Dosing of first patient in Phase 3 trial of rilvegostomig, a PD-1/TIGIT bispecific antibody, will trigger $10 million milestone payment from AstraZeneca

在rilvegostomig（一种PD-1/TIGIT双特异性抗体）的3期试验中，第一名患者的剂量将引发阿斯利康1000万美元的里程碑付款

HOLON, Israel, Dec. 19, 2023 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced it will be eligible to receive a milestone payment of $10 million from AstraZeneca (LSE/STO/Nasdaq: AZN), when the first patient is dosed in AstraZeneca's ARTEMIDE-Bil01 trial with rilvegostomig.

以色列HOLON，2023年12月19日/PRNewswire/--Compugen Ltd.（纳斯达克：CGEN）（TASE：CGEN）是一家临床阶段癌症免疫治疗公司，也是计算靶标发现的先驱，今天宣布，当第一名患者在阿斯利康使用rilvegostomig进行的ARTEMIDE-Bil01试验中服用时，它将有资格从阿斯利康（AstraZeneca）获得1000万美元的里程碑付款。

Rilvegostomig is a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical-stage anti-TIGIT antibody, COM902. The ARTEMIDE-Bil01 trial is expected to recruit about 750 subjects in more than 20 countries with biliary tract cancer who will be randomized to receive rilvegostomig or placebo with investigator choice chemotherapy as adjuvant treatment after resection with curative intent..

Rilvegostomig是一种PD-1/TIGIT双特异性抗体，其中TIGIT成分来源于Compugen的临床阶段抗TIGIT抗体COM902。ARTEMIDE-Bil01试验预计将在20多个国家招募约750名患有胆道癌的受试者，这些受试者将被随机分配接受rilvegostomig或安慰剂，研究者选择化疗作为根治性切除术后的辅助治疗。。

'I am delighted to see the advancement of rilvegostomig into Phase 3 by AstraZeneca, a global leader in oncology,' said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. 'I believe that the progress of the rilvegostomig clinical program in this Phase 3 trial along with the Phase 1 and 2 trials in additional indications, demonstrates the commitment to explore the potential of this bispecific antibody, where the TIGIT component is derived from our anti-TIGIT antibody COM902.'.

Compugen总裁兼首席执行官Anat Cohen Dayag博士说：“我很高兴看到全球肿瘤学领导者阿斯利康将rilvegostomg推进第三阶段。”我相信，rilvegostomig临床计划在这项3期临床试验中的进展以及在其他适应症中的1期和2期试验，表明了探索这种双特异性抗体潜力的承诺，其中TIGIT成分来源于我们的抗TIGIT抗体COM902“。

About the Compugen-AstraZeneca license agreement

关于Compugen AstraZeneca许可协议

In 2018, Compugen and AstraZeneca entered into an agreement by which Compugen provided an exclusive license to AstraZeneca to use Compugen's monospecific antibodies that bind to TIGIT, including COM902, for the development of bispecific and multispecific antibody products, excluding such bispecific and multispecific antibodies that also bind to PVRIG, PVRL2 and/or TIGIT.

2018年，Compugen和阿斯利康签订了一项协议，根据该协议，Compugen向阿斯利康提供了独家许可，可以使用Compugen与TIGIT结合的单特异性抗体（包括COM902）开发双特异性和多特异性抗体产品，不包括这种双特异性和多特异性抗体也与PVRIG，PVRL2和/或TIGIT结合。

AstraZeneca is responsible for all research, development, and commercial activities. AstraZeneca has the right to create multiple products under this license. In addition to the $10 million milestone payment described here which Compugen will be eligible to receive on dosing of the first patient in the Phase 3 ARTEMIDE-Bil01 trial, Compugen has received a $10 million upfront payment, and an additional $15.5 million in milestone payments to date, all out of up to an aggregate milestone amount of $200 million that the Company is eligible to receive in development, regulatory and commercial milestones for the first product, as well as tiered royalties on future product sales.

阿斯利康负责所有的研究、开发和商业活动。阿斯利康有权根据本许可证创建多个产品。除了此处描述的1000万美元里程碑付款（Compugen有资格在第3阶段ARTEMIDE-Bil01试验中给第一名患者服用时获得）之外，Compugen还收到了1000万美元的预付款，以及迄今为止额外的1550万美元里程碑付款，该公司有资格在第一个产品的开发、监管和商业里程碑中获得总计2亿美元的里程碑金额，以及未来产品销售的分层版税。

If additional bi- or multi-specific products are developed based on Compugen's monospecific antibodies that bind to TIGIT, additional milestones and royalties would be due to Compugen..

如果基于Compugen与TIGIT结合的单特异性抗体开发出其他双特异性或多特异性产品，则额外的里程碑和版税将由Compugen承担。。

Further details about ARTEMIDE-Bil01 trial are available on ClinicalTrials.gov, identifier: NCT06109779.

有关ARTEMIDE-Bil01试验的更多详细信息，请访问ClinicalTrials.gov，标识符：NCT06109779。

About Compugen

关于Compugen

Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive computational discovery capabilities to identify new drug targets and biological pathways for developing cancer immunotherapies. Compugen has developed two proprietary product candidates: COM701, a potential first-in-class anti-PVRIG antibody and COM902, a potential best-in-class antibody targeting TIGIT for the treatment of solid tumors.

Compugen是一家临床阶段的治疗发现和开发公司，利用其广泛适用的预测性计算发现功能来识别用于开发癌症免疫疗法的新药靶标和生物途径。Compugen开发了两种专有候选产品：COM701（一种潜在的一流抗PVRIG抗体）和COM902（一种针对TIGIT治疗实体瘤的潜在一流抗体）。

Compugen also has a clinical stage partnered program, rilvegostomig (previously AZD2936), a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical stage anti-TIGIT antibody, COM902, in Phase 3 development by AstraZeneca through a license agreement for the development of bispecific and multispecific antibodies. In addition, the Company's therapeutic pipeline of early-stage immuno-oncology programs consists of programs aiming to address various mechanisms of immune resistance, of which the most advanced program, COM503, is in IND enabling studies.

Compugen还有一个临床阶段合作项目rilvegostomig（以前是AZD2936），一种PD-1/TIGIT双特异性抗体，其中TIGIT成分来源于Compugen的临床阶段抗TIGIT抗体COM902，由阿斯利康通过开发双特异性和多特异性抗体的许可协议在第3阶段开发。此外，该公司早期免疫肿瘤学项目的治疗管道由旨在解决各种免疫抵抗机制的项目组成，其中最先进的项目COM503正在进行IND研究。

COM503 is a potential first-in-class, high affinity antibody which blocks the interaction between IL-18 binding protein and IL-18, thereby freeing natural IL-18 in the tumor microenvironment to inhibit cancer growth. Compugen is headquartered in Israel, with offices in San Francisco, CA. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. .

COM503是一种潜在的一流高亲和力抗体，可阻断IL-18结合蛋白与IL-18之间的相互作用，从而释放肿瘤微环境中的天然IL-18以抑制癌症生长。Compugen总部位于以色列，在加利福尼亚州旧金山设有办事处。Compugen的股票在纳斯达克和特拉维夫证券交易所上市，股票代码为CGEN。。

Forward-Looking Statement

前瞻性声明

This press release contains 'forward-looking statements' within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the current beliefs, expectations, and assumptions of Compugen.

本新闻稿包含《1933年证券法》和《1934年证券交易法》（经修订）以及《1995年私人证券诉讼改革法》的安全港条款所指的“前瞻性声明”。此类前瞻性陈述基于Compugen当前的信念、期望和假设。

Forward-looking statements can be identified using terminology such as 'will,' 'may,' 'expects,' 'anticipates,' 'believes,' 'potential,' 'plan,' 'goal,' 'estimate,' 'likely,' 'should,' 'confident,' and 'intends,' and similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

前瞻性陈述可以使用“意志”、“可能”、“期望”、“预期”、“相信”、“潜力”、“计划”、“目标”、“估计”、“可能”、“应该”、“自信”和“打算”等术语以及旨在识别前瞻性陈述的类似表达来识别，尽管并非所有前瞻性陈述都包含这些识别词。

Forward-looking statements include, but are not limited to, statements relating to our expectation to receive the milestone payment from AstraZeneca and statement regarding the progress of the rilvegostomig clinical program and our belief that it demonstrates the commitment to explore the potential of this bispecific antibody, where the TIGIT component is derived from our anti-TIGIT antibody COM902.

前瞻性声明包括但不限于与我们期望从阿斯利康获得里程碑付款有关的声明，以及关于rilvegostomig临床计划进展的声明，以及我们相信它表明了探索这种双特异性抗体潜力的承诺，其中TIGIT成分来源于我们的抗TIGIT抗体COM902。

These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance, or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: Compugen's business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model; Compugen's approach to the discovery of therapeutic products is based on its proprietary computational target discovery inf.

这些前瞻性陈述涉及已知和未知的风险和不确定性，这些风险和不确定性可能导致Compugen的实际结果、绩效或成就与此类前瞻性陈述所表达或暗示的任何未来结果、绩效或成就存在重大差异。这些风险包括：Compugen的商业模式在很大程度上取决于与第三方签订合作协议，Compugen可能无法成功产生足够的收入或将其商业模式的各个方面商业化；Compugen发现治疗产品的方法基于其专有的计算目标发现inf。

Company contact:Yvonne Naughton, Ph.D.Head of Investor Relations and Corporate CommunicationsEmail: [email protected] Tel: +1 (628) 241-0071

公司联系人：Yvonne Naughton，Ph.D.投资者关系和公司沟通主管电子邮件：[受电子邮件保护]电话：+1（628）241-0071

SOURCE Compugen Ltd.

SOURCE Compugen有限公司。