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Soligenix acquires novel innate defense regulator clinical program

Tuesday, December 18, 2012

Soligenix, a Princeton, N.J.-based development stage biopharmaceutical company, has acquired a novel drug technology, known as SGX94, representing a unique approach to modulation of the innate immune system. 

SGX94 is an innate defense regulator (IDR) that regulates the innate immune system to reduce inflammation, eliminate infection and enhance tissue healing by binding to the pivotal regulatory protein p62, also known as sequestosome-1. As part of the acquisition, Soligenix acquired all rights, including composition of matter patents, preclinical and phase I clinical study datasets for SGX94, which is poised to enter phase II clinical testing in humans and is highly synergistic with the company’s existing development pipeline.

Due to its novel mechanism acting on the regulatory molecule p62, SGX94 is simultaneously anti-inflammatory and anti-infective. SGX94 is active in a wide range of disease models including life-threatening bacterial infections as well as the severe side-effects of chemo- and/or radiation-therapy. Moreover, since SGX94 targets the host and not the bacteria, it evades antibiotic resistance mechanisms and has potential as both an alternative and/or an adjunct to antibiotic therapy. SGX94 has demonstrated safety in a phase I clinical study in healthy human volunteers and is the subject of an open Investigational New Drug (IND) application which has been cleared by the FDA.

SGX94 is being developed pursuant to discoveries made by B. Brett Finlay and Robert Hancock, professors at the University of British Columbia in Canada with approximately $40 million having been put towards its development to date, inclusive of government grants.

In addition to SGX94, the acquired technology package includes other analogs and crystal structures of SGX94 with its protein target p62, opening the possibility for a pipeline of additional products to be developed. Soligenix intends to continue development of SGX94 in both of its key business segments, namely, cancer supportive care applications, such as oral mucositis under its biotherapeutics business segment, and infectious disease applications such as melioidosis under its vaccines/biodefense business segment.

“We are very excited by the acquisition of this cutting edge science which represents a new paradigm for the treatment of tissue injury and infection,” said Christopher J Schaber, PhD, president and CEO of Soligenix. “With SGX94 we will be able to leverage our experience in clinical development of cancer supportive care and biodefense products. We also anticipate the potential for a number of grant funding opportunities for SGX94 across both segments of our business.”

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