The CF33, Vaxinia and Oncarlytics Deal, page-241

Lot's of talking going on here.

I'm wondering if anyone has addressed the fact that there is limited preclinical evidence that has demonstrated a significant benefit from intravenous administration of CF33 either as a single agent or in combination with an anti-PDL1 in every murine model tested? In cases were there may have been benefit, the clinical trial either administered the OV/combination immediately after transfection into the murine model or did not have a single-agent PDL1 arm.

Intratumoral administration of anti-cancer agents for metastatic cancers is not and has never been an effective method of administration. In metastases, cancer has spread around the body and in most cases the cancer sites are not accessible by a needle (just look below). Notice in the most recent announcement that they only accepted patients that had cancers close to the skin, and it was those specific cancer locations they were examining. Need I say that cancers in early stages that are close to the skin are removed surgically, so who exactly is your target market?



Oncolytic viral therapy has always struggled to penetrate the tumor microenvironment, survive the immune system, and display significant efficacy in the clinic, which is why it's worth just $23-84M globally. Not to mention it is a crowded space with 114 clinical trials currently underway.




If CF33 as a single agent or in combination with any drug can't demonstrate a significant benefit administered intravenously, then it will fail in the clinic and commercialisation. I think IMU is about to head below 10c as people begin to understand the significant clinical and commercial risks associated with CF33, and with the realisation that HER-VAXX was a substandard therapy hyped as superior.