Biotech Values

[Titan V]

Do you think the delivery system is enough to make it an investment? Or that the market will be large enough that it does not matter?

It's a combination of both, the market, and the results we have seen so far from the delivery system, IMO.

Plasmid IL-12 delivery via electroporation seems to have a much better safety and tolerability profile compared to other methods of IL-12 administration. In OncoSec's current trial, there was only 1 grade 3 AE of cellulitis which was resolved with antibiotics, which wasn't directly related to the treatment. Also ONCS patients have seen anti-tumor activity in non-treated lesions as well. Now add these factors to the response rates they are seeing.

I don't believe any other company (please correct me if I'm wrong) is going after the particular subset of anti-PD-1 refractory patients (patients who have been through anti-PD-1 monotherapy and haven't responded). In melanoma, that's about 70% of the patients. ONCS expects this to be a 10,000 patient market opportunity in 2019. Please see slide 53 in the below presentation.
http://lifesci.rampard.com/20170228/oncosec.pdf

Regarding time to market, ONCS expects to begin a pivotal phase 2 registration trial of EP IL-12 + Keytruda combo in Q2'17. They expect to have data by 2018 and are aiming for accelerated approval by 2019. They received Fast Track Status from the FDA on February 27. Please see slide 40 in the presentation. I am not sure how close ZIOP is to market and if they are specifically targeting the anti-PD-1 non-responder population.

What the company has also been saying since the last few months is that they are finalizing a drug supply partnership for the registration trial with a multinational, saying it will either be MRK or BMY. It is going to be MRK without a doubt given the existing relationship IMO. Anyway, they have given guidance that it will be announced before registration trial enrollment begins sometime in Q2'17. While it will not be a big $ collaboration at this time, validation of the science from a big pharma should bode well for the market cap and enterprise value by bringing in institutional investors IMO.