Imugene Advances Cancer Trials with Fresh Funding and Clinical Progress

Highlights

• Imugene receives A$5.87M in R&D tax refund for 2024.
• Initiates Phase II dosing for colorectal cancer therapy.
• Secures key US patent for onCARlytics platform

Imugene Ltd (ASX:IMU) has taken notable strides in advancing its immuno-oncology pipeline, backed by a research and development (R&D) tax refund totaling A$5,872,248 for the 2024 financial year. This sum includes A$84,990 in interest and was granted under the Australian Government’s R&D tax incentive program, which offers refundable tax offsets of up to 48.5% for eligible research efforts.

This refund comes at a pivotal time, as Imugene accelerates its clinical development efforts in innovative cancer immunotherapies.

Phase II Trial for Colorectal Cancer Underway

A major development for Imugene is the commencement of patient dosing in the Phase II Neo-POLEM trial for its PD1-Vaxx therapy. This immunotherapy is being evaluated in patients with mismatch repair-deficient / microsatellite instability-high (dMMR/MSI-high) colorectal cancer — a subtype accounting for approximately 15% of all colorectal cancer cases.

The trial’s neoadjuvant design aims to improve clinical outcomes by administering PD1-Vaxx before surgical procedures. The first patient was dosed at Queen Elizabeth Hospital in Adelaide, marking a critical milestone in the trial's rollout. Recruitment is actively ongoing across sites in Australia and the United Kingdom, with expectations of gaining valuable data in the coming months.

Strengthening Patent Portfolio with US Approval

In addition to its clinical progress, Imugene has expanded its intellectual property footprint. The United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for the company’s onCARlytics platform, CF33-CD19. The granted patent, titled Oncolytic Virus Expressing a CAR T Cell Target and Uses Thereof, offers coverage for both the composition and its method of use through to August 10, 2038.

This US patent complements similar patent allowances previously secured in other international jurisdictions, including China, underscoring Imugene’s strategy to protect and commercialize its innovation globally.

Supporting Innovation in a Competitive Sector

Imugene’s advancements arrive in a competitive and fast-evolving biopharmaceutical sector. While the company is not currently listed among ASX 100 companies, its continued progress in clinical trials and patent approvals could enhance its visibility among leading biotech firms on the ASX.

The R&D tax refund and recent trial and IP developments collectively reinforce Imugene’s commitment to developing novel cancer therapies and represent strategic steps toward long-term clinical and commercial success.