- Significant Clinical Progress Anticipated with Two Lead Immunotherapy Programs -
- Company also Expects to Announce New Product Development Initiatives Based on ImPACT Technology Platform -
DURHAM, N.C., Feb. 2, 2015 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”)(Nasdaq:HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today outlined its 2015 corporate objectives and reviewed the Company’s 2014 accomplishments.
2015 Corporate Objectives
Product Development
Phase 2 placebo-controlled clinical trial of Vesigenurtacel-L (HS-410) in non-muscle invasive bladder cancer
- Present further immune response data from the Phase 1 portion of HS-410 clinical trial in the second quarter
- Complete enrollment in the Phase 2 portion of this study during the second half of 2015
Phase 2 randomized controlled clinical trial of Viagenpumatucel-L (HS-110) in Non-Small Cell Lung Cancer (NSCLC)
- Report on two exploratory interim analyses for immune response in the ongoing Phase 2 clinical trial of HS-110 compared to physician’s choice
- First interim analysis expected to occur during the second quarter, while the second is anticipated in the fourth quarter
- Complete enrollment to Phase 2 study in the second half of 2015
- Initiate a master multi-arm protocol evaluating HS-110 for NSCLC patients in combination with other immunotherapies in the first half of 2015
ImPACT Technology Platform
- Present expanded combination immunotherapy data at various scientific and clinical conferences, such as the Keystone Symposia, the American Association of Cancer Research (AACR) and others
- Data to help inform Heat’s strategy for potential future combination clinical strategies
- Announce novel strategy for combination immunotherapy products that incorporate both T-cell co-stimulatory and checkpoint inhibitory compositions
Business and Operations
- Continue engaging in discussions with large pharmaceutical and biotechnology companies to identify potential partners for our technology and product candidates
- Continue to expand our significant intellectual property portfolio
“We expect 2015 to be a critical year for Heat Biologics in a number of ways,” said Jeff Wolf, Heat’s Chief Executive Officer. “We are looking forward to the immune response results from our Phase 2 clinical trials for non-small cell lung and non-muscle invasive bladder cancers. The recently released immune response data from the Phase 1 trial of HS-410 in bladder cancer is exciting and supports the mechanism of Heat’s ImPACT platform to generate substantial immune response. We intend to continue expanding our ImPACT technology platform and expect to announce additional product development initiatives and partnering opportunities in 2015.”
2014 Achievements
Product Development
Vesigenurtacel-L (HS-410) in non-muscle invasive bladder cancer
- Initiated a Phase 1/2 clinical trial in patients with non-muscle invasive bladder cancer
- Completed enrollment in the Phase 1 portion of the study
- Initiated Phase 2 placebo-controlled trial with a modified design three months sooner than planned
- In addition to the immune response data already reported, there have been no treatment-related serious adverse events to date and the therapy has shown to be well-tolerated
Viagenpumatucel-L (HS-110) in Non-Small Cell Lung Cancer (NSCLC)
- Initiated a revised Phase 2 clinical protocol of HS-110 in combination with low-dose metronomic cyclophosphamide compared to physician’s choice in NSCLC
- Redesigned trial better reflects the changing immunotherapy landscape and takes advantage of combination strategies that are expected to produce greater efficacy
ImPACT Technology Platform
- Presented combination immunotherapy data (ImPACT plus anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-LAG-3, anti-OX40, anti-4-1BB or anti-GITR antibodies) at the Keystone, AACR and American Association of Immunologists (AAI) conferences to enable the data-driven selection of combination regimens for clinical development
Business and Operations
- Relocated and expanded research team and opened state-of-the-art research facility in Research Triangle Park, NC to help support Heat’s R&D efforts
- Expanded product development team and established a clinical advisory board comprised of five distinguished individuals with extensive immunotherapy and oncology drug development experience to help Company efficiently execute its clinical development programs
- Established an Australian subsidiary to facilitate cost-effective and timely recruitment to international, randomized clinical trials
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 is conducting a Phase 2 trial of its viagenpumatucel-L (HS-110) in patients with non-small cell lung cancer as well as a Phase 2 trial with its vesigenurtacel-L (HS-410) in patients with non-muscle invasive 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 potential for impact of Heat’s ImPACT Therapy, the expected timing of the interim analysis, the continued expansion of Heat’s technology platform and the expected additional product development initiatives and partnership opportunities. 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, the ability of Heat to meet each of its anticipated objectives and to do so on a timely basis 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: Jeff Wolf Chief Executive Officer (919) 240-7133 investorrelations@heatbio.com Investor Relations Michael Wood LifeSci Advisors LLC (646) 597-6983 mwood@lifesciadvisors.com
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