SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that it has entered into an exclusive worldwide license agreement with Sanofi for three clinical-stage masked T-cell engagers (TCEs) and exclusive use of the protease-cleavable masking platform for oncology and infectious diseases, acquired by Sanofi from Amunix Pharmaceuticals.

旧金山--（商业新闻短讯）--Vir Biotechnology，Inc.（纳斯达克：Vir）今天宣布，它已与赛诺菲签订了一项全球独家许可协议，用于三种临床阶段掩盖的T细胞接受者（TCE），并独家使用赛诺菲从Amunix Pharmaceuticals收购的蛋白酶可切割掩蔽肿瘤和传染病平台。

The clinical-stage assets include SAR446309 (AMX-818), a dual-masked HER2-targeted TCE; SAR446329 (AMX-500), a dual-masked PSMA-targeted TCE; and SAR446368 (AMX-525), a dual-masked EGFR-targeted TCE. Sanofi’s proprietary masking platform can be applied to TCEs, cytokines, and other molecules by exploiting the intrinsically high protease activity of the tumor microenvironment to specifically activate drugs in tumor tissues.

临床阶段资产包括SAR446309（AMX-818），一种双重掩蔽的HER2靶向TCE；SAR446329（AMX-500），一种双屏蔽PSMA靶向TCE；和SAR446368（AMX-525），一种双重掩蔽的EGFR靶向TCE。赛诺菲专有的掩蔽平台可以通过利用肿瘤微环境固有的高蛋白酶活性来特异性激活肿瘤组织中的药物，从而应用于TCE，细胞因子和其他分子。

The selective activation of the molecules in the tumor microenvironment potentially increases the therapeutic index (TI) and mitigates toxicities associated with the systemic immune activation seen with traditional TCEs..

肿瘤微环境中分子的选择性激活可能会增加治疗指数（TI），并减轻与传统TCE所见的全身免疫激活相关的毒性。。

'At Vir, the cornerstone of our commitment is and always will be patient-centered, with the aim to advance transformative medicines for patients facing severe diseases with unmet medical needs. Despite recent innovation in cancer therapeutics, the prognosis for many patients remains poor and treatment-associated toxicity is a major problem,' said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer.

“在Vir，我们承诺的基石是并将始终以患者为中心，旨在为面临严重疾病且医疗需求未得到满足的患者推进变革性药物。Vir首席执行官、医学博士、MBA玛丽安·德巴克（MarianneDeBacker）说，尽管最近在癌症治疗方面有所创新，但许多患者的预后仍然很差，与治疗相关的毒性是一个主要问题。

Sanofi’s masking platform has yielded three promising clinical-stage TCE programs:

赛诺菲的掩蔽平台产生了三个有前途的临床阶段TCE计划：

SAR446309 is a dual-masked HER2xCD3 TCE in Phase 1 clinical study including participants with metastatic treatment resistant HER2+ tumors such as breast and colorectal cancers. Increasing the TI through this proprietary dual masking may allow for both monotherapy and combinations with checkpoint inhibitors..

SAR446309是一项在1期临床研究中的双重掩蔽HER2xCD3 TCE，包括患有转移性治疗耐药HER2+肿瘤（如乳腺癌和结直肠癌）的参与者。通过这种专有的双重掩蔽增加TI可能允许单一疗法和与检查点抑制剂的组合。。

SAR446329 is a dual-masked PSMAxCD3 TCE in Phase 1 clinical study including participants with metastatic castration-resistant prostate cancer. Increasing the TI through this proprietary dual masking may allow for both monotherapy and combinations.

SAR446329是1期临床研究中的双重掩蔽PSMAxCD3 TCE，包括转移性去势抵抗性前列腺癌的参与者。通过这种专有的双重掩蔽增加TI可能允许单一疗法和组合疗法。

SAR446368 is a dual-masked EGFRxCD3 TCE with a cleared IND. Phase 1 clinical study, which is expected to begin enrollment in the first quarter of 2025 or sooner, will include participants with EGFR-expressing tumors of various types such as colorectal, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma..

SAR446368是一种双重掩蔽的EGFRxCD3 TCE，具有明确的IND。第一阶段临床研究预计将于2025年第一季度或更早开始登记，将包括患有各种类型EGFR表达肿瘤的参与者，如结直肠癌，头颈部鳞状细胞癌，非小细胞肺癌和肾细胞癌。。

As part of the strategic agreement with Sanofi, key employees with extensive scientific and development expertise in TCEs, and in-depth experience using the masking platform technology, will join Vir upon receipt of Hart-Scott-Rodino (HSR) Act clearance.

作为与赛诺菲战略协议的一部分，在TCE领域拥有广泛科学和开发专业知识以及使用掩蔽平台技术的深入经验的关键员工将在获得哈特·斯科特·罗迪诺（HSR）法案许可后加入Vir。

“A central focus of our discovery team has been conditionally activated biologics, so adding this platform and key talents is highly strategic for us,” said Jennifer Towne, Ph.D., Vir’s Executive Vice President and Chief Scientific Officer. “Our demonstrated deep understanding of T-cell immunology, robust infrastructure, and leading machine learning and antibody engineering capabilities will create opportunities for real synergies and patient-centric innovation.”.

Vir执行副总裁兼首席科学官Jennifer Towne博士说：“我们发现团队的一个中心重点是有条件地激活生物制剂，因此添加这个平台和关键人才对我们来说具有高度战略意义。”。“我们对T细胞免疫学的深刻理解，强大的基础设施以及领先的机器学习和抗体工程能力将为真正的协同作用和以患者为中心的创新创造机会。”。

Pursuant to this agreement, Sanofi will receive an upfront payment and is eligible to receive future development, regulatory and commercial net sales-based milestone payments and tiered royalties on worldwide net sales. This agreement is subject to regulatory approval.

根据该协议，赛诺菲将收到预付款，并有资格获得未来开发、监管和商业净销售额里程碑付款以及全球净销售额的分层版税。本协议须经监管部门批准。

This strategic licensing transaction marks a significant milestone in Vir’s commitment to develop transformative therapeutics for some of the most severe diseases. Across its portfolio of clinical assets, below are anticipated upcoming catalysts:

这项战略性许可交易标志着Vir致力于为一些最严重的疾病开发变革性疗法的一个重要里程碑。在其临床资产组合中，预计未来的催化剂如下：

Tobevibart +/- Elebsiran: Phase 2 SOLSTICE 24-week treatment data for chronic hepatitis delta virus infection expected in the fourth quarter of 2024.

Tobevibart+/-Elebsiran：预计2024年第四季度，慢性肝炎三角洲病毒感染的2期至日24周治疗数据。

Tobevibart + Elebsiran +/- PEG-IFN-⍺: Phase 2 MARCH Part B 48-week end of treatment data for hepatitis B virus infection expected in the fourth quarter of 2024.

Tobevibart+Elebsiran+/-PEG-IFN-⍺：第二阶段3月B部分乙型肝炎病毒感染48周治疗结束数据预计在2024年第四季度。

SAR446309: Phase 1 monotherapy and combination study data expected in the second half of 2025.

SAR446309：预计2025年下半年的第一阶段单一疗法和联合研究数据。

SAR446329: Phase 1 monotherapy study data expected in the second half of 2025.

SAR446329：预计2025年下半年的第一阶段单一疗法研究数据。

SAR446368: Phase 1 study to begin enrollment in the first quarter of 2025 or sooner.

SAR446368：第一阶段研究将于2025年第一季度或更早开始招生。

Evercore Group L.L.C. acted as Vir’s exclusive financial advisor and Ropes & Gray LLP acted as Vir’s legal advisor for this transaction.

Evercore Group L.L.C.担任Vir的独家财务顾问，Ropes&Gray LLP担任Vir的法律顾问。

About Vir Biotechnology, Inc.

关于Vir Biotechnology，Inc。

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Vir’s clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections, in addition to multiple oncology programs.

Vir Biotechnology，Inc.是一家临床阶段的生物制药公司，专注于通过发现和开发治疗严重传染病和癌症的药物来增强免疫系统以改变生活。Vir的临床阶段投资组合包括针对慢性三角型肝炎和慢性乙型肝炎感染的传染病计划，以及多种肿瘤学计划。

Vir also has a preclinical portfolio of programs across a range of other infectious diseases and oncologic malignancies. Vir routinely posts information that may be important to investors on its website..

Vir还拥有一系列其他传染病和恶性肿瘤的临床前项目组合。Vir定期在其网站上发布对投资者可能很重要的信息。。