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Clinical Trial News

Celltrion Secures Preferred Bidder Status for US Manufacturing Facility to Navigate Tariff Challenges

  • Celltrion has been named the preferred bidder for a large-scale biologics manufacturing facility in the US, with a final agreement expected in early October.
  • The Korean pharmaceutical company plans to invest 700 billion won ($503 million) in the acquisition and operation, with potential additional investments of 300-700 billion won depending on US tariff policies.
  • The strategic move aims to eliminate tariff-related risks for Celltrion's 11 biosimilars currently sold in the US, with plans to expand the portfolio to 22 by 2030 and 41 by 2033.
  • The acquisition includes a contract manufacturing agreement covering 50% of the facility's capacity with exclusive rights to produce the seller's biologics for five years.

Syntara Initiates First-in-Human Trial of Topical Anti-Fibrotic Drug SNT-9465 for Hypertrophic Scars

  • Syntara Limited has dosed the first participant in a Phase 1a/b clinical trial of SNT-9465, a topical pan-lysyl oxidase inhibitor designed to treat hypertrophic scars.
  • The trial will initially assess safety and tolerability in healthy participants before moving to a Phase 1b extension evaluating improvements in scar appearance and composition after three months of daily treatment.
  • Current standard care for hypertrophic scars includes costly laser therapy or painful steroid injections requiring multiple treatments for only small incremental improvements.
  • Trial results expected in the first half of 2026 are anticipated to support an FDA IND application for what could become the first approved pharmacological treatment for skin scarring.

Alphamab Oncology's HER2-Targeting ADC JSKN003 Receives FDA Orphan Drug Designation for Gastric Cancer

FDA Approval
  • Alphamab Oncology's anti-HER2 biparatopic antibody-drug conjugate JSKN003 has been granted FDA Orphan Drug Designation for treating gastric cancer and gastroesophageal junction cancer.
  • The designation provides significant regulatory advantages including tax credits, fee waivers, accelerated review processes, and potential seven-year market exclusivity upon approval.
  • JSKN003 demonstrated favorable safety and promising efficacy in Phase I clinical studies, particularly in heavily pretreated patients with high HER2-expressing gastrointestinal tumors.
  • Gastric and gastroesophageal junction cancers represent a significant unmet medical need with poor survival outcomes, affecting approximately 960,000 new cases globally and 26,890 cases in the U.S. annually.

First-In-Human Study in Subjects With Advanced or Metastatic Solid Malignant Tumors

NCT05494918CompletedPhase 1
Alphamab (Australia) Co Pty Ltd.
Posted 9/2/2022

Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors

NCT05744427RecruitingPhase 1
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Posted 3/15/2023

Brazilian Research Institute Hcor Accelerates Phase 3 Immunology Trials with Oracle Clinical Platform

  • Hcor, a leading Brazilian research organization, has successfully implemented Oracle Clinical One Data Collection to independently build and manage two critical phase 3 immunology studies, eliminating reliance on third-party firms.
  • The cloud-based platform has enabled Hcor to reduce costs and accelerate trial execution timelines through its intuitive design that allows real-time study adjustments without costly external interventions.
  • Oracle Exadata Cloud@Customer has boosted Hcor's overall IT performance by 20%, allowing developers to launch healthcare projects five times faster and deliver fully tested applications in one month instead of five months.

Fertility Preservation Gains Momentum in Cancer Care as Awareness and Access Improve

Oncology
  • Cancer treatments including chemotherapy, radiation therapy, and surgery can severely impact fertility in reproductive-age patients, making early fertility preservation counseling essential.
  • Fertility specialists can now see patients within 24 hours of referral and complete preservation procedures within 2 weeks without delaying cancer treatment.
  • Advanced techniques like ovarian tissue cryopreservation offer options for patients who cannot undergo conventional egg freezing, including prepubertal girls.
  • ASCO guidelines now recommend that all reproductive-age cancer patients receive counseling on fertility preservation options as part of their standard care.

Bristol Myers Squibb and Bain Capital Launch $300M Immunology Drug Development Venture

  • Bristol Myers Squibb and Bain Capital have formed an independent company backed by $300 million to develop five experimental immunology drugs licensed from Bristol Myers.
  • The new venture will advance a late-stage lupus treatment and a mid-stage psoriasis drug that has shown promise in clinical trials.
  • Bristol Myers will retain nearly 20% equity in the company and receive royalties and milestone payments based on drug development success.
  • The collaboration allows Bristol Myers to focus its immunology research on immune system reset treatments while ensuring continued development of promising assets.

Nyxoah's Genio System Shows Strong Patient Satisfaction and Efficacy in DREAM Pivotal Study Publication

  • Nyxoah's DREAM pivotal study data published in the Journal of Clinical Sleep Medicine demonstrates 90% patient satisfaction with the Genio hypoglossal neurostimulation system for obstructive sleep apnea treatment.
  • The study achieved primary endpoints with 63.5% AHI responder rate and 71.3% ODI responder rate at 12 months, while showing high device usage with 85.9% of participants using the device over 70% of nights.
  • Genio's bilateral stimulation resulted in a 66.6% median reduction in supine AHI and significant improvements in quality-of-life measures, including a 3.4-point reduction in Epworth Sleepiness Score.
  • The leadless, battery-free design addresses patient needs for OSA treatment, particularly for those who fail or refuse CPAP therapy, with safety results comparable to other neuromodulation therapies.

Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM)

NCT03868618Active, Not RecruitingNot Applicable
Nyxoah S.A.
Posted 10/14/2020

Torrent Pharmaceuticals Prepares First-Wave Semaglutide Launch Following Patent Expiry

  • Torrent Pharmaceuticals is conducting Phase 3 clinical trials for oral semaglutide and has partnered for injectable versions, positioning itself for launch within 1-2 years following Novo Nordisk's patent expiry.
  • The company plans to manufacture the active pharmaceutical ingredient in-house at its Gujarat facility while potentially outsourcing fill-finish operations to optimize production costs.
  • Torrent's entry into the semaglutide market could address unmet demand in India's expanding obesity and diabetes segment, where GLP-1 drugs are gaining traction among clinicians and patients.
  • The strategic move represents a significant addition to Torrent's chronic medicine portfolio as generic drugmakers prepare for the high-stakes market opportunity post-patent expiry.

XVIVO Heart Preservation Technology Faces 6-12 Month CE Approval Delay Despite Promising Clinical Results

  • XVIVO's heart perfusion solution faces a 6-12 month delay in CE approval due to additional scientific consultation requirements at EU competent authorities, despite main system components already receiving approval.
  • The company's European multicenter heart trial demonstrated a 76% risk reduction in severe primary graft dysfunction (PGD) and improved one-year survival rates of 92% versus 86% in the control group.
  • The delay affects access to potentially life-saving heart preservation technology for European patients awaiting transplants, with CEO expressing disappointment over the regulatory setback.

Asahi Kasei to Build Fourth Planova Virus Filter Plant in Japan with Government Support

  • Asahi Kasei Life Science announced plans to construct a new spinning plant for Planova virus removal filters in Nobeoka City, Japan, with construction beginning July 2026 and operations starting January 2030.
  • The facility will be the company's fourth spinning plant for hollow-fiber cellulose membrane filters, backed by a grant from Japan's Ministry of Economy, Trade, and Industry under the Biopharmaceutical Manufacturing Project.
  • The expansion responds to accelerating global demand driven by the biopharmaceutical market forecast to surpass $500 billion by 2032 with 8.2% compound annual growth from 2022 to 2032.
  • The new plant will focus on producing Planova filters S20N, 15N, 20N, 35N, and 75N to enhance global supply chain resilience and strengthen the company's position in virus filtration for biologics.

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