Letetresgene autoleucel

本文翻译自科睿唯安旗下 BioWorld 新闻： Cancer stocks rebound, outpacing broader markets in Q3 2025 • BioWorld 癌症指数 (BCI) 在 2025 年第三季度 (Q3) 收盘时上涨 24.15%，创下年内最高水平。此次上涨扭转了早前的跌势，包括第一季度末下跌 12.81%，以及半年业绩为 2.21%。大盘也呈现类似的反弹势头，纳斯达克生物技术指数上涨 13.21%，道琼斯工业平均指数上涨 9.06%，两者在第三季度末均收于 2025 年的最高点。 由于并购 (M&A)，BCI 在第三季度有四家公司发生变动： Blueprint Medicines Corp. 被 Sanofi SA 以 95 亿美元的价格收购。该交易为 Sanofi 带来了一款处于商业化阶段、具有准重磅炸弹潜力的罕见病免疫疗法，以及一款 II/III 期后续候选药物和另一款处于中期阶段的自身免疫资产。 Cargo Therapeutics Inc. 被 Concentra Biosciences LLC 收购，Cargo 成为其全资子公司。 Tuhura Biosciences Inc. 是一家专注于克服癌症免疫疗法耐药性的 III 期免疫肿瘤学公司，该公司收购了 Kineta Inc.。该交易将 II 期就绪的 VISTA 抑制性单克隆抗体 TBS-2025（前称 KVA-1213）加入到 Tuhura 的管线中。 Springworks Therapeutics Inc. 被 Merck KGaA 以每股 47 美元的现金交易收购，该公司总部位于康涅狄格州斯坦福，公司股权价值约 39 亿美元，或根据年终现金计算的企业价值为 34 亿美元。该价格较 Springworks 截至 2 月 7 日的 20 日平均股价 37.38 美元溢价 26%。 被纳入指数以替代已被收购公司的企业：Day One Biopharmaceuticals Inc.、Kura Oncology Inc.、Recursion Pharmaceuticals Inc. 和 Relay Therapeutics Inc.。 在第三季度，BCI 中上涨股占主导地位，有 22 只股票上涨，仅 7 只股价下跌。在该三个月期间，指数中表现最佳的公司为 Olema Pharmaceuticals Inc.（上涨 130%）、Coherus Biosciences Inc.（上涨 125%）、Verastem Inc.（上涨 113%）、Terns Pharmaceuticals Inc.（上涨 102%）、Cellectis SA（上涨 86%）、Atara Biotherapeutics Inc.（上涨 85%）、Puma Biotechnology Inc.（上涨 55%）、Kura Oncology Inc.和Karyopharm Therapeutics Inc.（均上涨 53%）、Relay Therapeutics Inc.（上涨 51%）以及 Genelux Corp.（上涨 46%）。 第三季度 BCI 跌幅最大的公司是 Adaptimmune Therapeutics plc（下跌 46%）、Beyondspring Inc.（下跌 23%）、Mural Oncology plc（下跌 17%）和 Agenus Inc.（下跌 15%）。 BioWorld 癌症指数 注：历年数据请查看原文链接 Olema 第三季度股价上涨 得益于管线进展和试验更新 Olema Pharmaceuticals 是第三季度 BCI 中涨幅最大的公司，该季度股价上涨 130%。这家总部位于旧金山的公司于 8 月 12 日公布了 2025 年第二季度财报，其股价上涨 16%，收于 5.31 美元。公司重点介绍了 Palazestrant (pala) 联合 Ribociclib (ribo) 的临床进展，更新的数据将于 10 月在 ESMO 上公布。H.C. Wainwright 的 Emily Bodnar 指出，该数据集将包含超出 2025 年 2 月截止日期后约六个月的额外数据。在入组的 62 例患者中，有 24 例仍在研究中，其中包括 14 例未使用过 CDK4/6 抑制剂的患者。在总人群和接受过 CDK4/6i 治疗的组中，中位无进展生存期 (PFS) 均已超过 13 个月，由于近 40% 的患者仍在接受治疗，因此该数据仍有进一步改善的可能。结果优于其他口服 SERD 联合疗法，Bodnar 写道，分析师认为“pala + ribo 联合疗法在包括 ESR1 突变型 (ESR1m) 和 ESR1 野生型 (ESR1wt) 患者在内的不同患者亚型中，显示出与同类药物相比可能具有差异化的疗效特征，预示着公司计划于 2025 年第三季度启动的 III 期 (OPERA-02) 潜在 1L 联合疗法前景良好。” 公司其他新闻： III 期 OPERA-02 试验计划于 2025 年第三季度启动，将在约 1,000 例一线 ER+/HER2-转移性乳腺癌患者中，检验 pala 90 mg 联合 ribo 与来曲唑联合 Ribociclib 的疗效。主要终点是研究者评估的无进展生存期，次要终点包括总生存期、总缓解率、安全性和患者报告结局。分层将考虑绝经状态、内脏疾病以及复发与新发病例。Novartis 将提供 ribo，并在获得顶线结果后拥有优先谈判权。 Olema 将 OPERA-01 顶线数据的发布指引更新至 2026 年下半年。该 III 期试验 (n=510) 分为两部分：第 1 部分将 120 例患者随机分配至 90 mg 或 120 mg Palazestrant 组与标准治疗 (SOC) 内分泌疗法组，以选择剂量；第 2 部分将在 390 例 2L/3L ER+/HER2-转移性乳腺癌患者中测试所选的 90 mg 剂量。尽管之前大多数患者接受的是 120 mg 剂量，但 FDA 建议评价 90 mg 剂量，理由是该剂量在暴露量和疗效相似的情况下，可能降低胃肠道 (GI) 毒性。 Olema 正在为 OP-3136 的 I/II 期试验 (n=90) 招募患者，该试验针对 ER+/HER2-转移性乳腺癌、转移性去势抵抗性前列腺癌和晚期非小细胞肺癌，初步数据预计于 2026 年公布。剂量递增阶段将测试最多五个剂量水平，然后选择推荐剂量。根据 Bodnar 的说法，计划的联合用药方案包括 OP-3136 与氟维司群、Palazestrant 的联合用药，以及 Palazestrant 联合 Ribociclib 的三联疗法，这些策略可以产生“管线协同效应，并提供差异化的特征”。 Olema 报告 2025 年第二季度运营亏损 4,790 万美元，即每股亏损 52 美分。与 2025 年第一季度相比，支出有所增加，主要原因是向 Aurigene 支付了 1,000 万美元的研发里程碑付款，这与 OP-3136 进入 I/II 期临床试验有关；下一个里程碑付款要到关键性试验时才会支付。排除该一次性成本，随着 III 期 Palazestrant 试验、III 期 OPERA-02 启动和 OP-3136 开发的持续招募，预计 2025 年下半年支出将增长。全年运营支出预计为 1.719 亿美元。截至 2025 年第二季度末，Olema 拥有 3.619 亿美元现金，可支持公司运营至 2027 年下半年。 Terns 有望从日益增长的 GLP-1 和 THR-β 需求中获益 Terns Pharmaceuticals 在第三季度上涨 102%，其中包括 9 月 18 日上涨 11%。次日，Mizuho Securities USA 分析师 Graig Suvannavejh 重申了“跑赢大盘”的评级和 14 美元的目标价，理由是行业动态更新对 Terns（总部位于 Foster City，California）有利。其中包括礼来公司 (Eli Lilly and Co.) 的 Orforglipron 的积极数据、诺和诺德公司 (Novo Nordisk AG) 的 Ozempic（司美格鲁肽）的新心血管结果，以及罗氏制药 (Roche AG) 宣布以 35 亿美元收购 89bio Inc.。Suvannavejh 写道：“随着肥胖领域的积极势头持续，以及我们看来 NASH/MASH 领域的情绪和兴趣似乎正在改善，我们认为 TERN 凭借其 TERN-601（一种口服 GLP-1）和 TERN-501（一种口服 THR-β 激动剂）处于理想的受益位置，”他们认为这些资产对潜在合作伙伴具有战略价值。 Atara 因 tab-cel 预期和 超预期盈利在第三季度上涨 Atara Biotherapeutics 在第三季度跃升 85%，其中包括在 8 月 12 日发布第二季度财报后上涨 12%。H.C. Wainwright 分析师 Robert Burns 指出，投资者对 Atara 的关注点集中在 Tabelecleucel (tab-cel) 的 2026 年 1 月 10 日《处方药使用者付费法案》 (PDUFA) 日期上。重新提交的生物制品许可申请 (BLA) 旨在为成人和 2 岁及以上儿童 Epstein-Barr 病毒阳性移植后淋巴增殖性疾病患者寻求批准，这些患者既往至少一种治疗失败。该申请得到了来自超过 430 例患有危及生命疾病的患者数据的支持，其中包括关键的 Allele 试验结果，该结果显示客观缓解率为 48.8% (p<0.0001)。FDA 的批准将触发 Pierre Fabre 支付的 4,000 万美元里程碑付款，以及两位数的分级特许权使用费和额外的商业里程碑付款。 Atara（总部位于 Oaks，California）公布 2025 年第二季度每股净收益为 19 美分，远超 Wainwright 预测的每股亏损 4.04 美元。营收达到 1,760 万美元，而早前预估为 20 万美元，这促使公司将 2025 年全年指引更新为每股净收益 1.72美元，而此前的预测为每股亏损 8.41 美元。该公司本季度末拥有 2,230 万美元的现金和现金等价物。然而，尽管 tab-cel 的业绩和开发进展有所改善，Wainwright 仍维持“中性”评级，未设定目标价，理由是对近期的投资案例信心有限。 Adaptimmune 在出售 资产后股价跌至历史低点 7 月 28 日，在宣布将向美国 Worldmeds 出售其细胞疗法，包括 Tecelra (afamitresgene autoleucel)、lete-cel、afami-cel 和 uza-cel 后，Adaptimmune Therapeutics plc 的股价暴跌 71%，收于 10 美分。根据于 8 月完成的资产购买协议条款，美国  Worldmeds 在交易完成时支付了 5,500 万美元现金，并将根据商业和监管成果支付最高达 3,000 万美元的绩效里程碑付款。位于美国费城和英国牛津的 Adaptimmune 保留了其临床前项目的权利，包括 PRAME 和 CD70 靶向的 T 细胞疗法，以及其异体细胞疗法管线。   //   本文翻译自科睿唯安旗下 BioWorld 新闻： Cancer stocks rebound, outpacing broader markets in Q3 2025 点击文末阅读原文查看英文版 产品推介 BioWorld™ 是行业领先的一站式生物医药行业资讯平台，专注于为处于研发阶段的最具创新性的药物和医疗技术提供切实可行的情报。 扫码申请免费试用 产品咨询： Lulice.zhao@Clarivate.com +86 21 2026 8063 推荐阅读 关于科睿唯安 科睿唯安是全球领先的变革性资讯提供商。我们提供丰富的数据、洞见、工作流解决方案和专业服务，涵盖学术研究和政府机构，知识产权、生命科学与健康各个领域。如需了解更多信息，请访问www.clarivate.com.cn 敬请关注 科睿唯安生命科学与制药微信公众号 “科睿唯安生命科学与制药”微信公众号与本文作者对本文的全部内容以及可能附带的全部资料拥有全部知识产权，并受法律保护。网络转载请注明作者及内容来源。 商业合作请联系： lulice.zhao@clarivate.com +86 21 2026 8063

Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - October 20, 2025) - Adaptimmune Therapeutics plc (NASDAQ: ADAP) ("Adaptimmune" or the "Company") today announced that the Company's Board of Directors (the "Board") has determined to initiate the delisting of its American Depositary Shares ("ADSs"), each representing six ordinary shares, from The Nasdaq Capital Market ("Nasdaq") and deregistration under Section 12(b) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Adrian Rawcliffe, Adaptimmune's Chief Executive Officer: "As we noted previously, the transaction with USWM CT, LLC, a subsidiary of US WorldMeds Partners, LLC (collectively, "US WorldMeds") followed an extensive review of strategic alternatives and represented the best path forward for Adaptimmune, our patients and other stakeholders. Since closing the transaction on July 31, 2025, we have been restructuring to support the assets transferred to US WorldMeds, and have continued our efforts to maximize value from our remaining assets including programs targeting PRAME and CD70. The delisting from Nasdaq and deregistration should facilitate cost reductions and further support our goal to maximize value going forward." As previously reported by the Company, the Company received a written notice on September 22, 2025, from the Nasdaq Hearings Panel (the "Panel") confirming that the Company had been granted an exception period to regain compliance with Nasdaq Listing Rule 5550(a)(2), which requires a minimum bid price of $1.00 per share (the "Bid Price Rule"). The Company had until December 1, 2025 to regain compliance with the Bid Price Rule. Failure to regain compliance by December 1, 2025 would result in the delisting of the Company's ADSs from Nasdaq. On October 16, 2025, the Company notified The Nasdaq Stock Market, LLC, pursuant to authorization by the Board on October 15, 2025, that it intends to file a Form 25 with the U.S. Securities and Exchange Commission (the "SEC") on or about October 28, 2025 to effect the voluntary delisting of the Company's ADSs from Nasdaq and to deregister the ADSs under Section 12(b) of the Exchange Act. Following confirmation by The Nasdaq Stock Market, LLC on October 17, 2025, the Company currently expects that the trading of its ADSs on Nasdaq will be suspended following the closing of trading on Nasdaq on or about October 27, 2025. Following the delisting, any trading in the Company's ADSs would only occur in privately negotiated sales and potentially on an over-the-counter market. The Company currently expects that its ADSs will be quoted on the OTC Pink Limited Market, a market operated by OTC Markets Group Inc. (an "OTC market"), so that a trading market may continue to exist for its ADSs. There is no guarantee, however, that a broker will continue to make a market in the ADSs and that trading of the ADSs will continue on an OTC market or otherwise. Ninety days after the date of filing of the Form 25, the deregistration of the Company's ADSs under Section 12(b) of the Exchange Act is expected to become effective. Following the delisting of the Company's ADSs from Nasdaq, the Company intends to file a Form 15 with the SEC certifying that it has fewer than 300 shareholders of record, upon which the Company's filing obligations under the Exchange Act will immediately be suspended, including the obligations to file all periodic reports. The Board believes that the decision to delist the ADSs from Nasdaq and deregister and suspend the Company's reporting obligations under the Exchange Act is in the best interests of the Company and the holders of its ordinary shares and ADSs. As the Company continues with its efforts to maximize value from its remaining assets, the Board has determined that the burdens associated with operating as a registered public company listed on Nasdaq outweigh any advantages to the Company and the holders of its ordinary shares and ADSs. The Board's decision was based on careful review of numerous factors, including the potential for eliminating the significant costs associated with preparing and filing periodic reports with the SEC and the legal, audit and other expenses associated with being a public reporting company listed on Nasdaq, as well as the substantial costs and demands on management's time under the Sarbanes-Oxley Act of 2002, SEC rules and Nasdaq listing standards. About Adaptimmune We are a biopharmaceutical company working to redefine the treatment of solid tumor cancers with cell therapies. In August 2024, the U.S. Food and Drug Administration ("FDA") approved our first biologics license application ("BLA") for TECELRA® (afamitresgene autoleucel) ("TECELRA"), which is the first engineered T-cell therapy for the treatment of a solid tumor cancer approved in the U.S. In July 2025, TECELRA was acquired by US WorldMeds alongside letetresgene autoleucel ("lete-cel"), for people with synovial sarcoma and myxoid liposarcoma, in relation to which a commercial launch was planned for 2026. A third clinical candidate, uza-cel, and the collaboration with Galapagos related to that cell therapy was also assigned to US Worldmeds as part of the transaction. We are working to ensure a smooth transition of TECELRA, lete-cel and uza-cel to US WorldMeds. We have also developed certain pre-clinical assets including our PRAME directed T-cell therapy and our CD-70 directed TRuC therapy. We are looking for strategic options in relation to these assets. Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Exchange Act. Forward-looking statements address our expected future business, financial performance, financial condition, as well as the results of operations and often contain words such as "anticipate" "believe," "expect," "may," "plan," "potential," "will," and similar expressions. Such statements are based only upon current expectations of Adaptimmune. Reliance should not be placed on these forward-looking statements because they involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: risks associated with, and the timing and effectiveness of, the Company's voluntary delisting from Nasdaq; the Company's plans with respect to the delisting and deregistration of its ADSs; uncertainties regarding eligibility for and timing of quotation on an OTC market; and the trading of the Company's ADSs following the voluntary delisting of the ADSs from Nasdaq. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Annual Report on Form 10-K filed with the Securities and Exchange Commission for the year ended December 31, 2024, our Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances. Adaptimmune Contact Investor Relations and Media Relations Adrian Rawcliffe, Chief Executive Officer Adrian.Rawcliffe@adaptimmune.com To view the source version of this press release, please visit https://www.newsfilecorp.com/release/271003 SOURCE Adaptimmune Therapeutics PLC Released October 20, 2025