SEVEN POINT FOR NEWBIES.
1. We can expect results from two first generation ImPACT HS-110 NSCLC trials this fall. We should see the final Phase II results from the HS-110 plus low dose cyclophosphamide trial. We can also expect interim results from the open label Phase II HS-110 plus Opdivo NSCLC trial. We may hear top-line results at any time-but I would expect more detailed scientific data to be presented at the World Conference on Lung Cancer October 16-18 and at the Society for Immunotherapy of Cancer meeting November 8-12. Potential partners will be interested as phase II is frequently a "sweet spot" for partnering.
2. The second generation ComPACT technology(HS-110 plus OX40)has produced very impressive pre-clinical trial results. It is ready to enter the clinic in NSCLC and "several other" cancers. I expect this will happen with a partner.
3. Although the company is no longer pursuing the HS-410 bladder cancer program- the patients are still being monitored. So far interim analysis indicate that the 2 year results will show a very significant benefit over the BCG SOC. This indication could also be partnered in the future as the solo BCG treatment benefit drops off dramatically in years two and three.
4. The acquisition of an 80% interest in Pelican brought in over $15 million in grants. This will fund a 70 patient Phase I trial to see how PTX-25 might benefit lung, lymphoma, prostate, pancreatic, and ovarian cancers. We should expect more news from Pelican this fall.
5. The creation of the 100% Zolovax subsidiary was followed by the award of a $1 million grant to develop a Zika vaccine. Preclinical animal data can be expected soon. Other infectious diseases of interest include HIV, West Nile virus, Dengue and yellow fever. I would expect that any successful vaccines will be developed through further grants and partnerships.
6. Japanese pharma giant Takeda's recent collaboration with Heat's spin-off Shattuck Labs was signalled several months earlier when Shattuck announced that an "international pharma" had taken a substantial position in a cash raise. At that time Heat's CEO said that since Shattucks' technology was licenced from heat, Heat would benefit in the future from milestone and royalty payments. In addition to those benefits it is clear that Takeda would have done their due diligence on Heat! When the two ImPACT trial results are released this fall-Takeda along with half a dozen checkpoint inhibitor pharmas will be interested IMO.
7. The recent announcement of a Type C meeting with the FDA to seek quidance for the registration pathway for the HS-110 plus Opdivo combination is very significant. I believe that potential partners will be very interested in the outcome!
"The refusal of the real is the number one dogma of our time" Rene Girard
