Heat Biologics, Inc. (NASDAQ:HTBX) reported that it is has managed the safety and efficacy endpoint in the Phase 1b trial. It has achieved to get the approval to proceed to Phase 2.
The experiment details
The company is leading in development of immunotherapies which are meant to activate the immune systems of patients against cancer. It reported its achievement in Phase 1b which was an evaluation of different drugs’ tolerability and safety combinations meant for non-small cell lung cancer (NSCLC) treatment. The process was a success and the required safety level was achieved. In the analysis, 5 in 15 patients used in the experiment which is about 33%, experienced a 20% tumor size reduction. The Data Monitoring Committee thus gave the go ahead for the expansion to Phase 2 experiments.
Good news after a setback
The updates comes as a good thing to Heat Biologists shareholders. The HS-110 drug, one of the drugs used in the combinations had undergone a terrible setback in late 2016. This occurred after it was unable to conquer a placebo during a Phase 2 research proceedings. The drug is also being evaluated in a combination with cyclophosphamide in another early stage of NSCLC experiment. Non small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) are the two types of lung cancers with NSCLC being the most common, it develops and spreads less faster than SCLC.
Positive effects translated to share prices
The positive news were reflected on the share prices of the company. The prices hiked by 35% by Monday March, 13th morning to $1.25 per unit of stock. By the afternoon the same day, the shares were up 13% at $1.01.
Comments from the company
The company stated that it was pleased with the results in Phase1. It was encouraging to see the drugs being well tolerated and this warranted a larger sample size which will be able to proof in detail the trend identified in Phase 1. Phase one used a small sample size but the fact that positive changes were identified, it is encouraging enough. The company promises to remain focused on having new patients enroll for improved objective response rate, lifespan of the response as well as associated immune activity.