Heat Biologics, Inc. (NASDAQ:HTBX) Files An 8-K Other EventsItem 8.01 Other Events.
On December 7, 2017, Heat Biologics, Inc. (the “Company”) issued a press release announcing that it received written responses from the U.S. Food and Drug Administration (FDA) following the Company’s Type C meeting regarding its planned registrational HS-110 clinical trial design for the treatment of non-small cell lung cancer (NSCLC).
The discussion focused on elements of proposed clinical trial designs, both single-arm and controlled, which the FDA agreed would be appropriate to support a registrational trial of HS-110. Clinical endpoints and post-marketing commitments were also discussed in the context of accelerated approval.
The press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 8.01Financial Statements and Exhibits.
The following exhibit is filed with this Current Report on Form 8-K:
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Exhibit Number |
Description |
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99.1 |
Press Release of Heat Biologics, Inc. dated December 7, 2017 |
HEAT BIOLOGICS, INC. ExhibitEX-99.1 2 htbx_ex99z1.htm PRESS RELEASE Press Release EXHIBIT 99.1 Heat Biologics Receives FDA Guidance at Type C Meeting for HS-110 Clinical Trial in the Treatment of Non-small Cell Lung Cancer DURHAM,…To view the full exhibit click here
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.
