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Clinical Trial News

Formycon Launches €50 Million Corporate Bond to Accelerate Biosimilar Portfolio Development

Drug Approval
  • Formycon AG announced plans to issue a four-year corporate bond with a target volume of €50 million to fund the development and expansion of its biosimilar product portfolio.
  • The unsecured floating rate bond carries an interest rate based on three-month EURIBOR plus a 7.0% to 7.5% margin, with proceeds supporting the company's transition from development to commercial focus.
  • The public offering will be available in Germany, Luxembourg, and Austria, with subscription periods running from June 18-30, 2025, marking Formycon's first use of debt capital financing.
  • The company currently has three FDA and EMA-approved biosimilars including FYB201/ranibizumab already marketed in Europe and the USA, with four additional candidates in development targeting a biosimilar market projected to reach $74 billion by 2030.

BASF Opens New GMP Solution Center in Michigan to Strengthen Biopharma Manufacturing Capabilities

  • BASF opened a new Good Manufacturing Practice Solution Center in Wyandotte, Michigan on June 17, 2025, expanding its network of GMP sites for biopharma and pharmaceutical ingredient production.
  • The facility features state-of-the-art clean room packaging and high-sensitivity analytical testing capabilities that enable closer collaboration with customers on customized product development.
  • The new center offers unique production capabilities with tightly controlled parameters beyond compendial limits and validated control systems for high reproducibility in bioprocessing ingredients and excipients.

Isomorphic Labs Appoints Dr. Ben Wolf as Chief Medical Officer, Establishes US Operations

AIDrug Discovery
  • Isomorphic Labs, the AI-first drug discovery company, has appointed Dr. Ben Wolf as Chief Medical Officer to lead translation of AI-driven discoveries into clinical medicines.
  • Dr. Wolf brings nearly 20 years of biopharmaceutical experience, including expertise in precision oncology and advancing therapeutics from discovery through regulatory approval.
  • The company has established a new US presence in Cambridge, Massachusetts, following a $600 million external investment round earlier this year.
  • The appointment positions Isomorphic Labs to advance its AI drug design engine across multiple therapeutic areas and drug modalities into clinical development.

UCSF Researchers Develop CAR-T Therapy for Aggressive Bladder Cancer Variant Using Novel Biomarkers

CAR-TPrecision Medicine
  • UCSF scientists identified CA125 and TM4SF1 as novel biomarkers in histologic variant bladder cancer, which affects up to 25% of bladder cancer patients but is typically excluded from clinical trials.
  • Researchers developed CAR-T cell therapy targeting TM4SF1 protein that successfully eliminated bladder tumors in preclinical mouse models.
  • The breakthrough uses single-cell sequencing technology to characterize previously untreatable bladder cancer subtypes that resist conventional therapy and frequently recur after surgery.
  • This discovery could transform treatment options for patients with histologic variant bladder cancer who currently have limited therapeutic alternatives beyond radical surgery.

Alzheimer's and Parkinson's Charities Launch Drug Repurposing Partnership to Accelerate Treatment Development

  • Cure Parkinson's and Alzheimer's Research UK have formed a partnership to repurpose existing drugs for treating both Alzheimer's disease and Parkinson's disease, potentially reducing treatment development time by 5-10 years.
  • The collaboration builds on the success of the International Linked Clinical Trials (iLCT) programme, which has contributed to approximately 30% of disease-modifying therapies currently in Parkinson's clinical trials.
  • Both diseases share common biological processes including inflammation, mitochondrial dysfunction, and protein misfolding, making them suitable targets for cross-disease drug development approaches.
  • The partnership comes after NHS spending watchdog NICE rejected new Alzheimer's drugs lecanemab and donanemab for widespread NHS use, citing insufficient benefits relative to costs.

VSA Announces Acquisition of AI Clinical Development Company HopeAI to Transform Drug Development Timelines

AI
  • TCTM Kids IT Education Inc. (VSA) has signed a letter of intent to acquire HopeAI, an AI company specializing in clinical trial optimization that has helped pharmaceutical partners reduce development timelines by up to 2.5 years.
  • HopeAI's proprietary platforms have demonstrated significant impact by reducing Phase 3 trial sample sizes by up to 20% and enabling 24-hour responses to FDA feedback through AI-powered clinical development solutions.
  • The acquisition addresses a critical industry need, as pharmaceutical companies spent over $200 billion on clinical development in 2024 alone, with average development cycles taking 9 years.

NodThera Appoints Former AstraZeneca Executive Elisabeth Björk to Board as Phase 2 Obesity Trial Advances

  • NodThera has appointed Elisabeth Björk, M.D., Ph.D., former Senior Vice President at AstraZeneca's obesity franchise, to its Board of Directors.
  • The appointment follows the commencement of NodThera's Phase 2 RESOLVE-1 trial evaluating oral NLRP3 inflammasome inhibitor NT-0796 in patients with obesity.
  • Björk brings over 20 years of experience in late-stage clinical development and commercialization, particularly in cardiovascular and metabolic diseases.
  • NodThera is developing brain-penetrant NLRP3 inflammasome inhibitors to treat chronic inflammatory diseases through selective modulation of metabolic pathways.

Eli Lilly Acquires Gene-Editing Biotech Verve Therapeutics for $1.3 Billion to Expand Cholesterol Treatment Pipeline

Gene Editing
  • Eli Lilly will acquire gene-editing startup Verve Therapeutics for up to $1.3 billion, including an upfront payment of almost $1 billion and $300 million in milestone-based payments.
  • The acquisition strengthens Lilly's pipeline beyond its blockbuster weight-loss and diabetes drugs, focusing on one-time gene-editing therapies for high cholesterol in heart disease patients.
  • Verve's lead therapies use base editing technology to target PCSK9, ANGPTL3, and LPA genes responsible for regulating blood cholesterol levels.
  • The companies were already partnering on cholesterol-lowering treatments, with Verve's VERVE-102 therapy currently in early-stage trials for familial hypercholesterolemia.

China Patent Office Upholds Harbour BioMed's Heavy Chain Antibody Patent in Legal Victory Over Biocytogen

Monoclonal Antibody
  • The China National Intellectual Property Administration affirmed the validity of Harbour BioMed's patent covering fully human heavy chain-only antibody production methods on June 5, 2025.
  • Harbour BioMed's patent infringement lawsuit against Biocytogen advances to trial after China's Supreme Court dismissed jurisdictional challenges and affirmed Shanghai court authority.
  • The legal victory strengthens Harbour BioMed's intellectual property position for its Harbour Mice® platform technology used in developing novel antibody therapeutics for immunology and oncology.

ANGLE Advances Liquid Biopsy Technology with Dual DNA Analysis and Androgen Receptor Profiling at EACR 2025

  • ANGLE presented breakthrough data at EACR 2025 demonstrating DNA dual analysis combining CTC-DNA and ctDNA from single blood samples, revealing 53% of mutations found exclusively in CTCs in lung cancer patients.
  • The company's Parsortix system successfully identified druggable targets including CHEK2, ESR1, NTRK1, and RET that were missed by ctDNA analysis alone, offering comprehensive tumor profiling capabilities.
  • ANGLE introduced a novel androgen receptor expression assay for prostate cancer monitoring, showing statistically significant reduction in AR expression with increasing drug concentrations and enabling real-time treatment response assessment.
  • The AR assay validated in 20 metastatic castration-resistant prostate cancer patients demonstrated 50% CTC-positive detection rate with all positive patients showing AR-positive CTCs for expression level assessment.

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