OBX-115

Obsidian Therapeutics to focus on the advancement of its pipeline of novel engineered TIL cell therapies for the treatment of patients with solid tumors Post-transaction cash and cash equivalents of approximately $350 million expected to fund operations into 2H 2028, including NSCLC Phase 1 data expected in 1H 2027 and melanoma registration-enabling data expected year-end 2027 Shares to begin trading on Nasdaq under ticker symbol “OBX” on August 4, 2026 CAMBRIDGE, Mass.--(BUSINESS WIRE)--Obsidian Therapeutics, Inc. (“Obsidian”) (Nasdaq: OBX), a clinical-stage biopharmaceutical company harnessing novel protein-regulation technology to develop engineered tumor-infiltrating lymphocyte (TIL) cell therapies, today announced the completion of its previously announced transaction with Galera Therapeutics, Inc. (“Galera”). The combined company will operate under the name Obsidian Therapeutics, Inc., and its shares are expected to begin trading on Nasdaq on August 4, 2026 under the ticker symbol “OBX”. Prior to closing the merger, Obsidian completed a previously announced oversubscribed private placement financing of $350 million in gross proceeds from a syndicate of new investors, including Balyasny Asset Management, Caligan Partners LP, Eventide Asset Management, Nantahala Capital, Octagon Capital, Redmile, Spruce Street Capital and Trails Edge Capital Partners, and with participation from current Obsidian investors, including Atlas Venture, Deep Track Capital, Foresite Capital, Janus Henderson Investors, Logos Capital, Novo Holdings A/S, Paradigm BioCapital Advisors, Pivotal bioVenture Partners, RA Capital Management, RTW Investments, TCGX and Wellington Management, among other leading investment management firms. The combined company’s cash and cash equivalents balance at closing, including the funds from the private placement financing, is anticipated to fund the combined company’s operations into the second half of 2028 and provide runway through key clinical milestones for Obsidian’s lead product candidate, OBX-115. These include Phase 1 data from the ongoing non-small cell lung cancer (NSCLC) trial expected in the first half of 2027, and topline data from the melanoma registration-enabling trial, which are expected by year-end 2027. The combined company will also continue to support Galera’s pipeline. “The completion of the merger with Galera and closing of our $350 million private placement mark a transformative milestone that propels Obsidian into its next stage of growth,” said Madan Jagasia, M.D., Chief Executive Officer of Obsidian. “With a strong financial position backed by a syndicate of leading biotechnology investors, robust leadership team, and promising early Phase 2 clinical data from our lead product candidate, OBX-115, we are well-positioned to deliver best-in-class TIL cell therapies to patients with solid tumors. We look forward to continuing to advance OBX-115 through the clinic and we are on track to begin enrolling patients with immune checkpoint inhibitor-resistant advanced melanoma in the registration-enabling cohort of our multicenter study in mid-2026.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Obsidian leverages its cytoDRiVE ® platform to develop engineered TIL cell therapies. OBX-115 is a novel engineered TIL cell therapy armored with pharmacologically regulatable membrane-bound IL15 and designed to deliver an improved, patient-centric treatment regimen. OBX-115 has the potential to reduce overall treatment burden with the option for minimally invasive core needle biopsy tumor tissue procurement, exclusively low-dose lymphodepletion compatible with outpatient administration and elimination of IL2 in the treatment regimen. OBX-115 has been granted Fast Track and Regenerative Medicine Advanced Therapy designations from the U.S. Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma that is resistant to immune checkpoint inhibitor therapy. OBX-115 is currently in a Phase 2 clinical trial for the treatment of advanced melanoma and a Phase 1 clinical trial for the treatment of NSCLC (NCT06060613). Transaction Details Prior to the closing of the transaction, Galera effected a 1-for-200 reverse stock split of its common stock. In connection with the closing of the transaction, Galera issued a non-transferable contingent value right (a "CVR") to Galera stockholders of record as of July 31, 2026, which does not include the former holders of shares of Obsidian or the private placement investors, representing the right to receive contingent payments upon the occurrence of certain events. Pursuant to the merger agreement and based on the final exchange ratio in each of the mergers, at the closing of the mergers, former Galera stockholders own approximately 1.2%, and former Obsidian stockholders own approximately 51.6%, and investors in the concurrent financing own approximately 47.2% of the combined company’s outstanding common stock. Leerink Partners served as the exclusive financial advisor and Goodwin Procter LLP served as legal counsel to Obsidian. Leerink Partners, TD Cowen, Piper Sandler, William Blair and LifeSci Capital acted as placement agents in connection with the concurrent private placement financing. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. served as legal counsel to the placement agents. Sidley Austin LLP served as legal counsel to Galera. Lucid Capital Markets provided a fairness opinion to Galera’s Board of Directors. About Obsidian Therapeutics Obsidian Therapeutics, Inc. is a clinical-stage biopharmaceutical company harnessing novel protein-regulation technology to develop engineered TIL cell therapies for the treatment of patients with solid tumors. Obsidian’s proprietary cytoDRiVE ® technology is designed to precisely regulate the timing and level of protein function by using FDA-approved small-molecule drugs. Obsidian has offices in Cambridge and Bedford, MA. For more information, please visit . About OBX-115 Obsidian leverages its cytoDRiVE ® platform to develop engineered TIL cell therapies. Obsidian’s lead investigational TIL program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential, if approved, to become a meaningful therapeutic option for patients with advanced (unresectable or metastatic) melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process designed to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. Obsidian is investigating OBX-115 in the phase 1/2 Agni-01 multicenter trial in patients with advanced solid tumors (NCT06060613). Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, implied and express statements concerning beliefs and expectations regarding: future clinical development activities, therapeutic potential, clinical benefits and safety of our product candidates, the transaction and completion of the concurrent private placement financing, the expected effects, perceived benefits or opportunities and related timing with respect thereto, cash runway, and expectations regarding timing, progress, objectives or plans for the combined company’s development of its clinical pipeline. These forward-looking statements relate to Galera, Obsidian and the newly formed company (together, “us” or “we”), our business, prospects and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading “Risk Factors” included in Registration Statement on Form S-4 filed with the SEC on July 2, 2026 (SEC 333-295249). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise, except as required by applicable law. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: statements about the synergies or benefits of the proposed transaction, including future financial and operating results, plans, objectives, expectations and intentions; the anticipated timing of closing of the proposed transaction and the private placement financing; negative effects of the announcement or consummation of the proposed transaction on the market price of our capital stock and our operating results; risks relating to the value of shares of the newly formed company to be issued in the proposed transaction; risks related to the ability to obtain approval of the Galera stockholders; changes in capital resource requirements; risks related to our inability to obtain sufficient additional capital to continue to advance our product candidates; our and our collaborators’ ability to execute clinical programs for our product candidates; timing, progress, enrollment or results of clinical trials with our product candidates; our ability to obtain and maintain intellectual property rights and regulatory exclusivities; and our ability to establish a market for our product candidates if the combined company receives regulatory approval therefor. Contacts Inquiries: Caroline Code VP Corporate Development and Investor Relations ir@obsidiantx.com

关注无癌家园 我们战癌到底 2024年2月，美国FDA加速批准lifileucel（Amtagvi®）用于治疗晚期黑色素瘤，肿瘤浸润淋巴细胞（tumor-infiltrating lymphocyte, TIL）疗法由此成为全球首个获批的实体瘤T细胞疗法。在此之前，细胞治疗在实体瘤领域的尝试几乎全线受挫——CAR-T虽然席卷血液瘤，却在实体瘤面前步步艰难。而TIL疗法凭借其多克隆抗原识别能力和天然归巢特性，为“破冰”实体瘤提供了截然不同的思路。 两年之后，2026年上半年的两次盛会——AACR和ASCO年会上，TIL疗法不再是一个“值得关注的新方向”，而是端出了实实在在的大规模数据和获批后验证。从中国原研到美国下一代，从黑色素瘤到肺癌、软组织肉瘤，从快速制备到基因编辑，TIL正从“最后一道防线”变成“多癌种全面出击”。 图源摄图网（已授权） 技术革新：新型TIL疗法的“版本迭代” 近五年来，TIL疗法的迭代呈现出极为清晰的方向性：从天然TIL到工程化TIL，从高剂量IL-2依赖到低/无IL-2依赖，从28天培养到12天快速制备。2026年AACR和ASCO大会上，这种“版本迭代”以多个候选产品的临床数据集中呈现。 01 HS-IT101：中国原研TIL的“速度与疗效”双重突破 在2026年AACR年会上，我国自主研发的FAST-TIL（HS-IT101）Ⅰ期临床试验6个月随访数据重磅亮相，凭借“快速制备、低IL-2依赖”的突破性优势引起广泛关注。在此前披露的数据中，HS-IT101在晚期黑色素瘤患者中取得了客观缓解率50%、完全缓解率20%、疾病控制率100%的亮眼成绩，70%患者治疗后肿瘤显著缩小。 最新的6个月随访数据进一步夯实了这一临床价值：中位无进展生存期达8.4个月，中位持续缓解时间未达到，其中2例完全缓解患者已分别持续超过18个月和14个月。这一数据在当前标准治疗（不足3个月的中位PFS）面前形成了跨越性的提升。 截图源自AACR官网 FAST-TIL之所以能够实现“快速制备”，核心在于其独特的生产工艺——将TIL的培养周期从传统的28天大幅压缩至16天左右，同时降低了对高剂量IL-2给药的依赖，从而在疗效不降的前提下改善了治疗的可及性和患者耐受性。目前，HS-IT101治疗晚期黑色素瘤的关键Ⅱ期临床试验正在全国多中心全面启动，也正在加速推进产品上市进程。 02 GT201：全球首款膜结合IL-15 TIL的头颈部鳞癌突破 2026年3月31日，我国自主研发的GT201注射液获得美国FDA快速通道认定，用于治疗复发或转移性头颈部鳞状细胞癌。GT201是全球首款膜结合IL-15复合物编辑型TIL产品，通过StaViral®逆转录病毒载体平台在TIL细胞表面高表达IL-15，从而强化TIL的增殖能力、功能性细胞因子释放和肿瘤杀伤力，并在不依赖IL-2或低浓度IL-2的条件下提升TIL的长期存续和抑瘤效果。 在2026年的AACR会议上，GT201的一例典型病例数据引起轰动：一名接受GT201治疗的头颈部鳞癌患者，在TIL输注后仅3周即达到临床部分缓解，9周随访时影像学评估显示所有病灶完全消失，达到完全缓解。 GT201在头颈部鳞癌等多种晚期实体瘤中显示出优异的初步有效性信号，为传统TIL难以企及的PD-1耐药患者提供了新的治疗希望。更值得关注的是，GT201目前已在中美两地获批IND并进入Ⅰ期临床研究阶段，标志着中国原研TIL产品正式进入“中美双报”的国际竞技场。 03 OBX-115：ASCO口头报告中的明星 2026年ASCO年会上，OBX-115无疑是TIL领域最受瞩目的口头报告之一。OBX-115是一种新型工程化自体TIL细胞疗法，其核心创新在于通过药理学调控的膜结合IL-15（mbIL15）“武装”TIL细胞，增强其体内持久性、抗肿瘤活性和临床安全性。此外，OBX-115独有的差异化生产工艺消除了对高剂量IL-2给药的需求——传统TIL疗法中高剂量IL-2是主要的毒性来源，此突破直接改善了治疗的耐受性。 在Immuno-01的Ⅱ期数据显示，OBX-115在既往接受过免疫检查点抑制剂治疗后进展的晚期黑色素瘤患者中，确认客观缓解率达40%，疾病控制率达80%，中位持续缓解时间（mDOR）未达到。值得注意的是，该数据是在不依赖高剂量IL-2给药的条件下获得的，安全谱显著改善。这些发现于2026年ASCO年会口头报告中正式公布，为该领域带来了关键临床验证。 如何寻求TIL细胞治疗>> 目前无癌家园有TILs免疫细胞临床试验正在招募中，急招黑色素瘤、宫颈癌患者，除此之外，也招募非小细胞肺癌、子宫内膜癌、乳腺癌，卵巢癌等实体瘤。 有意向的患者若想参加可整理出完整的病理报告、治疗经历、出院小结等再致电无癌家园医学部（400-626-9916），详细评估病情。 临床数据：Lifileucel / Amtagvi的“第二战场”全面铺开 Lifileucel（Amtagvi®）作为全球首个获批上市的TIL疗法，其上市后在2026年的拓展数据是TIL领域最受关注的“晴雨表”。从黑色素瘤到非小细胞肺癌，从软组织肉瘤到真实世界验证，lifileucel在AACR和ASCO前后密集释放数据，展现了TIL作为“平台技术”在多个癌种中的广阔前景。 01 黑色素瘤：真实世界数据巩固“best-in-class”地位 2026年2月，Iovance公布了lifileucel在晚期黑色素瘤患者中的真实世界临床研究数据。在41例可评估患者中，确认的客观缓解率为44%，疾病控制率为73%。更为关键的是，更早线治疗组的疗效显著优于后线治疗组：在既往接受过≤2线治疗的患者中，ORR达52%，而在≥3线治疗的患者中ORR降至33%。这一趋势提示：TIL疗法的获益在疾病更早期介入时更为显著。 相比支持FDA加速批准的C-144-01临床试验中31%的ORR，真实世界的44%实现了“反超”——这在肿瘤治疗领域极为罕见，通常真实世界数据会因患者异质性而劣于受控临床试验。 Amtagvi当前是全球首个获批用于实体瘤的一站式T细胞疗法，也是唯一经FDA批准的用于既往接受过抗PD-1治疗和靶向治疗（如适用）的晚期黑色素瘤患者的治疗选项。 02 非小细胞肺癌：历史性突破 2026年最令人振奋的TIL临床数据之一，来自Lifileucel在非鳞状非小细胞肺癌（non-squamous NSCLC）中的Ⅱ期IOV-LUN-202试验。该试验的关键疗效数据为：在39例可评估患者中，客观缓解率为25.6%（10例），其中包括2例完全缓解和7例部分缓解，疾病控制率达71.8%。在中位随访25.4个月后，中位持续缓解时间尚未达到——“持久性”成为lifileucel在这一人群中最突出的标签。 该试验入组的是既往接受过化疗和免疫检查点抑制剂治疗、且不存在EGFR、ROS1或ALK驱动基因突变的NSCLC患者。对于这一群体而言，现有治疗选择的客观缓解率和持久性均非常有限。 IOV-LUN-202试验预计将支持lifileucel针对非鳞状NSCLC的补充生物制品许可申请，有望在2027年下半年迎来NSCLC领域首个TIL疗法的上市。 03 软组织肉瘤：填补“无药可治”的空缺 软组织肉瘤是实体瘤中预后极差的亚型之一。2026年2月，Iovance发表了lifileucel在晚期软组织肉瘤患者中的早期探索性临床研究数据。在首批6例可评估患者中，经研究者确认的客观缓解率达到50%，且安全性表现良好。相比该类肿瘤二线治疗历史数据中不足5%的客观缓解率，这一数据堪称“量级飞跃”。 考虑到软组织肉瘤多亚型、高异质性和低应答率的临床困境，lifileucel的这一初步信号极为可贵。公司表示，与监管机构的讨论正在推进，如果结果持续显示临床获益，注册试验可能于2026年启动。该拓展标志着TIL疗法可能在黑色素瘤和NSCLC之外，开辟第三个具有注册潜力的实体瘤适应症。 患者TIL治疗典型病例 01 病例一：Emma Dimery——晚期结肠癌患者，十年抗争后肿瘤完全消失 2026年2月发表于《Lancet》上的一名近十年病史的晚期结肠癌患者Emma Dimery的治疗故事，她在传统治疗手段均告失败后入组了明尼苏达大学的首次人体CRISPR基因编辑TIL临床试验。在接受了单次基因编辑TIL输注后，她的肿瘤完全消失，迄今保持缓解状态，并且入选TIME2026全球健康影响力100榜单。 02 病例二：GT201治疗头颈部鳞癌——3周病灶显著缩小，9周完全缓解 一名接受沙砾生物GT201治疗的头颈部鳞癌患者在TIL输注后仅3周影像学评估即显示病灶显著缩小（达部分缓解）；9周随访时所有病灶完全消失，达到完全缓解。 03 HS-IT101——70%患者肿瘤显著缩小，CR持续超过18个月 FAST-TIL（HS-IT101）治疗晚期黑色素瘤，Ⅰ期数据显示客观缓解率50%、完全缓解率20%、疾病控制率100%。其中2例CR患者完全缓解已分别持续超过18个月和14个月，70%患者治疗后肿瘤显著缩小。 哪些人适合TIL治疗？ 目前TIL疗法主要聚焦于一线或二线标准治疗失败、没有更好选择的“后线”患者。但一个明确的趋势是，TIL疗法正在研究用于更前线的治疗，以及用于术后高危患者的复发预防。 从癌种来看，TIL疗法对所谓的“免疫热肿瘤”效果更为明显。这些肿瘤往往是病毒相关或突变较多，易于被免疫系统识别。典型的“热肿瘤”包括： 黑色素瘤 宫颈癌（大部分为鳞癌，与HPV病毒感染相关） 头颈鳞癌 非小细胞肺癌 肝癌 三阴性乳腺癌 手术后TIL细胞存储 对于某些复发风险极高、但当前没有实施TIL治疗指征的患者，可以考虑在手术时提前将部分肿瘤组织进行单细胞悬液或TIL细胞的冻存。这类似于“储存生命种子”，一旦未来疾病复发且符合治疗条件，即可直接复苏制备，避免了再次手术取材的困难。 具体的方法和冻存流程大家可以致电无癌家园医学部（400-626-9916）进行详情咨询。 结语：从“谈癌色变”迈向“慢病管理” TIL疗法为传统治疗耐药后的患者提供了新选择，特别是其“存储”理念，为复发高危患者提前布局了治疗策略。随着国内TIL临床研究的全面开花，我们有理由相信，未来将会有更多新药问世，让肿瘤治疗真正进入“慢病管理”时代。 本文为无癌家园原创，转载需授权 参考文献 1.https://www.aacrmeetingnews.org/wednesday-morning-plenary-session-will-examine-innovative-cancer-treatment-modalities/?utm_content=buffer182e4&utm_medium=social&utm_source=bsky&utm_campaign=Comms 2.https://www.abstractsonline.com/pp8/#!/21436/presentation/9817 3.https://synapse.patsnap.com/drug/80eb26f3aafe422ba0ca202afef76317 4.https://www.geneonline.com/aacr-2026-car-t-cell-therapies-complex-immunotherapies/ 如果您对于目前的治疗方案有疑问，或者想要咨询更合适的治疗方案，请联系无癌家园医学部（400-626-9916）申请国际会诊。 免疫治疗国际专家推荐 无癌家园提醒癌友们 国内细胞免疫治疗技术，包括CAR-T细胞（除上市的CAR-T外）、树突细胞疫苗、NK细胞、TILs细胞（除上市的TILs外）、TCR-T细胞（除上市的TCR-T外）、癌症疫苗等技术均处于临床试验阶段，未获准在医院正式使用。国内患者可以参加正规临床试验，在医生的监管下使用，无癌家园网不推荐患者冒然尝试任何医疗机构和研发机构的收费治疗。 无癌家园 抗癌资讯｜新技术｜新药研发｜权威专家 热门细胞疗法 细胞疗法相关文章 Review past  ▶▶▶ 1.8周肿瘤病灶完全消失！我国首例TILs疗法癌症治愈出现！国研多款疗法厚积薄发！ 2.肿瘤病灶接近完全缓解！NK细胞疗法联合化疗、靶向治疗晚期胰腺癌疗效惊艳！ 3.横扫33种癌症！最长生存期延长35个月！肿瘤免疫新贵γδT细胞主攻肺癌、肝癌等癌！ 4.肿瘤完全缓解！TILs细胞疗法竟能调动全身免疫军团对抗“红颜杀手”宫颈癌！ 5.370万天价TILs细胞疗法来袭！用自身免疫细胞杀灭实体瘤！手术前、标准治疗失败后更需关注！ 6. 20款抗癌新药冲刺2025年医保！5款百万细胞疗法上桌，肺癌、乳腺癌等患者有救了！ 分享、收藏、点赞、在看安排一下？