MedPath

Clinical Trial News

Yatiri Bio Acquires NGeneBioAI to Strengthen AI-Powered Proteomics Platform for Precision Medicine

AIPrecision Medicine
  • Yatiri Bio has successfully acquired NGeneBioAI, a San Diego-based company specializing in plasma proteomics and AI-powered diagnostics, to strengthen its position in biomarker discovery and translational drug development.
  • The acquisition expands Yatiri Bio's operational capabilities by integrating CLIA- and CAP-certified laboratory infrastructure and enhancing its AI-proteomics platform that uses deep learning to map disease biology.
  • The expanded platform will support biomarker-driven programs across oncology, immunology, and neurodegeneration while strengthening partnerships with biopharma companies seeking companion diagnostics.
  • Yatiri Bio's platform uses deep neural networks to integrate proprietary proteomics, clinical metadata, and functional testing to identify responsive patient populations for clinical candidates.

Israeli Researchers Achieve First Long-Term Growth of Human Kidney Organoids, Opening Path to Regenerative Therapies

  • Researchers at Sheba Medical Center and Tel Aviv University have successfully grown human fetal kidney components from tissue stem cells for up to 34 weeks, marking the first time such organoids have survived beyond four weeks in laboratory conditions.
  • The breakthrough enables scientists to study congenital kidney defects in real-time, test drug toxicity during pregnancy, and develop new treatments using human-like models instead of relying solely on mouse studies.
  • The team is now seeking funding, including from China, to advance the technology toward clinical trials, with hopes of developing regenerative therapies that could repair damaged kidneys and reduce transplant needs.

Contract Manufacturing Industry Report Reveals Impact of Global Conflicts and Inflation on Pharmaceutical Production

Drug Approval
  • The 15th edition of the CMO industry analysis uses FDA NDA approvals as the primary performance indicator for contract manufacturing organizations.
  • This year's report specifically examines how inflation and increasing global conflict have impacted pharmaceutical manufacturers and their outsourcing strategies.
  • The comprehensive analysis covers outsourcing trends for New Molecular Entities, special product categories including Accelerated Approval and Orphan designations, and CDMO performance metrics.
  • Key findings include record-high biosimilar approvals, increased outsourcing of special product categories, and concentration of dose contracts among a few large CMOs.

180 Life Sciences Pivots from Biotech to Ethereum Treasury Strategy with $581 Million in Funding

  • 180 Life Sciences Corp. (Nasdaq: ATNF) has raised a total of $581 million through a $425 million private placement and $156 million convertible notes offering to execute an Ethereum treasury strategy.
  • The company plans to rebrand as ETHZilla Corporation and will use the proceeds primarily to purchase Ethereum (ETH) while maintaining its legacy biotech and iGaming operations.
  • Electric Capital will serve as external asset manager to implement a differentiated yield generation program designed to outperform traditional ETH staking through various DeFi strategies.
  • The financing was led by prominent crypto investors including Electric Capital, Polychain Capital, and notable Ethereum ecosystem founders, positioning the company as a public market vehicle for Ethereum exposure.

Axogen Raises 2025 Revenue Growth Target to 17% as Avance Nerve Graft BLA Approval Approaches

Drug Approval
  • Axogen reported strong Q2 2025 results with revenue of $56.7 million, representing 18.3% growth compared to the same period last year.
  • The company has raised its 2025 revenue growth guidance to at least 17%, or $219 million for the full year, driven by anticipated regulatory approval.
  • The FDA has assigned a September 5, 2025 goal date for the Biologics License Application (BLA) of Avance Nerve Graft, with key regulatory milestones completed in Q2.
  • Axogen expects to maintain gross margins of 73-75% for the year and achieve net cash flow positive status despite one-time costs related to the anticipated BLA approval.

Sensei Biotherapeutics Advances VISTA-Targeting Cancer Therapy with Q2 2025 Results and ESMO Presentation

  • Sensei Biotherapeutics reported Q2 2025 financial results with $28.6 million in cash to fund operations into Q2 2026, while advancing its lead cancer immunotherapy solnerstotug.
  • The company completed enrollment of 64 patients in its Phase 1/2 dose expansion cohort, including 41 patients with PD-(L)1 resistant tumors, with full data expected by year-end 2025.
  • Solnerstotug demonstrated favorable safety profile in combination with cemiplimab without significant additional toxicity, positioning the VISTA-targeting therapy for multiple Phase 2 studies.
  • Clinical data from the dose expansion cohort will be presented at the European Society for Medical Oncology Congress in October 2025, marking a key milestone for the program.

Polpharma Biologics and Fresenius Kabi Partner on Vedolizumab Biosimilar for Inflammatory Bowel Disease

Monoclonal Antibody
  • Polpharma Biologics has signed a global licensing agreement with Fresenius Kabi for PB016, a proposed biosimilar to Entyvio (vedolizumab) targeting moderate-to-severe ulcerative colitis and Crohn's disease.
  • Under the partnership, Polpharma Biologics will handle development and manufacturing while Fresenius Kabi manages global commercialization, excluding Middle East and North Africa markets.
  • The collaboration aims to expand access to affordable biologic therapies for chronic inflammatory conditions, building on Polpharma's growing biosimilar portfolio that includes ranibizumab and natalizumab.
  • The strategic partnership leverages Fresenius Kabi's extensive global reach and commercialization expertise to support broad distribution of PB016 upon regulatory approval.

Ethris Initiates Phase 2a Trial of Novel mRNA Therapy ETH47 for Viral-Triggered Asthma Exacerbations

  • Ethris has dosed the first patient in a Phase 2a clinical trial of ETH47, an intranasal mRNA therapy encoding interferon lambda designed to prevent viral-triggered asthma exacerbations.
  • The randomized, placebo-controlled study will enroll 50 adults with asthma to evaluate ETH47's ability to reduce respiratory symptoms following rhinovirus challenge.
  • Phase 1 data demonstrated favorable safety and tolerability with robust local antiviral activity and no systemic exposure, supporting progression to efficacy testing.
  • The therapy represents a novel approach targeting viral triggers upstream rather than managing symptoms, potentially establishing a new paradigm for asthma treatment.

Nucleus Network Acquires Hammersmith Medicines Research to Create Global Early-Phase Clinical Trial Network

  • Nucleus Network has acquired Hammersmith Medicines Research (HMR), establishing the only early-phase clinical research provider with dedicated facilities across Australia, the United States, and the United Kingdom.
  • The acquisition creates a fully integrated global platform that enables studies to commence in one regulatory environment and seamlessly transition to another, accelerating timelines and reducing operational risk.
  • The combined organization expands access to broader and more diverse volunteer and patient populations, supporting faster recruitment and more inclusive study designs critical for first-in-human and adaptive trial protocols.
  • With over 20 years of experience and more than 1,500 first-in-human studies conducted, the expanded network strengthens capabilities for delivering early-phase clinical trials across three continents.

Fapon Biopharma Enrolls First Patient in Phase I Trial of FP008, Novel Anti-PD-1 Fusion Protein for Solid Tumors

  • Fapon Biopharma has enrolled the first patient in China for its Phase I clinical trial of FP008, a first-in-class anti-PD-1 × IL-10M fusion protein immunotherapy for advanced solid tumors.
  • The novel therapy is designed to overcome limitations of current PD-1 inhibitors and offers potential treatment for patients who are refractory to or relapsed from anti-PD-1/PD-L1 therapies.
  • Preclinical studies demonstrated FP008 significantly reduces CD8⁺ T-cell exhaustion and exhibits potent anti-tumor efficacy with enhanced T-cell infiltration into tumors.
  • The first patient has completed the Dose Limiting Toxicity observation period with a favorable safety profile, and FP008 has received IND approval from both FDA and China's NMPA.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.