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Clinical Trial News

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.

Innospera Pharma Appoints Dr. Glenn Crater as Chief Medical Officer to Advance IPF Drug ING-006

  • Innospera Pharma has appointed Dr. Glenn Crater, a board-certified pulmonologist with over 25 years of experience, as Chief Medical Officer to support the clinical advancement of ING-006.
  • ING-006 is a first-in-class synthetic lipid designed to treat Idiopathic Pulmonary Fibrosis by modulating GPR84 and GPR40 receptors to resolve inflammation and reduce fibrogenesis.
  • Dr. Crater brings specialized expertise in IPF and respiratory drug development, having previously served as CMO at multiple biotechnology companies with successful regulatory submissions.
  • The appointment comes at a critical time as ING-006 is poised to enter clinical development in the near future for IPF treatment.

Complement 1 Raises $16M to Scale AI-Powered Cancer Lifestyle Platform with 90% Patient Adherence

Oncology
  • Complement 1 secured $16 million in seed funding led by Owl Ventures and Blume Ventures to scale its clinically validated lifestyle modification platform for cancer patients.
  • Clinical trials demonstrate the platform achieves over 90% patient adherence while reducing treatment side effects by 37%, pain by 18%, and improving sleep by 27%.
  • The evidence-based platform combines daily one-on-one CoActive coaching with AI-driven personalization, potentially reducing healthcare costs by up to 30% for cancer patients.
  • Research shows lifestyle modifications can reduce cancer recurrence by 35% and mortality by 37%, addressing a critical gap in oncology care delivery.

Olanzapine Shows Promise in Preventing Radiation-Induced Nausea and Vomiting in Phase 3 Trial

  • A phase 3 placebo-controlled trial demonstrated that adding 5 mg olanzapine to standard ondansetron therapy significantly reduced radiation-induced nausea and vomiting in patients receiving abdominal/pelvic radiotherapy.
  • The study showed dramatic reductions in nausea rates (14.2% vs 83.6% with placebo) and vomiting episodes (4.1% vs 25.5% with placebo) among 301 cancer patients.
  • Olanzapine treatment also improved quality of life measures, reduced anxiety and depression scores, and showed consistent benefits across multiple cancer types including rectal, prostate, and endometrial cancers.
  • Researchers recommend larger multi-center studies to validate these findings for this repurposed psychiatric medication in radiation oncology supportive care.

Beacon Therapeutics Appoints Gene Therapy Veteran Dr. Daniel Chung as Chief Medical Officer

Rare Disease
  • Beacon Therapeutics has appointed Dr. Daniel Chung as Chief Medical Officer, bringing over three decades of experience in clinical ophthalmology and gene therapy development.
  • Dr. Chung previously played an instrumental role in developing Luxturna, the first FDA and EMA-approved gene therapy for a blinding genetic disease.
  • The appointment comes as Beacon approaches completion of enrollment for its registrational Phase 2/3 VISTA trial of laru-zova for X-linked retinitis pigmentosa.
  • Beacon recently announced positive six-month interim safety and efficacy results from the Phase 2 DAWN trial of laru-zova in patients with X-linked retinitis pigmentosa.

Citius Oncology Partners with Cardinal Health for LYMPHIR Distribution Ahead of Commercial Launch

Targeted TherapyDrug ApprovalOrphan Drug
  • Citius Oncology has entered into a distribution services agreement with Cardinal Health to support the upcoming U.S. commercial launch of LYMPHIR for cutaneous T-cell lymphoma treatment.
  • LYMPHIR is an FDA-approved targeted immunotherapy indicated for adults with relapsed or refractory Stage I-III cutaneous T-cell lymphoma after at least one prior systemic therapy.
  • The partnership leverages Cardinal Health's proven specialty pharmaceutical distribution capabilities to ensure efficient and reliable access to LYMPHIR for healthcare providers and patients.
  • Management estimates the initial market for LYMPHIR currently exceeds $400 million and is underserved by existing therapies.

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