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Journal of Biotechnology Published Preclinical Efficacy Results with Soligenix’s Dusquetide in Infectious Disease

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Soligenix

Princeton, NJ based Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Soligenix’s BioTherapeutics business segment is developing SGX301 as a first-in-class photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis. Soligenix’s Vaccines/BioDefense business segment includes active development programs for RiVaxTM, our ricin toxin vaccine candidate, OrbeShield®, their GI acute radiation syndrome therapeutic candidate and SGX943, their melioidosis therapeutic candidate. The development of their vaccine programs incorporates the use of their proprietary heat stabilization platform technology, known as ThermoVax®. Currently, this business segment is supported with up to $57 million in government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

Soligenix announced today the publication of data demonstrating the mechanism and broad-spectrum activity of dusquetide in preclinical bacterial infection models. Dusquetide, also known by the research name SGX94, is a novel Innate Defense Regulator (IDR) composed of 5 amino acids and is the active ingredient in the lead IDR drug product, SGX942. The preclinical results were published online in the Journal of Biotechnology and are available at the following link: http://dx.doi.org/10.1016/j.jbiotec.2016.03.032.

As an IDR, dusquetide modulates the innate immune system by interacting at an intracellular integration point, operating downstream of most innate immune receptors and upstream of most cytokine and chemokine effectors. IDRs directly interact with an important protein known as p62, or sequestosome-1, thereby enhancing anti-infective mechanisms of the innate immune system and decreasing the often deleterious inflammatory responses. Because IDRs such as dusquetide target the host innate immune system, and not the bacteria directly, they are effective irrespective of the specific biological characteristics of the bacteria, whether antibiotic sensitive or resistant, gram-positive or gram-negative, intracellular or extracellular. IDRs are also complementary to antibiotics, and may provide an important tool in the fight against antibiotic-resistant and emerging infectious diseases.

Innate immunity is not only triggered by infection, but also by tissue damage. As such, IDRs also provide an ability to modulate inflammatory reactions to tissue damage, such as in the pathogenesis of oral mucositis. In a Phase 2 clinical trial, SGX942, containing dusquetide at a dose of 1.5 mg/kg, successfully reduced the median duration of severe oral mucositis by 50% in all patients and by 67% in patients receiving the most aggressive chemoradiation therapy for treatment of their head and neck cancer. In addition to the oral mucositis findings, an increased incidence of “complete response” of tumor at the one month follow-up visit was observed (47% in placebo versus 63% in SGX942 at 1.5 mg/kg). Decreases in infection rate were also observed with SGX942 treatment.

Oreola Donini, PhD, Senior Vice President and Chief Scientific Officer of Soligenix stated,  “The IDR technology was initially discovered in the context of infectious disease. Because IDRs target the host innate immune system, and not the bacteria, they are effective even when the bacteria are antibiotic resistant. Extensive testing has been done in the context of methicillin-resistant Staphylococcus aureus (MRSA) and has demonstrated that IDRs not only are effective as stand-alone therapy, but also are complementary to antibiotics, allowing a “two-pronged” attack on the bacterial infection. The Phase 2 results not only confirm the potential efficacy of IDRs in the context of oral mucositis, but also prove that the unique biology of IDRs translates well into the human clinical setting. The multiple modes of efficacy observed in the Phase 2 study and the demonstrated safety in both the Phase 1 and Phase 2 clinical trials were very consistent with the preclinical findings and the highly conserved nature of the innate immune system.”

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated,  “These data demonstrate the broad and promising potential of our IDR technology platform. While we continue to actively develop dusquetide for the treatment of oral mucositis, we are also poised to expand the platform to the infectious disease space and hope to fund these advancements through both partnerships and government grants/contracts, such as we have done to date with Burkholderia pseudomallei infection, a category B biothreat agent and the causative agent in melioidosis, an endemic tropical disease which is poorly treated by antibiotics.”

These studies were partially funded with grants from the National Research Council of Canada Industrial Research Assistance Program, agreement #703724, the National Institutes of Allergy and Infectious Diseases Small Business Innovation Research grant # 1R43 AI108175-01A1 and grant # 1R43DE024032-01.

Dusquetide and related analogs have a strong intellectual property position, including composition of matter. Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada.

SGX942 has received fast track designation from the US Food and Drug Administration (FDA) for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients. Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for SGX942 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of approximately six months.

Recently, SGX942 demonstrated positive results in a Phase 2 clinical trial of oral mucositis in head and neck cancer patients receiving chemoradiation therapy, not only reducing the duration of severe oral mucositis, but also reducing the incidence of infection as well as potentially enhancing the anti-tumor response.

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