Soligenix acquires immune-regulating drug technology

Development-stage biopharmaceutical company Soligenix(OTCQB:SNGX) has acquired SGX94 - a drug technology that regulates the immune system. 

The innate defense regulator (IDR) regulates the immune system to reduce inflammation, eliminate infection, and improve tissue healing by binding to the regulatory protein p62. 

Soligenix is planning to develop the drug technology in both of its key units, namely cancer supportive care in its biotherapeutics segment, and infectious diseases under its vaccines/biodefense division. 

The company has acquired all rights to the technology as part of the deal, including composition of matter patents, and preclinical and phase 1 clinical study data. 

SGX94, which Soligenix says is "highly synergistic" with its existing development pipeline, is poised to enter phase 2 clinical testing in humans. 

The company said the drug 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.  

Soligenix also noted that since SGX94 targets the host, and not the bacteria, it evades antibiotic resistance mechanisms, and has the potential as both an alternative and an adjunct to antibiotic therapy.  

The drug has proven safe in a phase 1 clinical study in healthy humans, Soligenix said, and is the subject of an open investigational new drug (IND) application by the U.S. FDA. 

Around $40 million has been spent on its development so far, including government grants. 

The acquired technology package by Soligenix also includes other analogs and crystal structures of SGX94, lending potential for a pipeline of additional products to be developed. 

"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 president and CEO of Soligenix, Christopher J Schaber. 

"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."

In early November, the company's shares surged as it announced that its program for SGX203, or the oral form of  beclomethasone 17,21-dipropionate (BDP) as a treatment for mild-to-moderate pediatric Crohn's disease, received fast track designation from the US FDA.

In September, the company received a green light from the US FDA to start a clinical program for the drug. The clearance allows it to start a phase 1/2 study of the drug in healthy adolescents and young adults. 

Soligenix is developing proprietary formulations of oral BDP for the prevention and treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec).

Meanwhile, through its biodefense division, the company is developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.