Rilvegostomig

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 Broadening the assessment of rilvegostomig reinforces Compugen's partnering strategy to expand opportunities for its pipeline Compugen to receive $5 million milestone payment from AstraZeneca 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. 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. 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. 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. "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. 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." 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. About the Compugen-AstraZeneca license agreement 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. 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. 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. 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. About 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. 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. 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. Forward-Looking Statement 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. 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. 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. 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 commercial value; and the general market, political and economic conditions in the countries in which Compugen operates, including Israel; and the effect of the evolving nature of the recent war in Gaza between Israel and Hamas. These risks and other risks are more fully discussed in the "Risk Factors" section of Compugen's most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission (SEC) as well as other documents that may be subsequently filed by Compugen from time to time with the SEC. In addition, any forward-looking statements represent Compugen's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law. Company contact: Yvonne Naughton, Ph.D. Head of Investor Relations and Corporate Communications Email: ir@cgen.com Tel: +1 (628) 241-0071 Company Codes: TelAviv:CGEN, Berlin:CW9, Tokyo:4568, OTC-PINK:DSNKY, Dusseldorf:CW9, NASDAQ-NMS:CGEN

Pictured: Exterior of AstraZeneca’s building in South San Francisco, California/iStock, Michael Vi AstraZeneca announced an ambitious goal last week: to reach $80 billion in total revenue and launch 20 new medicines by 2030. The U.K.-based pharma giant said it plans to focus on improving productivity in its operations and initiating other efforts designed to usher in a “new era” of growth. But how feasible is it for AstraZeneca to hit this lofty target? While AstraZeneca currently has several mid- to late-stage pipeline programs with strong potential, Etzer Darout, a senior biotech analyst at BMO Capital Markets, in an email to BioSpace said the company’s $30 billion goal is “above our and consensus projections.” Other analysts have also provided cautious estimates. AstraZeneca’s “revenue ambition” is “broadly expected” but Jefferies analysts project the company will only reach $70 billion by 2030, while the consensus is around $66.8 billion, according to the firm’s note to investors last week. Still, AstraZeneca has delivered strong and consistent growth from 2018 to 2023 with the help of its product launches. A report last week from Zacks Equity Research noted that the company has been “quite successful with its new products, and almost every new product it has launched in recent years has done well,” as AstraZeneca touts 12 blockbuster drugs. Though the company has a track record of recent success, including delivering last year on its ambitious $45 billion revenue goal set a decade ago, Darout cautioned that past performance is not always an indicator of future results. At the same time, he contends that AstraZeneca’s target for a mid-30% core operating margin by 2026 is achievable, as part of a strategy to focus on improving productivity throughout its operations. Jefferies reiterated its hold rating on AstraZeneca, noting that assets outside of oncology are “largely being ignored” while offering “significant longer-term upside optionality.” AstraZeneca “is primarily a top-line growth and pipeline story,” Jefferies analysts concluded. “However, clear aims from management may be needed for stock upside, and 2024 has fewer major pipeline catalysts.” A major challenge looming on the horizon is patent expirations for AstraZeneca’s key marketed products. Medicines that will lose their exclusivity include the cancer drug Lynparza, which is set to lose its patent this year, as well as the asthma medication Fasenra. The type 2 diabetes therapy Farxiga, which is also used to treat patients with heart failure and chronic kidney disease, will lose its patent in 2025. “Pharma companies face loss of exclusivity, competition and IRA [drug price negotiations] headwinds, so new product launches [are] critical to sustained growth for these companies,” Darout said. “The $80 billion figure the company disclosed takes these headwinds into account.” The Path to $80 Billion CEO Pascal Soriot told investors last week that AstraZeneca will see significant growth from its existing portfolio and that “many” of the 20 new medicines planned for launch by 2030 have the potential to generate more than $5 billion in peak year revenues. But what new products will get across the finish line for AstraZeneca to start reaching its $80 billion goal? Darout estimates that the company has several programs in the mid-to-late stage of development, with at least seven new drugs from its cohort of over 30 in its pipeline that can deliver on AstraZeneca’s $5 billion-plus peak revenue target. These products include the Daiichi Sankyo-partnered antibody-drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd), which has a target action date for the second line for non-small cell lung cancer (NSCLC) set for Dec. 20, 2024. The ADC is also being investigated in several types of breast cancer. Other oncology assets that have the potential to get over $5 billion in peak revenue include: camizestrant, which is being investigated on its own and in combination for breast cancer which is primarily in the later stages of development; rilvegostomig, in clinical trials for solid tumors and in the late stage for biliary tract cancer; volrustomig, in late stage trials for several types of cancer including NSCLC and cervical cancer; and saruparib, which is in a late-stage trial for metastatic castration-sensitive prostate cancer. Darout also identified baxdrostat, which has two Phase III trials in chronic kidney disease and hypertension, as a potential blockbuster. AstraZenceca’s recent acquisitions of radiopharma biotech Fusion Pharmaceuticals and cancer biotech Gracell and its partnership with GLP-1 developer Eccogene could all yield lucrative results. “Like other global pharmaceutical companies, AstraZeneca faces competitive, pricing and regulatory risks as well as loss of exclusivities of key programs,” Darout said. “Loss of exclusivities are more predictable but competition, pricing and regulatory risks are dynamic, and so the impact of these factors is less certain and harder to predict.” Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.