MedPath

Clinical Trial News

Boehringer Ingelheim Partners with Re-Vana for $1B Extended-Release Eye Therapy Development

  • Boehringer Ingelheim and Re-Vana Therapeutics announced a strategic collaboration to develop extended-release ophthalmic therapies using Re-Vana's drug delivery technology that releases treatments over 6-12 months.
  • The partnership allows Boehringer to add up to three development programs per year, with potential total deal value exceeding $1 billion for the initial three targets plus royalty payments.
  • Re-Vana's technology aims to reduce injection frequency for eye disease patients, potentially improving treatment compliance and therapeutic outcomes.
  • Boehringer will combine the delivery platform with its existing eye health pipeline, which includes four assets currently in Phase II trials.

UCLA Study Shows Can-Fite's Piclidenoson Restores Function in Vascular Dementia Model

  • UCLA researchers led by Dr. S. Thomas Carmichael demonstrated that Piclidenoson restored tissue integrity and behavioral function in a vascular dementia mouse model with focal ischemia.
  • The study addresses a significant unmet medical need, as vascular dementia is the second most common cause of dementia with no FDA-approved therapies currently available.
  • Piclidenoson, a highly selective A3 adenosine receptor agonist, has already shown compelling safety in hundreds of psoriasis patients and could potentially capture a large share of the $6 billion vascular dementia market.
  • Can-Fite's Chief Scientific Officer noted that a first-in-class agent providing neuroprotection and improved vascular health would fill a significant treatment gap in this growing market.

Quanterix Launches First-to-Market p-Tau 205 and p-Tau 212 Assays for Alzheimer's Disease Research

  • Quanterix Corporation announced the commercial launch of two novel phospho-tau assays, p-Tau 205 and p-Tau 212, marking the first-to-market availability of these blood-based biomarkers for Alzheimer's disease research.
  • The new assays enable precise detection of tau phosphorylation sites associated with early and progressive stages of Alzheimer's disease, developed on Quanterix's ultra-sensitive Simoa® platform.
  • The company's recent acquisition of Akoya Biosciences has expanded its capabilities by integrating advanced spatial proteomics with the Human FFPE Neurobiology Panel for tissue-based analysis.
  • More than 55 posters and presentations at AAIC 2025 featured data generated using Quanterix's Simoa® technology, demonstrating its significant impact on neurodegenerative disease research.

Zymeworks Receives FDA Clearance for ZW251, Novel Glypican-3 Targeted ADC for Hepatocellular Carcinoma

Oncology
  • The FDA has cleared Zymeworks' investigational new drug application for ZW251, a first-in-class antibody-drug conjugate targeting glypican-3 for hepatocellular carcinoma treatment.
  • ZW251 incorporates Zymeworks' proprietary topoisomerase 1 inhibitor payload and demonstrated strong anti-tumor activity in preclinical studies with favorable tolerability up to 120 mg/kg in non-human primates.
  • The Phase 1 clinical trial is expected to begin in 2025, marking the second ADC from Zymeworks' pipeline to advance to clinical development using their proprietary payload technology.
  • Glypican-3 is expressed in over 75% of hepatocellular carcinoma cases, representing a significant target for this most common form of primary liver cancer.

Transgene and BioInvent to Present Updated BT-001 Oncolytic Virus Data at ESMO 2025

  • Transgene and BioInvent will present updated Phase I data on BT-001, an armed oncolytic virus expressing anti-CTLA-4 antibody, at the ESMO Annual Meeting in Berlin from October 17-21, 2025.
  • BT-001 demonstrated clinical responses in two out of six refractory patients when combined with pembrolizumab, showing shrinkage of both injected and non-injected lesions.
  • The treatment successfully converted "cold" tumors into "hot" ones by inducing T-cell infiltration and PD(L)-1 expression in the tumor microenvironment.
  • The ongoing Phase I/IIa study (NCT04725331) evaluates BT-001 as monotherapy and in combination with pembrolizumab, with the last Phase I patient enrolled in August 2024.

A Clinical Trial Assessing BT-001 Alone and in Combination With Pembrolizumab in Metastatic or Advanced Solid Tumors

NCT04725331RecruitingPhase 1
Transgene
Posted 2/25/2021

Ivonescimab Demonstrates Superior Efficacy in Phase III Lung Cancer Trials, Positioning for Global Regulatory Approvals

Drug Approval
  • Ivonescimab, a PD-1/VEGF bispecific antibody, achieved a 48% reduction in progression-free survival risk compared to chemotherapy in EGFR-mutated NSCLC patients.
  • The drug outperformed pembrolizumab in head-to-head comparison with median PFS of 11.14 months versus 5.82 months in PD-L1-positive NSCLC.
  • Akeso has secured two NMPA approvals in China for 2025, while Summit Therapeutics prepares BLA filing for U.S. market entry.
  • The projected $500 million market opportunity reflects growing adoption across Asia-Pacific region with 15% CAGR expected through 2033.

KYAN Technologies' Ex Vivo Platform Demonstrates Clinical Utility in Relapsed/Refractory Non-Hodgkin Lymphoma

Precision Medicine
  • KYAN Technologies' Optim.AI™ platform achieved 74.5% accuracy in predicting clinical response in a prospective study of 117 relapsed/refractory non-Hodgkin lymphoma patients published in JCO Precision Oncology.
  • Patients treated with platform-guided combinations showed 59% objective response rates and three-fold improvement in progression-free survival compared to prior treatment lines.
  • The study represents the largest published cohort using an ex vivo functional precision medicine platform in lymphoma, demonstrating statistically significant survival benefits over salvage therapy (P = 0.0191).
  • The platform tests hundreds of clinically relevant drug treatments simultaneously on live tumor cells, providing oncologists with real-time, patient-specific treatment guidance.

Robles BioCeutics Partners with Innovigen to Scale Production of Senolytic-Enhanced Skincare

  • Robles BioCeutics has entered a strategic manufacturing partnership with Innovigen to scale production of its flagship product GlowSelle™, which combines senolytic compounds with stem cell-derived growth factors for regenerative skincare.
  • The collaboration focuses on refining and manufacturing formulations that target senescent "zombie cells" while stimulating natural skin regeneration through growth factors produced under injury-mimicking conditions.
  • This partnership represents a significant step toward commercializing advanced biotechnological skincare, leveraging Innovigen's GMP production expertise to ensure consistent quality and regulatory compliance.
  • The agreement includes comprehensive manufacturing services and explores co-development opportunities for next-generation regenerative dermatology products.

Delhi High Court Rules Against Roche in Pertuzumab Patent Disclosure Case, Clarifies Section 104A Requirements for Biologics

Monoclonal AntibodyOncology
  • The Delhi High Court denied F. Hoffmann-La Roche's request to access Zydus Lifesciences' manufacturing process for their Pertuzumab biosimilar, ruling that Roche failed to meet mandatory requirements under Section 104A of the Patents Act.
  • The court established that Section 104A can be invoked at interim stages of patent litigation and prevails over general discovery provisions under the Commercial Courts Act.
  • The ruling clarifies that "identical product" requirements under Section 104A cannot be diluted for biological drugs, even though absolute replication is scientifically difficult.
  • The decision impacts ongoing patent disputes in India's biosimilar market, particularly for cancer treatments where regulatory reference to branded biologics does not automatically imply process infringement.

GSK Secures $12.5 Billion Deal with Hengrui for COPD Drug and 11 Additional Programs

  • GSK has entered into agreements with Chinese pharmaceutical company Hengrui worth up to $12.5 billion for exclusive global rights to develop 12 innovative medicines, including a potential best-in-class COPD treatment.
  • The deal centers on HRS-9821, a PDE3/4 inhibitor in clinical development for chronic obstructive pulmonary disease that has demonstrated potent bronchodilation and anti-inflammatory effects in early studies.
  • GSK will pay $500 million upfront and potentially $12 billion in milestone payments, with Hengrui leading development of 11 additional programs through Phase I trials before GSK can exercise options.
  • The collaboration spans therapeutic areas including respiratory, immunology, inflammation, and oncology, representing a significant milestone in China's growing presence in global pharmaceutical development.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.