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Clinical Trial News

Onco360 Partners with Deciphera to Distribute QINLOCK for Advanced GIST Patients

Oncology
  • Onco360, the nation's leading independent specialty pharmacy, has been selected as a national pharmacy partner for QINLOCK (ripretinib), an FDA-approved treatment for advanced gastrointestinal stromal tumors.
  • QINLOCK is indicated for adult patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib, based on the Phase III INVICTUS study.
  • The INVICTUS trial demonstrated significant efficacy with median progression-free survival of 6.3 months for ripretinib versus 1.0 month for placebo in 129 patients with relapsed or refractory GIST.
  • Ripretinib is a tyrosine kinase inhibitor targeting KIT and PDGFRA kinases, including wild type, primary, and secondary mutations, with generally well-tolerated safety profile.

Perceptive Discovery and Pfizer Launch FIBRE Consortium to Advance Fibrosis Drug Development Through Advanced Imaging

  • Perceptive Discovery announced the launch of the FIBRE Consortium, a pre-competitive collaboration with Pfizer, Lantheus, and Lumina Pharmaceuticals to revolutionize multi-organ fibrotic disease treatment through advanced imaging biomarkers.
  • The consortium will leverage PET and MRI imaging to identify and validate early disease biomarkers, with initial studies focusing on Metabolic Dysfunction-Associated Steatohepatitis (MASH) and potential expansion to other fibrotic conditions.
  • Lantheus will supply LNTH-1363S targeting Fibroblast Activation Protein, while Lumina Pharmaceuticals will contribute [⁶⁸Ga]CBP8 tracer targeting Collagen Type I for comprehensive fibrosis imaging research.
  • The initiative aims to streamline disease-modifying therapy development by enabling more precise decisions, reducing trial size and cost, and increasing success likelihood in bringing new therapies to patients.

SHINE Technologies' Lutetium-177 Isotope Ilumira Reaches Global Milestone with 19-Country Distribution Network

  • SHINE Technologies' Ilumira (lutetium-177) has achieved significant commercial success in its first year, reaching customers in 19 countries across four continents with over 95% on-time delivery performance.
  • The radioisotope demonstrated exceptional therapeutic potential in preclinical studies, showing 100% survival rates in kidney cancer models with 8-20x greater efficacy compared to other compounds in development.
  • SHINE has submitted a centralized Marketing Authorization Application to the European Medicines Agency and acquired Lantheus' SPECT division to expand its nuclear medicine portfolio.
  • The company's Cassiopeia facility produces 100,000 doses annually with potential expansion to 200,000 doses, positioning SHINE as a key U.S.-based manufacturer of this critical cancer therapy isotope.

European Medicines Agency Recommends Approval of Partner Therapeutics' IMREPLYS for Acute Radiation Syndrome Treatment

Drug Approval
  • The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Partner Therapeutics' IMREPLYS (sargramostim) for treating patients exposed to myelosuppressive radiation doses.
  • IMREPLYS represents the same formulation as LEUKINE, which received FDA approval in 2018 for Hematopoietic Syndrome of Acute Radiation Syndrome in the United States.
  • European Commission approval is expected within 67 days, enabling sales and government stockpiling across all EU member states plus Norway, Iceland, and Liechtenstein.
  • The approval addresses critical preparedness needs amid current geopolitical threats involving tactical nuclear weapons and radiation exposure risks.

Bridge Biotherapeutics Pivots to Bitcoin Treasury Strategy Following Clinical Trial Failures

  • Bridge Biotherapeutics will transfer controlling interest to U.S. digital asset firm Parataxis Holdings for KRW 25 billion, creating South Korea's first Bitcoin treasury company on public markets.
  • The biotech company's pivot follows significant clinical setbacks, including BBT-877's failure to meet primary endpoints in idiopathic pulmonary fibrosis Phase 2 trials and BBT-401's discontinuation in ulcerative colitis studies.
  • Following the transaction, the company will rebrand as Parataxis Korea while maintaining its KOSDAQ listing, with existing biotech operations continuing under co-founder James Jungkue Lee.
  • The deal represents a strategic shift from pharmaceutical R&D to Bitcoin-based financial strategies, targeting institutional investors seeking digital asset exposure in the Korean market.

Immuno Cure Partners with PharmaJet to Advance HIV Therapeutic DNA Vaccine Using Needle-Free Delivery Technology

  • Immuno Cure and PharmaJet signed a collaboration agreement to evaluate the HIV therapeutic DNA vaccine ICVAX using PharmaJet's needle-free Tropis intradermal delivery system in clinical trials.
  • The partnership builds on ICVAX's successful Phase I trial results showing exceptional safety and promising immunogenicity profiles for achieving HIV virological control without antiretroviral therapy.
  • The study will be conducted at Prince of Wales Hospital in Hong Kong and leverages intradermal delivery to potentially enhance immune responses through the rich network of immune cells in the dermal layer.
  • This collaboration represents a significant step toward developing a functional cure for HIV/AIDS, addressing the critical need for effective immunotherapy beyond current antiretroviral treatments.

ValiRx Secures £16 Million Licensing Deal for Repurposed Risperidone Cancer Therapy VAL401

  • ValiRx PLC announced that Ambrose Healthcare Ltd has exercised its option to license VAL401, a reformulated risperidone with anti-cancer properties, for up to £16 million plus royalties.
  • VAL401 represents a drug repurposing approach, utilizing the established anti-psychotic drug risperidone which has demonstrated anti-cancer effects in preclinical studies.
  • The licensing agreement includes milestone payments totaling £16 million plus royalties, with Ambrose committing to complete development and commercialization of the asset.
  • ValiRx plans to leverage its subsidiary's 19 pancreatic patient-derived cell models for preclinical validation, utilizing 3D systems supported by FDA guidance for investigational new drug submissions.

European Phase II Trial Tests Simple Home Intervention to Prevent Heart Failure in Cancer Survivors

  • A phase II clinical trial is testing Remote Ischemic Conditioning (RIC), a simple blood pressure cuff-like intervention, to prevent heart failure in cancer patients receiving anthracycline chemotherapy.
  • The RESILIENCE project has recruited 355 of 608 planned participants across 22 hospitals in six European countries, marking the first preventive intervention offered during cancer treatment for long-term heart protection.
  • With 3 million Europeans receiving anthracyclines annually and 35% developing cardiotoxicity, this non-invasive intervention could address a significant unmet medical need affecting one million heart failure survivors.
  • The trial will also investigate gender differences in treatment response and test new MRI protocols for earlier detection of cardiac damage in cancer patients.

Researchers Develop First Risk Prediction Model for Early-Stage Hodgkin's Lymphoma

Precision MedicineOncology
  • An international research team has developed and validated the first individualized risk prediction model for early-stage classic Hodgkin's lymphoma, called the Early-stage Hodgkin International Prognostication Index (E-HIPI).
  • The model was developed using data from over 3,000 patients in four international phase III clinical trials and validated in more than 2,300 patients from real-world registry cohorts.
  • E-HIPI uses routine clinical measures like patient sex, tumor size, hemoglobin and albumin levels to predict two-year progression-free survival and outperformed existing classification systems.
  • The research team created interactive online risk calculators to support shared decision-making between clinicians and patients, with findings published in NEJM Evidence.

Altum Sequencing's Liquid Biopsy Technology Detects Breast Cancer Relapse Up to 68 Months Before Clinical Symptoms

  • Altum Sequencing has developed a liquid biopsy technology that can detect breast cancer relapse up to 68 months before symptoms become apparent through traditional diagnostic methods.
  • The technology analyzes circulating tumor DNA from blood samples and can detect one tumor cell among a million healthy cells using next-generation sequencing.
  • Published in Breast Cancer Research, the study focused on HR+ breast cancer patients, where up to 40% experience relapse despite initial treatment response.
  • The technology is applicable to any solid tumor type and aims to transform cancer monitoring by providing minimally invasive, personalized treatment tracking.

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