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

On March 26, 2018, Heat Biologics, Inc. (the “Company”) issued a press release reporting 2 year recurrence rate data from the Phase 2 trial evaluating HS-410 (vesigenurtacel-L) in combination with standard of care, Bacillus Calmette-Guérin (BCG), for the treatment of non-muscle invasive bladder cancer. As previously announced, the Company discontinued its HS-410 program in order to focus its resources on current and future checkpoint combination trials, including its HS-110 Phase 2 lung cancer program in combination with Bristol-Myers Squibb’s checkpoint inhibitor nivolumab. However, in keeping with clinical trial guidance, the Company continued to monitor all patients enrolled in the study for a 2-year duration.

Within the subgroup of patients who received the low dose of the Company’s ImPACT HS-410 with standard of care BCG and who demonstrated a positive immune response, 10 out of 10 (50%) remained disease free after a 2-year period. A positive immune response was defined as 2-fold or greater increase from baseline of CD8+ T cells in peripheral blood as measured by ELISPOT analysis.

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:

HEAT BIOLOGICS, INC. Exhibit
EX-99.1 2 htbx_ex99z1.htm PRESS RELEASE Press Release   EXHIBIT 99.1 Heat Biologics Reports Positive Data to Further Support the Mechanism of Action for its Proprietary T-Cell Activation Platform 100% of non-muscle invasive bladder cancer patients who generated an immune response to low dose HS-410 and also received standard of care BCG remain disease free after 2 years 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.