Soligenix inks collaboration for lead drug candidate with SciClone Pharma that is expected to enrich clinical trials

Soligenix (OTCQB:SNGX) has signed another collaboration agreement as the company works on developing its promising drug pipeline, this time inking a deal with SciClone Pharmaceuticals for its lead candidate SGX942. 

The news comes just weeks after it signed a collaboration deal with Intrexon - a company backed by pharmaceutical billionaire entrepreneur R.J. Kirk - for Soligenix's Melioidosis drug. 

The company, which is focused on developing products to treat inflammatory diseases and biodefense countermeasures, will develop its SGX942 candidate for oral mucositis with SciClone, thereby receving access to SciClone's clinical and regulatory data library in exchange for commercialization rights in China. 

Detailed deal terms were not disclosed in Monday's statement. 

The drug, an innate defense regulator, is being developed to treat oral mucositis in solid tumor patients, especially those with head and neck cancer. The disease is often a complication of cancer therapy such as radiation or chemo, and has no current approved drug therapy. According to Soligenix's statement, it is estimated that the condition affects around 90,000 head and neck cancer patients per year in the U.S. 

The candidate recently received investigational new drug clearance from the U.S. FDA, with a phase II clinical trial set to start by the end of the year. 

The deal to develop the treatment brings quite an advantage to Soligenix, as SciClone completed two phase II clinical studies in 2010 and 2012 on drug SCV-07, which was also targeted for the treatment of oral mucositis in head and neck cancer patients, before deciding to terminate the program. 

"As this is the same population that Soligenix is pursuing for its OM program, this information has the potential to increase the probability of success of its upcoming Phase 2 clinical study," according to Soligenix's statement released today. 

The company specifically cited the ability to analyze data available from the placebo subjects in the SciClone trials, acquiring insight into the disease progression, along with a better understanding of incidence and severity in this patient population. This could ultimately lead to a more optimized Soligenix trial. 

In addition, blood samples from these subjects could also be used to potentially identify key biomarkers that could lead to the development of a prognostic tool capable of predicting patients expected to develop a severe level of the disease, Soligenix said. 

"This collaboration is unique in that it is the first time that a personalized medicine approach has been comprehensively integrated with an oral mucositis development program," said Soligenix's president and CEO Christopher J. Schaber, in the statement Monday.

"The extension of these biomarker approaches in the SGX942 clinical trials also has the potential to form the basis of a predictive enrichment tool and companion diagnostic to identify patients more likely to respond to SGX942 treatment, thereby increasing the likelihood of program success. 

"The concept of personalized medicine is the understanding that people differ in their genetic makeup, their environment and their lifestyle and that these differences are critical factors in the severity and type of disease and how individuals respond to therapies," he said, also referring back to a 2010 keynote speech from US FDA commissioner Margaret Hamburg, who called personalized medicine one of the most important themes for healthcare of the future. 

The approach to optimize clinical trials could result in smaller studies, shortened drug development times and lower development costs. 

Indeed, Schaber said the deal with SciClone is an ideal match, given the company's "significant commercial presence" in China, and its clinical and regulatory contribution to the Soligenix program, which no doubt has the potential to speed up the development timeline. 

The drug is a new class of short, synthetic peptides that work through anti-inflammatory and anti-infective activity. About $40 million has been used to develop SGX942 to date, including government grants. 

Soligenix's other main platforms include SGX203 -- one of its main product candidates and a potential treatment for pediatric Crohn's disease -- and the ThermoVax vaccine thermostabilization technology in its biodefense unit. 

The company's potential has not escaped investors. Its stock has risen more than 88 per cent year-to-date, to close at $1.13 on Friday.