MedPath

Clinical Trial News

Scottish Health Authority Rejects Alzheimer's Drug Donanemab Despite UK Regulatory Approval

Monoclonal Antibody
  • The Scottish Medicines Consortium rejected donanemab (Kisunla) for NHS Scotland use, citing uncertainty around the drug's modest clinical benefit despite UK regulatory approval in October.
  • This marks the second Alzheimer's drug rejection by Scottish authorities in three months, following a similar decision on lecanemab (Leqembi).
  • Alzheimer Scotland advocates are calling for a specialized Dementia Drugs Fund and reformed assessment processes, arguing current evaluation methods are inadequate for addressing the UK's leading cause of death.
  • Donanemab works by targeting amyloid protein buildup in the brain through antibody infusions, potentially slowing Alzheimer's progression by up to two years in some cases.

Aethlon Medical's Hemopurifier Shows Promise for Long COVID Treatment Through Extracellular Vesicle Removal

  • Aethlon Medical will present pre-clinical data at the Keystone Symposium showing their Hemopurifier device can bind extracellular vesicles from Long COVID patients.
  • The study, conducted with UC San Francisco, found that extracellular vesicles from Long COVID participants contain mannose targets that bind to the device's proprietary affinity resin.
  • Long COVID affects 44-48 million Americans with a $2 billion economic burden, yet no effective treatments exist despite over $1 billion in research funding.
  • The Hemopurifier is an FDA Breakthrough Device that uses lectin-based technology to remove harmful extracellular vesicles implicated in Long COVID pathogenesis.

Electric Fields Combined with Immunotherapy Show 70% Survival Improvement in Glioblastoma Patients

  • A Phase 2 trial demonstrated that combining Tumor Treating Fields (TTFields) with immunotherapy and chemotherapy increased overall survival by 70% in newly diagnosed glioblastoma patients.
  • TTFields enhanced immune response by attracting more T cells into tumors and improving the effectiveness of pembrolizumab immunotherapy through in situ immunization.
  • Patients with large, inoperable tumors showed particularly strong responses, living approximately 13 months longer with enhanced immune activation compared to those who underwent surgical tumor removal.
  • A Phase 3 trial is now underway across 28 sites to validate these findings in over 740 participants through April 2029.

Mosanna Therapeutics Secures $80M Series A to Advance Nasal Spray Treatment for Obstructive Sleep Apnea

  • Mosanna Therapeutics raised $80 million in Series A funding led by EQT Life Sciences and Pivotal bioVenture Partners to advance its nasal spray therapy MOS118 through Phase 2 clinical trials.
  • The company's lead therapy MOS118 represents a pharmaceutical approach to treating obstructive sleep apnea by targeting upper airway muscles and restoring the body's natural airway reflex.
  • Obstructive sleep apnea affects nearly 1 billion people globally, with the majority undiagnosed and underserved by current mechanical treatment options.
  • Biotech veteran David Weber has been appointed CEO to lead the company through clinical development of this novel neurological and muscular dysfunction approach.

RxMP Therapeutics Advances Hemostatic Agent RMP-402 with DoD Partnership and FDA Manufacturing Approval

FDA Approval
  • RxMP Therapeutics secured a Cooperative Research and Development Agreement with the Department of Defense's Institute of Surgical Research to validate RMP-402 in large animal models of polytrauma hemorrhage and shock.
  • The company reached consensus with the FDA on its GMP allogeneic manufacturing process for RMP-402, enabling large-scale production of the red cell-derived hemostatic agent.
  • RxMP appointed Shawna Khouri as Chief Operating Officer to oversee operational strategy for its injectable drug platform focused on hemostasis and bleeding management.

Axio BioPharma and Likarda Form Strategic Partnership to Integrate AI Manufacturing with Advanced Drug Delivery

Monoclonal Antibody
  • Axio BioPharma and Likarda announced a strategic partnership combining AI-powered protein manufacturing with advanced drug delivery technologies to accelerate biologic drug development timelines.
  • The collaboration integrates Likarda's Core-Shell Spherification® hydrogel technology for encapsulation and controlled release with Axio's discovery-to-GMP manufacturing capabilities.
  • The partnership aims to enhance workflows for monoclonal antibodies, bispecifics, and Fc-fusions while providing clients with more efficient and scalable paths to clinical manufacturing.
  • Both companies emphasize integrating delivery technologies earlier in the development process to improve stability, efficacy, and patient outcomes while reducing development friction.

GL CHEMTEC Completes State-of-the-Art GMP Facility to Accelerate Clinical Trial Material Production

  • GL CHEMTEC has completed a new Good Manufacturing Practice (GMP) Kilo lab facility in Ontario to meet growing demand for advanced pharmaceutical materials suitable for human clinical trials.
  • The facility features two specialized rooms meeting ISO 8 specifications and significantly increased production capacity at the multi-kilogram scale for seamless transition from preclinical to clinical development.
  • This strategic expansion enables the North American CDMO to bridge the gap between preclinical offerings and first-in-human studies, offering clients a complete pathway from concept to commercialization.
  • The investment strengthens GL CHEMTEC's capabilities in material science and drug delivery, positioning the company to better support partners in navigating clinical trial complexities.

Sino Biopharmaceutical's TQC3721 Inhalation Drug Receives Phase III Approval for COPD Treatment

  • Sino Biopharmaceutical received approval from China's Center for Drug Evaluation to conduct phase III registration clinical studies for TQC3721, an innovative inhalable PDE3/4 inhibitor for COPD maintenance treatment.
  • TQC3721 demonstrates dual bronchodilation and anti-inflammatory effects, with clinical research showing significant improvements in bronchodilation and St. George's scores compared to existing drugs targeting the same pathway.
  • The drug represents only the second inhaled PDE3/4 inhibitor globally in development, with phase III trials planned to include a broader COPD patient population receiving various background treatments.
  • The company is also developing a dry powder formulation of TQC3721 currently in phase I clinical development, which is expected to enhance patient compliance.

Neowise Biotechnology Partners with BeOne Medicines to Advance iPSC-Based Off-the-Shelf Cell Therapies

  • Neowise Biotechnology has entered a non-exclusive licensing agreement with BeOne Medicines to grant rights to proprietary antigen-specific TCR molecules for next-generation iPSC-based cell therapies.
  • The partnership will enable BeOne to develop allogeneic, off-the-shelf cell therapy platforms using Neowise's CAST® tumor antigen-natural TCR pairing library technology.
  • Neowise will receive upfront payments plus milestone-based payments and royalties, while BeOne gains commercialization rights for the licensed TCR technology.
  • The collaboration aims to expand access to universal cancer treatments by combining Neowise's TCR-T expertise with BeOne's iPSC-derived cell therapy platform capabilities.

Fable Therapeutics Appoints Former AstraZeneca Executive David J. Baker as Chief Scientific Officer

Drug Discovery
  • Fable Therapeutics, a discovery-stage biotech developing AI-powered protein therapeutics for metabolic diseases, has appointed David J. Baker, PhD, as Chief Scientific Officer.
  • Dr. Baker brings extensive drug discovery experience from AstraZeneca, where he led metabolism bioscience programs from target selection through Phase 2b trials in diabetes, obesity, MASH and dyslipidemia.
  • The appointment comes at a pivotal time as Fable advances its machine learning-enabled protein design platform toward IND filing and first-in-human studies.
  • Fable recently secured $43.5 million in Series A funding to develop next-generation protein-based therapeutics for metabolic diseases affecting millions of patients worldwide.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.