Heat Biologics Rockets as Lung Cancer Med Hits Mid-Stage Goals
March 21, 2017
By Alex Keown, BioSpace.com Breaking News Staff
DURHAM, N.C. – Shares of Heat Biologics are continuing to rise this morning following the company’s report of positive interim Phase II data from an experimental lung cancer treatment.
This morning the North Carolina-based company announced its experimental drug HS-110 in combination with Bristol-Myers Squibb ’s Opdivo, a checkpoint inhibitor, demonstrated tumor reductions and overall survival in 12 of 15 patients. The drug combination is being explored in the treatment of non-small cell lung cancer (NSCLC). In its announcement, Heat said researchers reported “a strong correlation between T cell activation, tumor reductions and increased overall survival” in those 12 patients. The interim data, the company said, reinforced preliminary results in the first eight patients initially reported on at the International Association for the Study of Lung Cancer annual meeting in December.
“Checkpoint inhibitors, such as nivolumab, are currently effective in treating approximately 10 percent of lung cancer patients with low TIL (tumor-infiltrating lymphocytes) and about 20 percent of patients overall in the 2nd line setting,” Jeff Hutchins, Heat’s chief scientific officer, said in a statement. “Our results appear to further validate the expected mechanism of action of our approach in combination with checkpoint inhibitors, with a continuing trend towards early and sustained T cell activation in the peripheral blood cells.”
Additionally, Hutchins said all patients who mounted a sustained immune response to HS-110 showed substantial tumor reductions. He said Heat researchers did not see those tumor reductions in patients who did not mount a response to the vaccine. If the assay results continue to match up with the clinical results, Hutchins said the combination of HS-110 and Opdivo “may become an attractive therapeutic approach for the approximately 80% of patients that do not respond well to nivolumab alone, particularly with the positive safety profile of this combination seen to-date.”
Key findings from the interim data show:
• Immune responses to HS-110 were observed in all five patients that exhibited tumor reductions.
• The timing of immune responses to HS-110 corresponded to the timing of observed clinical responses, and those responses appear to be sustained.
To-date, five patients have been enrolled in the low tumor infiltrating lymphocytes (TIL) cohort (patients with “cold” tumors). Three of these five patients (60 percent) have experienced significant tumor reduction, which is higher than the 10 percent response rate of low TIL patients reported for existing data on nivolumab (Opdivo) alone.
HS-110 utilizes modified lung cancer cells to stimulate an immune system response to activate T cell responses against antigens known to be expressed by a high proportion of patients with NSCLC, the company said. In addition to evaluating HS-110 in combination with Opdivo, Heat is also studying the drug with the chemotherapy drug, cyclophosphamide.
The news is certainly promising for Heat, which this time last year was forced to slash 22 percent of its workforce as part of a cost-savings program that allowed the company to use its resources on the development of HS-110 and HS-410. HS-410 is being developed for the treatment of non-muscle invasive bladder cancer. HS-410 is designed to generate CD8+ “killer” T cells that attack cancer cells.