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Clinical Trial News

Minerva Biotechnologies Achieves Breakthrough in Patient-Derived Stem Cell Manufacturing for Regenerative Medicine

  • Minerva Biotechnologies published research in PLOS One resolving the scientific controversy around Wnt/β-catenin pathway effects on human stem cell pluripotency versus differentiation.
  • The company's NME7AB protein enables GMP-compliant manufacturing of homogeneous naïve-state stem cells that differentiate more efficiently than traditional primed state cells.
  • iPSCs generated with NME7AB successfully differentiated into senescence-resistant mesenchymal stem cells capable of forming pure populations of chondrocytes, osteoblasts, and adipocytes.
  • This breakthrough could replace current practices using MSCs from unknown bone marrow donors with patient-derived alternatives for therapeutic applications.

Vetigenics Initiates First Dual Immune Checkpoint Inhibitor Trial in Dogs with Solid Tumors

Monoclonal Antibody
  • Vetigenics has dosed the first patient in its CHECKMATE K9 pilot study at the University of Wisconsin, combining anti-cCTLA-4 and anti-cPD-1 monoclonal antibodies in dogs with solid tumors.
  • The open-label multisite study involves seven leading veterinary oncology investigators across academic centers and aims to assess safety and preliminary efficacy signals.
  • This marks a major advancement in veterinary oncology and represents the first dual immune checkpoint inhibitor study in canine cancer treatment.
  • The research builds on landmark dual immune checkpoint inhibitor studies in human cancer and aims to strengthen the bridge between animal and human cancer research.

JiuZhou Pharma Wins China Patent Excellence Award for Breakthrough Synthesis Technology

  • JiuZhou Pharma received the 25th China Patent Excellence Award for its asymmetric hydrogenation technology using metal iridium chiral helical ligand complexes.
  • The patented technology reduced chiral intermediate costs by over 50% and supported the development of China's first domestically produced Class 1 anti-lung cancer drug.
  • This breakthrough fills a technical gap in asymmetric hydrogenation of α-keto acid compounds and opens new pathways for drug synthesis.
  • The company has accumulated 310 international and domestic patents as of 2024, demonstrating strong intellectual property capabilities.

First-in-Human iPSC-CAR-NK Cell Therapy Shows Promise for Autoimmune Disease Treatment

Gene Editing
  • Qihan Biotech's QN-139b represents the first-ever application of iPSC-CAR-NK cells in treating autoimmune disease, successfully inducing immune reset in a patient with refractory systemic sclerosis.
  • The dual-targeting therapy eliminates pathogenic B cells and plasma cells by targeting both CD19 and BCMA, incorporating nine gene edits and advanced safety features including a tEGFR safety switch.
  • After six months of treatment, the patient showed significant reduction in autoantibodies, dramatic improvement in skin scores, and histological evidence of B cell clearance and fibrosis suppression.
  • The groundbreaking clinical results were published in Cell, marking a potential breakthrough for treating severe autoimmune diseases with off-the-shelf cell therapies.

Stryker Receives FDA Clearance for Incompass Total Ankle System Integrating Dual Platform Technologies

  • Stryker has received FDA 510(k) clearance for the Incompass Total Ankle System, designed for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
  • The new platform integrates technologies from Stryker's Inbone and Infinity systems into a single comprehensive solution for total ankle replacement procedures.
  • The system incorporates data from more than 85,000 CT scans and 100,000 clinical cases to support patient-specific care and surgical efficiency.
  • Incompass features Adaptis Boney Ingrowth Technology and redesigned instrumentation aimed at improving long-term fixation and streamlined surgical workflow.

Bryn Pharma Initiates Clinical Trial for Dual-Dose Epinephrine Nasal Spray to Address Anaphylaxis Treatment Gaps

  • Bryn Pharma has dosed the first participant in a clinical trial evaluating its second-generation epinephrine nasal spray with an innovative dual-dose profile that delivers two complete therapeutic doses from a single device.
  • The upgraded nasal spray device features enhanced reliability, easier handling, improved comfort and fit, and an integrated dose indicator, addressing key limitations of current injectable epinephrine treatments.
  • The trial aims to compare pharmacokinetics, pharmacodynamics, and safety of the nasal spray against injectable epinephrine standards, with results expected in Q3 2025.
  • More than 50% of patients prescribed epinephrine autoinjectors do not carry or use them as recommended due to needle phobia, accessibility issues, and portability challenges, highlighting significant unmet medical need.

Recordati Secures Exclusive European Rights to Cardiovascular Drug Vazkepa in $175 Million Deal with Amarin

  • Recordati has acquired exclusive licensing and supply rights to commercialize Vazkepa (icosapent ethyl) across 59 European countries in a deal worth up to $175 million with Amarin.
  • Vazkepa is the only treatment proven to reduce cardiovascular risk in statin-treated patients with elevated triglycerides, backed by the REDUCE-IT study involving over 8,000 patients.
  • The drug generated €12 million in net sales across 11 European countries in 2024 and is projected to exceed €40 million in revenues by 2027.
  • The agreement includes a $25 million upfront payment and potential milestone payments up to $150 million based on sales performance thresholds starting at €100 million annually.

OPKO Health and Entera Bio Advance First-in-Class Oral Dual GLP-1/Glucagon Tablet for Obesity Treatment

  • OPKO Health and Entera Bio announced that new pharmacologic and pharmacokinetic data for their investigational oral OPK-88006 tablet will be presented at the ENDO 2025 annual meeting.
  • The companies are developing a proprietary dual agonist GLP-1/glucagon peptide as both a once-daily tablet and weekly subcutaneous injection for patients with obesity and metabolic disorders.
  • The oral program combines OPKO's long-acting oxyntomodulin analog with Entera's N-Tab technology, with IND applications planned for later this year.
  • The treatment aims to provide durable, sustainable weight loss and help prevent comorbidities such as severe fatty liver and sleep apnea.

Acadia Pharmaceuticals Unveils $12 Billion Pipeline Strategy at Inaugural R&D Day

  • Acadia Pharmaceuticals outlined an ambitious multi-year strategy with a pipeline potentially generating up to $12 billion in annual peak sales across eight clinical programs.
  • The company highlighted near-term catalysts from five mid- to late-stage programs, including ACP-101 for Prader-Willi syndrome and next-generation ACP-204 for neuropsychiatric conditions.
  • Combined peak sales from marketed products Nuplazid and Daybue are expected to reach up to $2 billion, providing a foundation for pipeline advancement.
  • H.C. Wainwright analysts maintained a Buy rating with $32 price target, citing ACP-101 as the most important near-term catalyst for the company.

Q32 Bio Names Adrien Sipos as Interim CMO to Lead Alopecia Areata Drug Development

Monoclonal AntibodyLeadership Change
  • Q32 Bio appointed Adrien Sipos, M.D., Ph.D., as Interim Chief Medical Officer to oversee the ongoing SIGNAL-AA Phase 2a clinical trial of bempikibart for alopecia areata treatment.
  • Dr. Sipos brings over 25 years of immunology and inflammation drug development experience from leadership roles at Biogen, Sanofi Genzyme, and Eli Lilly.
  • The company expects topline results from Part B of the SIGNAL-AA Phase 2a trial in the first half of 2026 for their novel anti-IL-7Rα antibody therapy.
  • Bempikibart represents a novel therapeutic approach targeting IL-7 and TSLP signaling pathways to treat alopecia areata, which affects approximately 700,000 Americans.

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