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Heat Biologics Amends Bladder Cancer Protocol For Early Advancement Into Phase 2 Clinical Studies



8/4/2014 8:19:56 AM

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- Amended Design Expedites Phase 1/2 Trial of Heat's Immuno-Therapy Bladder Cancer Product Candidate –

- Provides Accelerated Timeline to Phase 2 Results -

DURHAM, N.C., Aug. 4, 2014 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. ("Heat Biologics", "Heat" or the "Company") (Nasdaq:HTBX), a clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapies, announced today that it has amended the Phase 1/2 clinical protocol for Vesigenurtacel-L (HS-410) in patients with high-risk non-muscle invasive bladder cancer after transurethral resection of bladder tumor (TURBT). The modified treatment regimen facilitates a more robust dose-response analysis and will permit Heat to advance directly into Phase 2 trials following enrollment of a single cohort of Phase 1 data rather than the two cohorts required by the original trial design. Heat expects to complete enrollment of the Phase 1 portion of the study in the third quarter of 2014 and anticipates the Phase 2 study will commence in the fourth quarter of 2014, one quarter earlier than initially expected.

The original Phase 1/2 bladder cancer trial protocol called for evaluation of two doses of monotherapy Vesigenurtacel-L after induction bacillus Calmette Guérin (BCG) to assess initial safety and determine the best dose to advance to Phase 2. The amended protocol changes the treatment regimen from monotherapy Vesigenurtacel-L following BCG to combination with BCG based on proposed synergy with the combination. This new regimen will start treatment with Vesigenurtacel-L earlier in the disease process and enable concurrent administration of BCG and HS-410 throughout the adjuvant therapy period. Furthermore, the revision advances both doses into Phase 2 to correlate the dose with recurrence rate.

Heat's management team worked closely in consultation with its Clinical Advisory Board to develop this combination study with a clinically more meaningful and efficient design. The protocol revision is expected to allow for expedited advancement into Phase 2 and is accompanied by robust safety evaluation during the Phase 2 study. In the first seven patients treated to date, there have been no reported serious adverse events.

Gary Steinberg, M.D., the Lead Principal Investigator for the trial and The Bruce and Beth White Family Professor and Director of Urologic Oncology at the University of Chicago Medical Center, commented, "To date, the positive safety data for Heat's immuno-oncology treatment is promising. There is a clear rationale for patients to receive treatment with Vesigenurtacel-L earlier in the disease process and we believe the amended regimen to start treatment closer to TURBT will better optimize patient outcomes. We are very interested in advancing into Phase 2 studies so we can begin to assess the response to Vesigenurtacel-L in high-risk patients in desperate need of viable treatment options for non-muscle invasive bladder cancer."

Melissa Price, Ph.D., Heat's Vice President of Clinical and Regulatory Affairs, commented, "We are very pleased to be moving forward with this revised protocol. After careful consideration for safety, it was important for us to provide combination therapy at an earlier stage of disease progression with the optimal standard of care. We strongly believe that the redesign of the Phase 2 portion of our Vesigenurtacel-L study will produce more meaningful safety and efficacy results."

The primary endpoint for the Phase 2 bladder study is one-year recurrence-free survival. The Company expects to complete patient enrollment and dosing in the third quarter of 2015. Following a twelve-month observation period of all patients in the trial, Heat expects to report top-line results in the third quarter of 2016.

For patients and physicians interested in enrollment information for the Phase 1/2 study of Vesigenurtacel-L in patients with high-risk non-muscle invasive bladder cancer, please visit clinicaltrials.gov and use Identifier NCT02010203.

About Bladder Cancer

According to the American Cancer Society, in 2014, there will be 74,690 new bladder cancer diagnoses and 15,580 deaths from the disease in the U.S. alone. More than 500,000 people in the U.S. have been treated for bladder cancer. Importantly, the U.S. Food and Drug Administration (FDA) has not approved any new drugs to treat bladder cancer in more than 25 years. Heat's Vesigenurtacel-L (HS-410) represents a viable opportunity to address a significant unmet medical need.

About Vesigenurtacel-L ( HS-410 )

Vesigenurtacel-L (HS-410) is an investigational biologic originating from Heat's proprietary Immune Pan Antigen Cytotoxic Therapy (ImPACT) based allogeneic cell lines designed to activate a T-cell mediated pan-antigen immune response for the treatment of bladder cancer. ImPACT Therapy reprograms live cancer cells from a single tumor source to continually secrete gp96, a chaperone protein found in all human cells. In turn, gp96 chaperones tumor antigens to T-cells to activate a robust, pan-antigen T-cell immune response and direct killer T-cells to attack the patient's cancer.

About the Vesigenurtacel-L ( HS-410 ) Phase 1/2 Study

The multi-center Phase 1/2 study will enroll approximately 84 patients with non-muscle invasive bladder cancer and is designed to determine whether vaccination with Vesigenurtacel-L after transurethral resection of bladder tumor (TURBT) extends the time to disease recurrence compared to placebo. The trial will also test the safety and immune response of Vesigenurtacel-L in bladder cancer patients.

About Heat Biologics, Inc.

Heat Biologics, Inc. (www.heatbio.com) is a clinical-stage biopharmaceutical company focused on developing its novel, "off-the-shelf" ImPACT therapeutic vaccines to combat a wide range of cancers. Our ImPACT Therapy is designed to deliver live, genetically-modified, irradiated human cells which are reprogrammed to "pump out" a broad spectrum of cancer-associated antigens together with a potent immune adjuvant called "gp96" to educate and activate a cancer patient's immune system to recognize and kill cancerous cells. Heat's Viagenpumatucel-L (HS-110) will be entering Phase 2 trials against non-small cell lung cancer and its Vesigenurtacel-L (HS-410) is being evaluated in an ongoing Phase 1/2 clinical trial against bladder cancer.

Forward Looking Statements

This press release includes forward-looking statements on our current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and include statements regarding the anticipated results of the redesigned study, the expected enrollment date for the Phase 1 study, expected commencement and completion date of the Phase 2 study, the date of release of top-line results and the potential for Heat's ImPACT Therapy. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability for Heat's ImPACT Therapy to perform as designed and ability to enroll patients as planned and the other factors described in our annual report on Form 10-K for the year ended December 31, 2013 and our other filings with the SEC. The information in this release is provided only as of the date of this release, and we undertake no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.

CONTACT: Heat Biologics, Inc. Contact Information: Matthew Czajkowski Chief Financial Officer (919) 240 7133 matt@heatbio.com Jenene Thomas Investor Relations and Corporate Communications Advisor Jenene Thomas Communications, LLC (908) 938-1475 investorrelations@heatbio.com

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