On June 13, 2022 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies for autoimmune diseases, enhance gene therapies and mitigate unwanted immune responses to biologics, reported several pipeline advancements and partnership updates (Press release, Selecta Biosciences, JUN 13, 2022, View Source [SID1234615932]).
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Extension of Sarepta’s Research License and Option Agreement
Sarepta Therapeutics (NASDAQ: SRPT) has extended the options under the Research License and Option Agreement to license the rights to develop and commercialize Selecta’s immune tolerance platform, ImmTOR, for use in Duchenne Muscular Dystrophy (DMD) and certain Limb-Girdle Muscular Dystrophies (LGMD). Selecta will receive a $2 million payment for the nine-month extension to both options. Additionally, Selecta is eligible to receive an additional $4 million payment upon the achievement of certain near-term preclinical milestones by Sarepta. If Sarepta exercises its option to enter a commercial license agreement for DMD or LGMD Selecta will be eligible for additional development, regulatory, and commercial milestone payments, as well as tiered royalties on net product sales.
Clinical Pipeline Updates
DISSOLVE II, the second of two Phase 3 clinical studies evaluating SEL-212 for chronic refractory gout, continues to progress. SEL-212 is a combination of Selecta’s ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase).
"As a result of Selecta’s proactive addition of 11 trial sites in the United States and the commitment of our clinical team, investigators and study participants around the world, DISSOLVE II is on track to successfully enroll approximately 140 study participants by the end of Q2 2022," said Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta. "We expect to complete the study in Q4 2022 and announce joint topline data from DISSOLVE I and II in Q1 2023. The upcoming completion of enrollment for DISSOLVE II brings us one step closer to our ultimate goal of providing a differentiated and more convenient treatment option for patients suffering from chronic refractory gout."
Swedish Orphan Biovitrum AB, (Sobi) has in-licensed SEL-212 from Selecta and is responsible for development, regulatory and commercial activities in all markets outside of China. The Phase 3 program for SEL-212 is being run by Selecta and funded by Sobi. The completion of enrollment in DISSOLVE I & II will result in a $10 million milestone payment obligation from Sobi to Selecta.
Additionally, Selecta continues to progress its wholly owned gene therapy program, SEL-302 for the treatment of patients with methylmalonic acidemia (MMA), toward the clinic. Selecta expects to start a Phase 1 clinical trial in Q4 2022.
DISSOLVE clinical program
The DISSOLVE Phase 3 clinical program consists of two double-blind, placebo-controlled studies of SEL-212, titled "A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients with Gout Refractory to Conventional Therapy," in which SEL-212 will be evaluated at two doses of ImmTOR (0.1 mg/kg and 0.15 mg/kg), and one dose of pegadricase (0.2 mg/kg) in both studies. In DISSOLVE I, safety and efficacy will be evaluated in 112 patients at six months and will have a six-month extension to evaluate safety. DISSOLVE II will assess safety and efficacy in approximately 140 patients at only the six-month time point, with no extension. The primary endpoint in both studies is serum uric acid (SUA) control during month six, a well-validated measure of disease severity in chronic refractory gout. Secondary endpoints include tender and swollen joint counts, tophus burden, patient-reported outcomes of activity limitation and quality of life and gout flare incidence. For more details about the study, visit clinicaltrials.gov (NCT04513366).
SEL-212
SEL-212 is a novel combination medicine designed to sustain SUA levels in people with chronic refractory gout, potentially reducing harmful tissue urate deposits which when left untreated can lead to debilitating gout flares and joint deformity.1 SEL-212 consists of pegadricase, Selecta’s proprietary pegylated uricase, co-administered with ImmTOR, designed to mitigate the formation of anti-drug antibodies (ADAs). ADAs develop due to unwanted immune responses to biologic medicines, reducing their efficacy and tolerability, which remains an issue across multiple therapeutic modalities and disease states including chronic refractory gout.
Chronic refractory gout
Gout is the most common form of inflammatory arthritis with more than 8.3 million people in the United States having been diagnosed with gout, which is caused by high levels of uric acid in the body that accumulate around the joints and other tissues and can result in flares that cause intense pain. Approximately 160,000 people in the United States suffer from chronic gout refractory to conventional medicines, a painful and debilitating condition in which people SUA levels below 6 mg/dL and therefore have several flares per year and can develop nodular masses of uric acid crystals known as tophi.1 Elevated SUA levels have been associated with diseases of the heart, vascular system, metabolism, kidney and joints.2