► Biomarker signatures were developed to predict histological treatment response to lanifibranor treatment in patients with MASH and fibrosis ► The biomarker signatures developed for fibrosis improvement, MASH resolution and composite histological endpoints, suggested better predictive accuracy than other diagnostic scores available including FIB4, FIBC3, ABC3D, NFS, ELF and MACK-3 ► The biomarker signatures suggested strong predictive accuracy, with AUROC values above 0.80 that may indicate high reliabilit ...

Core Insights - Tevogen Bio Holdings Inc. has commissioned Databricks, Inc. to enhance the development of its AI-driven target prediction model, PredicTcell, aimed at precision immunotherapy [1][2] - The collaboration will focus on modeling immunologically active HLA+ peptide complexes and predicting T cell receptor (TCR) engagement, utilizing the ExacTcell™ platform [2] - This initiative represents a significant step in Tevogen's AI strategy, which is designed to transform precision medicine [3] Company Overview - Tevogen is dedicated to providing innovative and affordable healthcare solutions, operating through three strategic pillars: Tevogen Bio, Tevogen.AI, and Tevogen Generics [3] - Tevogen Bio focuses on genetically unmodified precision T cell therapies, while Tevogen.AI leverages AI for drug discovery and healthcare optimization [3] - The company possesses all key intellectual property and is led by a team with extensive experience in drug development and global product launches [3] Strategic Partnerships - Databricks will supply a dedicated data engineering team and expertise in data and AI systems to support the development of PredicTcell [2][6] - Microsoft Research is also contributing digital infrastructure and AI expertise to bolster the initiative [6]

Core Insights - IDEAYA Biosciences announced a successful FDA Type D meeting regarding the Phase 3 trial design for darovasertib as a neoadjuvant therapy for primary uveal melanoma (UM) [1][2] - The trial aims to assess safety and efficacy with primary endpoints focused on eye preservation and vision loss, alongside secondary endpoints related to Event-Free Survival (EFS) [2][6] Company Overview - IDEAYA Biosciences is a precision medicine oncology company dedicated to developing targeted therapeutics through molecular diagnostics [8] - The company integrates capabilities in identifying translational biomarkers with drug discovery to optimize patient selection for its therapies [8] Drug Development Details - Darovasertib is a selective protein kinase C (PKC) inhibitor targeting both primary and metastatic UM [3] - The drug has received Breakthrough Therapy Designation and Fast Track designation from the FDA for its use in neoadjuvant therapy and in combination with crizotinib for metastatic UM [3] Phase 3 Trial Design - The Phase 3 trial is projected to enroll approximately 520 patients, randomized in a 2:1 ratio between darovasertib and control [5][6] - Two cohorts will be included: 120 enucleation-eligible UM patients and 400 plaque brachytherapy (PB) eligible UM patients [5][6] Clinical Endpoints - Primary endpoints include eye preservation rate for enucleation patients and vision loss for PB patients, with no detriment to EFS as a secondary endpoint [6][7] - Additional secondary endpoints will assess overall response rate, macular edema, and vision loss metrics [7] Regulatory Pathway - The company plans to initiate the Phase 3 trial in the first half of 2025, with potential for earlier regulatory submission of enucleation cohort data [4][11]

Core Viewpoint - The merger between Renovaro Biosciences Inc. and BioSymetrics aims to enhance advanced AI-driven drug development and expand precision medicine applications in oncology and neurology [1][4]. Group 1: Merger Details - Renovaro completed its merger with BioSymetrics on April 8, 2025, to strengthen its capabilities in data repository and biomarker discovery [2][1]. - The merger integrates BioSymetrics' Elion platform, which utilizes AI and machine learning to accelerate the discovery of diagnostics and therapeutics [3][4]. Group 2: Technological Synergy - BioSymetrics' Phenograph and advanced in vivo modeling systems are designed to improve target and biomarker identification, enabling patient stratification and drug repurposing [3][4]. - The combined company aims to streamline the translation of biomarker insights into accelerated drug discovery timelines, enhancing research efficiency [3][5]. Group 3: Strategic Goals - The merger is expected to enhance Renovaro's ability to identify new therapeutic targets and validate diagnostics, particularly in oncology and neurology [4][5]. - The focus will be on integrating AI-powered biomarker discovery with innovative drug development to improve patient outcomes globally [5].

INmune Bio (INMB) Q4 2024 Earnings Call March 27, 2025 04:30 PM ET Company Participants David Moss - Chief Financial OfficerRaymond Tesi - CEO & ChairmanGeorge Farmer - Managing DirectorMark Lowdell - Chief Scientific Officer & Chief Manufacturing OfficerCJ Barnum - Head of NeuroscienceDenis Reznik - Senior Equity Research AssociateElemer Piros - Senior Managing Director Conference Call Participants Thomas Shrader - Equity Research AnalystJames Molloy - Managing Director, Senior Biotechnology & Specialty Ph ...

Investment Highlights - Oncocyte is taking a disruptive approach to molecular diagnostic testing by empowering local labs with kits, contrasting the central lab model[14] - The company has secured a go-to-market strategic partner and equity investment[14] - Oncocyte has a science-driven team experienced in molecular diagnostics and rapid growth[14] - The company possesses a full R&D pipeline to fuel growth and portfolio expansion over the next decade[14] - Oncocyte's IP portfolio is attractive to partners and enables value protection[14] Transplant Market - Kidney transplant patients face a 20.2% chance of developing Antibody-Mediated Rejection (AMR) within 10 years of transplant, and up to 70% of those patients will progress to graft failure[43] - The US market supports $500 million in annual revenue for Laboratory Developed Tests (LDTs), which is currently generated by competitors[79] - The global transplant testing market is currently a $1 billion Total Addressable Market (TAM) and can expand to approximately $2 billion with claims expansion[67, 79] - Global transplants are growing at approximately 9% per year[68] Oncology Market - The estimated Total Addressable Market (TAM) for oncology in the US alone is $2 billion[97, 98] - The estimated Total Addressable Market (TAM) for Copy Number Instability (CNI) in the US Market is $4 billion[101] - There are 26 million estimated annual global testing opportunities for oncology[97] - There are 78 million estimated annual global testing opportunities for Copy Number Instability (CNI)[101]

Core Viewpoint - Tempus AI, Inc. has acquired Deep 6 AI to enhance its precision medicine capabilities through AI-driven insights, aiming to improve patient recruitment and trial efficiency [1][4]. Company Developments - The acquisition of Deep 6 AI will streamline the process of connecting patients with relevant clinical trials, expediting the development of new treatments [2][6]. - Tempus integrates Deep 6 AI's advanced machine learning algorithms into its existing platform, allowing for real-time analysis of patient data to optimize trial outcomes [9]. - Tempus has a market capitalization of $7.85 billion and expects 42% earnings growth over the next five years, compared to the industry's 20.8% growth [5]. Industry Context - The acquisition strengthens Tempus' position in the rapidly growing AI-driven healthcare market, potentially boosting its stock price in the long run [4]. - Deep 6 AI's technology mitigates risks in clinical trials and enhances patient recruitment by analyzing both structured and unstructured electronic medical record data [8].

Group 1 - Tevogen Bio, a clinical-stage specialty immunotherapy biotech company, is leveraging AI to enhance precision medicine and operational efficiencies [2][3][5] - The company has reported positive safety data from its proof-of-concept clinical trial and owns key intellectual property assets, including three granted patents and multiple pending patents related to AI [5][6] - Tevogen Bio aims to make advanced therapies more accessible and affordable by combining proprietary datasets with generative AI models [3][5] Group 2 - The recent AI discussion panel featured industry leaders discussing the transformative impact of AI across finance, biotech, and legal sectors [2][4] - The event highlighted the importance of tailoring AI applications to address unique challenges within each industry [3][4] - Tevogen Bio's leadership emphasizes the need for disruptive business models to sustain medical innovation and ensure patient accessibility [5][6]

Core Insights - Renovaro Biosciences Inc. has initiated the first tranche of financing to Predictive Oncology, Inc. to integrate AI/ML platform technologies and core laboratory capabilities in Europe and the United States [1][3] - The merger with Predictive Oncology and BioSymetrics significantly enhances Renovaro's capabilities in biomarker and drug discovery, particularly in oncology [1][2] Company Developments - The combined entity will leverage Predictive's AI-driven drug discovery platform, which includes a biobank of over 150,000 patient tumor samples and 200,000 pathology slides, to commercialize drug discovery and diagnostic platforms [2][4] - Renovaro has committed an additional $15 million in equity to accelerate its focus on revolutionizing healthcare through advanced diagnostics and drug discovery [3] Strategic Goals - The integration aims to create a comprehensive AI stack and an end-to-end solution for biomarker discovery and validation for precision medicine [3] - The transaction involves issuing an 18-month $3 Redeemable Preferred share to each Predictive Oncology shareholder, with further developments to be disclosed upon Board approval [3] Industry Context - Predictive Oncology is at the forefront of using AI and machine learning for early biomarker and drug discovery, with a scientifically validated platform that predicts drug response with 92% accuracy [4] - The company offers one of the industry's broadest AI-based drug discovery solutions, supported by its CLIA lab and GMP facilities [4][5]

Strategic Combination Aims to Accelerate Biomarker Identification, Enhance Drug Discovery, and Expand Precision Medicine Applications in Cancer and Beyond LOS ANGELES, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Renovaro Biosciences Inc. (NASDAQ: RENB), a TechBio leader focused on next-generation diagnostics, drug discovery, and genetically enhanced cancer therapies, today announced a definitive agreement to merge with BioSymetrics, an artificial intelligence (AI)-driven drug discovery and biomarker identification co ...