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Selecta Biosciences Announces Fourth Quarter and Year End 2016 Financial Results and Provides Corporate Update
WATERTOWN, Mass., March 27, 2017 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ:SELB), a clinical-stage biopharmaceutical company focused on developing biologic therapies for rare and serious diseases that avoid unwanted immunogenicity, today reported financial results for the fourth quarter and full year ended December 31, 2016 and provided a corporate update. “After a pivotal 2016, we believe that 2017 will be a year of great and lasting importance for Selecta Biosciences and for patients with rare and serious diseases,” said Werner Cautreels, Ph.D., CEO and Chairman of Selecta. “While we are still in the early stages of our Phase 2 trial of SEL-212 that was initiated in the fourth quarter of 2016, we are emboldened by its progress and the patient data that have been generated thus far. Patient enrollment has been faster than we expected, and SEL-212 has been generally well tolerated at clinically active doses. We are particularly pleased that we have already reached a dose level of SEL-212 that has thus far enabled all patients that had received a repeat administration to maintain persistent clinical activity. We are eager to collect additional patient data that we believe should be the basis for the development of a major new treatment for severe gout patients.” “In recent months, we and various collaborators have also presented preclinical data demonstrating the transformative potential of our immune tolerance SVP technology to create novel and differentiated therapies in a number of additional strategic areas such as gene therapy, oncology and enzyme replacement therapy,” continued Cautreels. “We believe SVP has uniquely demonstrated the potential to avoid the immunogenicity that hampers today’s biologic treatments, which is garnering increasing interest throughout the industry.” SEL-212 Phase 2 Trial Update Published data show that uricases, exogenous biologic enzymes that metabolize uric acid, have the ability to significantly reduce serum uric acid levels and eliminate uric acid crystal deposits in severe gout patients. However, the efficacy and safety of currently marketed uricases have been compromised by the formation of anti-drug antibodies (ADAs) that are induced in most patients early in their treatment and prevent further administrations. Leveraging the immune tolerance application of Selecta’s SVP platform, SEL-212 (SVP-Rapamycin in combination with pegsiticase) is designed to be the first non-immunogenic version of uricase, which would allow for the effective and safe administration of multiple doses. A prolonged elevation of serum uric acid levels can lead to the formation of uric acid crystal deposits in joints and tissue. These deposits have been shown to cause severe gout symptoms such as pain, inflammation of joints and debilitating flares, which can potentially exacerbate kidney and cardiovascular disease if untreated. Multi-dose treatment with SEL-212 has the potential to drastically and durably lower serum uric acid levels, enabling the removal of uric acid crystal burden over a short treatment cycle, which cannot be achieved for severe gout patients by oral therapy. In the fourth quarter of 2016, Selecta began enrolling patients with symptomatic gout and elevated serum uric acid levels (above 6.0 mg/dL) in an open-label, multiple ascending dose Phase 2 clinical trial of SEL-212. The primary and secondary endpoints for this trial include the safety, tolerability and pharmacokinetics of repeated monthly doses of SEL-212; the clinical activity of SEL-212 as defined by the reduction of serum uric acid levels; and the reduction of ADA levels. As of March 23, 2017, a total of 38 patients had been dosed in the Phase 2 trial at 10 active U.S. clinical sites. In the company’s single-dose Phase 1a/b trial, it was determined that 0.4 mg/kg of pegsiticase combined with 0.1 mg/kg SVP-Rapamycin prevented the formation of ADAs, thereby enabling the control of uric acid for at least 30 days in the majority of patients. In the ongoing Phase 2 study, patients are being enrolled in multiple ascending dose cohorts to identify the optimal dose ratio of SVP-Rapamycin and pegsiticase, the minimal effective dose level of SEL-212 for repeat monthly administration, and the dose regimen to take forward into Phase 3. Enrollment has been completed for the first six patient cohorts, and recruitment of two additional patient cohorts is ongoing. Serum uric acid data was available as of March 23, 2017. Multiple serum samples have been collected from all patients for the measurement of ADA levels, and this analysis was ongoing. Patient and enrollment data as of March 23, 2017 was as follows:
Additional patient data from these cohorts are included in a presentation entitled “Selecta Q4 and Year End 2016 Conference Call Presentation” that Selecta posted to its website today. To access this presentation, please visit www.selectabio.com, select Investors & Media and then Events & Presentations. Selecta developed stopping rules for its Phase 2 trial to ensure patient safety given the well-recognized immunogenicity of uricase enzymes. The loss of serum uric acid control during treatment is an accepted surrogate for the formation of ADAs and potential risk of subsequent infusion reactions. In order to ensure patient safety, these rules call for serum uric acid levels to be rapidly analyzed and dosing to cease upon a loss of serum uric acid control at Day 21 following a dose. As expected, these stopping rules have been applied more frequently in cohorts dosed with pegsiticase alone and the lower SVP-Rapamycin dose. Consistent with the expected reduction in immunogenicity of pegsiticase as SVP-Rapamycin doses increase, SEL-212 has been generally well tolerated thus far in patients in the mid-dose cohorts, with no SAEs being reported for these patients. One infusion reaction was reported in the control cohorts, which was classified as a serious adverse event (SAE) and successfully treated. Two infusion reactions occurred in the low-dose cohorts; they were classified as SAEs and were successfully treated. In March 2017, recruiting began for two higher dose cohorts of patients, which will receive three monthly doses of 0.1 mg/kg of SVP-Rapamycin plus 0.2 mg/kg or 0.4 mg/kg of pegsiticase followed by two monthly doses of 0.2 mg/kg or 0.4 mg/kg of pegsiticase alone. Selecta plans to present initial data from this trial at a medical meeting by the end of June 2017. The Phase 2 trial is expected to be completed in 2017. Following an End of Phase 2 Meeting with the U.S. Food and Drug Administration (FDA), the company expects to initiate its Phase 3 program in 2018. Additional Recent Business Highlights and Activities
Fourth Quarter Financial Results:
Conference Call Reminder Selecta management will host a conference call at 5:00 p.m. ET today to provide a corporate update and review the company’s fourth quarter and year end 2016 financial results. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, http://selectabio.com. Individuals may also participate in the live call via telephone by dialing (877) 270-2148 (domestic) or (412) 902-6510 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10100540. About Selecta Biosciences, Inc. Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing biologic therapies for rare and serious diseases that avoid the immune responses that compromise efficacy and lead to life-threatening complications. Selecta is applying its proprietary Synthetic Vaccine Particles (SVP™) to a range of therapeutic areas in which immunogenicity is a key challenge. SEL-212, the company’s lead candidate in Phase 2, is being developed to treat severe gout patients and reduce their debilitating symptoms, including flares and inflammatory arthritis. Further, Selecta’s two proprietary gene therapy product candidates have the unique potential to enable repeat administration, allowing for dose adjustment in patients and maintenance of therapeutic activity over time. The company is seeking to expand the use of its SVP platform in other areas, such as immuno-oncology, allergies, autoimmune diseases and vaccines. Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com. Forward-Looking Statements 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 development of its pipeline, the ability of the company’s SVP platform, including SVP-Rapamycin, to mitigate immune response and create better therapeutic outcomes, the potential treatment applications for products utilizing the SVP platform in areas such as gene therapy, immuno-oncology, allergies, autoimmune diseases and vaccines, whether the company’s proprietary gene therapy product candidates will enable repeat administration, allow for dose adjustment in patients or maintain therapeutic activity over time, the receipt of additional payments under the company’s license agreement and/or stock purchase agreement with Spark Therapeutics, the sufficiency of the company’s cash, cash equivalents, investments, and restricted cash 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 unproven approach of the company’s SVP technology, 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, substantial fluctuation in the price of its common stock, a significant portion of the company’s total outstanding shares have recently become eligible to be sold into the market, 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 10, 2016, and in other filings that the company makes with the SEC. 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.
Contact Information: Jason Fredette Selecta Biosciences, Inc. 617-231-8078 [email protected] |