Date: 2016-09-12
Type of information: Licensing agreement
Compound: dusquetide (SGX942)
Company: Soligenix (USA - NJ) SciClone (USA - CA)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
Action mechanism: peptide. SGX942 is a fully synthetic, 5-amino acid peptide with high aqueous solubility and stability. This peptide is an Innate Defense Regulator (IDR), a new class of short, synthetic peptides that has a novel mechanism of action in that it has simultaneous anti-inflammatory and anti-infective activity. IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.
Disease: oral mucositis in patients undergoing chemoradiation therapy for head and neck cancer
Details: * On September 12, 2016, Soligenix and SciClone Pharmaceuticals announced that the companies have entered into an exclusive license agreement granting rights to SciClone to develop, promote, market, distribute and sell SGX942 (dusquetide), a novel, first-in-class therapy being developed for the treatment of oral mucositis in patients with head and neck cancer. The licensing agreement includes the People's Republic of China, including Hong Kong and Macau, as well as Taiwan, South Korea and Vietnam. This exclusive agreement builds on an existing collaboration between the two companies, in which SciClone provided its complete oral mucositis clinical and regulatory data library to Soligenix in exchange for certain, previously undisclosed, commercialization rights to SGX942 in the Greater China market. This exclusive license agreement builds on an existing collaboration, wherein SciClone provided its significant oral mucositis clinical and regulatory data library, thus increasing the probability of success for the Soligenix SGX942 Phase 2 exploratory clinical study. By analyzing data available from the placebo subjects in the SciClone trials, Soligenix acquired essential insight into disease progression, along with quantitative understanding of its incidence and severity in the head and neck cancer patient population. This information assisted with the design of the SGX942 phase 2 clinical trial, in which positive preliminary results were announced in December 2015. 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 receiving 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. Additional observations included an improved tumor response to CRT therapy at the one month follow up visit (47% in placebo versus 63% in SGX942 at 1.5 mg/kg), as well as decreases in infection rate.
Financial terms: Under the terms of the agreement, SciClone will make a $3 million upfront equity investment in Soligenix for 3,529,412 shares of Soligenix common stock. In addition, SciClone will be responsible for all aspects of development, product registration and commercialization in the Territory (People's Republic of China, Hong Kong, Macau, Taiwan, South Korea and Vietnam) having access to data generated by Soligenix. In exchange for exclusive rights, SciClone will pay to Soligenix royalties on net sales, and Soligenix will supply commercial drug product to SciClone on a cost-plus basis, while maintaining worldwide manufacturing rights.
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