork for further investigation into azer-cel's safety and effectiveness.”
“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,” Chong said.
Launch of the onCARlytics CD19 virus technology clinical trial
Marking a significant milestone, IMU launched its Phase 1 clinical trial for CD19 oncolytic virotherapy onCARlytics.
The trial introduces a pioneering approach to treating solid tumours by integrating the company’s novel therapy with established CD19 drugs. As the first clinical trial globally to test a CD19 oncolytic virus in tandem with a CD19 drug, it opens new therapeutic possibilities for patients with solid tumours, a group that has traditionally been difficult to treat effectively with CD19-targeting biological drugs.
2024 outlook
Writing in IMU’s recent newsletter, Chong outlined the plans for 2024 saying, “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.”