Ann: PTX successful immunogenicity testing of OmniCAR, page-84

Omni-CAR is ready as it is safe for initiating clinical trials and ready for licensing with the in silico tests and coupled with the recent success in manufacturing.

While the in silico immunogenicity results are certainly very positive and encouraging, they don’t signify that human trials are ready to commence.

As shown on the Macro Work Plan slide (31-33 minute mark) in last weeks’ webinar, in vitro and in vivo testing will take place over the rest of this year, followed by the requisite IND enabling work, which will take a further 18 months (this will include further safety testing through animal toxicology studies). The lead CAR-T candidate (Her2) won’t enter human trials for another two years.

But, as SYC was at pains to point out during the webinar, the value of a good CAR-T platform can be seen well before human clinical trials have commenced. He uses the example of US CAR-T biotech, Xyphos, which was acquired by Astellas in December 2019 for the equivalent of A$160m upfront and a further potential A$725m payable in development milestones. At the time of acquisition, Xyphos had 4-5 early-stage clinical candidates, with the lead candidate still at least a year from first human studies. The Xyphos website suggests that the first clinical trial has yet to commence.

https://xyphosinc.com/pipeline/