RESEARCH TRIANGLE PARK – Heat Biologics has hit upon a new name that it says is a better reflection of its recent growth and evolution as a company.

The Morrisville-based clinical stage biopharmaceutical business will become NightHawk Biosciences (NYSE American: NHWK)  May 3. It specializes in disease-fighting therapies that activate patients’ immune systems against cancer and other diseases, and in biodefense biopharmaceuticals.  NightHawk said it will focus on fast and efficient drug development through its various businesses. They include SkunkWorx Bio, Pelican Therapeutics, Scorpion Biological Services, Elusys Therapeutics, and Heat Biologics – which will be a fifth subsidiary.

The company had just announced that it is working with Scorpion – its San Antonio, Texas-based contract research, development and manufacturing organization – to build a new biodefense-focused large molecule and biologics manufacturing facility in Manhattan, Kansas. The primary goal of biodefense is to counter biological threats that could be introduced as a form of bioterrorism.

NightHawk logo

The $650 million project will create 500 jobs over the next seven years.

Elusys – acquired by Heat in December 2021 – is the developer of Anthim, a monoclonal antibody that neutralizes the anthrax toxin. The therapy is approved in the United States, Canada, Europe and the United Kingdom to treat inhalation anthrax.

Heat recently finalized a $50 million contract with the Department of Health and Human Services for the product, which will be stockpiled in case of a potential anthrax attack. Elusys – located in Parsippany, New Jersey – has been awarded more than $350 million in research and development contracts and procurement orders from various federal agencies.

Heat also has unveiled another cellular vaccine platform, RapidVax, that targets emerging biological threats by providing a quick response to a wide variety of infectious agents.

SkunkWorx Bio – in North Brunswick, NJ – is a discovery subsidiary that works across a number of infectious disease, biodefense and oncology-related indications.

Pelican Therapeutics, also based in San Antonio, is nearing final enrollment in a Phase 1 solid tumor trial of its lead product, PTX-35. It is a humanized monoclonal antibody designed to harness the body’s natural antigen-specific immune activation mechanisms to help eliminate cancer tumor cells.

“Over the past 18 months, we’ve built a powerful drug discovery engine in our SkunkWorx subsidiary,” said Heat/NightHawk CEO Jeff Wolf. “We’ve been building our Scorpion subsidiary to deliver world-class biomanufacturing. And we announced the acquisition of Elusys Therapeutics, a biodefense company, which we intend to grow into a biodefense powerhouse.”

Heat – soon to become NightHawk – is a 2008 University of Miami spinout. The North Carolina Biotechnology Center was instrumental in encouraging Wolf to relocate the fledgling company to the state in 2011, and in supporting it when it arrived.

NCBiotech provided Heat’s initial source of funding in 2011 – a $225,000 Strategic Growth Loan – and also made temporary office space available in the Center’s Landing Pad. It granted a $3,000 industrial intern award in 2012 to support the company’s initial public offering of stock.

Wolf set up shop in Durham in 2013 as Heat Biologics began to grow. The company moved to its current Morrisville location six years later – in 2019 –  where it focuses on drug development, from discovery through manufacturing. Last year Heat announced that it was doubling the size of its R&D facilities in Morrisville to approximately 15,000 square feet to better support its business.

“The pandemic highlighted the fact that the development of new drugs is tremendously slow, encumbered and expensive,” Wolf said. “These are enormous barriers to American progress. We believe the solution is full integration of discovery, preclinical testing and manufacturing, optimized to quickly and efficiently deliver drugs to the people who need them. We are excited to continue to build and enhance this ecosystem under the NightHawk banner.”

(C) N.C. Biotech Center