COMPANY:

Lunit

"Lunit...today announced the presentation of seven studies at the American Association for Cancer Research (AACR) 2024 Annual Meeting...In a poster presentation, Lunit's AI-powered HER2 analyzer, Lunit SCOPE HER2's precision shines through its analysis of 194,259 pan-cancer samples, correlating different ERBB2 mutations with changes in HER2 protein expression. This AI-powered assessment successfully identified key mutation-expression correlations, particularly focusing on exon 20 insertions (ex20ins) and S310x mutations across a variety of cancers, including NSCLC, urothelial, and breast cancers...Through detailed HER2 intensity examination, the AI analysis highlighted that, among ERBB2-mutated cases with HER2 IHC images, a higher proportion of HER2 3+ tumor cells was observed in S310x and ex20ins cases compared to others....The analysis of 795 pan-cancer tissue samples revealed an important inverse correlation between CNTN4 expression and PD-L1 levels."

P2 | N=48 | NCT03737968 | "Lunit... announced the publication of a new study featuring Lunit SCOPE IO, Lunit's AI-powered analyzer for quantitative immune phenotyping from H&E...This investigation addresses the current lack of exploration into the clinical implications of neoadjuvant immunotherapy in HNSCC patients with resectable tumors, utilizing Lunit SCOPE IO to examine the changes in tumor microenvironment when treated with durvalumab and tremelimumab...In this phase II randomized clinical trial, 48 HNSCC patients were enrolled, with 24 receiving preoperative durvalumab and 24 receiving a combination of durvalumab plus tremelimumab before surgical resection....The study findings revealed that patients treated with the combination of durvalumab and tremelimumab exhibited significantly better 4-year distant recurrence-free survival (DRFS) compared to those receiving durvalumab monotherapy (91.1% vs. 53.3%)..."

"Lunit...announced the publication of a new study featuring Lunit SCOPE HER2 and Lunit SCOPE ER/PR, Lunit's AI-powered analyzer of human epidermal growth factor receptor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR)...The study aimed to evaluate the role of Lunit SCOPE in enhancing pathologists' consistency and accuracy of breast cancer molecular subtype classification, including expression levels of HER2, ER, and PR."

"Lunit...announced a significant update on its acquisition of Volpara Health Technologies...An initial order from the High Court of New Zealand has been granted, and all necessary consents under New Zealand's Overseas Investment Act and Overseas Investment Regulations have been secured to facilitate the implementation of the Scheme. The initial order signals approval and mandates the upcoming shareholder meeting as the next step."

"Lunit...today announced a groundbreaking study published in the Journal for ImmunoTherapy of Cancer (JITC). The study demonstrates the ability of Lunit SCOPE IO, to enable quantitative immune phenotyping from H&E stained slides as a broadly accessible biomarker for immunotherapy...The study, conducted on a real-world multicenter cohort of 1,806 Immune Checkpoint Inhibitor (ICI)-treated patients across 27 tumor types, showcases a correlation between the Inflamed Immune Phenotype and positive ICI treatment responses....More favorable ORRs (26.3% vs 15.8%), prolonged PFS (5.3 vs. 3.1 months) and OS (25.3 vs. 13.6 months) were observed in IIP patients, irrespective of ICI regimen or programmed death-ligand 1 (PD-L1) expression."

"Lunit...announced its proposal to acquire Volpara Health Technologies Ltd...The strategic move comes as a result of an exhaustive evaluation of potential avenues for growth and innovation by Lunit."

"Lunit...published a new study in npj Precision Oncology (Nature Partner Journal), using Lunit SCOPE IO to predict prognosis in stage II–III colon cancer via AI-powered spatial analysis of tumor-infiltrating lymphocytes (TIL). This study showed that Lunit SCOPE IO and the power of AI for spatial TIL analysis can provide clinicians with a practical and efficient tool to enhance prognosis prediction."

"Lunit...announced the presentation of six studies at the upcoming SITC (Society for Immunotherapy of Cancer) 2023 Annual Meeting, taking place from November 1 to 5, in San Diego, California...A collaborative study with the Samsung Medical Center assessed tumor-infiltrating lymphocytes (TILs) using AI-powered spatial analysis with Lunit SCOPE IO in EGFR-mutated non-small cell lung cancer (NSCLC) patients pre- and post-tyrosine kinase inhibitors (TKI) treatment."

"Lunit...today announced a research collaboration with The University of Texas MD Anderson Cancer Center to analyze the use of Merck's (known as MSD outside the US and Canada) Keytruda (pembrolizumab), a type of immunotherapy drug used in cancer treatment, in multiple cancer types. The project will use Lunit's proprietary AI solution for tissue data analysis, Lunit SCOPE IO....Lunit will collaborate with Aung Naing, M.D., professor of Investigational Cancer Therapeutics at MD Anderson, as the lead Principal Investigator (PI) for this study. The goal of the study is to evaluate AI technology with the objective of improving patient data analysis and increasing the effective use of treatment for patients with different types of cancer."

P3 | N=228 | ATTLAS (NCT03991403) | "A groundbreaking study, conducted by Samsung Medical Center and utilizing Lunit SCOPE IO, showcases the efficacy of atezolizumab plus bevacizumab and chemotherapy for NSCLC patients with EGFR or ALK mutations....By assessing patients' immune phenotype and predicting response to immunotherapy, Lunit SCOPE IO enabled the identification of individuals more likely to benefit from ABCP arm treatment. In the group with an Inflamed Score below 20%, there was no significant difference in PFS between ABCP arm and PC arm (8.28 months vs. 6.93 months). However, a substantial difference in PFS was observed in the group with an Inflamed Score of 20% or higher (12.91 months vs. 4.86 months), surpassing the overall study group. Immune phenotype as assessed by Lunit SCOPE IO showed predictive power in stratifying patients more likely to respond to ABCP treatment."

"Lunit...today announced the presentation of 9 studies at the upcoming European Society for Medical Oncology (ESMO) 2023 Congress, to be held in Madrid, Spain, from October 20-24....A collaborative study indicated that AI-based immune phenotyping can predict therapy outcomes in advanced biliary tract cancer (BTC) patients who are planning to be treated with anti-PD-1 therapy....In another study, it was found that TIL density in tumor microenvironment is highly correlated with favorable treatment response to immune checkpoint inhibitor (ICI) in head and neck squamous cell carcinoma (HNSCC)....In another study, HER2 (human epidermal growth factor receptor-2) scoring in biliary tract cancer was evaluated using Lunit SCOPE HER2. The analysis showed a substantial concordance of 75.3% between AI and human pathologists' assessments."

"Lunit...announced the presentation of 9 studies featuring its AI pathology research at the upcoming European Society for Medical Oncology (ESMO) 2023 Congress, scheduled to be held in Madrid, Spain, from October 20 to 24, 2023...This year's collection of abstracts delves into multifaceted research, including the use of AI-powered analysis to predict treatment outcomes in different cancer types, assess HER2 expression in breast and biliary tract cancer, and streamline clinical workflows for treatment decisions in lung cancer, all utilizing the Lunit SCOPE suite."

"Lunit...announced the presentation of 6 abstracts featuring its Lunit SCOPE suite at the upcoming SITC 2023 (Society for Immunotherapy of Cancer 2023) Annual Meeting, scheduled to take place from November 1 to November 5, in San Diego, California. This year's posters span a spectrum of research, from predicting treatment outcomes in non-small cell lung cancer (NSCLC) to examining immune responses in breast cancer subtypes, utilizing the Lunit SCOPE suite."

P=NA | N=85 | "A total of 85 patients with non-small cell lung cancer (NSCLC) who received immune checkpoint inhibitors (ICI) were analyzed for the study. According to the study, the utilization of Lunit SCOPE IO for TLS evaluation yielded clinically significant correlations with patients' overall survival (OS). 25 patients with detected TLS had notably prolonged overall survival compared to 60 patients without TLS. This correlation remained consistent irrespective of PD-L1 expression, a known biomarker for treatment response in NSCLC patients."

"Lunit...today announced the presentation of a groundbreaking study at the ASCO (American Society of Clinical Oncology) Breakthrough conference, to be held from August 3 to August 5 in Yokohama, Japan...This study showcases the potential of Lunit SCOPE HER2, an AI-powered solution designed to detect HER2 expression profile in detail, to provide valuable insights that can predict treatment response, thereby advancing personalized medicine in mCRC patients....Objective response rates (ORR) for Pertuzumab plus Trastuzumab treatment in the entire patient group and the HER2 IHC 3+ patient subgroup assessed by pathologists were 26.7% and 34.8%, respectively. Importantly, Lunit SCOPE HER2 identified that the >50% HER2 3+ patient subgroup had an ORR of 42.1%, which contained all 8 responding patients."

"Lunit...announced its participation in the Conference on Computer Vision and Pattern Recognition 2023 (CVPR 2023) to be held at the Vancouver Convention Center from June 18th to 22nd...In the second study, Lunit unveils the potential of self-supervised learning (SSL), an innovative approach that eliminates the need for experts to manually label cells in pathology images. By leveraging this technique, Lunit conducted the largest-ever study of its kind on pathology images, utilizing a staggering 33 million image patches that required no manual labeling. The results of this study demonstrate the efficacy of self-supervised learning and showcase Lunit's distinctive enhancements that further optimize its application in pathology."

"Lunit...announced collaboration with the National Cancer Center Hospital East (NCCHE) to evaluate and validate its AI pathology solution for tissue data analysis...This partnership aims to leverage the capabilities of Lunit SCOPE, an AI-biomarker platform, in analyzing Immunohistochemistry and H&E tissue slide data from various clinical trials, including NCCHE's molecular profiling projects such as SCRUM-Japan MONSTAR-SCREEN."

Lunit...is set to make a significant impact at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. This year, Lunit will present 16 abstracts at the conference, showcasing the groundbreaking capabilities of its AI-biomarker platform, Lunit SCOPE. This comprehensive collection of studies includes 10 poster presentations and 6 online publications, covering a wide spectrum of topics. From predicting clinical outcomes to exploring the complex dynamics of tumor microenvironments, these advancements highlight Lunit's unwavering commitment to advancing AI pathology research and personalized cancer care."

"Lunit...announced the presentation of 16 abstracts featuring its AI-biomarker platform at the American Society of Clinical Oncology (ASCO) Annual Meeting, to be held in Chicago, Illinois, on June 2-6."

"Indica Labs...and Lunit...announced an agreement to provide a fully interoperable solution between Indica Labs’ HALO AP® image management software platform and Lunit’s suite of AI pathology products...Lunit SCOPE PD-L1 NSCLC can be activated in the HALO AP user interface. Analysis progress, all results and visual markup images can be reviewed in HALO AP, so users never have to leave the viewer or shift between systems."

"One of the studies to be presented evaluates a deep learning-based ensemble model to predict the KRAS G12C mutation...According to the research, the prediction model showed improved accuracy compared to previously reported KRAS mutation prediction studies. The Lunit SCOPE based KRAS G12C mutation prediction model showed a high predictive power with an AUC (Area Under the Curve) of 0.787, indicating the accuracy of the AI algorithm. It also showed AUC of 0.745 in validation with independent external data....Other studies to be presented further demonstrate the effectiveness of Lunit SCOPE IO as a diagnostic aid in the treatment of various cancer types."

"Lunit...today announced its participation in the American Association for Cancer Research (AACR) Annual Meeting 2023. Lunit will deliver five poster presentations featuring its AI-biomarker platform at the annual meeting to be held in Orlando, Florida, on April 14-19."

"Lunit said it has completed validation of Lunit Scope PD-L1, its artificial intelligence pathology analysis solution, in Clinical Laboratory Improvement Amendments (CLIA)'s laboratory-developed test (LDT)...The company conducted the test at Guardant Health's CLIA Lab."

"Guardant Health, Inc...announced today the introduction of Guardant Galaxy^TM, a suite of advanced analytical technologies developed internally and through outside partnerships to enhance the performance and clinical utility of Guardant Health’s portfolio of cancer tests and to power the next generation of biomarker and drug discovery....The AI-powered scoring algorithm for the enhanced Guardant360 TissueNext PD-L1 test, which is now commercially available, improved detection of the cancer biomarker by more than 20 percent compared to manual pathologist interpretation in the most challenging non-small cell lung cancer (NSCLC) cases....Guardant Health also plans to expand the Guardant Galaxy technology suite over time to include other technology partnerships that will support additional segments of its cancer diagnostics portfolio."

"Lunit...announced that it will deliver two poster presentations at the upcoming 2023 ASCO Gastrointestinal Cancers Symposium (ASCO GI), to be held in San Francisco, CA, and online from Jan. 19 - 21....Findings showed progression-free survival (PFS) of the nivolumab or nivolumab plus ipilimumab (Niv+/-Ipi) regimen to be significantly longer in patients with high inflamed scores—the proportion of area with a high intra-tumoral TIL infiltration. Thus, results showed that the inflamed score, as evaluated by Lunit SCOPE IO, can be used as a biomarker to predict outcomes of Niv+/-Ipi treatment. Lunit will also present findings from a study assessing the clinical significance of Lunit SCOPE IO for the prediction of prognosis in stage II-III colon cancer patients treated with surgery and adjuvant chemotherapy."

"Lunit...announced that it will present three abstracts at the upcoming Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting, to be held in Boston, MA, and virtually from Nov. 8 – 12...Lunit’s presentations at SITC 2022 will highlight the effectiveness of Lunit SCOPE IO in accelerating immunotherapy clinical trials and drug development."

"Lunit will also present clinical findings that demonstrate the accuracy of Lunit SCOPE PD-L1 CPS. After classifying PD-L1 Combined Positive Score (CPS) levels in 543 urothelial carcinoma (UC) cases, the AI-powered CPS analyzer showed an equivalent level of accuracy to that of pathologists....Another study from Lunit reveals the capability of the AI-powered TIL and PD-L1 CPS analysis solution to be utilized as a predictive biomarker for immune checkpoint inhibitor (ICI) response in neuroendocrine neoplasms (NEN)....The last study shows that Lunit SCOPE can discover novel targets for antibody-drug conjugates (ADC) by precisely analyzing linked NGS and IHC data in tumors, highlighting the potential of multimodal analysis linking molecular and visual methods."

"A new phase II clinical trial validated the efficacy of Lunit’s AI biomarker, Lunit SCOPE IO, in predicting outcomes of immunotherapy in patients with nasopharyngeal carcinoma. The study has been published in Clinical Cancer Research...'This study shows that, by applying Lunit SCOPE IO to a clinical trial, it is possible to find a target group that responds better to treatment'..."

"Lunit...announced that it has signed a contract with FujiFilm Thailand and Microsoft to supply AI cancer screening products to Bumrungrad International Hospital, located in Bangkok, Thailand. Under the agreement, Lunit INSIGHT CXR, a CE-marked chest x-ray analysis AI software, and Lunit INSIGHT MMG, an FDA-cleared AI solution for detecting breast cancer in early stages, are deployed in Bumrungrad hospital."

"New findings demonstrate the clinical efficacy of AI-powered tissue analysis as a guide in cancer treatment, according to medical AI provider Lunit. The findings will be presented at the 2022 ASCO Annual Meeting, to be held from June 3 to 7...One of the poster presentations by Lunit elaborates on the validation of the Inflamed Immune Phenotype (IIP) as a practical biomarker to guide immune checkpoint inhibitor (ICI) treatment. The IIP is assessed by Lunit SCOPE IO, Lunit’s AI-powered immune phenotype analyzer, from H&E slide images...Lunit will also deliver a presentation on Lunit SCOPE PD-L1 TPS, the company’s AI-powered PD-L1 tumor proportion score (TPS) analyzer."

"A recent study revealed that with the assistance of AI, multiple pathologists showed improved consensus in analyzing PD-L1 tumor proportion scores, finding more patients eligible for immunotherapy. The study has been published on May 14 in the European Journal of Cancer (EJC)...Findings from the study demonstrate the clinical efficacy of Lunit SCOPE PD-L1, the company’s AI-powered programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) analyzer, which recently received the CE mark for commercial use in the European market."

"Lunit...announced it has received the CE-IVDD Mark for ‘Lunit SCOPE PD-L1 TPS’, an AI-based PD-L1 tumor proportion score (TPS) analyzer...Lunit SCOPE PD-L1 is an AI solution that performs PD-L1 TPS classification that enhances objective and accurate analysis compared to traditional method...Lunit is working on launching Lunit SCOPE PD-L1 in Europe within the second half of 2022, paving the way for deployment and use in European pathology practices."

"Lunit today announced the presentation of 11 abstracts featuring its AI-biomarker platform at the 2022 ASCO Annual Meeting from June 3 to 7....Findings from the study validate the effectiveness of Lunit SCOPE IO—Lunit's AI biomarker—in predicting clinical outcomes of immunotherapy across more than 16 different cancer types....In addition, Lunit will also present clinical findings that demonstrate the accuracy of its AI imaging solution in detecting high-risk breast cancer patients."