In an ongoing Phase 1 trial published in Nature Medicine, MB-101 was well-tolerated and 50% of patients achieved stable disease or better with two partial responses and two complete responses lasting 7.5 and 66+ months, respectively

在《自然医学》发表的正在进行的1期试验中，MB-101耐受性良好，50%的患者病情稳定或更好，其中两例部分缓解，两例完全缓解，分别持续7.5个月和66个月以上。

Preclinical data support a novel combination of MB-101 (IL13Rα2‐targeted CAR-T cell therapy) and MB-108 (HSV-1 oncolytic virus) to optimize clinical results

临床前数据支持将MB-101（靶向IL13Rα2的CAR-T细胞疗法）与MB-108（HSV-1溶瘤病毒）这一新型组合用于优化临床结果。

FDA previously granted Orphan Drug Designation to Mustang for MB-108 for the treatment of malignant glioma

FDA先前授予Mustang公司的MB-108孤儿药资格，用于治疗恶性胶质瘤。

WORCESTER, Mass., July 07, 2025 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell therapies into potential cures for difficult-to-treat cancers, today announced that the U.S.

伍斯特，马萨诸塞州，2025年7月7日（环球新闻社）——Mustang Bio公司（“Mustang”或“公司”）（纳斯达克：MBIO），一家专注于将当今细胞疗法的医学突破转化为潜在治愈难治性癌症的临床阶段生物制药公司，今天宣布，美国。

Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to Mustang for MB-101 (IL13Ra2-targeted CAR T-cells) for the treatment of recurrent diffuse and anaplastic astrocytoma (astrocytomas) and glioblastoma (GBM)..

美国食品药品监督管理局（“FDA”）已授予Mustang公司的MB-101（靶向IL13Ra2的CAR T细胞）孤儿药资格，用于治疗复发性弥漫性和间变性星形细胞瘤（星形细胞瘤）以及胶质母细胞瘤（GBM）。

The FDA grants Orphan Drug Designation to drugs and biologics that are intended for safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain incentives, such as tax credits toward the cost of clinical trials upon approval and prescription drug user fee waivers.

美国食品药品监督管理局（FDA）授予用于安全有效治疗、诊断或预防在美国影响不到20万人的罕见疾病或病症的药物和生物制品孤儿药资格。获得孤儿药资格可享有某些激励措施，例如在批准后可获得临床试验费用的税收抵免以及处方药用户费用的豁免。

If a product receives Orphan Drug Status from the FDA, that product is entitled to seven years of market exclusivity for the disease in which it has Orphan Drug designation, which is independent from intellectual property protection..

如果一个产品获得FDA的孤儿药资格，该产品将享有七年的市场独占期，针对其获得孤儿药认定的疾病，这一独占期独立于知识产权保护。

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “We are thrilled that MB-101 received Orphan Drug Designation on time and with a designation that is broader than the indication proposed. The Orphan Drug Designation for MB-101, coupled with the Orphan Drug Designation granted previously for MB-108, is strong validation for our science, as we hope to advance MB-101, in combination with MB-108, as a potential treatment option for patients living with malignant glioma, including patients with recurrent glioblastoma (“GBM”) and high-grade astrocytomas.

穆斯塔格公司的总裁兼首席执行官曼努埃尔·利奇曼医学博士表示：“我们非常高兴MB-101按时获得了孤儿药资格认定，并且其认定范围比所提出的适应症更为广泛。MB-101的孤儿药资格认定，加上此前授予MB-108的孤儿药资格认定，为我们的科学提供了强有力的验证。我们希望能够将MB-101与MB-108联合作为一种潜在的治疗选择，用于治疗恶性胶质瘤患者，包括复发性胶质母细胞瘤（‘GBM’）和高级别星形细胞瘤患者。”

Our novel therapeutic strategy, combining our MB-101 CAR-T cell therapy with our MB-108 oncolytic virus, leverages MB-108 to reshape the tumor microenvironment (“TME”) to make cold tumors “hot,” thereby potentially improving the efficacy of MB-101 CAR-T cell therapy. This progress demonstrates our dedication to exploring new possibilities for improving outcomes in patients with challenging-to-treat cancers.”.

我们的新型治疗策略，将我们的MB-101 CAR-T细胞疗法与我们的MB-108溶瘤病毒相结合，利用MB-108重塑肿瘤微环境（“TME”），使“冷”肿瘤变为“热”肿瘤，从而可能提高MB-101 CAR-T细胞疗法的疗效。这一进展展示了我们致力于探索改善难治癌症患者预后的可能性。

As previously reported, preclinical data presented at the American Association for Cancer Research (“AACR”) Annual Meeting in 2022 supported a combination therapy to potentially optimize results to treat recurrent GBM. The combination leverages MB-108 to reshape the TME and make cold tumors “hot,” thereby potentially improving the efficacy of MB-101 CAR-T cell therapy.

此前报道显示，2022年美国癌症研究协会（“AACR”）年会上展示的临床前数据支持采用一种联合疗法来优化治疗复发性GBM的效果。该联合疗法利用MB-108重塑肿瘤微环境（TME），将“冷”肿瘤转化为“热”肿瘤，从而可能提高MB-101 CAR-T细胞疗法的疗效。

Data presented separately on MB-101 and MB-108 showed that administration of these therapies was well tolerated in recurrent GBM patients. As reported in City of Hope’s 2024 .

分别针对MB-101和MB-108提供的数据显示，这些治疗在复发性GBM患者中具有良好的耐受性。正如希望之城在2024年所报道的。

Nature Medicine

自然医学

paper, 2 patients treated solely with MB-101 who had high levels of intratumoral CD3+ T cells pre-therapy (i.e., “hot” tumors) achieved complete responses lasting 7.5 and 66+ months, respectively. Importantly, of the 57 City of Hope Phase 1 patients evaluable for survival in that paper, these 2 complete responses were observed in the cohort of 3 patients with the “hottest” tumors prior to treatment with MB-101.

论文中提到，2名仅接受MB-101治疗且治疗前肿瘤内CD3+ T细胞水平较高的患者（即“热”肿瘤）分别达到了持续7.5个月和66个月以上的完全缓解。重要的是，在该论文中可评估生存期的57名希望之城1期患者中，这2例完全缓解出现在治疗前肿瘤最“热”的3名患者队列中。

Phase 1 clinical trials of MB-101 at City of Hope and of MB-108 at The University of Alabama at Birmingham continue to enroll patients..

希望之城的MB-101一期临床试验和伯明翰阿拉巴马大学的MB-108一期临床试验继续招募患者。

The Company’s ability to further develop the MB-109 program for recurrent GBM and high-grade astrocytomas is contingent upon raising additional funding and / or consummating a strategic partnership.

公司进一步开发用于复发性GBM和高级别星形细胞瘤的MB-109项目的能力取决于筹集额外资金和/或达成战略合作伙伴关系。

About MB-109 (MB-101 (IL13Rα2

关于MB-109（MB-101（IL13Rα2）

targeted CAR-T cells) + MB-108 oncolytic virus)

靶向CAR-T细胞）+ MB-108溶瘤病毒）

MB-109 is Mustang’s designation for the treatment regimen combining MB-101 (IL13Rα2‐targeted CAR-T cell therapy licensed from City of Hope) with MB-108 (HSV-1 oncolytic virus licensed from Nationwide Children’s Hospital). The combination is designed to leverage MB-108 to make cold tumors “hot” and potentially improve the efficacy of MB-101 CAR-T cell therapy.

MB-109是Mustang公司对结合MB-101（从希望之城授权的IL13Rα2靶向CAR-T细胞疗法）与MB-108（从 Nationwide Children’s Hospital 授权的HSV-1溶瘤病毒）的治疗方案的命名。该组合旨在利用MB-108将“冷”肿瘤转化为“热”肿瘤，并可能提高MB-101 CAR-T细胞疗法的疗效。

MB-108 oncolytic virus is first injected to infect tumor cells which, in turn, leads to reshaping of the TME through recruitment of endogenous CD8- and CD3-positive effector T-cells. This inflamed TME potentially permits MB-101 CAR-T cells injected into and around the tumor to better infiltrate into and throughout the tumor mass, undergo activation and, ideally, effect tumor cell killing..

MB-108溶瘤病毒首先被注射以感染肿瘤细胞，这反过来通过招募内源性CD8阳性和CD3阳性效应T细胞来重塑肿瘤微环境（TME）。这种发炎的肿瘤微环境可能使注入和围绕肿瘤的MB-101 CAR-T细胞更好地浸润到肿瘤组织中并贯穿整个肿瘤块，经历激活，并理想地实现肿瘤细胞杀伤。

About Mustang Bio

关于野马生物

Mustang Bio, Inc. is a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell therapies into potential cures for difficult-to-treat cancers. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market.

穆斯塔格生物公司是一家处于临床阶段的生物制药公司，专注于将当今细胞治疗领域的医学突破转化为潜在的难治性癌症治疗方法。穆斯塔格旨在通过许可或获取所有权权益来获得这些技术的权利，为研发提供资金，并将技术进行转许可或推向市场。

Mustang has partnered with top medical institutions to advance the development of CAR-T therapies. Mustang’s common stock is registered under the Securities Exchange Act of 1934, as amended, and Mustang files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). Mustang was founded by Fortress Biotech, Inc.

Mustang 已与顶级医疗机构合作，以推进 CAR-T 疗法的开发。Mustang 的普通股已根据修订后的《1934 年证券交易法》注册，并且 Mustang 会定期向美国证券交易委员会（“SEC”）提交报告。Mustang 由 Fortress Biotech, Inc. 创立。