Selecta Biosciences Expands Potential for ImmTOR Platform and Streamlined Structure

Selecta Biosciences (Nasdaq:SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR (SVP-Rapamycin), today provided updates on its platform priorities and streamlined structure under the leadership of its new President and CEO, Carsten Brunn, Ph.D.

As quoted in the press release:

The company remains committed to the development of its lead product candidate, SEL-212, (ImmTOR+pegadricase) in chronic refractory gout. Based on interim data from the recently completed Phase 2 study, inclusive of the five outstanding patients who had not previously completed their course of therapy as of October 9th, 2018, 66% of evaluable patients (21/32), maintained serum uric acid (sUA) levels of <6mg/dL after five once-monthly treatments of SEL-212 at doses of 0.1 or 0.15 mg/kg of ImmTOR in combination with 0.2mg/kg of pegadricase. Furthermore, reduced total urate burden and lowered flare rates and severity were observed in the Phase 2 clinical trial, and SEL-212 continued to be generally well tolerated.

Following a December 2018 U.S. Food and Drug Administration (FDA) meeting, the company plans to initiate a head-to-head superiority trial of SEL-212, utilizing revised stopping rules, compared to the current FDA-approved uricase therapy, Krystexxa, in the first quarter of 2019. An interim six-month data readout is projected for the fourth quarter of 2019 with a full statistical superiority data analysis expected in the first quarter of 2020. The results of the planned head-to-head superiority trial are expected to inform the design of the planned Phase 3 clinical trial of SEL-212, which the company plans to initiate in the fourth quarter of 2019.

Click here to read the full press release.