Selecta Biosciences Provides Update on Phase 1/2 Clinical Trial of SEL-302 for the Treatment of Methylmalonic Acidemia-U.S. FDA has issued a clinical hold on Phase 1/2 Clinical Trial of SEL-302 due to CMC related questions-

Selecta Biosciences提供SEL-302治疗甲基丙二酸血症的1/2期临床试验的最新进展-美国由于CMC相关问题,FDA对SEL-302的1/2期临床试验发出临床暂停-

2021-11-25 13:30:07 BioSpace

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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.” About MMA 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. For Investors: Bruce Mackle LifeSci Advisors, LLC +1-929-469-3859 bmackle@lifesciadvisors.com For Media:  Brittany Leigh, Ph.D. LifeSci Communications, LLC +1-646-751-4366 bleigh@lifescicomms.com 
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。 11月23日,Selecta收到了FDA的一封信,该信发出了临床暂停,以获得与MMA-101候选产品相关的化学、制造和控制(CMC)的额外信息。在FDA的信中没有悬而未决的临床或临床前问题。这项临床试验还没有开始,在FDA的所有问题得到解决之前,不会有人类患者服用MMA-101。Selecta打算与林业发展局密切合作,以满足对补充信息的要求。 Selecta总裁兼首席执行官Carsten Brunn博士说:“患者安全是我们的首要问题,我们致力于尽快解决FDA关于CMC的问题。”“我们期待着与美国食品和药物管理局密切合作,以满足所有悬而未决的问题,并在明年初提供额外的更新。” 关于MMA MMA是一种罕见的代谢疾病,影响身体代谢某些氨基酸和脂肪的能力。这种情况可能导致代谢性酸中毒、高氨血症和长期并发症,包括喂养问题、发育迟缓、智力残疾和慢性肾脏疾病。 关于Selecta生物科学公司。 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。 选择前瞻性陈述 本新闻稿中关于未来预期的任何声明,Selecta Biosciences的规划与展望,Inc.(“本公司”),包括但不限于,关于公司独有专有技术平台的声明,以及合作伙伴独有的专有平台,该协议下预期的方案和疾病适应症目标,根据协议开发的任何候选药物提供治疗益处的能力,ImmTOR能够再次给药AAV基因治疗的潜力,为了提高转基因表达和降低免疫原性,利用ImmTOR平台的候选产品在基因治疗等领域的潜在治疗应用,公司及其合作伙伴在适用情况下使用ImmTOR开发基因治疗产品的能力,公司能够开发的治疗范式的新颖性,ImmTOR技术平台的总体潜力和公司发展战略伙伴关系的能力,以及其他包含“预期”、“相信”、“继续”、“可能”、“估计”、“预期”、“假设”、“打算”、“可能”、“计划”、“潜力”、“预测”、“项目”、“应该”、“目标”、“将”以及类似表述的陈述,构成1995年《私人证券诉讼改革法》含义内的前瞻性陈述。由于各种重要因素,包括,但不限于,以下内容:该公司的ImmTOR技术未经证实的方法,我们的合作伙伴在协议下开发产品的能力,公司技术的不良副作用,它依赖第三方制造其候选产品并进行其开发活动,公司无力维持现有或未来的合作,许可证或合同关系,它无力保护其专有技术和知识产权,可获得的资金足以满足其可预见和不可预见的经营费用和资本支出要求,公司的经常性经营损失和业务产生的负现金流,使人们对其继续作为持续经营企业的能力、其普通股价格的大幅波动以及在本发布后提交的公司最新年度报告10-K表的“风险因素”部分和公司向证券交易委员会提交的其他文件中讨论的其他重要因素产生了重大怀疑。此外,本新闻稿中包含的任何前瞻性陈述仅代表本公司截至其发布之日的观点,不应被认为代表其自任何后续日期的观点。本公司特别声明不打算更新本新闻稿中包含的任何前瞻性陈述。 对于投资者: 布鲁斯·麦克尔 LifeSci Advisors有限责任公司 +1-929-469-3859 bmackle@lifesciadvisors.com 对于媒体: 布列塔尼·利博士 LifeSci通信有限责任公司 +1-646-751-4366 @lifescicomms.com

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