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Adaptimmune Announces Completion of Strategic Combination With TCR2 Therapeutics Creating a Preeminent Solid Tumor Cell Therapy Company

Adaptimmune Announces Completion of Strategic Combination With TCR2 Therapeutics Creating a Preeminent Solid Tumor Cell Therapy Company

Adaptimmune 宣布完成与 TCR2 Therapeutics 的战略合并,创建一家卓越的实体瘤细胞疗法公司
newsfile ·  2023/06/02 03:29

First marketed engineered T-cell therapy for a solid tumor; BLA for afami-cel on track to complete submission in mid-2023

首次上市用于实体瘤的工程化 T 细胞疗法;afami-cel 的 BLA 有望在 2023 年中期完成申请

Compelling clinical data with late-stage programs targeting MAGE-A4 and mesothelin

针对 MAGE-A4 和美索替林的后期项目提供令人信服的临床数据

Preclinical programs targeting PRAME and CD70 in IND-enabling studies

在支持IND的研究中针对PRAME和CD70的临床前项目

Adaptimmune funded into early 2026 with multiple value creating catalysts

Adaptimmune 的资金将持续到 2026 年初,采用多种创造价值的催化剂

Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - June 1, 2023) - Adaptimmune Therapeutics plc (NASDAQ: ADAP) today announced completion of an all-stock transaction in which Adaptimmune has combined with TCR2 Therapeutics Inc. (NASDAQ: TCRR) to create a preeminent T-cell therapy company to treat solid tumors.

宾夕法尼亚州费城和英国牛津--(Newsfile Corp.,2023年6月1日)——Adaptimmune Therapeutics plc(纳斯达克股票代码:ADAP)今天宣布完成一项全股交易,在该交易中,Adaptimmune与TCR2 Therapeutics Inc.(纳斯达克股票代码:TCRR)合并,创建了一家治疗实体瘤的卓越的T细胞疗法公司。

Adaptimmune's lead clinical franchises utilize engineered T-cell therapies targeting MAGE-A4 and mesothelin, which are expressed on a broad range of solid tumors. Use of these cell therapies is supported by compelling clinical data including results in late-stage synovial sarcoma which will form the basis of the Company's first BLA submission to complete in mid-2023. The Company has access to an enhanced "next-gen toolbox" and an extended preclinical pipeline with development initially focused on PRAME and CD70.

Adaptimmune 的主要临床特许经营权使用针对 MAGE-A4 和间皮素的工程 T 细胞疗法,这些疗法在各种实体瘤上表达。这些细胞疗法的使用得到了包括晚期滑膜肉瘤结果在内的令人信服的临床数据的支持,这些数据将构成公司于2023年年中完成的首份BLA申报的基础。该公司可以获得增强的 “下一代工具箱” 和扩展的临床前产品线,最初的开发重点是PRAME和CD70。

Adrian Rawcliffe, Adaptimmune's Chief Executive Officer: "We are delighted to welcome our new colleagues to Adaptimmune. Together, we will advance our industry leading pipeline making cell therapy a mainstream option for people with cancer. This starts with gaining approval for the first engineered T-cell therapy for a solid tumor - afami-cel for the treatment of synovial sarcoma - and progressing our Phase 2 trials for patients with ovarian cancer with both ADP-A2M4CD8 and gavo-cel."

Adaptimmune 首席执行官阿德里安·罗克利夫: “我们很高兴欢迎我们的新同事加入Adaptimmune。我们将共同推进行业领先的产品线,使细胞疗法成为癌症患者的主流选择。首先是获得第一种用于实体瘤的工程化 T 细胞疗法(用于治疗滑膜肉瘤的 afami-cel)的批准,以及我们针对同时患有 ADP-A2M4CD8 和 gavo-cel 的卵巢癌患者的第 2 期试验取得进展。”

Significant Solid Tumor Opportunity

实体瘤的重大机会

  • Solid tumors represent approximately 90% of all cancers. The combined company's clinical programs targeting MAGE-A4 or mesothelin can address multiple solid tumor indications with the potential to treat ~300,000 patients per year.
  • The preclinical pipeline, including PRAME and CD70, could expand the addressable population to more than 500,000 patients per year.
  • The Company plans to complete submission of its first BLA for afami-cel for the treatment of synovial sarcoma in mid-2023. Data will be presented from the pivotal trial, SPEARHEAD-1, at ASCO demonstrating that 70% of patients with late-stage synovial sarcoma who respond to afami-cel are alive 2-years post-treatment. Link here for press release.
  • The Company has a deep pipeline with multiple late-stage products and will evaluate development priorities based on emerging data as outlined in the figure below:
  • 实体瘤约占所有癌症的90%。合并后的公司针对 MAGE-A4 或美索替林的临床项目可以解决多种实体瘤适应症,每年有可能治疗约 300,000 名患者。
  • 包括PRAME和CD70在内的临床前产品线可以将目标人群扩大到每年超过50万名患者。
  • 该公司计划在2023年中期完成其首份用于治疗滑膜肉瘤的afami-cel的BLA的提交。将公布ASCO的关键试验 SPEARHEAD-1 的数据,表明对afami-cel有反应的晚期滑膜肉瘤患者中有70%在治疗两年后还活着。点击此处链接查看新闻稿。
  • 该公司拥有多款后期产品的深度开发渠道,并将根据下图所列的新数据评估开发优先事项:


Clinical development decisions driven by data catalysts


由数据催化剂驱动的临床开发决策

Overview of strategic combination
The strategic combination was consummated on June 1, 2023. Adaptimmune shareholders own approximately 75% of the combined company and prior TCR2 stockholders own approximately 25% of the combined company.

战略组合概述
战略组合于 2023 年 6 月 1 日完成。Adaptimmune 股东拥有合并后公司和之前的 TCR 约75%的股份2 股东拥有合并后公司约25%的股份。

The combined company will continue to trade on the Nasdaq Stock Market under the symbol "[ADAP]". The combined company comprises a team of leading cell therapy experts led by Adrian Rawcliffe, the CEO of Adaptimmune. The Board of Directors is composed of three members from TCR2 and six continuing from Adaptimmune: David Mott (Chair); Andrew Allen, MD, PhD; Lawrence Alleva; Ali Behbahani, MD; John Furey; Priti Hegde, PhD, Kristen Hege, MD (as of November 1, 2023), Garry Menzel, PhD, Adrian Rawcliffe, Elliot Sigal, MD, PhD.

合并后的公司将继续在纳斯达克股票市场上交易,股票代码为 “[ADAP]”。合并后的公司由一支由Adaptimmune首席执行官阿德里安·罗克利夫领导的领先细胞疗法专家团队组成。董事会由来自 TCR 的三名成员组成2 Adaptimmune 还有六位继续:大卫·莫特(主席);安德鲁·艾伦,医学博士;劳伦斯·阿列娃;医学博士阿里·贝巴哈尼;约翰·弗里;普里蒂·黑格博士,克里斯汀·黑格,医学博士(截至2023年11月1日),加里·门泽尔博士,阿德里安·罗克利夫,艾略特·西格尔,医学博士。

Advisors
Cowen and Company LLC is serving as financial advisor to Adaptimmune and Ropes & Gray LLP is serving as legal counsel to Adaptimmune. Piper Sandler is serving as financial advisor to TCR2 and Goodwin Procter LLP is serving as legal counsel to TCR2.

顾问
Cowen and Company LLC 担任 Adaptimmune 的财务顾问,Ropes & Gray LLP 担任 Adaptimmune 的法律顾问。派珀·桑德勒担任 TCR 的财务顾问2 而且 Goodwin Procter LLP 担任 TCR 的法律顾问2

Webcast Information
The Company will host a live webcast to provide additional details at 8:00 a.m. EDT (1:00 p.m. BST) Friday, June 2, 2023. A live webcast of the conference call and replay can be accessed at . Call in information is as follows: (800)-319-4610 (US or Canada) or +1 (416)-915-3239 (International and additional options available HERE). Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.

网络直播信息
公司将于2023年6月2日星期五美国东部时间上午 8:00(英国夏令时间下午 1:00)举办网络直播,提供更多细节。可以在以下网址观看电话会议的网络直播和重播。电话信息如下:(800) -319-4610(美国或加拿大)或 +1 (416) -915-3239(此处提供国际和其他选项)。呼叫者应在预定开始时间前 5-10 分钟拨打电话,只需要求加入 Adaptimmune 通话即可。

Forward-Looking Statements
This communication includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Actual events or results may differ materially from these forward-looking statements. Words such as "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "future," "opportunity" "will likely result," "target," variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding: the business combination and related matters, including, but not limited to, prospective performance and opportunities with respect to Adaptimmune or TCR2, post-closing operations and the outlook for the companies' businesses; Adaptimmune's, TCR2's or the combined company's targets, plans, objectives or goals for future operations, including those related to Adaptimmune's and TCR2's product candidates, research and development, product candidate introductions and product candidate approvals as well as cooperation in relation thereto; projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other financial measures; future economic performance, future actions and outcomes of contingencies such as legal proceedings; and the assumptions underlying or relating to such statements.

前瞻性陈述
本通讯包括经修订的1933年《证券法》第27A条和经修订的1934年《证券交易法》(“交易法”)第21E条所指的明示或暗示的前瞻性陈述。实际事件或结果可能与这些前瞻性陈述存在重大差异。诸如 “将”、“可以”、“会”、“应该”、“期望”、“计划”、“预期”、“打算”、“相信”、“估计”、“预测”、“项目”、“潜力”、“继续”、“未来”、“机会” “很可能会产生”、“目标”、“这些词的变体,以及这些词的类似表达方式或否定词,旨在识别此类词语前瞻性陈述,尽管并非所有前瞻性陈述都包含这些识别性词语。此类前瞻性陈述的示例包括但不限于以下方面的明示或暗示陈述:业务合并及相关事项,包括但不限于与Adaptimmune或TCR相关的预期业绩和机会2,收盘后的运营和公司业务前景;Adaptimmune's,TCR2或合并后的公司未来运营的目标、计划、目的或目标,包括与 Adaptimmune 和 TCR 相关的目标、计划、目的或目标2候选产品、研发、候选产品介绍和候选产品批准以及与此相关的合作;收入、成本、收入(或亏损)、每股收益、资本支出、分红、资本结构、净财务和其他财务指标的预测或目标;未来的经济表现、未来行动和法律诉讼等突发事件的结果;以及此类陈述所依据或相关的假设。

These statements are based on Adaptimmune's and TCR2's current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: the risk that Adaptimmune and TCR2 may not realize the anticipated benefits of the transaction in the time frame expected, or at all; the effects of the transaction on relationships with Adaptimmune's or TCR2's employees, business or collaboration partners or governmental entities; the ability to retain and hire key personnel; potential adverse reactions or changes to business relationships resulting from the completion of the transaction; significant or unexpected costs, charges or expenses resulting from the transaction; the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, synergies, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the combined business; uncertainties as to the long-term value of Adaptimmune's American Depositary Shares (and the ordinary shares represented thereby), including the dilution caused by Adaptimmune's issuance of additional American Depositary Shares (and the ordinary shares represented thereby) in connection with the transaction; unknown liabilities related to Adaptimmune or TCR2; the nature, cost and outcome of any litigation and other legal proceedings involving Adaptimmune, TCR2 or their respective directors, including any legal proceedings related to the transaction; risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations; potential delays or failures related to research and/or development of Adaptimmune's or TCR2's programs or product candidates; risks related to any loss of Adaptimmune's or TCR2's patents or other intellectual property rights; any interruptions of the supply chain for raw materials or manufacturing for Adaptimmune or TCR2's product candidates, the nature, timing, cost and possible success and therapeutic applications of product candidates being developed by Adaptimmune, TCR2 and/or their respective collaborators or licensees; the extent to which the results from the research and development programs conducted by Adaptimmune, TCR2, and/or their respective collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of Adaptimmune's or TCR2's product candidates, and the impact of studies (whether conducted by Adaptimmune, TCR2 or others and whether mandated or voluntary) on any of the foregoing; unexpected breaches or terminations with respect to Adaptimmune's or TCR2's material contracts or arrangements; risks related to competition for Adaptimmune's or TCR2's product candidates; Adaptimmune's or TCR2's ability to successfully develop or commercialize Adaptimmune's or TCR2's product candidates; Adaptimmune's, TCR2's, and their collaborators' abilities to continue to conduct current and future developmental, preclinical and clinical programs; potential exposure to legal proceedings and investigations; risks related to changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing, development or commercialization of any of Adaptimmune's or TCR2's product candidates; unexpected increase in costs and expenses with respect to the transaction or Adaptimmune's or TCR2's business or operations; and risks and uncertainties related to epidemics, pandemics or other public health crises and their impact on Adaptimmune's and TCR2's respective businesses, operations, supply chain, patient enrollment and retention, preclinical and clinical trials, strategy, goals and anticipated milestones. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. A more complete description of these and other material risks can be found in Adaptimmune's filings with the U.S. Securities and Exchange Commission (the "SEC"), including Adaptimmune's Annual Report on Form 10-K for the year ended December 31, 2022, subsequent Quarterly Reports on Form 10-Q and other documents that may be filed from time to time with the SEC.

这些声明基于 Adaptimmune 和 TCR2目前的计划、估计和预测。就其本质而言,前瞻性陈述涉及固有的风险和不确定性,包括一般和具体的风险和不确定性。许多重要因素,包括本通讯中描述的因素,可能导致实际结果与任何前瞻性陈述中设想的结果存在重大差异。可能影响未来业绩并可能导致这些前瞻性陈述不准确的因素包括但不限于:Adaptimmune 和 TCR 的风险2 可能无法在预期的时间范围内实现交易的预期收益,或者根本无法实现交易的预期收益;交易对与 Adaptimmune 或 TCR 关系的影响2的员工、业务或合作伙伴或政府实体;保留和雇用关键人员的能力;交易完成对业务关系的潜在不良反应或变化;交易产生的重大或意外成本、费用或支出;不可预见的负债、未来资本支出、收入、成本、支出、收益、协同效应、经济表现、债务、财务状况和损失对未来前景、业务和管理的潜在影响合并后业务的管理、扩张和增长策略;Adaptimmune的美国存托股份(及其所代表的普通股)长期价值的不确定性,包括Adaptimmune发行与交易相关的额外美国存托股票(以及由此产生的普通股)所造成的摊薄;与Adaptimmune或TCR2相关的未知负债;涉及的任何诉讼和其他法律诉讼的性质、成本和结果 Adaptimmune、TCR2 或它们各自的董事,包括与交易相关的任何法律程序;与全球和地方政治和经济状况相关的风险,包括利率和货币汇率波动;与Adaptimmune或TCR的研发和/或开发相关的潜在延误或失败2的项目或候选产品;与 Adaptimmune 或 TCR 丢失相关的风险2的专利或其他知识产权;Adaptimmune 或 TCR 原材料或制造供应链的任何中断2候选产品、Adaptimmune 正在开发的候选产品的性质、时机、成本以及可能的成功和治疗应用,TCR2 和/或其各自的合作者或被许可人;Adaptimmune、TCR 开展的研发计划的成果在多大程度上得到了2,和/或他们各自的合作者或被许可人可能会在其他研究中被复制和/或导致候选产品进入临床试验、治疗应用或监管部门的批准;Adaptimmune或TCR的使用、市场接受度和商业成功的不确定性2的候选产品,以及研究(无论是由 Adaptimmune、TCR2 还是其他机构开展,无论是强制性还是自愿的)对上述任何内容的影响;与 Adaptimmune 或 TCR 相关的意外违规行为或终止2的重大合同或安排;与 Adaptimmune 或 TCR 的竞争相关的风险2的候选产品;Adaptimmune 或 TCR2成功开发 Adaptimmune 或 TCR 或将其商业化的能力2的候选产品;Adaptimmune、TCR2 及其合作者继续开展当前和未来的开发、临床前和临床项目的能力;可能面临法律诉讼和调查的风险;与政府法律及其相关解释的变化相关的风险,包括与报销、知识产权保护和对任何 Adaptimmune 或 TCR 的测试、批准、制造、开发或商业化的监管控制相关的风险2的候选产品;与交易或 Adaptimmune 或 TCR 有关的成本和支出意外增加2的业务或运营;以及与流行病、流行病或其他公共卫生危机相关的风险和不确定性及其对Adaptimmune和TCR的影响2各自的业务、运营、供应链、患者注册和留用、临床前和临床试验、战略、目标和预期里程碑。尽管此处列出的上述因素清单被认为具有代表性,但不应将任何清单视为所有潜在风险和不确定性的完整陈述。对这些风险和其他重大风险的更完整描述可以在Adaptimmune向美国证券交易委员会(“SEC”)提交的文件中找到,包括Adaptimmune截至2022年12月31日的10-K表年度报告、随后的10-Q表季度报告以及可能不时向美国证券交易委员会提交的其他文件。

Any forward-looking statements speak only as of the date of this communication and are made based on the current beliefs and judgments of Adaptimmune's management, and the reader is cautioned not to rely on any forward-looking statements made by Adaptimmune. Unless required by law, Adaptimmune is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this document, including without limitation any financial projection or guidance, whether as a result of new information, future events or otherwise.

任何前瞻性陈述仅代表截至本通讯发布之日,并基于Adaptimmune管理层目前的信念和判断作出,提醒读者不要依赖Adaptimmune的任何前瞻性陈述。除非法律要求,否则在本文件发布后,Adaptimmune没有义务也没有义务更新或修改任何前瞻性陈述,包括但不限于任何财务预测或指导,无论是由于新信息、未来事件还是其他原因。

Adaptimmune Contacts
Investor Relations
Juli P. Miller, Ph.D. - VP, Corporate Affairs and Investor Relations
Juli.Miller@adaptimmune.com

Adaptimmune 联系人
投资者关系
Juli P. Miller,博士——公司事务和投资者关系副总裁
Juli.Miller@adaptimmune.com

Media Relations
Dana Lynch, Senior Director of Corporate Communications
Dana.Lynch@adaptimmune.com

媒体关系
达娜·林奇,企业传播高级总监
Dana.Lynch@adaptimmune.com

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