CAMBRIDGE, Mass.--(BUSINESS WIRE)--Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today provided an update on its Phase 1 first-in-human study of OBX-115 tumor-infiltrating lymphocyte (TIL) cell therapy in patients with advanced or metastatic melanoma, including 25-week median study follow-up safety data and newly detailed efficacy data, during a presentation at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA.

马萨诸塞州剑桥市。-（商业新闻短讯）--临床阶段生物技术公司Obsidian Therapeutics，Inc.，一家开创工程细胞和基因疗法的公司，今天在加利福尼亚州圣地亚哥美国癌症研究协会（AACR）年会上的一次演讲中，提供了其关于晚期或转移性黑色素瘤患者OBX-115肿瘤浸润淋巴细胞（TIL）细胞疗法的第一阶段人体研究的最新进展，包括25周的中位研究随访安全性数据和最新详细的疗效数据。

The poster, “OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy induced deepening and durable responses without interleukin 2 (IL2) in patients with immune checkpoint inhibitor (ICI)-resistant unresectable or metastatic melanoma,” was presented by Rodabe N. Amaria, M.D., professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center and principal investigator of the study..

海报“OBX-115工程化肿瘤浸润淋巴细胞（TIL）细胞疗法在免疫检查点抑制剂（ICI）耐药的不可切除或转移性黑色素瘤患者中诱导了无白细胞介素2（IL2）的加深和持久反应”，由德克萨斯大学MD安德森癌症中心黑色素瘤医学肿瘤学教授兼该研究的主要研究者Rodabe N.Amaria医学博士介绍。。

The single-center study (NCT05470283) is evaluating the safety, tolerability, dosing, and efficacy of OBX-115 in patients with ICI-resistant metastatic melanoma. All 6 patients had disease that was primary-resistant to anti–PD-1 therapy, with a median of 2.5 (range, 1–5) lines of prior therapy.

单中心研究（NCT05470283）正在评估OBX-115在ICI耐药转移性黑色素瘤患者中的安全性，耐受性，剂量和疗效。所有6例患者均患有抗PD-1治疗的原发性耐药疾病，先前治疗的中位数为2.5（范围1-5）。

OBX-115 was well-tolerated with a differentiated safety profile from non-engineered TIL cell therapy, which utilizes high-dose IL2:

OBX-115具有良好的耐受性，与非工程化TIL细胞疗法具有不同的安全性，该疗法利用高剂量IL2：

No dose-limiting toxicities were observed

没有观察到剂量限制性毒性

No Grade 4 or higher non-hematologic events were reported and 2 patients experienced limited Grade 3 events

没有报告4级或更高级别的非血液学事件，2名患者经历了有限的3级事件

No confirmed events of cytokine release syndrome, capillary leak syndrome, or ICANS were reported

没有确诊的细胞因子释放综合征、毛细血管渗漏综合征或ICANS事件的报道

OBX-115 induced consistently deepening and durable responses:

OBX-115引起持续加深和持久的反应：

50% objective response rate and 33% complete response rate using investigator-assessed RECIST 1.1 criteria

使用研究者评估的RECIST 1.1标准，客观缓解率为50%，完全缓解率为33%

All patients experienced tumor burden reduction and meaningful disease control for ≥12 weeks after infusion

输注后≥12周，所有患者均经历了肿瘤负荷减轻和有意义的疾病控制

All patients were alive and median PFS had not been reached, with 6-month PFS of 67%

所有患者均存活，中位PFS尚未达到，6个月PFS为67%

Dr. Amaria stated, “The clinical safety and efficacy data from the first 6 patients treated with OBX-115 are promising and demonstrate a meaningful objective response rate. The results are particularly encouraging since OBX-115 is the first engineered TIL cell therapy not requiring IL2 co-administration.

Amaria博士表示：“前6名接受OBX-115治疗的患者的临床安全性和有效性数据很有希望，并显示出有意义的客观缓解率。结果特别令人鼓舞，因为OBX-115是第一种不需要IL2共同给药的工程化TIL细胞疗法。

OBX-115 has the potential to drive durable responses in patients with ICI-resistant metastatic melanoma, without the well-described toxicity associated with IL2.”.

OBX-115有可能驱动ICI耐药转移性黑色素瘤患者的持久反应，而没有与IL2相关的良好描述的毒性。”。

“We are highly encouraged by the promising OBX-115 data being shared today, which not only clinically validate Obsidian’s cytoDRiVE technology, but also demonstrate that OBX-115, with its positively differentiated safety profile, has the potential to further expand eligibility for TIL cell therapy and comprehensively address the unmet need in ICI-resistant advanced melanoma,” commented Parameswaran Hari, M.D., Chief Development Officer of Obsidian..

黑曜石首席开发官Parameswaran Hari医学博士评论道：“我们对今天共享的有前景的OBX-115数据感到非常鼓舞，这些数据不仅在临床上验证了黑曜石的细胞驱动技术，而且还证明了OBX-115具有积极差异的安全性，有可能进一步扩大TIL细胞治疗的资格，并全面解决ICI耐药晚期黑色素瘤未满足的需求。”。。

In addition to the first-in-human study, Obsidian is actively enrolling patients with metastatic melanoma and NSCLC at multiple sites in its ongoing Phase 1/2 multicenter study. Additional details may be found at clinicaltrials.gov, using identifier: NCT06060613.

除了第一项人体内研究外，黑曜石还在其正在进行的1/2期多中心研究中积极招募多个部位的转移性黑色素瘤和非小细胞肺癌患者。其他详细信息可以在clinicaltrials.gov上找到，使用标识符：NCT06060613。

Obsidian also has 3 other poster presentations at AACR 2024:

在2024年AACR上，黑曜石还有另外3张海报展示：

Title: Trial in progress: A Phase 1/2 study to investigate the safety and efficacy of OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy in patients (pts) with immune checkpoint inhibitor (ICI)-resistant advanced or metastatic melanoma

标题：正在进行的试验：一项1/2期研究，旨在研究OBX-115工程化肿瘤浸润淋巴细胞（TIL）细胞治疗对免疫检查点抑制剂（ICI）耐药的晚期或转移性黑色素瘤患者（pts）的安全性和有效性

Presenting Author: Sajeve S Thomas, Orlando Health Cancer Institute, Orlando, FL

演示作者：萨杰夫·托马斯，奥兰多健康癌症研究所，佛罗里达州奥兰多

Title: Tumor-infiltrating lymphocytes (TIL) engineered with membrane-bound IL15 (cytoTIL15 cells) exhibit pharmacologically regulatable signal transduction in cis and trans

标题：用膜结合的IL15（cytoTIL15细胞）工程化的肿瘤浸润淋巴细胞（TIL）在顺式和反式中表现出药理学可调节的信号转导

Presenting Author: Rachel Burga, Obsidian Therapeutics, Inc., Cambridge, MA

演示作者：Rachel Burga，黑曜石治疗公司，马萨诸塞州剑桥

Title: Tumor-infiltrating lymphocytes (TIL) engineered with regulatable membrane-bound IL15 (mbIL15) and LIGHT (TNFSF14) show enhanced efficacy in fibroblast-containing cold tumors

标题：用可调节的膜结合IL15（mbIL15）和LIGHT（TNFSF14）工程化的肿瘤浸润淋巴细胞（TIL）在含成纤维细胞的冷肿瘤中显示出增强的功效

Presenting Author: Balazs Koscso, Obsidian Therapeutics, Inc., Cambridge, MA

演示作者：Balazs Koscso，Obsidian Therapeutics，Inc.，剑桥，马萨诸塞州

About OBX-115

关于OBX-115

Obsidian’s lead investigational cytoTIL15™ 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 to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy.

黑曜石首席研究cytoTIL15™计划OBX-115是一种新型工程化肿瘤衍生的自体T细胞免疫疗法（肿瘤浸润淋巴细胞（TIL）细胞疗法），由药理学可调节的膜结合IL15（mbIL15）包裹。OBX-115有可能成为晚期或转移性黑色素瘤和其他实体瘤患者的有意义的治疗选择，通过利用mbIL15和黑曜石专有的差异化制造工艺的预期益处来增强TIL细胞疗法的持久性，抗肿瘤活性和临床安全性。

OBX-115 is being investigated in 2 ongoing and enrolling clinical trials in advanced or metastatic melanoma and NSCLC (NCT05470283 and NCT06060613)..

OBX-115正在进行2项正在进行的晚期或转移性黑色素瘤和非小细胞肺癌临床试验（NCT05470283和NCT06060613）的研究。。

About Obsidian Therapeutics

关于黑曜石疗法

Obsidian Therapeutics, Inc. is a clinical-stage biotechnology company pioneering engineered cell and gene therapies to deliver transformative outcomes for patients with intractable diseases. 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 Therapeutics，Inc.是一家临床阶段生物技术公司，开创了工程细胞和基因疗法的先河，为难治性疾病患者提供了变革性的结果。黑曜石专有的cytoDRiVE®技术旨在通过使用FDA批准的小分子药物精确调节蛋白质功能的时间和水平。

Obsidian is headquartered in Cambridge, MA. The Company has collaborations with Bristol Myers Squibb and Vertex Pharmaceuticals.

黑曜石总部位于马萨诸塞州剑桥。该公司与百时美施贵宝和Vertex制药公司合作。

英文链接：https://obsidiantx.com/news-releases/obsidian-therapeutics-presents-positive-25-week-median-study-follow-up-safety-and-efficacy-data-from-first-in-human-study-of-obx-115-in-advanced-melanoma-at-the-american-association-for-cancer-rese/#:~:text=CAMBRIDGE%2C