Heat Biologics, Inc. (NASDAQ:HTBX) Files An 8-K Other Events
Item8.01. Other Events.
On March 21, 2017, Heat Biologics, Inc. (the Company) issued a
press release announcing the latest results of its ongoing Phase
2 clinical trial of HS-110 in combination with Bristol-Myers
Squibbs anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), for
the treatment of non-small cell lung cancer (NSCLC). Fifteen
patients have completed the HS-110/nivolumab combination
treatment to-date and 12 of these 15 patients were evaluable for
ELISPOT analysis. Researchers reported a strong correlation
between T cell activation, tumor reductions and increased overall
survival in these 12 patients. These data reinforce preliminary
results seen in the first eight patients as reported last
December at the International Association for the Study of Lung
Cancer Annual Meeting.
Key findings include:
Immune responses to HS-110 were observed in all 5 patients that
exhibited tumor reductions.
No tumor reductions were observed in patients that did not mount
an immune response to HS-110.
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, 5 patients have been enrolled in the low tumor
infiltrating lymphocytes (TIL) cohort (patients with cold
tumors). Three of these 5 patients (60%) have experienced
significant tumor reduction, which is higher than the 10%
response rate of low TIL patients reported for existing data on
nivolumab alone.
Researchers also reported that the safety profile continues
to be favorable in the HS-110/nivolumab combination, with no
evidence of additional toxicities seen as compared to existing
data on nivolumab alone.
A copy of the press release is attached as Exhibit 99.1 to
this Current Report on Form 8-K and is incorporated herein by
reference.
Teng et al, Cancer Research 75(11) June 1,
2015
Item 9.01. Financial Statements and
Exhibits.
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(d) |
Exhibits. |
The following exhibit is filed with this Current Report on
Form 8-K:
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Exhibit No. |
Description |
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99.1 |
Press Release of Heat Biologics, Inc. dated March 21, 2017 |
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About Heat Biologics, Inc. (NASDAQ:HTBX)
Heat Biologics, Inc. is a development-stage company focused on developing allogeneic, off-the-shelf cellular therapeutic vaccines to combat a range of cancers. The Company is an immuno-oncology company, which focuses on T cell-stimulating platform technologies, such as Immune Pan-Antigen Cytotoxic Therapy (ImPACT) and Combination Pan-Antigen Cytotoxic Therapy (ComPACT). Using its ImPACT platform technology, the Company has developed HS-410 (vesigenurtacel-L) as a product candidate to treat non-muscle invasive bladder cancer (NMIBC), and HS-110 (viagenpumatucel-L), which is intended for use in combination with an anti-PD-1 checkpoint inhibitor, as a potential treatment for patients with non-small cell lung cancer (NSCLC). Using its ComPACT platform technology, it has developed HS-120 as a potential treatment for NSCLC. It is conducting a Phase II trial of HS-410 in patients with NMIBC, and a Phase Ib trial of HS-110, in combination with nivolumab (Opdivo) to treat patients with NSCLC. Heat Biologics, Inc. (NASDAQ:HTBX) Recent Trading Information
Heat Biologics, Inc. (NASDAQ:HTBX) closed its last trading session up +0.050 at 0.930 with 487,192 shares trading hands.