It’s a very rewarding trading day for investors in Soligenix (SNGX) with shares up nearly 25%, making the stock Wall Street’s bull of the day.
Why the excitement? The late-stage biopharmaceutical company announced today that the European Patent Office has granted the patent entitled “Novel 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 innate defense regulator (IDR) analogs, expanding patent protection around the Company’s lead IDR, dusquetide. Similar claims have been previously allowed in the United States (US) and are being pursued in other worldwide jurisdictions.
Dusquetide (the active ingredient in SGX942) is a novel, first-in-class IDR. It modulates the response of the innate immune system in response to various stimuli, including infection, tissue damage and inflammation. Dusquetide has demonstrated efficacy in an extensive array of preclinical models emphasizing all three aspects of its activity. SGX942, the drug product containing dusquetide, demonstrated positive results in a Phase 2 study in the treatment of oral mucositis in head and neck cancer patients. SGX942 at a dose of 1.5 mg/kg successfully reduced the median duration of severe oral mucositis 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 and 12-month follow-up visits were observed. Decreases in infection rate and an increase in the 12-month survival rate were also observed with SGX942 treatment.
SGX942 is currently being evaluated in a pivotal Phase 3, randomized, double-blind, placebo-controlled, multinational clinical study for the treatment of oral mucositis in head and neck cancer patients. The ongoing Phase 3 trial, referred to as the “DOM–INNATE” study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity), is actively enrolling patients in the US and Europe.
The new patent corresponds to US patent 9,416,157, granted on August 16, 2016.
“Soligenix continues to pursue broad patent coverage for dusquetide and its library of related IDR analogs, first with composition of matter claims followed by therapeutic use claims, such as in oral mucositis,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “The composition of matter patents are generally valid until 2028. The therapeutic use claims in oral mucositis will follow in the same jurisdictions, including the US where it has already been granted, and will provide extended intellectual property coverage.”
The Street Verdict
Where does the Street side on this biotech player? It appears mostly bullish, as TipRanks analytics demonstrate SNGX as a Buy. Out of 3 analysts polled in the last 12 months, 2 are bullish on Soligenix stock while 1 remains sidelined. With a return potential of over 210%, the stock’s consensus target price stands at $3.90. (See SNGX’s price targets and analyst ratings on TipRanks)