An Adaptive Clinical Platform Trial to Evaluate the Safety and Efficacy of COM701 as Monotherapy or Combination Therapy as Maintenance Therapy in Participants With Relapsed Platinum Sensitive Ovarian Cancer (PSOC)

The goal of this clinical trial is to learn if the experimental antibody COM701 delays the progression of ovarian cancer in participants with Relapsed Platinum Sensitive Ovarian Cancer. It will also learn about the safety of COM701.
The main questions the trial aims to answer are:
* Does COM701, when used as a maintenance treatment, stop or slow the progression of ovarian cancer?
* Does COM701 delay the time to needing a new anti-cancer treatment?
* What side effects do participants have when taking COM701?
Participants will:
* Visit the clinic once every 3 weeks during which the study treatment will be administered intravenously
* Undergo various tests and procedures to monitor general health throughout the trial including physical examinations, vital sign measurements (heart rate, blood pressure, breathing, and body temperature), weight measurements, electrocardiography (ECG), blood and urine tests and pregnancy tests if relevant.
* Undergo various tests and procedures to assess disease response throughout the trial including tumor imaging by CT scans or MRI to assess the tumor, its location, and size, and the testing of a sample of tumor tissue (from a prior biopsy or a fresh biopsy if feasible, to evaluate tumor response to treatment and to measure levels of tumor markers,

Start Date01 Mar 2025

Sponsor / Collaborator

Compugen Ltd.

NCT04570839

/ CompletedPhase 1/2

A Phase 1/2 Study Evaluating the Safety, Tolerability and Preliminary Antitumor Activity of COM701 in Combination With BMS-986207 (Anti-TIGIT Antibody) and Nivolumab in Subjects With Advanced Solid Tumors.

This is a phase 1/2 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM701 in combination with BMS-986207 and nivolumab in patients with advanced solid tumors.

Start Date31 Aug 2020

Sponsor / Collaborator

Compugen Ltd.

[+1]

NCT04354246

/ RecruitingPhase 1

A Phase 1 Study of The Safety and Tolerability of COM902 in Subjects With Advanced Malignancies

Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM902 as monotherapy and in combination with COM701 in subjects with advanced malignancies.

Start Date31 Mar 2020

Sponsor / Collaborator

Compugen Ltd.

100 Clinical Results associated with COM-701

100 Translational Medicine associated with COM-701

100 Patents (Medical) associated with COM-701

Literatures (Medical) associated with COM-701

01 Jun 2020·Cancer discoveryQ1 · MEDICINE

COM701 Shows Antitumor Activity, +/− Nivolumab

Q1 · MEDICINE

Article

Abstract:

According to results from an ongoing phase I trial, the novel immune checkpoint inhibitor COM701, which targets PVRIG, has shown early signs of efficacy, on its own and combined with nivolumab, in patients with a variety of advanced solid tumors.

News (Medical) associated with COM-701

04 Mar 2025

·www.prnewswire.com

Compugen Reports Fourth Quarter and Full Year 2024 Results

Clinical data presented at SITC 2024 supports further development of COM701, potential first-in-class anti-PVRIG antibody On track to initiate a randomized adaptive platform trial of COM701 maintenance therapy in patients with platinum sensitive ovarian cancer, scheduled to start in Q2 2025 The first patient was dosed in Q1 2025 in the first in human Phase 1 solid tumor trial of GS-0321 (previously COM503), a potential first-in-class anti-IL18BP antibody licensed to Gilead Partner AstraZeneca reported promising rilvegostomig data in 2024, expanded the rilvegostomig program to seven Phase 3 trials across lung and gastrointestinal cancers and plans to share early data for rilvegostomig in combination with their ADCs in 2025 Solid financial position with cash runway expected to fund operations into 2027 HOLON, Israel, March 4, 2025 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today reported financial results for the fourth quarter and full year 2024 and provided a corporate update. "I believe Compugen is well-positioned for growth, building on significant progress made in 2024 together with a diverse and innovative pipeline and with a strong focus on execution in 2025," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "The clinical data we presented at SITC 2024, consistent with previous data, support advancing our potential first-in-class anti-PVRIG, COM701, to be evaluated as a maintenance treatment option for patients with platinum sensitive ovarian cancer. We are on track to initiate an adaptive platform trial, which is scheduled to start with a randomized placebo controlled sub-trial evaluating single agent COM701 therapy in Q2 2025. This development path is supported by a strong clinical and biological rationale and has the potential to open the door to advance COM701 as a single agent and as a backbone to future drug combinations." Dr. Cohen-Dayag continued, "We are also encouraged by the promising rilvegostomig data presented by our partner, AstraZeneca, in 2024. Rilvegostomig is a PD-1/TIGIT bispecific antibody, the TIGIT component of which is derived from COM902. AstraZeneca is running seven Phase 3 trials with rilvegostomig across lung and gastrointestinal cancers and plans to share early data for rilvegostomig in combination with their ADCs in 2025. AstraZeneca's broad development strategy for rilvegostomig to replace existing PD-1/PD-L1 inhibitors represents a significant potential revenue source for Compugen as we may be eligible for both future milestone payments and mid-single digit tiered royalties on future sales. Dr. Cohen-Dayag added, "Our solid financial position with a cash runway expected to fund our operations into 2027 allows us to advance our innovative clinical and early-stage pipeline. This includes advancing the Phase 1 trial of GS-0321, a potential first-in-class anti-IL18BP licensed to Gilead, for which we received a $30 million milestone payment for achieving IND clearance in 2024. Additionally, it enables us to continue to leverage our AI/ML powered predictive computational discovery platform, UnigenTM, to accelerate our research efforts supporting our early pipeline. Our Unigen platform is validated by our multiple potential first-in-class and potential best-in-class clinical programs, as well as our partnerships with AstraZeneca and Gilead." Next Planned Milestones Q2 2025 – initiation of a randomized adaptive platform trial comparing COM701 maintenance therapy to placebo in total of 60 patients with relapsed platinum sensitive ovarian cancer 2025 – Compugen's partner, AstraZeneca, plans to share early data for rilvegostomig in combination with their ADCs H2 2026 – data from projected interim analysis of single agent COM701 sub-trial 1 as maintenance therapy in relapsed platinum sensitive ovarian cancer Fourth Quarter and Full Year 2024 Financial Highlights Cash: As of December 31, 2024, Compugen had approximately $103.3 million in cash, cash equivalents, short-term bank deposits and investment in marketable securities. The cash balance at the end of 2024 includes the receipt of the upfront payment of $60 million from Gilead for the licensing of GS-0321, the $30 million milestone payment from Gilead for IND clearance (both subject to a 15% withholding tax) and the $15 million milestone payments from AstraZeneca on dosing of the first patient in the first and second major indications for rilvegostomig Phase 3 trials. In January and February 2025, subsequent to the financial results for the year ended December 31, 2024, a total of approximately 3.96 million shares were sold through the Company's ATM facility contributing net proceeds of approximately $8.87 million (net of $274 thousand commission issuance expenses). Compugen expects that its current cash will be sufficient to fund its operating plans into 2027. The Company has no debt. Revenues: Compugen reported approximately $1.5 million in revenues for the fourth quarter of 2024 and $27.9 million in revenues for the year ended December 31, 2024, compared to approximately $33.5 million in revenues for each of the comparable periods in 2023. The revenues for 2024 include the portion of the upfront payment and the IND milestone payment from the license agreement with Gilead and the $5 million clinical milestone payment from AstraZeneca, while the revenues for 2023 reflect the portion of the upfront payment from the license agreement with Gilead allocated to the license and the previous clinical milestone from the license agreement with AstraZeneca in the amount of $10 million. Cost of Revenues for the fourth quarter and year ended December 31, 2024, were approximately $0.7 million and $7.9 million, respectively, compared with approximately $2.0 million for both comparable periods in 2023. Cost of revenues for 2024 represents the cost of IND and Phase 1 activities and royalty payments in connection with Compugen's revenues, offset by royalty reversal in 2024 due to exemption received from the Israeli Innovation Authority from the requirement to pay royalties on income derived from sales associated with products related to IL-18BP, while cost of revenues for 2023 represents milestone and royalty payments in connection with our revenues. R&D expenses for the fourth quarter and year ended December 31, 2024, decreased to approximately $5.9 million, and $24.8 million, respectively, compared with approximately $10.9 million and $34.5 million for the comparable periods in 2023, respectively. The decrease in 2024 was mainly due to the classification of expenses related to GS-0321 to cost of revenues and to lower CMC and IND enabling activities related to GS-0321, partially offset by an increase in clinical expenses. G&A expenses for the fourth quarter and year ended December 31, 2024, were approximately $2.2 million and $9.4 million, respectively, compared with approximately $2.5 million and $9.7 million for the comparable periods in 2023, respectively. Net Income / Loss: During the fourth quarter of 2024, Compugen reported a net loss of approximately $6.1 million, or approximately 7 cents per basic and diluted share, compared to a net income of approximately $9.7 million, or approximately 11 cents per basic and diluted share in the comparable period of 2023. Net loss for the year ended December 31, 2024, was approximately $14.2 million, or approximately 16 cents per basic and diluted share, compared with a net loss of approximately $18.8 million, or approximately 21 cents per basic and diluted share in the comparable period in 2023. Full financial tables are included below. Conference Call and Webcast Information The Company will hold a conference call today, March 4, 2025, at 8:30 AM ET to review its fourth quarter and full year 2024 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen's website, located at the following link. Following the live audio webcast, a replay will be available on the Company's website. About Compugen Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive computational discovery platform (UnigenTM) to identify new drug targets and biological pathways for developing cancer immunotherapies. Compugen has two proprietary product candidates in Phase 1 development: 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. GS-0321 (previously COM503), a potential first-in-class, high affinity anti-IL-18 binding protein antibody, which is in Phase 1 development is licensed to Gilead. In addition, the Company's therapeutic pipeline of early-stage immuno-oncology programs consists of research programs aiming to address various mechanisms to enhance anti-cancer immunity. 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 To be updated 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, statement regarding our expectations regarding the advancements of COM701 as a single agent and as a backbone to future drug combinations; statements regarding the initiation of a randomized adaptive platform trial comparing COM701 maintenance therapy to placebo in total of 60 patients with relapsed platinum sensitive ovarian cancer as well as the timing of any interim results from such sub-trial; statements regarding the timing of any data announcement by AstraZeneca regarding the combination of rilvegostomig with their ADCs; statements to the effect that our cash and cash-related balances will be sufficient to fund our operating plans into 2027; and statements that our cash position will enable us to continue to leverage our AI/ML powered predictive computational discovery platform, Unigen, to accelerate our research efforts supporting our early pipeline. 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: the clinical trials of any product candidates that Compugen, or any current or future collaborators, may develop may fail to satisfactorily demonstrate safety and efficacy to the FDA, and Compugen, or any collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates; 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; general market, political and economic conditions in the countries in which Compugen operates, including Israel; the effect of the evolving nature of the recent war in Israel; and Compugen does not know whether it will be able to discover and develop additional potential product candidates or products of commercial value. 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: [email protected] Tel: +1 (628) 241-0071 SOURCE Compugen Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1License out/inPhase 3Financial StatementImmunotherapy

03 Mar 2025

·www.biospace.com

The Search for the Next Keytruda: Immuno-Oncology’s Next Play

iStock/ Bulat Silvia More than a decade after Merck’s Keytruda and BMS’ Yervoy ushered in the immuno-oncology revolution, the space is at a crossroads, with experts highlighting novel targets, combinations and pre-emptive immunization as the next wave for IO. Last year marked 10 years since Keytruda’s seminal approval . That FDA greenlight signaled a new day in immuno-oncology and set the stage for the subsequent approvals of several more checkpoint inhibitors. Now, the field is looking for its next breakthrough—but it’s been a bumpy road. Overall, the immuno-oncology (IO) space “continues to be quite disappointing,” Graig Suvannavejh, senior biopharmaceuticals and biotechnology equity research analyst at Mizuho Americas, told BioSpace . “Industry is in search of that next great IO target, and they just haven’t been able to identify one that works.” In the last 15 years, the FDA has approved 11 checkpoint inhibitors — therapies targeting immune checkpoint proteins, including PD-1 and its partner protein PD-L1, plus CTLA-4 and LAG-3—to help the immune system locate and attack cancer cells. While Keytruda, an anti-PD-1, gets the most credit for having kickstarted the IO revolution, it was preceded by a CTLA-4 inhibitor called Yervoy, which BMS picked up in its $2.4 billion acquisition of Medarex in 2009. Two years later, the FDA approved Yervoy as the first anti-CTLA-4 drug. “That, really, along with the anti-PD-1s, kind of ushered in this whole immuno-oncology revolution,” Suvannavejh said. Jeremy Levin, now CEO of Ovid Therapeutics who was instrumental in BMS’ transformation to an immuno-oncology company in the aughts, agreed: “It became increasingly clear that there was science that said that this whole concept of immune modulation was beginning to evolve, and that CTLA-4 was breaking open the first concepts behind it.” Lately, however, the industry appears to have hit the proverbial therapeutic wall. But it’s not for a lack of trying, according to Christiana “Chris” Bardon, co-managing partner of MPM BioImpact. “When PD-1 was first released, we spent a lot of energy as an industry looking for the next PD-1 and we must have had tens of thousands of combinations of drugs in the clinic, testing everything with PD-1,” she told BioSpace . “Basically, we were looking for the next-generation IO checkpoint inhibitor.” But despite the emergence of more therapeutic options targeting the immune system, IO treatment response rates have plateaued at around 30%, Caroline Loew, CEO of Mural Oncology, wrote in a November 2024 opinion piece for BioSpace , meaning that 70% of patients do not respond to these therapies. “Despite the incredible efficacy of PD-1,” Bardon said, there is still a huge unmet need. “We still have many cancers that don’t respond to PD-1, things that are immunologically cold.” Striking Out With TIGITs Branching out has proven difficult, however. In the IO space, Suvannavejh said anti-TIGIT checkpoint therapies have been “probably the biggest disappointment” in the past two years. In December 2021, Roche ignited the field with promising results from the Phase II CITYSCAPE study of its anti-TIGIT drug tiragolumabin in metastatic non-small cell lung cancer (NSCLC). When combined with the company’s anti-PD-L1 blocker Tecentriq, tiragolumabin reduced the risk of disease worsening or death by 38% compared to Tecentriq alone. “I think the IO space was in kind of a low place about five years ago until Roche announced positive Phase II data for their TIGIT antibody,” he said. “All of a sudden, people were like, ‘oh my god, IO is back.” But in the Phase II/III data reported last year, the tiragolumab/Tecentriq combo failed to significantly improve progression-free and overall survival versus Keytruda and chemotherapy in patients with NSCLC and Roche elected to terminate that study. The excitement fizzled after that, Suvannavejh said. It was almost the nail in the coffin for TIGITs, or at least the buzz around the drug class. Seven months earlier, in December 2023, Merck had struck out in NSCLC with its experimental anti-TIGIT antibody vibostolimab when the candidate, in combination with Keytruda, failed to hit the endpoints in a mid-stage study. Recent results have breathed new life into the space, however. In September 2024, iTeos and GSK sparked excitement with Phase II results from patients with NSCLC taking a combination of iTeos’ anti-TIGIT candidate belrestotug and GSK’s anti-PD-1 therapy Jemperli. The combo elicited a 30% better confirmed objective response rate versus Jemperli alone. The partners are now studying the regimen as a first-line therapy for NSCLC in a Phase III trial . While it remains to be seen if TIGIT-targeting checkpoint inhibitors will reach the market, Bardon noted that the industry has seen some progress with drugs that hit CTLA-4 and LAG-3. In October 2022, the FDA greenlit AstraZeneca’s anti-CTLA-4 drug Imjudo, in combination with its first-generation PD-L1 inhibitor Imfinzi, for hepatocellular carcinoma, while the LAG-3 space saw its first approval in March of that year in BMS’ relatlimab (in combination with Opdivo and marketed as Opdualag) in unresectable or metastatic melanoma. Looking ahead, Bardon said ivonescimab—a PD-1/VEGF bispecific antibody in development by Summit Therapeutics, “is really the new . . . wave of checkpoint inhibitors.” “Ivonescimab has shown superiority to PD-1 alone, which is incredible,” she said. In September, Summit presented Phase III data at the International Association for the Study of Lung Cancer’s 2024 World Conference on Lung Cancer, showing that ivonescimab outperformed Keytruda in first-line advanced NSCLC. In the HARMONi-2 trial, Summit’s candidate cut the risk of disease progression or death by nearly 50% compared with Keytruda. While the results sent Summit’s stock skyrocketing by as much as 140%, some analysts urged caution , particularly noting that the data were from a trial run only in China. “Results may or may not be generalizable beyond the China-focused patient population initially assessed,” BMO Capital Markets wrote in an investor note at the time. Summit is currently studying ivonescimab in a multi-regional Phase III NSCLC study in the U.S. Bardon added that ivonescimab has the potential to work in multiple tumor types outside of lung cancer and predicted that it would be “a huge blockbuster in the future.” Pfizer appears to agree. Last week, the New York–based pharma struck a deal with Summit to combine its vedotin-based antibody-drug conjugates with ivonescimab. Part of the reason the industry has not been successful in developing checkpoint inhibitors “is that the development path is very, very hard,” Bardon said. One key challenge, she explained, is that most checkpoint therapies do not have monotherapy efficacy and therefore need to be developed in combination with PD-1 drugs. Definitive combination therapy can only be demonstrated in a comparator trial. “It’s just a very difficult and long path to de-risk the drug.” In this way, ivonescimab benefited from being created and developed in China, where there are faster enrollment times, limited treatment options and clinical trials are less expensive, Bardon said. Other IO targets of particular interest, Suvannavejh said, are PRAME (preferentially expressed antigen of melanoma) and the “very complicated RAS pathway, which includes the commonly mutated KRAS.” “This is a pathway that people have been trying to target for decades,” Suvannavejh said. “[It is] very difficult to do, trying to get that mix of efficacy and safety.” Amgen and BMS already have KRAS drugs — Lumakras and Krazati —on the market for NSCLC. The developmental “darling” of this space, Suvannavejh said, is Revolution Medicines, whose daraxonrasib is currently in a registrational trial to treat cancers with a wide range of common RAS mutations. Other players include Eli Lilly, Immuneering Corporation and Erasca. IO Developments On the Horizon Levin indicated that the IO space is at a crossroads. “The first wave of immuno-oncology has passed us by,” he said. “We know what we know about it.” Biopharma’s appetite for IO is certainly understandable. For Merck, Keytruda brought in a cool $29.5 billion in global sales in 2024 and ranks among the best selling drugs of all time. With that drug going off patent in just a few years’ time, many companies are eager to grab more of a market that is projected to be worth more than $17 billion by 2032. So, how does biopharma catch the next wave? For Suvannavejh, the answer lies in identifying novel targets—potentially through artificial intelligence and machine learning. As an example, he offered Compugen , a Tel Aviv–based biotech that uncovered a previously unidentified checkpoint called PVRIG using its proprietary computational discovery platform. Compugen is currently studying the resulting asset, COM701 , in trials of ovarian, gastric and other cancers. “That’s what companies can do if they want to go down this path of like, hey, maybe there’s another checkpoint inhibitor that we just haven’t identified yet,” Suvannavejh said. Meanwhile, Levin said the current focus is on combination therapies. “The world teaches you this repeatedly for complex diseases,” he continued, citing childhood leukemia, hypertension and congestive heart failure as examples of where combinations have ultimately been the answer. However it’s done, Levin continued, the holy grail for IO is pre-emptively engaging the human body to defeat a cancer cell before it has even proliferated. “Immuno-oncology is the clue that you can do this,” he told BioSpace . “It says that you can absolutely galvanize the human tissue to reawaken attack on a cancer cell. The big question is, can you actually pre-emptively immunize us such that we can be ready for this?”

Clinical ResultImmunotherapyPhase 3Phase 2Drug Approval

26 Feb 2025

·www.prnewswire.com

Compugen Enhances its AI/ML Predictive Computational Discovery Platform, Unigen™ with Ultima Genomics' Single Cell Genomics Sequencing Technology

Gene structure information identified by combining Compugen's AI/ML predictive computational discovery platform, Unigen™ with Ultima's UG 100™ sequencing platform to better understand tumor biology and immune regulation Leveraging Compugen's computational analytical tools uncovered high consistency in single-cell expression levels across Ultima's UG 100 sequencing platform, offering a potential advantage for demarcation of transcript termination. Research presented at Advances in Genome Biology and Technology (AGBT) 2025 General Meeting HOLON, Israel, Feb. 26, 2025 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced results generated in a joint research collaboration, combining Compugen's AI/ML powered predictive computational discovery platform, Unigen, with high throughput single cell sequencing on Ultima's UG 100 to uncover new insights on gene structure for immuno-oncology. "We are excited to collaborate with Ultima Genomics, a pioneer in next generation gene sequencing, to enhance our proprietary gene sequencing database, which is part of our Unigen platform," said Eran Ophir, Ph.D., Chief Scientific Officer at Compugen. "We developed algorithms to study gene splicing in single cell resolution and applied it to analyze patient tumor samples to uncover new potential regulatory mechanisms in immuno-oncology. Some of the findings were presented at the AGBT conference. Compugen plans to further harness Ultima's technology to develop its proprietary single cell atlases for accelerated discovery of new immunotherapies." "We are excited to support Compugen's capabilities in predictive computational discovery of new drug targets and development of new cancer immunotherapies," said Gilad Almogy, Founder and CEO of Ultima Genomics. "We built our innovative sequencing architecture and our UG 100 sequencing platform to enable researchers to unlock new applications and insights through lower cost sequencing and more omics data. The successful outcome of our collaboration with Compugen is a great example of an application that is data-starved due to the constraints of conventional sequencing technology and can be transformed through large scale data and AI/ML techniques. Single cell sequencing is also an excellent fit for our technology which is now compatible with the leading library prep technologies." Dr. Roy Granit, Head of Computational Discovery at Compugen is the lead author on a poster presented by Ultima Genomics at the Advances in Genome Biology and Technology (AGBT) 2025 general meeting on February 25, 2025, in Marco Island, Florida. Poster presentation details: Title: Using 3' Single Cell Sequencing to Study Patient-Derived Tumor Cells Reveals Enhanced Potential to Study Differential Splicing at the Cell Type Level Poster number: 224 Date and time: Tuesday, February 25, 4:45 p.m. - 6:10 p.m. ET Leading author: Roy Granit, Ph.D., Director, Head of Computational Discovery, Compugen, Israel Presenter: Zohar Shipony, Ph.D. Ultima Genomics, United States Key Findings: Comparative analysis using tumor samples from cancer patients, found high consistency in single-cell expression levels across Ultima Genomics' UG 100 and Illumina's Novaseq 6000 sequencing platforms. UG 100 offers clearer demarcation of 3' mRNA transcript end and provides a unique opportunity to study gene structure, which can potentially be harnessed to better understand tumor biology and immune regulation. Gene structure information identified in this approach is contributing to the predictive models of Unigen. The poster is available on the publications section of Compugen's website, . About Unigen™ Compugen has been at the forefront of decoding cancer biology, with its AI/ML powered predictive computational discovery platform, recently branded as Unigen™. Unigen is Compugen's code-to-cure, flexible-loop platform for the computational prediction of novel drug target discovery and development of cancer immunotherapy. Unigen combines Compugen's deep scientific knowledge, AI/ML predictive algorithms and a cloud-based, technology-agnostic platform integrating a variety of biological data such as multi-omics, single-cell RNA sequencing and spatial omics data. The outcomes from Compugen's preclinical and clinical trials enrich the proprietary knowledgebase to discover additional novel drug targets and further understand complex biology. To date, Unigen has yielded multiple novel immuno-oncology drug targets, potential first- or best-in-class clinical stage immuno-oncology programs, validating partnerships with multiple pharmaceutical companies and undisclosed programs in its early-stage pipeline. About Compugen Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive computational discovery platform (Unigen™) to identify new drug targets and biological pathways for developing cancer immunotherapies. Compugen has two proprietary product candidates in Phase 1 development: 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. GS-0321 (previously COM503), a potential first-in-class, high affinity anti-IL-18 binding protein antibody, which is in Phase 1 development is licensed to Gilead. In addition, the Company's therapeutic pipeline of early-stage immuno-oncology programs consists of programs aiming to address various mechanisms of immune resistance. 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, statement regarding Ultima's UG 100™ sequencing platform offering a potential advantage for demarcation of transcript termination and statements regarding Compugen's plans to further harness Ultima's technology to develop its proprietary single cell atlases for accelerated discovery of new immunotherapies. 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: the clinical trials of any product candidates that Compugen, or any current or future collaborators, may develop may fail to satisfactorily demonstrate safety and efficacy to the FDA, and Compugen, or any collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates; 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; general market, political and economic conditions in the countries in which Compugen operates, including Israel; the effect of the evolving nature of the recent war in Gaza; and Compugen does not know whether it will be able to discover and develop additional potential product candidates or products of commercial value. 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. Compugen contact: Yvonne Naughton, Ph.D. VP, Head of Investor Relations, and Corporate Communications Email: [email protected] Tel: +1 (628) 241-0071 SOURCE Compugen Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 1License out/inPhase 3

100 Deals associated with COM-701

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Platinum-sensitive epithelial ovarian cancer	Phase 2	-	Compugen Ltd.	01 Mar 2025
Recurrent ovarian cancer	Phase 2	-	Compugen Ltd.	01 Mar 2025
Advanced Malignant Solid Neoplasm	Phase 2	United States	Compugen Ltd.	31 Aug 2020
Endometrial Carcinoma	Phase 2	United States	Compugen Ltd.	31 Aug 2020
Platinum-Resistant Epithelial Ovarian Carcinoma	Phase 2	United States	Compugen Ltd.	31 Aug 2020
Platinum-Resistant Ovarian Carcinoma	Phase 2	United States	Compugen Ltd.	31 Aug 2020
Squamous Cell Carcinoma of Head and Neck	Phase 2	United States	Compugen Ltd.	31 Aug 2020
Microsatellite Stable Colorectal Carcinoma	Phase 1	United States	Bristol Myers Squibb Co.	30 Jan 2022
Advanced cancer	Phase 1	United States	Bristol Myers Squibb Co.	06 Sep 2018
Advanced cancer	Phase 1	United States	Compugen Ltd.	06 Sep 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04354246 (ASCO2024)	Phase 1	Colorectal Liver Metastases	20	COM701 15 mg/kg + COM902 3 mg/kg + pembrolizumab 200 mg	nslenlhkye(wvddgdirwd) = Treatment related AEs were reported in 11/20 [55%] pts, the majority were ≤G2 7/20 [35%] with the most frequent TRAE of 4 pts each with ≤G2 fatigue, myalgia, 4/20 pts with G3 TRAE, there were no ≥G4 TRAEs vhhyloulei (doybuhigmz )	Positive	24 May 2024
NCT04570839 (ASCO2023) Manual	Phase 1/2	Endometrial Carcinoma Microsatellite Stable (MSS)	9	COM701 20 mg/kg+BMS-986207 480 mg+nivolumab 480 mg	gajixgdzsi(geeqtrfmmr) = xevsfuuodp mdhnwwrfmv (ruicrotwus ) View more	Positive	31 May 2023
NCT03667716 (ESMO_IO2022) Manual	Phase 1	Platinum-Resistant Epithelial Ovarian Carcinoma	20	nivolumab+COM701	fhzjdwttbe(jozezuisia) = nausea 11 pts, fatigue 11 pts ynqqckqeud (fmsddvvmba )	Positive	08 Dec 2022
NCT04570839 (ESMO_IO2022) Manual	Phase 1/2	Platinum-Resistant Ovarian Carcinoma	20	nivolumab+BMS 986207+COM701	gqqputzpaq(botxdogbta) = derunjjbgh fhjkmtzzgo (mregsqsqvo ) View more	Positive	08 Dec 2022
NCT04570839 (478, SITC2021)	Phase 1	Advanced Malignant Solid Neoplasm	14	COM701 0.3 mg/kg	mbtfivubtm(kmtygbxtnh) = 2 pts (14%) with G3 abdominal pain vxoyrahxfm (jzosobeuod ) View more	Positive	10 Nov 2021
				COM701 1 mg/kg
NCT03667716 (ASCO 12021 \| ASCO 22021) Manual	Phase 1	Advanced Malignant Solid Neoplasm Last line	51	COM701 (Arm A)	xvaumkwnvy(omcdmzkdgw) = pts on COM701 mono (N=38)- No AE (4), Grade≤2 (21), G3 (11), G4 (1), G5 (1, PD), pts on combo (N=16) - Grade≤2 (8), G3 (7), G5 (1, PD) vezjhalwhz (fkcdirwghw ) View more	Positive	20 May 2021
				COM701+nivolumab (Arm B)
NCT03667716 (P421, SITC2019)	Phase 1	Advanced Malignant Solid Neoplasm	13	COM701 0.01 mg/kg	czkjhbbvnx(jvsnrgyhve) = abdominal pain (6%) memziozhaz (gnafnyrgbh ) View more	Positive	01 Nov 2019
				COM701 0.03 mg/kg

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