Lutris Pharma to Present at the American Association for Cancer Research Annual Meeting 2025
New Clinical Data from Phase 2 Trial of LUT014 for the Treatment of Patients With EGFRI-Induced Acneiform Rash Accepted for Oral Presentation at the Clinical Trials Plenary Session
TEL AVIV, Israel, March 26, 2025 /PRNewswire/ -- Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing cutaneous dose limiting toxicity, today announced the upcoming presentation of the results of its double-blind, placebo-controlled phase 2 randomized clinical trial of lead compound, LUT014 gel. The topically-applied novel B-Raf inhibitor is optimized for paradoxical MAPK activation, for patients treated with epidermal growth factor receptor (EGFR) inhibitor therapy who develop dose-limiting acneiform rash. The new clinical data will be released in an oral presentation at the Clinical Trials Plenary Session at the American Association for Cancer Research (AACR) Annual Meeting 2025, being held April 25-30 in Chicago, IL.
Presentation Details:
Presentation Title: A double-blind placebo-controlled randomized phase 2 clinical trial to assess the efficacy of a topical BRAF inhibitor for acneiform rash toxicities from anti-EGFR therapies
Presenting Author: Anisha B. Patel, MD, Associate Professor, Department of Dermatology, University of Texas MD Anderson Cancer Center, Houston, TX
Abstract Number: CT018
Session Title: New Frontiers in Precision Oncology
Session Date: Sunday, April 27, 2025
Session Time: 3:30 pm – 5:30 pm CT
About EGFR Inhibitor-Induced RashEGFR is a receptor on the surface of cells which is expressed in many normal epithelial tissues, including skin. The EGFR signaling pathway is one of the key pathways that regulate growth, survival, proliferation, and differentiation of cells. B-Raf is a protein encoded by the BRAF gene and is a downstream effector component of the EGFR signaling pathway. EGFR has been shown to be over-activated in various human cancers, including colorectal, lung, head and neck, urinary bladder, pancreatic and breast cancers, eliciting downstream phosphorylation and activation of the MAP Kinase pathway.
EGFR inhibitors can block the EGFR signal responsible for cell growth. Among the various types of pharmacological therapies for cancer, EGFR inhibitors are increasingly being used both as primary therapy as well as in patients who have progressed on prior chemotherapy treatments. Although effective as anti-cancer therapy leading to tumor shrinkage, EGFR inhibitors have many adverse reactions associated with their use. The majority of patients treated with EGFR inhibitors will experience adverse dermatological side effects typically manifested as a papulopustular skin rash, also known as acneiform lesions, which can impact quality of life and affect adherence to therapy.
About LUT014LUT014 is a novel B-Raf inhibitor which is applied topically to the skin. When the B-Raf protein is mutated, as is the case in some human cancers such as melanoma, blocking this pathway leads to apoptosis of the cells and tumor shrinkage. However, when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAPK pathway is activated, and cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses the paradoxical effect of B-Raf Inhibitors in order to enhance cell proliferation and balance cell destruction, typical to radiation dermatitis.
About Lutris PharmaLutris Pharma is a clinical stage biopharmaceutical company focused on improving anti-cancer therapy effectiveness and quality of life for patients who are being treated with EGFR (Epidermal Growth Factor Receptor) inhibitors or with radiation, where dermal toxicity often leads to a reduction of anti-cancer therapy compliance. The company aims to provide novel topical therapies in order to mitigate these side effects. Lutris Pharma's lead asset, LUT014, a topical B-Raf Inhibitor, is a proprietary, first-in-class, small molecule currently in a phase 2 clinical trial in metastatic colorectal cancer patients with EGFR inhibitor induced acneiform lesions and has successfully completed a phase 1/2 study for the treatment of radiation-induced dermatitis in breast cancer patients.
For more information, please visit www.lutris-pharma.com.
Contacts:
Lutris PharmaNoa Shelach, Ph.D. Chief Executive Officerir@lutris-pharma.com
Rx Communications GroupMichael Miller+1-917-633-6086mmiller@rxir.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/lutris-pharma-to-present-at-the-american-association-for-cancer-research-annual-meeting-2025-302411050.html
SOURCE Lutris Pharma
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
28bio Announces Nexon™ Neurotechnology Platform Powered by Engineered Human Brains
Exhibits complex neurological processes—including memory, learning, and cognition—and predicts human outcomes in preclinical drug development NEW ORLEANS, June 9, 2025 /PRNewswire/ -- 28bio today announced the Nexon™ neurotechnology platform—a major advancement in understanding human brain function. The platform integrates tissue engineering, neural interfacing and AI to engineer human brains at-scale and replicate complex neurological processes. The Nexon™ platform is now being used to improve the prediction of therapeutic efficacy and toxicity in humans, with several of the world's largest pharma companies already integrating Nexon™ into their drug development workflows. The Nexon™ platform also incorporates Organoid Intelligence (OI). The growing field of OI combines human brain organoids with brain-machine interfaces to model memory, learning, and cognition in vitro, offering novel functional cognitive biomarkers with the potential to reshape drug development in neurodegenerative disorders including Alzheimer's disease. Neurological drug development faces some of the highest failure rates in the pharmaceutical industry, due to poor translatability of animal models. Despite promising preclinical study results, many therapies ultimately fail in humans—contributing to a growing neurological health crisis and need for more predictive, human-relevant models. "We engineer human brains capable of elucidating the complexity of neurological processes and produce predictive data needed to change the trajectory of neurological drug development," said Alif Saleh, CEO of 28bio. "Industry and regulators are urgently asking for solutions to develop better neurological drugs faster and cheaper." About 28bio28bio is a neurotechnology company engineering human brains at-scale exhibiting memory, learning, and cognitive functions. Its Nexon™ platform integrates tissue engineering, neural interfacing, and AI to reverse today's neurological health crisis by improving the ability to predict which therapies will work in humans. 28bio is committed to advancing ethical standards in the development of brain organoid technology and engineered human cognition. For more information, visit View original content to download multimedia: SOURCE 28bio Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
2 days ago
- Yahoo
Nucleus Genomics Launches Nucleus Embryo, Genetic Optimization Software Alongside Partnership with Genomic Prediction
Parents pursuing IVF now have a new level of choice to empower their family planning NEW YORK, June 4, 2025 /PRNewswire/ -- With U.S. birthrates plummeting and IVF on the rise, Nucleus Genomics today launched Nucleus Embryo, the first genetic optimization software that lets parents see and understand a complete genetic profile to select an embryo. "Before there's a heartbeat, there's DNA," said Kian Sadeghi, founder and CEO of Nucleus. "One file containing DNA and genetic markers can tell you more about your baby's future than any other test a doctor could possibly run at this stage. Most clinics stop at whether an embryo will develop. For many parents, that's not enough. Patients have long asked for more transparency from clinics, and Nucleus Embryo is an important step toward complete data ownership for parents planning their families." The software enables parents to analyze and compare up to 20 embryos across over 900 hereditary conditions and 40 additional analyses beyond basic viability, spanning cancers, chronic conditions, appearance, cognitive ability, mental health, and more. To widen access to the software, Nucleus will partner with Genomic Prediction, the first company to offer genome-wide screening on embryos. The partnership sets a new standard in genetic medicine, continuing Genomic Prediction's decade-long history of giving hopeful parents the best possible chance of implanting healthy embryos. The company's analyses focus on hereditary conditions, acting as the first line of defense against chronic and rare diseases. "As an organization, we are committed to supporting patients' rights to their DNA and any information that can aid in their family-building journey," said Kelly Ketterson, CEO of Genomic Prediction. "We have a legacy of innovation aimed at providing patients with access to the best scientific resources. Our partnership with Nucleus opens access to information our patients have requested and allows us to uphold our commitment to this legacy." Nucleus' partnership with Genomic Prediction reflects a growing shift in how parents think about genetics as a tool to give children the best possible start in life. A wide-ranging study of Americans found the majority accepted the use of genetic technology to choose embryos based on health and personality traits. Four in 10 parents would use genetic optimization as another tool to understand their future child's cognitive abilities. Most women undergo three to six IVF cycles before successfully having a baby, with each cycle costing up to $25,000. Many embryos are unviable within days of being fertilized, leaving parents with few to choose from. Facing high stakes, clinicians often recommend genetic testing to optimize a couple's chances of a healthy pregnancy. But these tests typically stop at a select number of hereditary conditions and chromosome count. Now, advanced genetic analysis from Nucleus gives parents a new window into the health and well-being of their future child. Nucleus Embryo provides a comprehensive genetic profile for each embryo, encompassing hereditary genetic diseases, like cystic fibrosis and hemochromatosis, alongside genetic measures of cognitive ability, mental health, and risk for chronic diseases. Wide access to genetic insights for embryos can also help extend lifespan from the earliest stages of life. While more than half of all deaths annually in the U.S. are attributed to chronic, age-related conditions — such as Alzheimer's disease, diabetes, cancer, and heart disease — research shows embryonic selection can materially help reduce disease risk for these conditions. "We celebrate health optimization and the pursuit of longevity in every other part of life via our focus on training, supplements, and sleep," Sadeghi said. "We all know health isn't just the absence of disease. It's the ability to understand our bodies and genetic makeup to reach our full potential. Now we can apply this principle to life's inception." About Nucleus Genomics Nucleus builds software for generational health. Inspired by the loss of his cousin who died of a rare — yet preventable — genetic disease, Nucleus founder and Thiel Fellow Kian Sadeghi left an Ivy League university to build a product that could have saved her life. Our advanced DNA health test and analysis takes the guesswork out of your health, whether it's perfecting your protocols, knowing your risk for cancer, or planning for a healthy family. Follow us on social media @nucleusgenomics. About Genomic Prediction Genomic Prediction, Inc. is the frontrunner in advanced embryo screening. Our proprietary LifeView platform is state-of-the-art technology that assesses embryos for genetic health aimed at improved IVF outcomes. The LifeView Embryo Health Score Test (EHS) offers insight into the likelihood of developing conditions driven by multiple genes. It tests for significant health issues, including cardiovascular disease, diabetes mellitus, certain cancers, and mental health conditions. The EHS results are derived from the same embryo sample used in the following PGT tests: PGT-A: Identifies chromosome abnormalities in embryos. PGT-A+: Pinpoints the origin (paternal, maternal, or embryonic) of chromosome abnormalities. PGT-M: Decreases the chances of passing on monogenic (single-gene) conditions. PGT-SR: Detects chromosome abnormalities and structural imbalances, providing clarity between normal and balanced chromosomes. View original content to download multimedia: SOURCE Nucleus
Yahoo
2 days ago
- Yahoo
The British Medical Journal Publishes Study Results on Sacituzumab Tirumotecan for Previously Treated EGFR-Mutant Advanced NSCLC
CHENGDU, China, June 6, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", today announced that results from its registrational study (OptiTROP-Lung03) evaluating sacituzumab tirumotecan (sac-TMT) versus docetaxel in patients with previously treated advanced EGFR-mutant non-small cell lung cancer (NSCLC) have been published in The British Medical Journal (impact factor: 93.6). These data were also presented as an oral presentation in the Lung Cancer—Non–Small Cell Metastatic session (Abstract #8507) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Based on the encouraging data from this study, sac-TMT was approved for marketing by the National Medical Products Administration (NMPA) for the treatment of adult patients with epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-tyrosine kinase inhibitor (TKI) therapy and platinum-based chemotherapy in March 2025. This marks the first global approval of a TROP2 ADC for a lung cancer indication. The published results are based on OptiTROP-Lung03, an open-label, randomized, multicenter registrational study evaluating the efficacy and safety profile of sac-TMT monotherapy versus docetaxel for the treatment of patients with locally advanced or metastatic EGFR-mutant NSCLC who have failed after treatment with an EGFR-TKI and platinum-based chemotherapy. A total of 137 patients with advanced EGFR-mutant NSCLC who had progressed after EGFR-TKI and platinum-based chemotherapy were randomized (2:1) to receive sac-TMT (5 mg/kg once every 2 weeks) or docetaxel (75 mg/m2 once every 3 weeks) until disease progression, intolerable toxicity or other reason for discontinuation, with a median follow-up time of 12.2 months (Data cutoff date: December 31, 2024). Sac-TMT achieved statistically significant and clinically meaningful outcomes compared to docetaxel: Confirmed objective response rate (ORR) (As assessed by blinded independent review committee (BIRC): 45% (95% CI, 35-56) vs 16% (95% CI, 7-30). Median progression-free survival (PFS) (As assessed by BIRC: 6.9 months [sac-TMT; 95% CI, 5.4-8.2] vs 2.8 months [docetaxel; 95% CI, 1.6-4.1], hazard ratio (HR)= 0.30 [range, 0.20 -0.46], one-sided p<0.0001; as assessed by investigator (INV): 7.9 months [sac-TMT; 95% CI, 6.2-9.5] vs 2.8 months [docetaxel; 95% CI, 1.5-3.8], HR=0.23 [95% CI, 0.15-0.36], one-sided p<0.0001). With 36.4% of patients in docetaxel group crossing over to receive sac-TMT, median overall survival (OS) was not reached (NR) for both groups (HR=0.49; 95% CI, 0.27-0.88; one-sided p=0.007). The median OS analysed by pre-specified rank-preserving structural failure time (RPSFT) model adjusted for crossover was 9.3 months for docetaxel and NR for sac-TMT (HR=0.36; 95% CI, 0.20-0.66). Efficacy benefit favored patients with sac-TMT over docetaxel across all pre-specified subgroups, including prior EGFR-TKI therapy, brain metastases, EGFR mutation type, etc. Grade ≥ 3 treatment-related adverse events (TRAEs) occurred in 56.0% of patients in sac-TMT group vs 71.7% in docetaxel group. The results demonstrated that sac-TMT monotherapy achieved statistically significant and clinically meaningful improvements in objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) compared to docetaxel, with a manageable safety profile. Sac-TMT is being extensively studied in the NSCLC field. Covering treatment settings from later-line therapy to early-stage postoperative adjuvant therapy, including both monotherapy and combination regimens. Currently, five company-led registrational clinical studies for sac-TMT in NSCLC are underway in China. Meanwhile, Merck Sharp & Dohme(the tradename of Merck & Co., Inc., Rahway, NJ, USA)is also conducting five global Phase III clinical trials of sac-TMT for NSCLC in regions where it has exclusive rights. Professor Li Zhang, National Lead Principal Investigator, Medical Oncologist and Deputy Director of the Lung Cancer Research Centre at Sun Yat-Sen University, stated: "EGFR mutation is the most common driver alteration in NSCLC. The prevalence of EGFR mutations reaches 28.2% among NSCLC patients in China. Although third-generation EGFR-TKIs have become the standard of care for advanced EGFR-mutant NSCLC and may significantly improve PFS, acquired resistance remains inevitable. Combining EGFR-TKIs with chemotherapy can offer additional survival benefits to some patients, but this approach is limited by safety concerns and may compromise future treatment options, posing significant clinical challenges. The publication of the OptiTROP-Lung03 study in the British Medical Journal marks a major milestone—not only highlighting international recognition of this study outcomes in lung cancer, but also demonstrating the global competitiveness of sac-TMT as a novel TROP2 ADC." Dr. Michael Ge, CEO of Kelun-Biotech, commented: "We are thrilled to see the OptiTROP-Lung03 study published in a top-tier journal. Currently, EGFR-TKIs and chemotherapy remain the standard of care for patients with EGFR-mutant advanced NSCLC, but the challenge of increasing efficacy with manageable tolerability. The results from OptiTROP-Lung03 highlight significant survival benefits with manageable safety profile and suggest that sac-TMT could emerge as a new standard of care for this population. We remain committed to working with our partners to establish sac-TMT as a new standard of care for this patient population and improve outcomes for lung cancer patients worldwide." Registrational Study Led by Kelun-Biotech OptiTROP-Lung03: Sac-TMT monotherapy versus docetaxel for locally advanced or metastatic EGFR-mutant NSCLC after treatment failure with EGFR-TKI and platinum-containing chemotherapy; OptiTROP-Lung04: Sac-TMT monotherapy versus pemetrexed in combination with platinum for locally advanced or metastatic non-squamous NSCLC with EGFR mutations that have failed EGFR-TKI therapy; OptiTROP-Lung05: Sac-TMT combined with pembrolizumab versus chemotherapy combined with pembrolizumab for first-line treatment of PD-L1-positive locally advanced or metastatic NSCLC; OptiTROP-Lung06: Sac-TMT combined with pembrolizumab versus chemotherapy combined with pembrolizumab for the first-line treatment of PD-L1-negative locally advanced or metastatic non-squamous NSCLC; OptiTROP-Lung07: First-line treatment of locally advanced or metastatic NSCLC with EGFR mutations by sac-TMT in combination with ositinib. Registrational Study Led by MSD NSCLC not achieving a pCR after neoadjuvant therapy followed by surgery. NSCLC expressing PD-L1 >50% pre-treated NSCLC with EGFR mutations or other genomic alterations EGFR-mutated, advanced non-squ NSCLC progressed on prior EGFR-TK metastatic sg NSCLC About sac-TMT Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells. In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan). To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) based on the OptiTROP-Breast01 study and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy based on the OptiTROP-Lung03 study. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world's first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the National Medical Products Administration (NMPA), and were reviewed via the priority review and approval process. As of today, the Company has initiated 8 registrational clinical studies in China. MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD. About Kelun-Biotech Kelun-Biotech( a holding subsidiary of Kelun Pharmaceutical ( which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC and novel coupled drug products in clinical or preclinical research stage. For more information, please visit Media: klbio_pr@ View original content to download multimedia: SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.