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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.

馬薩諸塞州劍橋市陶店。-（商業(yè)新聞短訊）--臨床階段生物技術公司Obsidian Therapeutics，Inc.谊某，一家開創(chuàng)工程細胞和基因療法的公司灼烫，今天在加利福尼亞州圣地亞哥美國癌癥研究協(xié)會（AACR）年會上的一次演講中暖释，提供了其關于晚期或轉移性黑色素瘤患者OBX-115腫瘤浸潤淋巴細胞（TIL）細胞療法的第一階段人體研究的最新進展修暑，包括25周的中位研究隨訪安全性數據和最新詳細的療效數據泽艘。

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..

海報“OBX-115工程化腫瘤浸潤淋巴細胞（TIL）細胞療法在免疫檢查點抑制劑（ICI）耐藥的不可切除或轉移性黑色素瘤患者中誘導了無白細胞介素2（IL2）的加深和持久反應”缘厢，由德克薩斯大學MD安德森癌癥中心黑色素瘤醫(yī)學腫瘤學教授兼該研究的主要研究者Rodabe N.Amaria醫(yī)學博士介紹保礼。沛励。

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.

單中心研究（NCT05470283）正在評估OBX-115在ICI耐藥轉移性黑色素瘤患者中的安全性，耐受性氓英，劑量和療效侯勉。所有6例患者均患有抗PD-1治療的原發(fā)性耐藥疾病鹦筹，先前治療的中位數為2.5（范圍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具有良好的耐受性以睦，與非工程化TIL細胞療法具有不同的安全性泌醋，該療法利用高劑量IL2：

No dose-limiting toxicities were observed

沒有觀察到劑量限制性毒性

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

沒有報告4級或更高級別的非血液學事件，2名患者經歷了有限的3級事件

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

沒有確診的細胞因子釋放綜合征滤钠、毛細血管滲漏綜合征或ICANS事件的報道

OBX-115 induced consistently deepening and durable responses:

OBX-115引起持續(xù)加深和持久的反應：

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

使用研究者評估的RECIST 1.1標準赌拒，客觀緩解率為50%，完全緩解率為33%

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

輸注后≥12周祠裸，所有患者均經歷了腫瘤負荷減輕和有意義的疾病控制

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

所有患者均存活贵郎，中位PFS尚未達到，6個月PFS為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治療的患者的臨床安全性和有效性數據很有希望眶昵，并顯示出有意義的客觀緩解率蒂轨。結果特別令人鼓舞，因為OBX-115是第一種不需要IL2共同給藥的工程化TIL細胞療法拔衙。

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有可能驅動ICI耐藥轉移性黑色素瘤患者的持久反應檩榕，而沒有與IL2相關的良好描述的毒性∷ǖ荆”关揣。

“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..

黑曜石首席開發(fā)官Parameswaran Hari醫(yī)學博士評論道：“我們對今天共享的有前景的OBX-115數據感到非常鼓舞，這些數據不僅在臨床上驗證了黑曜石的細胞驅動技術土辩，而且還證明了OBX-115具有積極差異的安全性支救，有可能進一步擴大TIL細胞治療的資格，并全面解決ICI耐藥晚期黑色素瘤未滿足的需求拷淘「髂”。启涯。

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.

除了第一項人體內研究外欲主，黑曜石還在其正在進行的1/2期多中心研究中積極招募多個部位的轉移性黑色素瘤和非小細胞肺癌患者。其他詳細信息可以在clinicaltrials.gov上找到逝嚎，使用標識符：NCT06060613。

Obsidian also has 3 other poster presentations at AACR 2024:

在2024年AACR上详恼，黑曜石還有另外3張海報展示：

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

標題：正在進行的試驗：一項1/2期研究补君，旨在研究OBX-115工程化腫瘤浸潤淋巴細胞（TIL）細胞治療對免疫檢查點抑制劑（ICI）耐藥的晚期或轉移性黑色素瘤患者（pts）的安全性和有效性

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

演示作者：薩杰夫·托馬斯，奧蘭多健康癌癥研究所昧互，佛羅里達州奧蘭多

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

標題：用膜結合的IL15（cytoTIL15細胞）工程化的腫瘤浸潤淋巴細胞（TIL）在順式和反式中表現出藥理學可調節(jié)的信號轉導

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

演示作者：Rachel Burga挽铁，黑曜石治療公司，馬薩諸塞州劍橋

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

標題：用可調節(jié)的膜結合IL15（mbIL15）和LIGHT（TNFSF14）工程化的腫瘤浸潤淋巴細胞（TIL）在含成纖維細胞的冷腫瘤中顯示出增強的功效

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

演示作者：Balazs Koscso机凭，Obsidian Therapeutics迟伤，Inc.窖升，劍橋，馬薩諸塞州

About OBX-115

關于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?計劃OBX-115是一種新型工程化腫瘤衍生的自體T細胞免疫療法（腫瘤浸潤淋巴細胞（TIL）細胞療法）娘型，由藥理學可調節(jié)的膜結合IL15（mbIL15）包裹呕瞎。OBX-115有可能成為晚期或轉移性黑色素瘤和其他實體瘤患者的有意義的治療選擇，通過利用mbIL15和黑曜石專有的差異化制造工藝的預期益處來增強TIL細胞療法的持久性铝矢，抗腫瘤活性和臨床安全性婉肆。

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

OBX-115正在進行2項正在進行的晚期或轉移性黑色素瘤和非小細胞肺癌臨床試驗（NCT05470283和NCT06060613）的研究。跪消。

About Obsidian Therapeutics

關于黑曜石療法

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衰惜，Inc.是一家臨床階段生物技術公司，開創(chuàng)了工程細胞和基因療法的先河准魁，為難治性疾病患者提供了變革性的結果挤夕。黑曜石專有的cytoDRiVE?技術旨在通過使用FDA批準的小分子藥物精確調節(jié)蛋白質功能的時間和水平。

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

黑曜石總部位于馬薩諸塞州劍橋卤竭。該公司與百時美施貴寶和Vertex制藥公司合作沪么。

英文鏈接：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