Phase 3 trial evaluating rilvegostomig as monotherapy and in combination with AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan in first-line nonsquamous non-small cell lung cancer

三期临床试验评估利维格司他米单药治疗一线非鳞状非小细胞肺癌，并与阿斯利康和第一三共的达托帕单抗联合治疗

Broadening the assessment of rilvegostomig reinforces Compugen's partnering strategy to expand opportunities for its pipeline

扩大对rilvegostomig的评估，加强了Compugen的合作战略，以扩大其管道的机会

Compugen to receive $5 million milestone payment from AstraZeneca

Compugen将从阿斯利康获得500万美元的里程碑付款

HOLON, Israel, May 30, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced it is entitled to receive a milestone payment from AstraZeneca (LSE/STO/Nasdaq: AZN) triggered by the dosing of the first patient in a Phase 3 trial evaluating rilvegostomig, AstraZeneca's PD-1/TIGIT bispecific antibody.

以色列HOLON，2024年5月30日/PRNewswire/--Compugen Ltd.（纳斯达克：CGEN）（TASE：CGEN），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，今天宣布它有权获得阿斯利康（LSE/STO/Nasdaq：AZN）的里程碑付款，这是由阿斯利康PD-1/TIGIT双特异性抗体rilvegostomig的3期试验中第一名患者的剂量引发的。

The TIGIT component of rilvegostomig is derived from Compugen's clinical-stage anti-TIGIT antibody, COM902. Both rilvegostomig and COM902 are designed to have reduced Fc effector function..

rilvegostomig的TIGIT成分来源于Compugen的临床阶段抗TIGIT抗体COM902。rilvegostomig和COM902都被设计为具有降低的Fc效应器功能。。

The trial, called TROPION-Lung10, is evaluating the efficacy and safety of rilvegostomig as monotherapy and in combination with datopotamab deruxtecan (Dato-DXd), AstraZeneca and Daiichi Sankyo's (TSE: 4568) TROP2-directed antibody drug conjugate versus pembrolizumab as first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

该试验称为TROPION-Lung10，正在评估利维格司琼作为单一疗法的疗效和安全性，并与达托巴单抗（Dato DXd），阿斯利康和第一三共（TSE:4568）TROP2定向抗体药物偶联物联合使用与pembrolizumab作为局部晚期或转移性非鳞状非小细胞肺癌患者的一线治疗，PD-L1表达高（TC≥50%），无可行的基因组改变。

The trial is sponsored by AstraZeneca in collaboration with Daiichi Sankyo and is expected to enrol approximately 675 patients in more than 14 countries. Further details about TROPION-Lung10 are available on ClinicalTrials.gov, identifier: NCT06357533..

该试验由阿斯利康（AstraZeneca）与第一三共（Daiichi Sankyo）合作赞助，预计将在14个以上国家招募约675名患者。有关TROPION-Lung10的更多详细信息，请访问ClinicalTrials.gov，标识符：NCT06357533。。

'We are very excited to see the advancement of rilvegostomig into its second Phase 3 trial by AstraZeneca in collaboration with Daiichi Sankyo, two global leaders in oncology,' said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. 'TROPION-Lung10 follows the start of the ARTEMIDE-Biliary01 Phase 3 trial evaluating rilvegostomig in biliary tract cancer, for which we received a $10 million milestone payment.

Compugen总裁兼首席执行官Anat Cohen Dayag博士说：“我们很高兴看到阿斯利康与两位全球肿瘤学领军人物第一三共（Daiichi Sankyo）合作，将rilvegostomg推进第二阶段的3期临床试验。”TROPION-Lung10是在ARTEMIDE-Biliary01 3期临床试验开始后进行的，该试验评估了rilvegostomig治疗胆道癌的疗效，为此我们收到了1000万美元的里程碑付款。

Now, after dosing the first patient in this lung cancer trial, we are eligible to receive a $5 million milestone payment from AstraZeneca. Broadening the assessment of rilvegostomig reinforces our partnering strategy to expand opportunities for our pipeline and brings us closer to realizing potential future milestone payments and royalties.'.

现在，在这项肺癌试验中给第一名患者服用药物后，我们有资格从阿斯利康获得500万美元的里程碑式付款。扩大对rilvegostomig的评估加强了我们的合作战略，以扩大我们管道的机会，并使我们更接近实现未来潜在的里程碑付款和版税。”。

The ARTEMIDE-Biliary01 Phase 3 trial is evaluating the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in patients with biliary tract cancer after surgical resection with curative intent. Further details about the ARTEMIDE-Biliary01 trial are available on ClinicalTrials.gov, identifier: NCT06109779..

ARTEMIDE-Biliary01 3期临床试验正在评估rilvegostomig与安慰剂相比的疗效和耐受性，并结合研究者对胆道癌患者手术切除后的化疗选择。有关ARTEMIDE-Biliary01试验的更多详细信息，请访问ClinicalTrials.gov，标识符：NCT06109779。。

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. Compugen has received $35.5 million in upfront and milestone payments to date and is eligible to receive an additional $5 million milestone payment as described in this press release.

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。迄今为止，Compugen已收到3550万美元的预付款和里程碑付款，并有资格获得本新闻稿中所述的额外500万美元里程碑付款。

Compugen is eligible to receive up to an aggregate milestone amount of $200 million in development and regulatory milestones for the first and second indications for the first product and commercial milestones for the first product, as well as tiered royalties on future product sales. 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..

Compugen有资格获得高达2亿美元的开发和监管里程碑总额，用于第一个产品的第一个和第二个适应症以及第一个产品的商业里程碑，以及未来产品销售的分层版税。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。。

Rilvegostomig (previously AZD2936) is a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical stage anti-TIGIT antibody, COM902. Rilvegostomig is in Phase 3 development by AstraZeneca through this license agreement. Both rilvegostomig and COM902 are designed to have reduced Fc effector function to avoid depletion of CD8+ T cells..

Rilvegostomig（以前的AZD2936）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。Rilvegostomig正通过本许可协议由阿斯利康进行第三阶段开发。rilvegostomig和COM902都被设计为具有降低的Fc效应子功能，以避免CD8+T细胞的消耗。。

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）。

Rilvegostomig, a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical stage anti-TIGIT antibody, COM902, is 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, in IND enabling studies is licensed to Gilead.

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，阿斯利康通过开发双特异性和多特异性抗体的许可协议正在进行3期开发。此外，该公司早期免疫肿瘤学项目的治疗渠道包括旨在解决各种免疫抵抗机制的项目，其中最先进的IND支持研究项目COM503被授权给Gilead。

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 statements regarding the progress of the rilvegostomig clinical program. 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.

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。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。

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 infrastructure, which is unproven clinically; Compugen does not know whether it will be able to discover and develop additional potential product candidates or products of comme.

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基础设施，这在临床上尚未得到证实；Compugen不知道它是否能够发现和开发其他潜在的候选产品或comme产品。

Company contact:

公司联系人：

Yvonne Naughton, Ph.D.

伊冯·诺顿博士。

Head of Investor Relations and Corporate Communications

投资者关系和企业沟通主管

Email: ir@cgen.com

电子邮件ir@cgen.com

Tel: +1 (628) 241-0071

电话：+1（628）241-0071

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SOURCE Compugen Ltd.

SOURCE Compugen有限公司。

Company Codes: TelAviv:CGEN, Berlin:CW9, Tokyo:4568, OTC-PINK:DSNKY, Dusseldorf:CW9, NASDAQ-NMS:CGEN

公司代码：特拉维夫：CGEN，柏林：CW9，东京：4568，OTC-PINK：DSNKY，杜塞尔多夫：CW9，NASDAQ-NMS：CGEN