Soligenix’s deep development pipeline nears multiple key inflection points

December 2, 2015 ctheodoropulos

Soligenix has grown into a late-stage biopharmaceutical company, with therapeutic and vaccine programs for orphan indications and unmet medical needs in the areas of inflammation, oncology and biodefense.

In-licensing from smaller private companies and academia is a key strategy in its growth. “We look for assets that are later stage with some clinical data behind them,” said Christopher J. Schaber, PhD, President and CEO. “Ideally, the programs will have progressed past clinical proof-of-concept (POC) and will be poised for Phase II/III registration trials.” Two of Soligenix’s current lead product candidates were acquired through in-licensing.

Christopher J. Schaber, President and CEO, Soligenix

Christopher J. Schaber, President and CEO, Soligenix

BioTherapeutic value drivers

In the biotherapeutics pipeline, the company is approaching multiple inflection points. “The two Phase III programs we are beginning will support registration, if successful,” Dr. Schaber said.

Patient recruitment is set to begin shortly for a pivotal Phase III trial with SGX301 in cutaneous T-cell lymphoma (CTCL). “SGX301, synthetic hypericin, is a topical drug applied to the malignant lesions on the skin and activated with safe, visible fluorescent light. “Top-line results are expected for this first-in-class photodynamic therapy the second half of 2016,” Schaber said. In addition to the orphan drug and fast track designations granted by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) also has granted orphan status for SGX301 for the treatment of CTCL.

SGX203, a proprietary formulation of oral beclomethasone 17,21-dipropionate (BDP), is being developed for the treatment of pediatric Crohn’s disease and other severe inflammatory disorders of the gastrointestinal (GI) tract. Contingent on funding, a pivotal Phase III study is targeted to begin the first half of 2016, with data available in 2017. FDA has also granted orphan and fast track designations for SGX203 in pediatric Crohn’s disease.

Earlier in development, a novel innate defense regulator, SGX942, currently is undergoing a Phase II POC trial treating oral mucositis in head and neck cancers. This synthetic compound modulates the body’s own innate defense system to treat disease. In the case of oral mucosits, which is linked to a dysregulation of the innate immune system, SGX942 has the potential to counter the negative effects caused by the patient’s chemotherapy and radiation treatments. In preclinical animal models, this compound has demonstrated it can eliminate infection and enhance tissue healing. “Preliminary results from this Phase II POC study are expected in December,” Schaber said.

BioDefense: Value drivers

Soligenix was awarded up to USD 57 million in government contracts from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) to support its biodefense programs in ricin exposure and GI acute radiation syndrome. “These contract awards provide a certain level of external scientific validation to our technology. Having a large portion of government support has allowed us to build out a robust pipeline that provides for multiple shots on goal to help mitigate risk,” Schaber pointed out.

The government funding supports two key biodefense programs, a ricin toxin vaccine, RiVax™ and a therapeutic to protect against acute radiation syndrome called OrbeShield™.

The vaccine programs are being developed using Soligenix’s proprietary heat stabilization platform, ThermoVax™. This technology, which uses a proprietary freeze-drying process, makes alum, an aluminum salt widely used in vaccines, stable at elevated temperatures. There is clear potential, therefore, for the ThermoVax™ technology to eliminate the need for cold-chain transportation and storage for many types of vaccines.

In preclinical studies involving RiVax™, ThermoVax™ produced a stable vaccine using adjuvants, protein immunogens and other components that typically cannot withstand temperatures above 8°C.

In tests, heat stable RiVax™ was stored at 40°C for one year. Traditional storage temperatures for vaccines of this type are 2-8°C, yet animals injected with the RiVax™ developed potent, high titer, antibodies to protect them against the effects of ricin exposure. Liquid vaccine stored at the same temperature did not elicit the same protective immune response. Similar results also were seen with Soligenix’s anthrax vaccine, VeloThrax™, and with a human papillomavirus (HPV) vaccine developed at the University of Colorado.

Based on this work, ThermoVax™ holds the promise of easier storage and distribution of national stockpiled vaccines, but also for routine vaccines in regions that lack reliable refrigeration.

Partnering opportunities across two business segments 

Because in-licensing is very important, Soligenix also is active in partnering. Its main efforts, naturally, center around its lead compounds. “We’re focusing on our Phase III-ready assets–SGX301 and SGX203–as well as SGX942, which is in Phase II,” Schaber said. Soligenix is interested in partnering to see these programs through clinical trials and then expanding the relationships to reach those companies’ geographic markets. The European and Asian markets are particularly important, he noted.

In other programs, Soligenix is working closely with Hawaii Biotech, Inc. and the University of Hawaiʻi at Mānoa to develop a heat-stable Ebola vaccine using the ThermoVax™ platform. “We are expanding our platform, and this was the first feasibility collaboration,” Schaber said. “We expect data from this work during the first half of 2016.”

The company also is keeping a close eye on research at the University of Colorado to develop a heat-stable HPV vaccine. “Researchers there can stabilize a subunit HPV vaccine using ThermoVax™,” he said. The implications of that research for Soligenix is as yet undetermined. “We are investigating the potential opportunity.”

On the biodefense side, Soligenix has partnered with Emergent BioSolutions Inc. to implement a commercially viable, scalable production process for the RiVax™ ricin vaccine. Emergent BioSolutions is well-known in the biodefense business sector for its bio-manufacturing expertise.

Soligenix also is interested in in-licensing additional clinical stage projects in orphan diseases and areas of high unmet medical need. Areas of particular interest include oncology, supportive cancer care, gastrointestinal conditions, biodefense and infectious diseases.

Leadership is deep and broad

The company has the leadership expertise to succeed. “We have very experienced people leading and advising Soligenix,” Schaber said. Senior leadership has worked in startups and large pharma, developing novel drugs for unmet medical needs in the US and internationally.

Dr. Schaber, for example, co-founded Acute Therapeutics, Inc. before joining Soligenix. He currently serves on the board of directors of the Biotechnology Council of New Jersey, the Alliance for Biosecurity and is a member of the corporate councils of both the National Organization for Rare Diseases and the American Society for Blood and Marrow Transplantation.

Likewise, Rasappa Arumugham, PhD, VP, Biopharmaceutical Development, previously was head of microbial vaccines analytics at Merck’s manufacturing division. He has held positions at Praxis Biologics, Lederle, Wyeth and Pfizer.

A sampling of the board of directors includes senior executives of Celgene Corporation, Cerium Pharmaceuticals, Inc., Sigma-Tau Pharmaceuticals Inc., and a former assistant Surgeon General of the US.

“We’re very hands-on with our programs, managing them directly,” Schaber said. The company established separate advisory boards for each of its lead candidates to provide the deep knowledge necessary to quickly advance development.

Finances, he says, are adequate to advance its programs. In addition to the up to USD 57 million in government contracts, in the summer of 2015 Soligenix entered into a USD 10 million equity purchase agreement that is designed to lend further support, if needed. “We use our equity lines very judiciously, to supplement funding as needed and to allow us to pursue new opportunities,” Schaber said.

”The company also continues to aggressively pursue non-dilutive capital through government grant and contract funding, as well as potential partnerships, to support its pipeline programs. If successful, this should continue to allow us to manage our cash burn very effectively.”

 

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