SAN DIEGO--(BUSINESS WIRE)--MBrace Therapeutics, Inc. (“MBrace”), a clinical-stage biopharmaceutical company devoted to improving the lives of cancer patients through the development of antibody-drug conjugates (ADCs) against novel oncology targets, today announced new preclinical data supporting ongoing development for lead investigational ADC therapeutic, MBRC-101, at the San Antonio Breast Cancer Symposium taking place December 5-9, 2023, in San Antonio, Texas..

圣地亚哥——（商业新闻短讯）——MBrace Therapeutics，Inc.（“MBrace”）是一家临床阶段的生物制药公司，致力于通过开发针对新型肿瘤学靶标的抗体-药物偶联物（ADC）来改善癌症患者的生活，今天宣布了新的临床前数据，支持正在进行的主要研究性ADC治疗剂MBRC-101的开发，2023年12月5日至9日在德克萨斯州圣安东尼奥举行的圣安东尼奥乳腺癌研讨会上。。

“The data presented today further characterize the safety and activity of MBRC-101 and support its potential to effectively treat various solid tumors, including difficult-to-treat breast cancers,” said Isan Chen, M.D., co-founder, president and chief executive officer at MBrace. “We are advancing our clinical evaluation of MBRC-101 in breast cancer, as well as for patients with other EphA5-expressing solid tumor cancers for whom there is a significant need for targeted treatment options.”.

MBrace联合创始人、总裁兼首席执行官Isan Chen医学博士说：“今天提供的数据进一步表征了MBRC-101的安全性和活性，并支持其有效治疗各种实体瘤（包括难治性乳腺癌）的潜力。”。“我们正在推进MBRC-101在乳腺癌以及其他表达EphA5的实体瘤癌症患者中的临床评估，这些患者迫切需要有针对性的治疗选择。”。

MBRC-101 is composed of a humanized anti-EphA5 IgG1 antibody conjugated to monomethyl auristatin E (MMAE). In the data presented today, robust and selective EphA5 expression was detected in greater than 80% of triple negative breast cancer (TNBC) and greater than 80% of HR+ breast cancer tissue samples.

MBRC-101由与单甲基auristatin E（MMAE）缀合的人源化抗EphA5 IgG1抗体组成。在今天提供的数据中，在超过80%的三阴性乳腺癌（TNBC）和超过80%的HR+乳腺癌组织样本中检测到稳健且选择性的EphA5表达。

EphA5 expression was not detected in adjacent, non-malignant breast tissue or normal breast..

在邻近的非恶性乳腺组织或正常乳腺中未检测到EphA5表达。。

Additionally, extensive in vitro testing showed that MBRC-101 binds to EphA5 exclusively, is rapidly internalized and is cytotoxic to cells expressing EphA5. Dramatic preclinical efficacy was observed in vivo, with weekly administration of intravenous MBRC-101 showing dose-dependent, robust, and reproducible anti-tumor activity in patient-derived xenograft murine models of TNBC.

此外，广泛的体外测试表明，MBRC-101仅与EphA5结合，迅速内化，对表达EphA5的细胞具有细胞毒性。在体内观察到显着的临床前疗效，每周静脉注射MBRC-101在TNBC患者来源的异种移植小鼠模型中显示出剂量依赖性，强大且可重复的抗肿瘤活性。

In addition, in preclinical models MBRC-101 was well tolerated at doses ranging from 10 mg/kg to 30 mg/kg. Toxicologic findings were attributed to the MMAE payload and not target-related. The highest non-severely toxic dose (HNSTD) was 10 mg/kg (HED = 3.2 mg/kg). At a dosage of 0.5 mg/kg, the safety margin was approximated at 15-fold based on projected human exposures..

此外，在临床前模型中，MBRC-101在10 mg/kg至30 mg/kg的剂量范围内具有良好的耐受性。毒理学发现归因于MMAE有效载荷，与靶标无关。最高非严重毒性剂量（HNSTD）为10 mg/kg（HED=3.2 mg/kg）。在0.5 mg/kg的剂量下，根据预计的人体暴露量，安全裕度约为15倍。。

The data presented are the results of research conducted both by MBrace, as well as in the laboratories of MBrace co-founders, Renata Pasqualini, Ph.D., Professor at Rutgers Cancer Institute of New Jersey and Chief of the Division of Cancer Biology at Rutgers New Jersey Medical School; and Wadih Arap, M.D., Ph.D., Professor and Chief of the Division of Hematology/Oncology and Director of the Rutgers Cancer Institute of New Jersey at University Hospital..

所提供的数据是由MBrace以及MBrace联合创始人Renata Pasqualini博士，新泽西州罗格斯癌症研究所教授和罗格斯大学新泽西医学院癌症生物学系主任进行的研究结果；和Wadih Arap，医学博士，博士，教授，血液学/肿瘤学系主任，新泽西大学医院罗格斯癌症研究所主任。。

Details of the poster presentation are as follows:

海报展示详情如下：

Abstract Title: MBRC-101: a novel antibody-drug conjugate (ADC) targeting the membrane-associated tyrosine kinase receptor EphA5 in breast cancer

摘要标题：MBRC-101：靶向乳腺癌中膜相关酪氨酸激酶受体EphA5的新型抗体-药物偶联物（ADC）

Presenter: Fernanda Staquicini, Ph.D., Director of Research & Development, MBrace Therapeutics

主持人：Fernanda Staquicini博士，MBrace Therapeutics研发总监

Presentation ID: P03-18-04

演示ID：P03-18-04

Spotlight Session: Poster Session 3

聚光灯会议：海报会议3

Session Date and Time: Thursday, December 7, 12:00 PM – 2:00 PM CST

Session Date and Time: Thursday, December 7, 12:00 PM – 2:00 PM CST

Location: Henry B. Gonzalez Convention Center, San Antonio, Texas

地点：德克萨斯州圣安东尼奥市亨利·B·冈萨雷斯会议中心

Published Abstract Number: 1580268

出版摘要编号：1580268

The poster is also available on the MBrace Therapeutics website at www.mbractetrx.com.

海报也可以在MBrace Therapeutics网站www.mbractetrx.com上找到。

About MBRC-101

关于MBRC-101

MBRC-101 is an investigational antibody drug conjugate (ADC) that uniquely targets the EphA5 receptor tyrosine kinase, which is present in multiple cancers including, but not limited to, breast, non-small cell lung (NSCLC), colorectal, gastric, and pancreatic cancers. MBRC-101 is currently being evaluated in the MBRC-101-001 Phase 1 clinical trial, a first-in-human, open-label, multi-center, dose escalation and dose expansion study enrolling patients with advanced metastatic solid tumors refractory to standard-of-care treatment.

MBRC-101是一种研究性抗体-药物偶联物（ADC），其独特靶向EphA5受体酪氨酸激酶，其存在于多种癌症中，包括但不限于乳腺癌，非小细胞肺癌（NSCLC），结直肠癌，胃癌和胰腺癌。MBRC-101目前正在MBRC-101-001第一阶段临床试验中进行评估，这是一项首次在人体内，开放标签，多中心，剂量递增和剂量扩展研究，招募标准治疗难治的晚期转移性实体瘤患者。

For more information about the MBRC-101-001 clinical trial and to review patient eligibility criteria visit clinicaltrials.gov (NCT06014658)..

有关MBRC-101-001临床试验的更多信息以及审查患者资格标准，请访问clinicaltrials.gov（NCT06014658）。。

About MBrace Therapeutics

关于Membrace Therapeutics

MBrace is a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutic agents for patients with cancer. MBrace develops innovative treatments for cancer patients by developing novel antibody-drug conjugates using the SPARTA technology pioneered by its founders.

MBrace是一家临床阶段制药公司，专注于为癌症患者开发和商业化新型治疗药物。MBrace通过使用其创始人开创的SPARTA技术开发新型抗体-药物偶联物，为癌症患者开发了创新的治疗方法。

MBrace is headquartered in San Diego, CA, with research facilities at The Thomas O. Daniel Research Incubator in Summit, NJ. For additional information, please visit MBrace’s website at www.mbracetrx.com..

MBrace总部位于加利福尼亚州圣地亚哥，在新泽西州萨米特的托马斯·丹尼尔研究孵化器拥有研究设施。有关更多信息，请访问MBrace的网站www.mbracetrx.com。。