Soligenix, Inc. a late-stage biopharmaceutical company announced that it has entered into a definitive license agreement with the University of Colorado (CU) for novel technology for use in the development of subunit vaccines with long-term stability, including stability at elevated temperatures. The technology is the subject of several United States and foreign patent applications that address the use of adjuvants in conjunction with vaccines that are formulated to resist thermal inactivation.

Soligenix has been developing this stabilization technology under an option-to-license agreement from CU that was initiated to support the technology development efforts funded by a $9.4 million grant from the National Institute of Allergy and Infectious Diseases (NIAID). The license agreement has an expanded scope for thermostable vaccines for bio-defence as well as all potential vaccine indications.

The novel technology involves the use of several unique process and formulation steps that fix sensitive vaccine ingredients in native configuration. For bio-defence indications, the company is using the stabilization technology to advance RiVax, its subunit vaccine against ricin toxin, as well a subunit vaccine for anthrax prevention. The underlying technology has been developed by Drs Amber Clausi, John Carpenter and Theodore Randolph at CU-Boulder. The terms of the license were not disclosed.

“Vaccines are a valuable part of our healthcare arsenal, providing great benefit per dollar spent,” says Theodore Randolph, PhD, Professor of Chemical and Biological Engineering at CU-Boulder. “Most current vaccines, however, require carefully controlled cold storage conditions to retain their potency and safety. This adds cost and greatly complicates strategies for their use, especially in public health emergencies or in developing countries. We are pleased that Soligenix has licensed our technology, which offers the potential to create vaccine formulations whose enhanced thermostability allows them to be stockpiled and delivered to patients with much less stringent temperature control requirements.”

“The achievement of extended stability as well as stability under elevated temperature would represent a significant step forward in vaccine technology. These properties are not shared with conventional vaccines that require refrigeration,” stated Robert N. Brey, PhD, Chief Scientific Officer of Soligenix. “Lack of long-term stability is a significant problem in vaccines for use in emergency situations and especially for vaccines used in the developing world where the cold storage chain is difficult to maintain.  Further, this novel thermostability technology has the potential to allow us to expand our vaccine business into the development of countermeasures against other more common infectious diseases.”

Soligenix, Inc. is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. Its Biodefense Division is developing biomedical countermeasures pursuant to the Project BioShield Act of 2004.