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Selecta Biosciences Expands Potential for ImmTOR™ Platform and Streamlined Structure Under Leadership of New CEO, Carsten Brunn, Ph.D.
- Reported completion of SEL-212 Phase 2 study with positive efficacy and tolerability results observed in the clinical trial, in addition to monthly dosing, indicating potential to serve unmet need for patients with chronic refractory gout
- Held end of Phase 2 meeting for SEL-212 with
- Head-to-head superiority trial for SEL-212 vs. KRYSTEXXA® expected to begin in Q1 2019; results anticipated to inform Phase 3 design
- Projected to dose first patient with combination of ImmTOR (SVP-Rapamycin) + AAV gene therapy in 2H 2019 in collaboration with CureCN consortium
“We believe 2019 will be a transformative year for
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
In addition to this renewed focus on AAV gene therapy applications,
Selecta’s new CEO, Dr. Brunn, announces a streamlined structure:
Effective December 1, 2018,
The company is restructuring to reduce the current workforce by 36% as of
Any statements in this press release about the future expectations, plans and prospects of Selecta Biosciences, Inc. (“the company”), including without limitation, statements regarding the progress of the clinical development of SEL-212, the anticipated timing of the head-to-head trial comparing SEL-212 and Krystexxa and related data readouts, whether the head-to-head trial with Krystexxa will demonstrate superiority or provide guidance for the design of the Phase 3 trial for SEL-212, the potential of ImmTOR to enable re-dosing of AAV gene therapy and the anticipated timing of preclinical toxicology studies and initiation of a clinical trial related thereto, the potential of SEL-212 to serve unmet needs in chronic refractory gout patients including sustained sUA reduction, reduced flares, and once monthly dosing, whether interim data related to the SEL-212 clinical program will be predictive of future data, the anticipated timing for advancing into Phase 3 (if at all), whether current evaluable SEL-212 patients will be predictive of future evaluable SEL-212 patients, anticipated achievement of key milestones for the company’s chronic refractory gout and gene therapy programs, the company’s ability to execute on its strategic priorities, advance its ImmTOR platform, and grow its strategic partnerships, the impact of the restructuring on the company’s ability to achieve its new priorities, the company’s ability to reduce its annual cash burn rate in connection with the restructuring, the company’s plans to deprioritize the SEL-403 program, the ability of the company’s ImmTOR platform to unlock the full potential of biologic therapies, the potential of SEL-212 to treat chronic refractory gout patients and resolve their debilitating symptoms, the potential treatment applications for products utilizing the ImmTOR platform in areas such as enzyme therapy and gene therapy, the company’s plan to apply its ImmTOR platform to a range of biologic therapies for rare and serious diseases, the potential of the company’s gene therapy product candidates to enable repeat administration, the potential of the ImmTOR platform generally, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including their uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, the unproven approach of the company’s ImmTOR technology, potential delays in enrollment of patients, undesirable side effects of the company’s product candidates, its reliance on third parties to manufacture its product candidates and to conduct its clinical trials, the company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the company’s recurring losses from operations and negative cash flows from operations raise substantial doubt regarding its ability to continue as a going concern, substantial fluctuation in the price of its common stock, the company’s strategy may change, and the company may not be able to effectively implement its current strategic plan, the size of the company’s workforce following the restructuring may not be sufficient, and the company may not be able to effectively attract or retain new employees, risks associated with the restructuring, such as employee claims and the risk that the actual financial and other impacts of the reduction could vary materially from the outcomes anticipated, and other important factors discussed in the “Risk Factors” section of the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on November 8, 2018, and in other filings that the company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The company specifically disclaims any obligation to update any forward-looking statements included in this press release.
Stern Investor Relations, Inc.
Source: Selecta Biosciences, Inc.