Soligenix, Inc., a late-stage biopharmaceutical company, has received the United States Patent Office (USPTO) patent entitled "Peptides for Treating and Preventing Immune-Related Disorders, Including Treating and Preventing Infection by Modulating Innate Immunity."

The newly issued patent claims composition of matter of analogs of dusquetide (research name: SGX94), the company's lead development compound.  Dusquetide recently demonstrated positive preliminary results in a phase 2 clinical trial for the treatment of oral mucositis in head and neck cancer patients.  The recently issued patent broadens the protection around dusquetide and provides further protection for the underlying innate defense regulator (IDR) technology platform. Similar claims have been granted and/or are being pursued in jurisdictions worldwide.  

IDRs are first-in-class small peptides with a novel mechanism of action. IDRs function by modulating the response of the innate immune system at a key convergence point in the intracellular signaling pathways.  The innate immune system is a non-specific system which responds to a variety of insults, including infections and tissue damage.  Because IDRs act by modulating the response of the innate immune system, they are agnostic as to either the cause of tissue damage (e.g., chemotherapy, radiation or trauma) or infection (e.g., antibiotic sensitive or antibiotic resistant infections).

"Soligenix continues to pursue broad patent coverage for its dusquetide technology, first with composition of matter claims followed by therapeutic use claims in various indications, including infectious disease and oral mucositis," stated Christopher J. Schaber, PhD, president and chief e officer of Soligenix.  "The IDR technology utilizes a novel mechanism, and first-in-class compounds, to address the underlying role of innate immune dysregulation in a broad spectrum of disease indications, including many areas of unmet medical need. The patent estate, including this most recent patent granted in the US, establishes a platform to pursue or partner these indications, as circumstances allow."

Dusquetide is an innate defense regulator (IDR), a new class of short, synthetic peptide. It has a novel mechanism of action in that it modulates the body's reaction to both injury and infection towards an anti-inflammatory and an anti-infective response.  IDRs have no direct antibiotic activity but, by modulating the host's innate immune system responses, increase survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens.  It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, melioidosis, macrophage activation syndrome (MAS) and other bacterial infections.

SGX942 (the drug product containing dusquetide) has demonstrated safety in a phase 1 clinical study in 84 healthy human volunteers.  Recently, SGX942 has demonstrated preliminary efficacy and safety in an exploratory phase 2 clinical study in 111 patients with oral mucositis due to chemoradiation (CRT) therapy for head and neck cancer. Consistent with preclinical findings, SGX942 at a dose of 1.5 mg/kg demonstrated positive improvements in decreasing the duration of severe oral mucositis by 50% overall compared to the placebo group, from 18 days to 9 days (p=0.099).  In patients at highest risk of oral mucositis (e.g., those exposed to the most aggressive concomitant chemotherapy), the reduction in the duration of severe oral mucositis was even more significant at 67% when treated with SGX942 1.5 mg/kg, from 30 days to 10 days (p=0.04).  The p-values meet the prospectively defined statistical threshold of p<0.1 in the study protocol.

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.

Drug products containing dusquetide have also received Fast Track Designations 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, and as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis. Orphan Drug Designation for use of dusquetide in the treatment of MAS has also been granted.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need.