Ann: FDA IND APPROVAL FOR THE PHASE 2 CLINICAL TRIAL OF HER-VAXX, page-167

Hi Davy, @QiQi, @mrdingo & @mumstheword & All,

I kind of got the feeling from these comments that an investigator led study is not off the cards, but that IMU would have to see benefit in for HER-VAXX in moving ahead with this (that was stated, & yes it was announced there would be 3 x Ph2 trials).

I wasn’t disappointed really, hearing this @QiQi - more interesting in that has something changed in the current 2 collaborations, where we will be funded with checkpoint inhibitors on these 2 trials?

We know that the most recent CR giving us a cash position of >$100 million to fund all trials (including 3 x Ph2 HER-VAXX) that one was also included, so I don’t think that is it.

The comment “only if it adds value to HER-VAXX” could mean a few things: a) including that there could be further amended plans for a third trial;

b) IMU aren’t satisfied at this point in time that it would add benefit vs cost, including the fact we have had a lot of pre-clinical data out on synergy with PD1-PDL1 & HER-VAXX from Professor Weidermann & University of Vienna, with immunotherapy enhancement for multiple checkpoint inhibitors - which is in the very short term, moving into clinical trials - and that has happened in the meantime from the initial announcement.

c) There could be other offers on the cards for collaborations, so what was initially planned may not be the best option for HER-VAXX in a fast-paced changing therapeutic area.

I actually was happy to hear that IMU are only willing to go ahead on an Investigator Lead trial, for benefit of the IP, and I certainly don’t have the answers, but I think that maybe they are also looking at value in moving into Registrational trials & approvals/commercialisation & weighing up the most benefit for the IP.

That’s the feeling I got from that. Not that we won’t do a third Ph2 full stop, but maybe the ‘landscape has changed’. Just my thoughts.