In coming weeks we will receive 4 sets of data.
We will receive top-line data from the two arms of a bladder cancer trial. One arm will be monotherapy HS-410. The other arm will be a combination of HS-410 with BCG - the current SOC. Two questions may be answered. Is HS-410 as effective as BCG as a monotherapy? Does the combination of HS-410 with BCG enhance efficacy? A question will remain about how HS-410 might work in combination with some of the new anti-PD-1 inhibitors which recently have had some success in bladder cancer.
Fortunately Heat's vaccine HS-110 for the NSCLC indication will also report in Q4. This may reveal how useful Heat's family of vaccines will be when combined with the growing number of anti-PD-1 drugs entering the market. Heat's first generation NSCLC drug HS-110 had impressive results as a monotherapy in a small phase 1 trial as a third and fourth line treatment. The median 1 year overall survival rate was 44% compared to historical rates ranging from 5% to 18%. This 44% rate is very similar to Opdivo's 41% median 1 year survival rate in third and fourth line cancer patients. In Q4 we will see the results of the combination of HS-110 with an anti-PD-1 in the first 8 patients of a phase 1b/2 trial.
It is also planned to release data from a phase 2 trial combining HS-110 with low dose cyclophosphamide in Q4. Cyclophosphamide in high doses has safety issues, but in low dose it is safe and has been shown to enhance immune response. Good results in this phase 2 trial would have huge implications. Anti-PD-1 checkpoint inhibitors are extremely expensive. If HS-110 combined with low cost, low dose cyclophosphamide are an effective combination, it would open up a very large world-wide market. Most cancer patients in most parts of the world cannot afford the high priced anti-PD-1's. Heat's allogenic ,off-the-shelf vaccines are much cheaper than autologous therapies with a COGS less than 5% of those treatments and much cheaper than the anti-PD-1's.
HS-110 combined with low dose cyclophosphamide for NSCLC and HS-410 for bladder cancer are completing phase 2. The CSO has stated that the company is "ramping up" for phase 3. Most frequently small biotechs partner for phase 3!
What is next? In the past the company has mentioned HS-310 for ovarian cancer, HS-210 for pancreatic cancer, and HS-510 for triple negative breast cancer. Obviously there are many more indications and many more combinations to come! And clearly the ImPACT technology will soon be complemented by the ComPACT technology. CEO Wolf has said that the company intend to bring the ComPACT technology into the clinic "as soon as possible".
Heat has a very exciting platform technology which will soon lead to partnering or a buyout IMO.
"The refusal of the real is the number one dogma of our time" Rene Girard
