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Lets Recap - Vaxinia and the FDA

In Sydney, Australia on 28 November 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, was pleased to announce its MAST (Metastatic Advanced Solid Tumours) clinical program evaluating the safety and efficacy of novel cancer-killing virus CF33-hNIS (VAXINIA), has been granted Fast Track designation from the US Food and Drug Administration (FDA).

At the time Imugene CEO and MD Ms Leslie Chong said, “The Fast Track process of drug development is designed to facilitate the development, and the review of drugs to treat serious conditions and fill an unmet medical need, with Fast Track status often leading to earlier drug approval and access by patients”.

FDA Fast Track was granted to the Imugene licensed Vaxinia based on the promising data package from Imugene detailing Phase 1 efficacy and tolerability data in patients suffering with bile duct cancer. Bile duct cancer is a rare disease in which malignant (cancer) cells form in the bile ducts. Bile duct cancer is also called cholangiocarcinoma. Bile duct cancers are difficult to treat and typically respond poorly to immunotherapy drugs.

The discovery of novel drugs is critical for pharmaceutical research and development as well as for patient treatment.

Speeding the availability of drugs that treat serious diseases are in everyone's interest, especially when the drugs are the first available treatment or if the drug has advantages over existing treatments. The Food and Drug Administration has developed four distinct and successful approaches to making such drugs available as rapidly as possible:

• Priority Review
• Breakthrough Therapy
• Accelerated Approval
• Fast Track

Because each of these approaches implies

speed, there can be confusion about the

specific meaning of each and the

distinctions among them.

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

A Priority Review designation means FDA’s goal is to take action on an application within 6 months.

Between 2000 and 2017, cancer therapeutics generated more fast track, accelerated, and priority approvals than any other therapeutic area.

A drug that receives Fast Track designation is eligible for some or all of the following:

• More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
• More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
• Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
• Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA

Once Fast Track is granted, there are significant benefits to a sponsor company, including the ability to “put in parts of your application piecemeal” and less risk of an “action by the FDA that would slow things down,” said Christopher-Paul Milne, director of Research, Tufts Center for the Study of Drug Development (CSDD).

“Basically, that’s what Fast Track is designed to do—head off problems while you’re in your normal development cycle,” Milne said. In addition, the program may trim the cost of drug development by shorting research timelines, opening up the opportunity of early approval.

Ultimately, the Fast Track program has been deemed a success, with approximately two thirds of all 770 Fast Track requests approved by the FDA from 2007 to 2015, according to the Government Accountability Office (GAO). The Fast Track program has “withstood the test of time” and is unlikely to be curtailed under the new FDA Commissioner Scott Gottlieb, said Milne.

As noted by Imugene back in November ta the time of the announcement the multicentre Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models¹. Overall, the study aims to recruit cancer patients across approximately 12 trial sites in the United States and Australia.

It is now well known that oncolytic viruses (ov’s) such as Vaxinia have the potential to transform oncology by directly causing tumour cell death, and also by delivering a potent payload in a targeted fashion that activates the immune system.

For those wishing to learn more about Vaxinia and the effect oncolytic viruses can have on the immune system the following video is a sound reference source. It was made by Imugene at the time they acquired CF33 from The City of Hope Research Facility in the US in 2017. The video features Vaxinia’s founder, Professor Yuman Fong.

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