Solitary Fibrous Tumors

New Multimodal Algorithm Highlights Predictive Benefit Of Artificial Intelligence (AI) for Cancer Research BOSTON and ROLLE, Switzerland, March 15, 2024 /PRNewswire/ -- SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native software company and a leader in data-driven medicine, and the French Kidney Cancer Research Network (UroCCR) collaborated on a study using a multimodal algorithm to help predict post-operative outcomes for those facing renal cell carcinoma (RCC), with the results recently published in npj Precision Oncology. The findings of the study showed the artificial intelligence (AI) model co-constructed by SOPHiA GENETICS and UroCCR provided a strong prediction for post-operative outcomes when compared to usual prognostic scores. This publication follows a prior collaboration that demonstrated the value of multimodal analysis on pre-operative kidney cancer upstaging. UroCCR is one of the world's largest collaborative kidney cancer networks with 51 multidisciplinary clinical teams across France. In close relationship with the French Association of Urology (AFU), the goal of UroCCR is to connect a national, multidisciplinary network of medical and scientific professionals who focus on therapeutic management and applied research into kidney cancer. In 2021, UroCCR partnered with SOPHiA GENETICS to develop an AI-based model to predict whether kidney cancer will progress from a localized tumor after surgery. The UroCCR database provided multimodal, real-world data, including radiological, clinical, and biological data from more than 3,300 patients across France operated between May 2000 and January 2020. Researchers applied SOPHiA GENETICS' proprietary AI offering to analyze the data into easily visualized, reliable predictions that were measured against, and outperformed most common risk scores. "The volume and complexity of available health data continues to increase, and while this can assist in personalized diagnostics and treatment, it is most effective when paired with AI," said Thierry Colin, VP, Multimodal Research and Development, SOPHiA GENETICS. "Our work with UroCCR over the last three years has significantly advanced its research of RCC and shown the power of AI to provide insights from real-world multimodal data. We are extremely pleased with the findings from this study and look forward to continued collaboration with UroCCR." SOPHiA GENETICS' technology and global decentralized network are designed to break data silos and empower researchers with data-driven insights to drive the use of precision medicine. The study from UroCCR and SOPHiA GENETICS shows that an AI-based prediction model has the potential to support clinical treatment decision-making and provide an indication of which patients may potentially benefit from adjuvant systemic therapy, versus those that can sustain with surveillance. "At UroCCR, our research is centered on the idea that a shared database helps facilitate and expand the use of precision medicine for patients facing kidney cancer," said Pr Jean-Christophe Bernhard, M.D., PhD., Urologic Surgeon at CHU Bordeaux and head of the UroCCR. "Our work with SOPHiA GENETICS and the results of our latest study demonstrated the benefits of using AI to analyze real-world multimodal data. SOPHiA GENETICS' technology and network have been key to the success of our research and will be imperative as we continue progressing with increased data inputs." UroCCR was created in 2011 and was funded and labeled by the French National Cancer Institute (INCa) as one of the fourteen official nationwide clinical and biological databases (BCB). The network makes it possible to identify and document clinical, biological, and radiological data – in a shared database – for all newly diagnosed patients in participating centers. The network has been referenced in 2023 by the High Authority on Health (HAS) as real-life data provider of interest. For more information connect on X and LinkedIn. The SOPHiA DDM™ Platform has the ability to analyze multimodal data due to its cloud-based AI-driven environment that integrates and standardizes diverse data modalities to fuel the development of predictive models capable of addressing research questions. For more information on the collaboration between SOPHiA GENETICS and UroCCR, visit SOPHiAGENETICS.com and UroCCR.fr. About SOPHiA GENETICS SOPHiA GENETICS (Nasdaq: SOPH) is a software company dedicated to establishing the practice of data-driven medicine as the standard of care and for life sciences research. It is the creator of the SOPHiA DDM™ Platform, a cloud-native platform capable of analyzing data and generating insights from complex multimodal data sets and different diagnostic modalities. The SOPHiA DDM™ Platform and related solutions, products, and services are currently used by a broad network of hospital, laboratory, and biopharma institutions globally. For more information, visit SOPHiAGENETICS.COM, or connect on X, LinkedIn, Facebook, and Instagram. Where others see data, we see answers. SOPHiA GENETICS products are for Research Use Only and not for use in diagnostic procedures, unless specified otherwise. The information in this press release is about products that may or may not be available in different countries and, if applicable, may or may not have received approval or market clearance by a governmental regulatory body for different indications for use. Please contact [email protected] to obtain the appropriate product information for your country of residence. SOPHiA GENETICS Forward-Looking Statements: This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business strategy, products, and technology, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements are based on our management's beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this press release speak only as of the date hereof. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based, unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. SOURCE SOPHiA GENETICS

New study reveals drivers of rare cancer and provides a possible alternative solution to surgery. The genetic code of a rare form of kidney cancer, called reninoma, has been studied for the first time. In the new paper, published today (25th September) in Nature Communications, researchers at the Wellcome Sanger Institute, Great Ormond Street Hospital and The Royal Free Hospital also revealed a new drug target that could serve as an alternative treatment if surgery is not recommended. There are around 100 cases of reninoma reported to date worldwide (1), and it is amongst the rarest of tumours in humans. Although it can usually be cured with surgery, it can cause severe hypertension or it can spread and develop into metastases. There are no existing medical treatments for reninoma and management involves surgery alone. Until now, it had been unknown what genetic error causes reninoma. In the new study, a collaboration between the Wellcome Sanger Institute and Great Ormond Street Hospital and The Royal Free Hospital, funded by The Little Princess Trust, researchers found that there is a specific error in the genetic code of a known cancer gene, NOTCH1, that is behind the development of this rare cancer. The team examined two cancer samples -- from a young adult and a child (2) -- with advanced genomic techniques, known as whole genome and single nuclear sequencing (3). Their findings suggest that the use of existing drugs targeting this specific gene is a possible solution to treating reninoma for patients where surgery is not a viable option. Taryn Treger, first author of the study and The Little Princess Trust Fellow at the Wellcome Sanger Institute, said: "Many cancerous tumours have already been deciphered with genomic technologies, however, this is not so true in rare cancers, particularly those affecting children. Our work aims to fill that gap. This is the first time that we have identified the drivers for reninoma and we hope that our work continues to pave the way towards new therapies for childhood cancers." Dr Tanzina Chowdhury, co-lead author of the study, at Great Ormond Street Hospital, said: "Rare kidney cancers known as reninomas do not respond to conventional anti-cancer therapies. The only known treatment at the moment is surgery. Our study shows that, actually, there is a specific and well-studied gene that drives this rare cancer. If we use already known drugs that affect this gene, we might be able to treat it without the need for an invasive technique such as surgery." Dr Sam Behjati, co-lead author of the study, Wellcome Senior Research Fellow at the Wellcome Sanger Institute and Honorary Consultant Paediatric Oncologist at Addenbrooke's Hospital, said: "Rare cancers are exceedingly challenging to study, and patients with such tumours may therefore not benefit from cancer research. Here, we have a powerful example of cutting-edge science rewriting our understanding of an ultra rare tumour type, reninoma, whilst delivering a finding that potentially has immediate clinical benefits for patients." Phil Brace, Chief Executive of The Little Princess Trust, said: "We are committed to funding research searching for more effective treatments for all childhood cancers and so we are delighted to hear of the discoveries that have been made. We also want to help researchers find kinder solutions for young people and so we are very pleased to hear there may be ways to treat this rare kidney cancer without the need for surgery." Notes: 1. Inam, R., Gandhi, J., Joshi, G., Smith, N. L. & Khan, S. A. Juxtaglomerular Cell Tumor: Reviewing a Cryptic Cause of Surgically Correctable Hypertension. Curr. Urol. 13, 7-12 (2019). 2. The samples came from a young child with a localised tumour from the UMBRELLA study and a young female adult with metastatic (lung) reninoma. 3. Whole genome sequencing is a method that analyses the entire genome of an organism. Single nucleus sequencing is a method that uses isolated nuclei -- the part of the cell that contains our DNA information -- instead of whole cells to understand genes and their functions.

Advancing enrollment in two proof-of-concept studies evaluating triple blockade of DNAM-1 axis in patients with microsatellite stable colorectal cancer and platinum resistant ovarian cancer; initial findings expected by year end Data from multiple studies planned to be presented by the end of the year: - New data from metastatic breast cancer study evaluating COM701+ nivolumab - New translational data and initial biomarker data from platinum resistant ovarian cancer studies evaluating COM701 + nivolumab ± BMS anti-TIGIT - Longer-term patient follow up from platinum resistant ovarian cancer study evaluating COM701 + nivolumab + BMS anti-TIGIT - New data from COM503 lead pre-clinical program HOLON, Israel, August 7, 2023 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced financial results for the second quarter ended June 30, 2023 and provided a corporate update on key events since the start of 2023. "In the first half of the year, we continued to execute on our goals," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "Patient enrollment is advancing in our two proof-of-concept studies with our unique triple immunotherapy combination approach and initial findings are expected by the end of the year. We presented new clinical data in metastatic endometrial cancer at ASCO in June showing durable responses, including in a patient failing immunotherapy which is consistent with data we previously presented in other hard to treat tumors. The totality of our data to date, suggest that our COM701 based combinations have the potential to offer a treatment option with a favorable safety profile for hard-to-treat patients, across the spectrum of PD-L1 expression levels, including in patients who are anti-PD-1 refractory, pointing to a potential COM701 mediated mechanism of action." Dr. Cohen-Dayag added, "Our immediate focus is on expanding our data in two indications, platinum resistant ovarian cancer and microsatellite stable colorectal cancer, while continuing to invest in biomarker discovery, which is important to efficiently set our development path forward. We believe that the therapeutic potential of COM701 and COM902 as part of the DNAM-1 axis may be much broader than these two indications." Dr. Cohen-Dayag concluded, "In the second half of the year we are planning to present new and follow up data with our COM701 combinations including in ovarian and breast cancer as well as additional data on our COM503 lead pre-clinical program. Additionally, we are delighted to see the continued advancement in the development of rilvegostomig derived from COM902 by our partner AstraZeneca." Corporate Update: March 2023: First patient dosed in microsatellite stable colorectal cancer study; enrollment is on track to complete by year end. CIMT May 2023: Presentation of data on lead pre-clinical asset COM503, an anti- IL-18BP antibody, designed to induce a potent anti-tumor response and pronounced localized tumor microenvironment immune modulation by unleashing natural IL-18 activity in the tumor and potentially overcoming the challenges of administering a cytokine therapeutic. June 2023: First patient dosed in platinum resistant ovarian cancer study. Enrollment to date is slower than anticipated, however we believe that we can catch up on enrollment with the planned activation of additional sites. June 2023: Win at the European Patent Office (EPO), which ruled to uphold the Company's broad PVRIG patent for the treatment of cancer reflecting the strength of Compugen's patent strategy in novel target discovery. The EPO ruling is subject to appeal. ASCO June 2023: Presentation of data from triple immunotherapy combination (COM701+ nivolumab + BMS anti-TIGIT) in microsatellite stable endometrial cancer study showing durable partial responses in patients who failed standard of care, including pembrolizumab and lenvatinib. ASCO June 2023: Presentation of clinical data by partner AstraZeneca on rilvegostomig, a PD -1/TIGIT bispecific derived from COM902, establishing its safety and pharmacokinetic profile and showing anti-tumor activity in checkpoint inhibitor experienced NSCLC patients who typically do not respond to immunotherapy. Next Planned Milestones in H2 2023: Report initial findings from ongoing triple combination (COM701 + COM902 + pembrolizumab) proof-of-concept studies in microsatellite stable colorectal and platinum resistant ovarian cancer by end of the year. Presentation of new translational data and initial biomarker data from platinum resistant ovarian cancer studies evaluating COM701 + nivolumab ± BMS anti-TIGIT. Presentation of longer-term patient follow up from platinum resistant ovarian cancer study evaluating COM701 + nivolumab + BMS anti-TIGIT. Presentation of new data from the metastatic breast cancer cohort expansion study of patients treated with COM701 and nivolumab. Presentation of data from COM503 lead pre-clinical program. Rilvegostomig (PD-1/TIGIT bispecific derived from COM902): AstraZeneca continues to advance the development of rilvegostomig in multiple trials, including a Phase 2 trial in checkpoint inhibitor naïve NSCLC and a Phase 2 trial in hepatobiliary cancer. AstraZeneca disclosed plans to initiate a Phase 3 trial with rilvegostomig this year Financial Results As of June 30, 2023, cash, cash equivalents and cash investments were approximately $66.5 million, compared with approximately $83.7 million as of December 31, 2022. The Company expects its existing cash and cash related balances to be sufficient to fund its operating plan into at least the end of 2024, based on current plans. During the three months ended June 30, 2023, the Company sold approximately 1.6 million ordinary shares under its "at-the-market offering" (ATM) facility pursuant to a sales agreement entered with Leerink Partners on January 31, 2023, for aggregate gross proceeds of approximately $1.6 million. Compugen has no debt. R&D expenses for the second quarter ended June 30, 2023, were approximately $7.8 million, up from $6.8 million for the comparable period in 2022. The increase is mainly due to end of the amortization of the deferred participation in R&D expenses following the termination of the agreement with Bristol Myers Squibb in the third quarter of 2022, and an increase in preclinical and CMC activities associated with COM503, offset by a decrease in clinical trial expenses, headcount and currency exchange effect. General and administrative expenses for the second quarter ended June 30, 2023, were approximately $2.4 million down from approximately $2.6 million for the comparable period in 2022. Net loss for the second quarter ended June 30, 2023, was approximately $9.3 million, or $0.11 per basic and diluted share, compared with a net loss of approximately $9.1 million, or $0.11 per basic and diluted share, for the comparable period in 2022. Full financial tables are included below Conference call and webcast information The Company will hold a conference call today, August 7, 2023, at 8:30 AM ET to review its second quarter 2023 results. To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call will be available via live webcast through the Company'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 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 also has a clinical stage partnered program, rilvegostomig (previously AZD2936), a PD-1/TIGIT bi-specific derived from COM902, in Phase 2 development by AstraZeneca through a license agreement for the development of bi-specific and multi-specific 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. The most advanced program, COM503 is in IND enabling studies. 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 to inhibit cancer growth in the tumor microenvironment. 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, our expectation to share initial finding from two proof-of-concept studies evaluating triple blockade of DNAM-1 axis in patients with microsatellite stable colorectal cancer and platinum resistant ovarian cancer by year; our plans to present data from multiple studies by the end of the year; COM701 based combinations having the potential to offer a treatment option with a favorable safety profile for hard-to-treat patients, across the spectrum of PD-L1 expression levels, including in patients who are anti-PD-1 refractory, pointing to a potential COM701 mediated mechanism of action; our belief that the therapeutic potential of COM701 and COM902 as part of the DNAM-1 axis may be much broader than in platinum resistant ovarian cancer and microsatellite stable colorectal cancer; our beliefs as to the pace and timing of trial patient enrollment; our belief that we can catch up on enrollment with the planned activation of additional sites for platinum resistant ovarian cancer study; and our expectation that existing cash and cash related balances will be sufficient to fund our operating plan through the end of 2024. 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: In the near term, Compugen is highly dependent on the success of COM701 and of COM902; Compugen may not be able to advance its internal clinical stage programs through clinical development or manufacturing or successfully partner or commercialize them, or obtain marketing approval, either alone or with a collaborator, or may experience significant delays in doing so; Clinical development involves a lengthy and expensive process, with an uncertain outcome and Compugen may encounter substantial delays or even an inability to begin clinical trials for any specific product or may not be able to conduct or complete its trials on the timelines it expects; Compugen relies and expect to continue to rely on third parties to conduct its clinical trials and these third parties may not successfully or professionally carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, and Compugen may experience significant delays in the conduct of its clinical trials as well as significant increased expenditures; Compugen has limited experience in the development of therapeutic product candidates, and it may be unable to implement its business strategy. 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.