Imugene (ASX: IMU) March quarter roundup: clinical trial progress, patent grant and strategic partnership

Highlights

• Under the Phase 1 MAST trial high cohort dose, dosing of first patients has been concluded.
• Bile tract cancer expansion study opened.
• Dosing commenced in the OnCARlytics (CF33-CD19) trial.
• Imugene joined hands with Kincell for strategic manufacturing and process development.
• Imugene secured a patent in China for its oncolytic virotherapy CF33, valid till 2037.
• The company ended the quarter with cash or equivalents of AU$114.1 million.

Clinical-stage immuno-oncology company Imugene Limited (ASX: IMU) has reported significant activities encompassing advancements across multiple clinical trials, establishment of a strategic partnership, patent grant, and conference presentations in its March 2024 quarterly report.  Imugene is pioneering therapies aimed at stimulating cancer patients' immune system to detect and eliminate tumours. During the March quarter, the company reported progress across all fronts of its pipeline.

Image source: Company ppt

VAXINIA MAST trial advances to higher dose cohort

During the quarter, first patients were dosed as part of the Phase 1 MAST trial high cohort dose. As of 24 April 2024, 47 heavily pre-treated patients have been dosed., with 40 being evaluable, meaning that these patients have received their first scan at least at day 42. Notably, 48% of the evaluable patients have been on treatment for over three months and indicated substantial disease control.

A bile tract cancer patient, who failed in three previous treatments, reported a complete response during the dose escalation. The complete response has continued for nearly 1.5 years.

An expansion trial for bile tract cancer, expected to enroll around 10 patients, has opened. Early data anticipated in 2H 2024.

It is supported by the US FDA Fast Track Designation, granted in November 2023, facilitating expedited review.

Dosing commences in OnCARlytics (CF33-CD19) trial

The trial is currently active across three US sites, with plans to open 10 sites and enroll 40-45 patients with advanced solid tumors. Under the trial, dosing in the intravenous monotherapy has started, with the first bile tract cancer patient treated at City of Hope, California. Preliminary combination data is expected in 4Q 2024.

Strategic partnership with Kincell

Imugene has announced a strategic collaboration with Kincell, encompassing the sale of IMU’s North Carolina Current Good Manufacturing Practice (CGMP) manufacturing facility. The transaction is for US$6 million in upfront and milestone-dependent payments. This agreement is anticipated to yield around AU$49 million to IMU in cost savings from drug manufacturing, salaries and overhead costs.

Additionally, a manufacturing supply pact has been established, under which Kincell will produce Imugene’s Azer-cel to assist in progressing clinical trials.

Patent granted to VAXINIA and CHECKvacc in China

Another important achievement is a patent grant in China titled-

The patent has been obtained for Imugene’s oncolytic virotherapy CF33, including VAXINIA and CHECKvacc. The patent safeguards the composition and application method of these therapies until 2037, complementing prior patent approvals in Japan and South Korea. This development strengthens Imugene's intellectual property holdings in key healthcare markets throughout Asia.

The company ended the quarter with cash or equivalents of AU$114.1 million.

IMU shares traded at AU$0.075 apiece at the time of writing on 10 May 2024.