Congratulations @davybabyk@Watmighthavben&@Jov88for your recent...

Congratulations @davybabyk@Watmighthavben&@Jov88for your recent posts.

The IMU threads continue to be richer for your ongoing commentary and research. HC readers now have little excuse for not understanding the potential of what Team IMU are doing. Any punter can now gain clear and valuable insights into IMU’s team, IP, timeframes and trials if they just set aside a little time to follow the many quality posters here and by reading the company announcements. It’s that simple!

Just today @Jov88 points out a very important point regarding current trial structure and the potential to speed up the approval process.

“among the big changes around drug development the FDAhas been including 'surrogate endpoints', 'anti tumour activity' and 'tumour-based endpoints' as relevant targets to aim at, instead of the more time-consuming endpoints such as progression-free survival and overall survival.”

I have recently been ‘harping on’ about what appears to be a ‘new’ openness and flexibility in the FDA’s attitude, certainly in the area of cancer research. I have linked this to Biden’s Cancer Moonshot focus.

Jov has picked up on this aspect also and makes great points around flexibility, and thus speed, through the possibility of ...

'Expansion Cohorts', which IMU is taking advantage of,have been introduced to speed up the approval process.

Jov continues ...

IMU already had its sights on an expansion cohort incholangio carcinoma and biliary tract cancers (also note these do not form partof the NCI-60), but we now also see head and neck looking like the next candidate with others to be determined.

Virtually any cancer target may be plucked from this very flexible MAST study, and spun off into an expansion cohort that may also attract ‘Fast Track’ status, and all that goes with it. I for one, see great possibilities for early registration trials if our data continues to be strong. After all, CF33 is clearly very, very safe.

Today also, Ben @Watmighthavben has made may good points about IMU’s potential and of course the possible interest of Big Pharma. I have no doubt that most BPs are monitoring what IMU is doing, after all they have whole departments, within their organisations, that do just this, monitor developing therapies.

Having noted that, I found one of Ben’s points just leapt off the page. Why? Because I have come to the same conclusion.

He says ...

“Whilst the most appropriate mode of delivery of the OVneeds to be ascertained, whether that is via a targeted combination therapy such as RenovoRX, or as a monotherapy, through IV, Oncarlytics or some other method, the OV’s effectiveness IMO is now undisputed. I for one am happy to call “proof of concept”, when it comes to the Vaxinia therapy arm in Imugene’s arsenal.”

I concur, and I am very happy to call ‘proof of concept’ with regard to the Vaxinia arm. This amazing virus works ... just as Yuman promised. So now we just need to establish how many cancers we can treat. This will be an amazing and most rewarding journey.

Just the opinion of this poster.