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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 宣佈完成與 TCR2 Therapeutics 的戰略合併,創建一家卓越的實體瘤細胞療法公司
newsfile ·  2023/06/01 15:29

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

首次上市用於實體瘤的工程化 T 細胞療法;afami-cel 的 BLA 有望在 2023 年中期完成申請

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

針對 MAGE-A4 和美索替林的後期項目提供令人信服的臨床數據

Preclinical programs targeting PRAME and CD70 in IND-enabling studies

在支持IND的研究中針對PRAME和CD70的臨床前項目

Adaptimmune funded into early 2026 with multiple value creating catalysts

Adaptimmune 的資金將持續到 2026 年初,採用多種創造價值的催化劑

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.

賓夕法尼亞州費城和英國牛津--(Newsfile Corp.,2023年6月1日)——Adaptimmune Therapeutics plc(納斯達克股票代碼:ADAP)今天宣佈完成一項全股交易,在該交易中,Adaptimmune與TCR2 Therapeutics Inc.(納斯達克股票代碼:TCRR)合併,創建了一家治療實體瘤的卓越的T細胞療法公司。

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 的主要臨床特許經營權使用針對 MAGE-A4 和間皮素的工程 T 細胞療法,這些療法在各種實體瘤上表達。這些細胞療法的使用得到了包括晚期滑膜肉瘤結果在內的令人信服的臨床數據的支持,這些數據將構成公司於2023年年中完成的首份BLA申報的基礎。該公司可以獲得增強的 “下一代工具箱” 和擴展的臨床前產品線,最初的開發重點是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 首席執行官阿德里安·羅克利夫: “我們很高興歡迎我們的新同事加入Adaptimmune。我們將共同推進行業領先的產品線,使細胞療法成爲癌症患者的主流選擇。首先是獲得第一種用於實體瘤的工程化 T 細胞療法(用於治療滑膜肉瘤的 afami-cel)的批准,以及我們針對同時患有 ADP-A2M4CD8 和 gavo-cel 的卵巢癌患者的第 2 期試驗取得進展。”

Significant Solid Tumor Opportunity

實體瘤的重大機會

  • 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:
  • 實體瘤約佔所有癌症的90%。合併後的公司針對 MAGE-A4 或美索替林的臨床項目可以解決多種實體瘤適應症,每年有可能治療約 300,000 名患者。
  • 包括PRAME和CD70在內的臨床前產品線可以將目標人羣擴大到每年超過50萬名患者。
  • 該公司計劃在2023年中期完成其首份用於治療滑膜肉瘤的afami-cel的BLA的提交。將公佈ASCO的關鍵試驗 SPEARHEAD-1 的數據,表明對afami-cel有反應的晚期滑膜肉瘤患者中有70%在治療兩年後還活着。點擊此處鏈接查看新聞稿。
  • 該公司擁有多款後期產品的深度開發渠道,並將根據下圖所列的新數據評估開發優先事項:


Clinical development decisions driven by data catalysts


由數據催化劑驅動的臨床開發決策

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.

戰略組合概述
戰略組合於 2023 年 6 月 1 日完成。Adaptimmune 股東擁有合併後公司和之前的 TCR 約75%的股份2 股東擁有合併後公司約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.

合併後的公司將繼續在納斯達克股票市場上交易,股票代碼爲 “[ADAP]”。合併後的公司由一支由Adaptimmune首席執行官阿德里安·羅克利夫領導的領先細胞療法專家團隊組成。董事會由來自 TCR 的三名成員組成2 Adaptimmune 還有六位繼續:大衛·莫特(主席);安德魯·艾倫,醫學博士;勞倫斯·阿列娃;醫學博士阿里·貝巴哈尼;約翰·弗裏;普里蒂·黑格博士,克里斯汀·黑格,醫學博士(截至2023年11月1日),加里·門澤爾博士,阿德里安·羅克利夫,艾略特·西格爾,醫學博士。

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.

顧問
Cowen and Company LLC 擔任 Adaptimmune 的財務顧問,Ropes & Gray LLP 擔任 Adaptimmune 的法律顧問。派珀·桑德勒擔任 TCR 的財務顧問2 而且 Goodwin Procter LLP 擔任 TCR 的法律顧問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.

網絡直播信息
公司將於2023年6月2日星期五美國東部時間上午 8:00(英國夏令時間下午 1:00)舉辦網絡直播,提供更多細節。可以在以下網址觀看電話會議的網絡直播和重播。電話信息如下:(800) -319-4610(美國或加拿大)或 +1 (416) -915-3239(此處提供國際和其他選項)。呼叫者應在預定開始時間前 5-10 分鐘撥打電話,只需要求加入 Adaptimmune 通話即可。

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.

前瞻性陳述
本通訊包括經修訂的1933年《證券法》第27A條和經修訂的1934年《證券交易法》(“交易法”)第21E條所指的明示或暗示的前瞻性陳述。實際事件或結果可能與這些前瞻性陳述存在重大差異。諸如 “將”、“可以”、“會”、“應該”、“期望”、“計劃”、“預期”、“打算”、“相信”、“估計”、“預測”、“項目”、“潛力”、“繼續”、“未來”、“機會” “很可能會產生”、“目標”、“這些詞的變體,以及這些詞的類似表達方式或否定詞,旨在識別此類詞語前瞻性陳述,儘管並非所有前瞻性陳述都包含這些識別性詞語。此類前瞻性陳述的示例包括但不限於以下方面的明示或暗示陳述:業務合併及相關事項,包括但不限於與Adaptimmune或TCR相關的預期業績和機會2,收盤後的運營和公司業務前景;Adaptimmune's,TCR2或合併後的公司未來運營的目標、計劃、目的或目標,包括與 Adaptimmune 和 TCR 相關的目標、計劃、目的或目標2候選產品、研發、候選產品介紹和候選產品批准以及與此相關的合作;收入、成本、收入(或虧損)、每股收益、資本支出、分紅、資本結構、淨財務和其他財務指標的預測或目標;未來的經濟表現、未來行動和法律訴訟等突發事件的結果;以及此類陳述所依據或相關的假設。

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.

這些聲明基於 Adaptimmune 和 TCR2目前的計劃、估計和預測。就其本質而言,前瞻性陳述涉及固有的風險和不確定性,包括一般和具體的風險和不確定性。許多重要因素,包括本通訊中描述的因素,可能導致實際結果與任何前瞻性陳述中設想的結果存在重大差異。可能影響未來業績並可能導致這些前瞻性陳述不準確的因素包括但不限於:Adaptimmune 和 TCR 的風險2 可能無法在預期的時間範圍內實現交易的預期收益,或者根本無法實現交易的預期收益;交易對與 Adaptimmune 或 TCR 關係的影響2的員工、業務或合作伙伴或政府實體;保留和僱用關鍵人員的能力;交易完成對業務關係的潛在不良反應或變化;交易產生的重大或意外成本、費用或支出;不可預見的負債、未來資本支出、收入、成本、支出、收益、協同效應、經濟表現、債務、財務狀況和損失對未來前景、業務和管理的潛在影響合併後業務的管理、擴張和增長策略;Adaptimmune的美國存托股份(及其所代表的普通股)長期價值的不確定性,包括Adaptimmune發行與交易相關的額外美國存托股票(以及由此產生的普通股)所造成的攤薄;與Adaptimmune或TCR2相關的未知負債;涉及的任何訴訟和其他法律訴訟的性質、成本和結果 Adaptimmune、TCR2 或它們各自的董事,包括與交易相關的任何法律程序;與全球和地方政治和經濟狀況相關的風險,包括利率和貨幣匯率波動;與Adaptimmune或TCR的研發和/或開發相關的潛在延誤或失敗2的項目或候選產品;與 Adaptimmune 或 TCR 丟失相關的風險2的專利或其他知識產權;Adaptimmune 或 TCR 原材料或製造供應鏈的任何中斷2候選產品、Adaptimmune 正在開發的候選產品的性質、時機、成本以及可能的成功和治療應用,TCR2 和/或其各自的合作者或被許可人;Adaptimmune、TCR 開展的研發計劃的成果在多大程度上得到了2,和/或他們各自的合作者或被許可人可能會在其他研究中被複制和/或導致候選產品進入臨床試驗、治療應用或監管部門的批准;Adaptimmune或TCR的使用、市場接受度和商業成功的不確定性2的候選產品,以及研究(無論是由 Adaptimmune、TCR2 還是其他機構開展,無論是強制性還是自願的)對上述任何內容的影響;與 Adaptimmune 或 TCR 相關的意外違規行爲或終止2的重大合同或安排;與 Adaptimmune 或 TCR 的競爭相關的風險2的候選產品;Adaptimmune 或 TCR2成功開發 Adaptimmune 或 TCR 或將其商業化的能力2的候選產品;Adaptimmune、TCR2 及其合作者繼續開展當前和未來的開發、臨床前和臨床項目的能力;可能面臨法律訴訟和調查的風險;與政府法律及其相關解釋的變化相關的風險,包括與報銷、知識產權保護和對任何 Adaptimmune 或 TCR 的測試、批准、製造、開發或商業化的監管控制相關的風險2的候選產品;與交易或 Adaptimmune 或 TCR 有關的成本和支出意外增加2的業務或運營;以及與流行病、流行病或其他公共衛生危機相關的風險和不確定性及其對Adaptimmune和TCR的影響2各自的業務、運營、供應鏈、患者註冊和留用、臨床前和臨床試驗、戰略、目標和預期里程碑。儘管此處列出的上述因素清單被認爲具有代表性,但不應將任何清單視爲所有潛在風險和不確定性的完整陳述。對這些風險和其他重大風險的更完整描述可以在Adaptimmune向美國證券交易委員會(“SEC”)提交的文件中找到,包括Adaptimmune截至2022年12月31日的10-K表年度報告、隨後的10-Q表季度報告以及可能不時向美國證券交易委員會提交的其他文件。

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.

任何前瞻性陳述僅代表截至本通訊發佈之日,並基於Adaptimmune管理層目前的信念和判斷作出,提醒讀者不要依賴Adaptimmune的任何前瞻性陳述。除非法律要求,否則在本文件發佈後,Adaptimmune沒有義務也沒有義務更新或修改任何前瞻性陳述,包括但不限於任何財務預測或指導,無論是由於新信息、未來事件還是其他原因。

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

Adaptimmune 聯繫人
投資者關係
Juli P. Miller,博士——公司事務和投資者關係副總裁
Juli.Miller@adaptimmune.com

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

媒體關係
達娜·林奇,企業傳播高級總監
Dana.Lynch@adaptimmune.com

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