Heat Biologics, Inc. (NASDAQ:HTBX) Files An 8-K Other Events
Item8.01. Other Events.
On March 13, 2017, Heat Biologics, Inc. (the Company) issued a
press release announcing that the Company achieved the efficacy
endpoint for its Phase 1b trial evaluating 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) and that the trial met the expansion criteria to
advance into a Phase 2. In reviewing the Phase 1b data, the Data
Monitoring Committee (the DMC) determined that the Phase 1b
safety endpoint was met and that there do not appear to be
additional toxicities seen in the HS-110/nivolumab combination
compared to existing data on nivolumab alone. Furthermore, 5 out
of 15 patients treated with the HS-110/nivolumab combination had
20% or greater tumor reduction. Patients with increased levels of
tumor infiltrating lymphocytes (TIL) at 10 weeks appeared to have
a durable benefit, with six out of eight of these patients (75%)
alive at the one-year follow-up point. The DMC concluded that the
positive safety profile, mechanistic evidence and encouraging
signs of synergistic efficacy warranted expansion to a Phase 2
trial.
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.
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 13, 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 down -0.018 at 0.900 with 269,358 shares trading hands.