WATERTOWN, Mass., Nov. 24, 2021 -- Selecta Biosciences Inc. , a biotechnology company leveraging its clinically validated ImmTOR™ platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, today announced that the U.S. Food and Drug Administration has placed a clinical hold on its Phase 1/2 clinical trial of SEL-302 for the treatment of patients with methylmalonic acidemia .
On November 23, Selecta received a letter from the FDA issuing a clinical hold in order to obtain additional information on the chemistry, manufacturing and controls (CMC) related to the MMA-101 product candidate. There were no outstanding clinical or pre-clinical questions in the FDA letter. This clinical trial had not yet been initiated, and no human patients will be dosed with MMA-101 until all of the FDA’s questions are resolved. Selecta intends to work closely with the FDA to address the requests for additional information.
“Patient safety is our primary concern, and we are committed to addressing the FDA’s questions regarding CMC as expeditiously as possible,” said Carsten Brunn, Ph.D., president and chief executive officer of Selecta. “We look forward to working closely with the FDA to satisfy all outstanding concerns, and to providing additional updates early next year.”
MMA is a rare metabolic disease that affects the body’s ability to metabolize certain amino acids and fats. The condition may lead to metabolic acidosis, hyperammonemia and long-term complications including feeding problems, developmental delays, intellectual disability and chronic kidney disease.
About Selecta Biosciences, Inc.
Selecta Biosciences Inc. (NASDAQ: SELB) is a clinical stage biotechnology company leveraging its ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses. With a proven ability to induce tolerance to highly immunogenic proteins, ImmTOR has the potential to amplify the efficacy of biologic therapies, including redosing of life-saving gene therapies, as well as restore the body’s natural self-tolerance in autoimmune diseases. Selecta has several proprietary and partnered programs in its pipeline focused on enzyme therapies, gene therapies, and autoimmune diseases. Selecta Biosciences is headquartered in the Greater Boston area. For more information, please visit www.selectabio.com.
Selecta 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 unique proprietary technology platform of the Company, and the unique proprietary platform of its partners, the programs and disease indication targets anticipated under this agreement, the ability of any drug candidate developed under the agreement to offer a therapeutic benefit, the potential of ImmTOR to enable re-dosing of AAV gene therapy, to enhance transgene expression and to mitigate immunogenicity, the potential treatment applications of product candidates utilizing the ImmTOR platform in areas such as gene therapy, the ability of the Company and its partners where applicable to develop gene therapy products using ImmTOR, the novelty of treatment paradigms that the Company is able to develop, the potential of the ImmTOR technology platform generally and the Company’s ability to grow its strategic partnerships, 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 unproven approach of the Company’s ImmTOR technology, our partners’ ability to develop products under the agreement, undesirable side effects of the Company’s technology, its reliance on third parties to manufacture its product candidates and to conduct its development activities, 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, 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, and other important factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K to be filed after this release, 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 intention to update any forward-looking statements included in this press release.
LifeSci Advisors, LLC
Brittany Leigh, Ph.D.
LifeSci Communications, LLC
马萨诸塞州沃特敦。2021年11月24日--生物技术公司Selecta Biosciences Inc.今天宣布，美国食品药品监督管理局已暂停其用于治疗甲基丙二酸血症患者的SEL-302的1/2期临床试验，该公司利用其临床验证的IMMTOR™平台开发选择性减轻不必要的免疫反应的耐受性疗法。
Selecta Biosciences Inc.（纳斯达克代码：SELB）是一家临床阶段生物技术公司，利用其ImmTOR平台开发耐受性疗法，选择性地减轻不必要的免疫反应。ImmTOR已被证明能够诱导对高免疫原性蛋白质的耐受，它有潜力扩大生物治疗的有效性，包括拯救生命的基因治疗的还原，以及在自身免疫性疾病中恢复机体的自然自我耐受。Selecta有几个专有和合作项目在其管道专注于酶治疗，基因治疗和自身免疫疾病。Selecta Biosciences总部位于大波士顿地区。欲了解更多信息，请访问www.selectabio.com。