Media Thread, page-11230

Hi Col

Umm - not quite. The infographic does show that a "Priority Review" designation means that the FDA has a goal to "take action" within 6 months. However that's not the current situation for Imugene.

Imugene is not at "Priority Review" stage yet. Imugene has received a "Fast Track" designation for Vaxinia, with specific regard to the Biliary Cancer expansion cohort. You can read all about "Fast Track" here: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

Basically - it means that the FDA will do whatever it can to help speed up the process of getting a drug to market - assuming that the clinical trials actually do demonstrate "significant advantage over available therapy." Clinical trials still have to happen though, in order to provide evidence of "significant advantage," and FDA fast track can't change the speed of the biological processes which are being monitored in the trial. "Fast Track" just means that the FDA will do what it can to ensure close communication with the company, and to reduce the time required for assessing and processing reports and applications sent to them.

Fast Track does induce "eligibility for Accelerated Approval and Priority Review, if relevant criteria are met."

I'm sure Imugene is aiming to get Accelerated Approval and Priority Review, but to get either or both, they will need to demonstrate strong results in the current Biliary Cancer expansion. If they DO get strong positive results, then the FDA may allow them to proceed to register the drug for commercial use under Accelerated Approval, ahead of conducting a Phase 3 clinical trial. Accelerated Approval would still require them to conduct a Stage 3 trial, but it would allow them to go to market before that trial has been completed. This would save years....

Under "Priority Review" - the FDA would try to ensure that an application for registration (eg under Accelerated Approval) would be actioned within 6 months. (Without Priority review, their goal is 10 months).

The FDA states that Priority Review "does not affect the length of the clinical trial period" - and "Designation of a drug as “Priority” does not alter the scientific/medical standard for approval or the quality of evidence necessary."

So the process looks like this:

Step 1 - IMU has to determine the "Optimal Biologic Dose" for Vaxinia - a key goal of the current Ph 1 trial.
Step 2 - Based on that OBD, Imugene will then start the clinical trial expansion cohort in Biliary Cancer
Step 3 - The BC expansion cohort of the trial needs to enrol 10 patients and reach a point where IMU can produce meaningful data on outcomes
Step 4 - Allow a couple of months to process the data, get it vetted by the Independent Data Monitoring Committee and get the required reports to the FDA
Step 5 - The FDA might grant Priority Review
Step 6 - IMU could apply for Accelerated Approval - and the FDA would try to come back with a response within 6 months.

I would expect them to have the OBD determined by the end of Q1 next year, and then the BC expansion can commence - but don't ask me how long it will take because it just isn't possible to know that. The result depends upon how long it takes to find and enrol 10 patients who meet the inclusion criteria, how the patients respond to the treatment, and how long that response takes to happen. It should take less time than we waited for the initial Vaxinia results though - because the initial Vaxinia trial results were delayed by the FDA's requirements for a slow staged "dose escalation" process. In the BC expansion cohort they will immediately start with the mot effect dose (the OBD which they are working to determine right now, through the dose escalation process).

Also - the OBD they will be using will be a higher dosage level than was given to the BC patients who were included in the report on initial results - which triggered this expansion for Biliary Cancer. (Note - BC is easier to write than Biliary Cancer, or Bile Duct Cancer, and a lot easier than the official title of "Cholangiocarcinoma"). So it's reasonable to assume that the patients on the BC expansion will respond faster, and hopefully just as well or even better, than the BC patients who were in the Phase 1 dose escalation.

So this should be a very rapid process, by clinical trial/drug development standards, but it will still take all of next year and well into 2025.

However in the next few months - hopefully in Q1 - we should get the next report on the progress of the wider Vaxinia Phase 1 trial. eg. They will come back with OBD - at least for the mono-therapy (the Combo study started later and may take a bit longer). When they report OBD for the Mon-therapy they will presumably also be reporting on clinical results for the mono therapy patients, because the OBD is determined by analysis of the clinical results.

Further confirmation that Vaxinia works should give the share price a very significant boost.

Cheers

Dave