Heat Biologics, Inc. (NASDAQ:HTBX) Files An 8-K Other Events

Heat Biologics, Inc. (NASDAQ:HTBX) Files An 8-K Other Events
Item 8.01   Other Information

On June 8, 2020, Heat Biologics, Inc. (the “Company”) issued a press release announcing that the U.S. Food & Drug Administration has cleared the Investigational New Drug (IND) application for PTX-35, a monoclonal antibody developed by Heat’s Pelican Therapeutics, Inc. subsidiary (“Pelican”)  and that Pelican has near-term plans to initiate its Phase 1 clinical trial in patients with solid tumors.

The information in the press release shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended.

Item 9.01   Financial Statements and Exhibits.

(d) Exhibits.

The following exhibit is furnished with this Current Report on Form 8-K.


EX-99.1 2 htbx_ex99z1.htm PRESS RELEASE Press Release   EXHIBIT 99.1 Heat Biologics Announces FDA Clearance of Investigational New Drug (IND) Application for PTX-35 PTX-35 represents a potential first-in-class agonistic antibody of TNFRSF25 Durham,…
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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.

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