IMU product line - CF33, page-45

A lot oftalk about the OBD and when it will be achieved in the Vaxinia trial so I thoughtI’d have a look at some current timelines based on previous cohort clearings. Currentlythe Vaxinia Monotherapy IV and IT arms of the trial are clearing cohorts at anaverage of around 102 and 150 days respectively as shown below. So far, we haveonly heard of “flu like symptoms” being observed from current patients on thetrial. In Professor Fongs pre-clinical trials he was able to push the therapeuticlog as high as 10^9 or 1bn PFU before seeing any toxicity within mice models. Depending on what therapeutic log humans can handle below is a rough timeline on when we can expect the OBD to be achieved depending on how high we go. The trial design is also just a stab in the dark based on the existing one and how it has been set out.

We knowthat IMU won’t stop until they see toxicity and achieve the largest dose possiblethat is safely administrable for humans. Having said that IMU appears to be lookingto start their bile duct expansion in Q2 of this year, we know that they willbe looking to use the OBD in this expansion which makes me think that we arenearing the end.

I hope wesee the OBD soon but depending on what patients can handle we could go wellpast the pre-clinical toxicity limit and into the unknown.