新闻稿Zug，瑞士和剑桥，质量。和圣地亚哥，11月16日，2021年11月16日（全球新闻界） - 克里普尔治疗（纳斯达克：CRSP），生物制药公司，专注于为严重疾病发展转化性基因的药物，以及ViaCyte，Inc。那a clinical-stage regenerative medicine company developing novel cell replacement therapies to address diseases with significant unmet needs, today announced that Health Canada has approved the companies’ Clinical Trial Application (CTA) for VCTX210, an allogeneic, gene-edited, immune-evasive, stem cell-derived therapy for the treatment of type 1 diabetes (T1D). Initiation of patient enrollment is expected by year-end.
“CTA的批准,我们兴奋地带来first-in-class CRISPR-edited细胞疗法治疗1型糖尿病诊所,一个重要的里程碑,使流行一种新群体,他们的gene-edited干细胞药物,”Samarth Kulkarni说,博士,首席执行官CRISPR疗法。“ViaCyte领先的干细胞能力和CRISPR Therapeutics卓越的基因编辑平台的结合，有可能对1型糖尿病患者的生活产生有意义的影响。”
“首次将基因编辑的免疫回避细胞疗法应用于临床治疗1型糖尿病患者是开创性的，因为它通过消除植入细胞疗法对免疫抑制的需求，开辟了一条拓宽可治疗人群的道路。”ViaCyte的总裁兼首席执行官Michael Yang说。“这一方法建立在两家公司之前取得的成就的基础上，代表着该领域向前迈出了一大步，我们努力为这种毁灭性疾病提供功能性治疗。”
VCTX210的第1阶段临床试验旨在评估T1D患者的安全性，耐受性和免疫逃避。该计划正在通过CRISPR治疗方法和ViaCyte推进，作为发现，开发和商业化基因编辑的干细胞疗法治疗糖尿病的战略合作的一部分。VCTX210 is an allogeneic, gene-edited, stem cell-derived product developed by applying CRISPR Therapeutics’ gene-editing technology to ViaCyte’s proprietary stem cell capabilities and has the potential to enable a beta-cell replacement product that may deliver durable benefit to patients without requiring concurrent immune suppression.
关于CRISPR疗法
CRISPR Therapeutics是一家领先的基因编辑公司，专注于利用其专有的CRISPR/Cas9平台开发针对严重疾病的变革性基因药物。CRISPR/Cas9是一项革命性的基因编辑技术，它允许对基因组DNA进行精确、直接的改变。CRISPR Therapeutics已经在广泛的疾病领域建立了一系列治疗项目，包括血红蛋白病、肿瘤学、再生医学和罕见疾病。为了加速和扩大其努力，CRISPR Therapeutics已经与包括拜耳、Vertex Pharmaceuticals和ViaCyte在内的领先公司建立了战略合作关系。CRISPR Therapeutics AG总部位于瑞士Zug，在美国有全资子公司CRISPR Therapeutics, Inc.，研发部门位于马萨诸塞州剑桥市，业务办公室位于旧金山、加州和英国伦敦。欲了解更多信息，请访问www.crisprtx.com。
关于ViaCyte.
ViaCyte是一种私下持有的临床阶段再生医学公司，基于两种主要技术进步发展新型细胞替代疗法：来自多能干细胞和用于细胞包封和植入的医疗器械系统的细胞替代疗法。ViaCyte有机会使用这些技术来解决可能通过替换丢失或畸形细胞或蛋白质来治疗的关键人类疾病和疾病。ViaCyte的第一款产品候选人正在开发为1型糖尿病患者的潜在长期治疗，以实现葡萄糖对照目标，降低低血糖和糖尿病相关并发症的风险。为了加快和扩大ViaCyte的努力，它建立了与领先公司的合作伙伴关系，包括Crispr疗法和W.L.戈尔和伙伴。ViaCyte总部位于加利福尼亚州圣地亚哥。有关更多信息，请访问www.viacyte.com连接ViaCyte推特那脸谱网,linkedin。
CRISPR治疗前瞻性陈述
该新闻稿可以在1995年私人证券诉讼改革法案的含义中包含一些“前瞻性陈述”，如1995年的修订，包括Kulkarni博士和杨先生在本新闻稿中提出的陈述，以及关于CRISPR Therapeutics’ expectations about any or all of the following: (i) the safety, efficacy and clinical progress of our various clinical programs including our VCTX210 program; (ii) the status of clinical trials (including, without limitation, activities at clinical trial sites) and expectations regarding data from clinical trials; (iii) the data that will be generated by ongoing and planned clinical trials, and the ability to use that data for the design and initiation of further clinical trials; and (iv) the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies, including as compared to other therapies. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects” and similar expressions are intended to identify forward-looking statements. You are cautioned that forward-looking statements are inherently uncertain. Although CRISPR Therapeutics believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the potential for initial and preliminary data from any clinical trial and initial data from a limited number of patients not to be indicative of final trial results; the potential that clinical trial results may not be favorable; potential impacts due to the coronavirus pandemic, such as the timing and progress of clinical trials; that future competitive or other market factors may adversely affect the commercial potential for CRISPR Therapeutics’ product candidates; uncertainties regarding the intellectual property protection for CRISPR Therapeutics’ technology and intellectual property belonging to third parties, and the outcome of proceedings (such as an interference, an opposition or a similar proceeding) involving all or any portion of such intellectual property; and those risks and uncertainties described under the heading “Risk Factors” in CRISPR Therapeutics’ most recent annual report on Form 10-K, quarterly report on Form 10-Q and in any other subsequent filings made by CRISPR Therapeutics with the U.S. Securities and Exchange Commission, which are available on the SEC’s website atwww.sec.gov.。警告现有和预期投资者不会依赖于这些前瞻性陈述，只截至他们所做的日期。CRISPR治疗方法可根据法律要求的范围内更新或修改本新闻稿所载的任何前瞻性陈述的任何义务或进行的义务或开展。
CRISPR治疗学投资者联系：
苏珊金
+ 1-617-307-7503
susan.kim@crisprtx.com
CRISPR治疗媒体联系人：
瑞秋艾德
+ 1-617-315-4493
rachel.eides@crisprtx.com.
ViaCyte Investor联系人：
大卫·凯里，Lazar-FINN Partners公司
+ 1-212-867-1768
david.carey@finnpartners.com.
其中媒体联络:
Glenn Silver, Lazar-FINN Partners
+ 1-973-818-8198
glenn.silver@finnpartners.com.
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