Biotech Values

[Titan V]

Hi kld2, I think the data shared today (43% ORR; 48% BORR) was very good. While majority of the 22 patients were biomarker-predicted non-responders to anti-PD-1, there were 9 patients who were actual non-responders from prior checkpoint treatment, 3 of whom showed complete response (33%). The currently available second-line therapy for anti-PD-1 non-responders is treatment with Yervoy which had a 0% complete response, only 10% ORR, and 35% GRADE 3-5 SAEs in a trial with 40 patients. ONCS had a remarkable safety profile.
https://www.researchgate.net/publication/301696831_Efficacy_and_toxicity_of_treatment_with_the_anti-CTLA-4_antibody_ipilimumab_in_patients_with_metastatic_melanoma_after_prior_anti-PD-1_therapy

The reason why the market didn't respond well today IMO could be the small size of the study and perhaps the emphasis on predicted non-responders in the summary of the PR (despite the fact that there were some actual non-responders in the trial with complete responses). Also the market is generally cautious when digesting news from nanocap biotechs.

As to where we go from here, the company has made it clear in recent public presentations that they are on track to start a phase II registration trial, on their own (as in not an investigator-sponsored trial like this UCSF p2b trial), and on an accelerated approval framework, in Q2'17. They have also said they will announce a drug supply partnership for this trial with a "multinational" (they've said either MRK or BMY but it has to be MRK given their relationship so far) before the registration trial begins. A formal validation from MRK is much needed (like co-development exclusivity language in the deal PR) IMO, with or without an upfront payment. I expect the deal to be announced this quarter / early Q2.

By the way, the company has also said in recent presentations that they expect to announce collaborations within their newly established Technology Access Program (TAP) that uses their next generation TRACE device. They have reiterated a couple of times that these TAP deals will be announced shortly and will be "cash flow positive" and that the deals can be outside oncology as well.

Lots to look forward to in the near term IMO. I'm happy to have the opportunity to add one more lot at these prices.