Selexis SA and Pelican Therapeutics Sign Agreement to Advance Pelican’s Immunotherapy Clinical Programs

Selexis to Develop High-performance Research Cell Banks to Expedite the Manufacturing of Immunotherapy Clinical Candidates Designed to Target Cancers of High Unmet Need

Geneva, Switzerland, and Durham, NC, 4 October 2017 – Selexis SA and Pelican Therapeutics (“Pelican”), a subsidiary of Heat Biologics, Inc. (“Heat”) (Nasdaq: HTBX), announced that they have entered into a service agreement to advance the development of Pelican’s proprietary immunotherapy clinical candidates. Under the agreement, Pelican intends to leverage Selexis’ proprietary SUREtechnology PlatformTM to rapidly develop high-performance research cell banks (RCBs) expressing two of Pelican’s clinical candidates, including PTX-35, a humanized monoclonal antibody that is a functional agonist of human TNFRSF25, and PTX-15, a human TL1A-Ig fusion protein. Both candidates have the potential to improve clinical response when used in combination with Heat’s ImPACT® therapeutic platform and other immunotherapy drugs.

“With immunotherapies dominating the treatment landscape, we continually find that our technology can help our partners, such as Pelican, advance candidates for unmet medical needs including certain cancers,” said Yemi Onakunle, PhD, MBA, Selexis vice president, licensing and business development. “By combining our ability to rapidly produce high-expressing and stable research cell banks with KBI Biopharma’s strong development, production and analytical capabilities, we are able to reliably and predictably support Pelican’s clinical development and provide the fastest timelines to the eventual commercialization of both clinical candidates.”

In June 2017, JSR Corporation acquired Selexis SA to bring best-in-class cell line development technology to JSR Life Sciences, its life sciences division. JSR Life Sciences is now offering industry partners best-in-class contract development manufacturing organization (CDMO) services by complementing its commercial subsidiary KBI Biopharma with Selexis technologies.

Rahul Jasuja, CEO of Pelican, added: “We chose Selexis for their expertise in cell line expression technologies for recombinant protein therapeutics for the CMC development of our two molecules, PTX-35 and PTX-15. We look forward to advancing our TNFRSF25 agonist program with both KBI Biopharma and Selexis as we prepare for our first-in-human clinical trial.”

PTX-35, Pelican’s lead product candidate, is a novel monoclonal antibody against TNFRSF25, an emerging costimulatory receptor on T cells. The agent provides highly selective and potent stimulation of ‘memory’ CD8+ cytotoxic T cells, a class of T cell that is responsible for eliminating tumor cells in patients. PTX-35 has the potential to enhance durability of antigen-specific immune responses in combination with other immunotherapies.

Selexis’ proprietary SUREtechnology Platform facilitates the rapid, stable, and cost-effective production of virtually any recombinant protein and provides seamless integration of the biologics development continuum, spanning discovery to commercialization.

Selexis SA is a pioneering life sciences company and a global leader in mammalian (suspension-adapted CHO-K1) cell line generation, providing unparalleled proprietary technology and the highly-specialized expertise that is necessary to translate scientific innovation into life-saving medicines for patients. Selexis’ SUREtechnology Platform™ facilitates the rapid, stable, and cost-effective production of virtually any recombinant protein and provides seamless integration of the bioproduction continuum, spanning discovery to commercialization. With more than 100 partners worldwide, 80+ drug products in clinical development and three commercial products utilizing Selexis-generated cell lines, the Company has a history of empowering scientists and biopharmaceutical companies around the world to realize the full potential of their research. More information is available at www.selexis.com.

Pelican Therapeutics (“Pelican”), a subsidiary of Heat Biologics, is a biotechnology company focused on the development of monoclonal antibody and fusion protein-based therapies designed to activate the immune system. PTX-35 targets the T-cell co-stimulator, TNFRSF25, and is designed to harness the body's natural immune mechanisms to reprogram the immune system and provide a long-term, durable effect after a short course of therapy. When combined with immunotherapies, including Heat’s ImPACT® and ComPACT™ platform technologies, PTX-35 may have the ability to activate T-cells and eliminate tumor cells in patients. PTX-15, Pelican’s second product candidate, is a human TL1A-lg fusion protein designed to stimulate the proliferation of T-cell subsets. It is designed to be used in immuno-oncology and other disorders.

In June 2016, Pelican was awarded a $15.2 million Cancer Prevention Institute of Texas (CPRIT) grant to support further development of PTX-35 and fund a Phase 1 clinical trial to examine potential benefits to patients with several types of cancers, such as lung, lymphoma, prostate, pancreatic and ovarian.

Heat Biologics is a biopharmaceutical company developing immunotherapies to activate a patient’s immune system against cancer using CD8+ "Killer" T-cells. Our T-Cell Activation Platform (TCAP) produces therapies designed to turn "cold" tumors "hot," and be administered in combination with checkpoint inhibitor therapies and other immuno-modulators to increase effectiveness. We are currently enrolling patients in our Phase 2 clinical trial for non-small cell lung cancer, in combination with Bristol-Myers Squibb's nivolumab (Opdivo®). We also have numerous pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.

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