Ann: Phase 1 CF33-hNIS Study Update - Positive Early Signals, page-123

The punters on the ASX don’t have to approve IMU’streatments ... the FDA does!

For the present, it doesn’t matter that the ASX doesn’t understand the potential of IMU’s CF33 suite ... because the FDA certainly does, and it seems to be doing every thing it can to support Biden’s CancerMoonshot project, and in so doing, expediate IMU’s trials.

A key focus of the Cancer Moonshot strategy is...

... to speed progress against the most deadly and rare cancers, including childhood cancers ... it goes on to state: we know cancer as a disease for which we lack good strategies for developing treatments against many of the more than 200 distinct types. We can invest in a robust pipeline for new treatments, and the COVID-19pandemic response has demonstrated we can accelerate clinical trials without compromising safety and effectiveness.

These, ie. ‘accelerating trials’, is exactly what we are seeing in and around our CF33 trials.

Yuman has more than intimated that the FDA was more than ‘cooperating’, a number of times, with statements around the amazing speed of the trial, and again when the FDA gave IMU the go ahead for the trial to target ANY solid tumour. This is a big deal.

Paul Woodard, our CMO, stated recently that ...

“We are very encouraged to received Fast Track Designation by the FDA. We have received a high level of interest from clinicians in the emerging data from the difficult to treat bile duct cancer patient population”

And these ‘excited’ oncologists are talking to the FDA, the NCI and other peak bodies, about what the IMU treatments are showing. These oncologists need answers for Bile Duct cancer, and they need it NOW.

Then in yesterday’s announcement, we see the Bile Duct cancer trial cohort has been doubled, from 10 to 20. What? This only occurs when you are in close and continuing consultation with the FDA. This is clearly the case here. The FDA would be loving what they are seeing in this trial ... strong responses in both the IT and IV arms.

IMO ... if the results continue to be highly positive in the expanded Bile Duct targeted trial, then ... the next trial will be registrational.

Vaxinia is just one, but one very important piece, in IMU’s world. They have many pieces ‘in play’, and amazingly, all at the same time. We still have onCARlytics and azer-cel dancing along too. More about them later.

As always, opinion only.