Imugene Rises 12 Percent On FDA Fast Track Designation For Bile Duct Cancer

About Imugene

Imugene Limited (Imugene, ASX:IMU) is an immuno-oncology company developing immunotherapies that seek to activate the immune system of cancer patients to eradicate tumours. Imugene’s approach is to harness the body’s immune system against tumours to achieve a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. The company’s objective is to develop its immune-oncology therapies to become foundation treatments for cancer.

FDA Fast Track Designation for Bile Duct Cancer

Imugene’s MAST (Metastatic Advanced Solid Tumours) clinical program that is evaluating the safety and efficacy of a novel cancer-killing virus for Bile Duct Cancer, has received Fast Track Designation status from the US Food and Drug Administration (FDA). The benefit of Fast Track Designation is that it offers closer cooperation with the FDA to expedite the MAST clinical program and subsequent potential approval process. The benefits of Fast Track Designation are increased frequency of FDA meetings to discuss the drug’s development plan, and eligibility for Accelerated Approval and Priority Review, as well as regular dialogue with the FDA to support a New Drug Application or a Biologic License Application. The Fast Track process of drug development often leads to earlier drug approval and access by patients.

Bile duct cancer cells form in the bile ducts, which makes it difficult to treat

The promising data package from Imugene’s Phase 1 efficacy and tolerability trial on patients with metastatic or advanced solid tumours shows shrinkage of colon, lung, breast, ovarian, and pancreatic cancer tumours in preclinical and laboratory and animal models. Imugene plans to recruit cancer patients across 12 trial sites in the United States and Australia for the trial that commenced in May 2022 and has about 6 months to run. The trial is being funded from existing budgets and resources. Phase 1 trials are designed to determine the optimal dose for further development, however the emerging data is generating a high level of interest from clinicians seeking more information about the difficult to treat bile duct cancer.

Contingent resolution to spill the board

The Annual General Meeting scheduled for 30 November includes a contingent resolution to ask shareholders if they wish to convene a meeting (‘Spill Meeting’) within 90 days of this year’s AGM at which all directors will be required to vacate office and may stand for re-election.

A Spill Meeting resolution is an ordinary resolution, which means it requires a 50 percent majority for it to pass. The Spill Meeting resolution is only required to be voted on by shareholders if 25 percent or more of votes at this year’s AGM vote against the Directors’ Remuneration Report. If less than 25 percent of shareholder votes are against the resolution for the Directors’ Remuneration Report, the Spill Resolution will not be put to the AGM.