MedPath

Clinical Trial News

QV Bioelectronics Secures £1.26 Million to Advance GRACE Brain Tumor Device Toward Clinical Trials

  • QV Bioelectronics has secured £1.26 million from Innovate UK's Biomedical Catalyst programme to prepare for the first in-human trial of its GRACE device.
  • GRACE is a surgically implanted device designed to deliver electric field therapy directly to glioma tumor margins to disrupt cancer cell division while preserving healthy tissue.
  • The funding follows QV's participation in the Brain Tumour Research Novel Therapeutics Accelerator programme, where they received expert guidance on manufacturing, funding, and clinical trial design.
  • The development represents progress in bridging the 'Valley of Death' in brain tumor research, moving innovative therapeutics closer to patient treatment.

Illumina Launches PromoterAI Tool to Detect Disease-Causing Mutations in Previously Overlooked Genomic Regions

AIRare DiseasePrecision Medicine
  • Illumina has introduced PromoterAI, an AI tool that detects disease-causing mutations in noncoding promoter regions of the genome, areas typically overlooked in clinical diagnostics.
  • The breakthrough technology, featured in Science, could explain up to 6% of undiagnosed rare disease cases and potentially double diagnostic success when combined with existing AI tools.
  • PromoterAI analyzes promoter sequences using deep learning and is freely available for academic research through Illumina Connected Software, offering precomputed scores to prioritize harmful mutations.

Iksuda Therapeutics Initiates First-in-Human Trial of CD19-Targeted ADC IKS03 for Advanced B-Cell Non-Hodgkin Lymphoma

Oncology
  • Iksuda Therapeutics has successfully dosed the first patient with IKS03, a CD19-directed antibody drug conjugate, in a Phase 1 first-in-human clinical trial for advanced B-cell non-Hodgkin lymphoma.
  • The study will evaluate safety, tolerability, pharmacokinetics, and preliminary antineoplastic activity of IKS03 across multiple international clinical sites in Italy, Spain, Australia, United States, and Canada.
  • IKS03 utilizes a tumor-activated prodrug pyrrolobenzodiazepine payload and demonstrated best-in-class efficacy in preclinical xenograft models compared to existing CD19-targeted therapies.
  • The trial represents Iksuda's second clinical asset and aims to address significant unmet medical needs in non-Hodgkin lymphoma treatment despite recent therapeutic advances.

IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas

2024-512415-45-00RecruitingPhase 1
Iksuda Therapeutics Limited
Posted 9/5/2023

AstraZeneca Advances Two Experimental Compounds Through Early-Stage Clinical Testing

  • AstraZeneca is conducting a comprehensive dose-escalation study of AZD2389 across 11 cohorts to evaluate safety and tolerability in healthy volunteers.
  • The AZD2389 trial employs both single and multiple ascending dose protocols with placebo controls to establish optimal dosing parameters.
  • A separate study is investigating AZD5004 through multiple ascending doses and bioavailability assessments to guide Phase 3 development.
  • Both compounds represent AstraZeneca's continued investment in early-stage drug development with structured clinical programs designed to optimize therapeutic potential.

Astellas Secures $1.4 Billion License Deal for Novel CLDN18.2-Targeting ADC XNW27011

Oncology
  • Astellas Pharma has entered an exclusive worldwide licensing agreement with Evopoint Biosciences for XNW27011, a clinical-stage antibody-drug conjugate targeting CLDN18.2 for solid tumors.
  • The deal includes a $130 million upfront payment and potential milestone payments totaling up to $1.34 billion, plus royalties on net sales if approved.
  • XNW27011 has demonstrated encouraging monotherapy efficacy in an ongoing Phase 1/2 study for patients with gastric cancer, gastroesophageal cancer, and pancreatic cancer.
  • The ADC utilizes a proprietary topoisomerase I inhibitor payload and linker technology, expanding Astellas' oncology pipeline alongside their existing CLDN18.2 expertise.

UC Davis Clinical Trial Identifies Gene Mutations as Key to Treating Aggressive Prostate Cancer

OncologyPrecision Medicine
  • UC Davis researchers have launched a clinical trial demonstrating that gene mutations play a key role in treating aggressive prostate cancer, offering new hope for men with this challenging disease.
  • The study represents a significant advancement in personalized cancer treatment by focusing on biomarkers to guide therapeutic decisions for aggressive prostate cancer cases.
  • This research builds on UC Davis's strong position in prostate cancer research, supported by substantial NIH funding of around $210 million for the School of Medicine.

Saudi Arabia Launches National Biotech Initiative at BIO 2025 with Strategic Partnerships

Precision Medicine
  • Saudi Arabia inaugurated its first-ever national pavilion at BIO International Convention 2025 in Boston, showcasing its ambition to become a global biotechnology hub under Vision 2030.
  • The Kingdom signed multiple partnership agreements with global biotech leaders including Vertex Pharmaceuticals for precision medicine and Illumina for genomics research.
  • The initiative represents a comprehensive biotech ecosystem spanning regulation, research, infrastructure, and investment, supported by streamlined clinical trial approvals and digital health platforms.
  • Saudi Arabia's integrated approach brings together government entities, research institutions, and investment facilitators to accelerate biotech innovation and localize advanced therapeutic solutions.

Concurrent Hypertension and Type 2 Diabetes Double Mortality Risk as Prevalence Surges in US Adults

  • The prevalence of concurrent hypertension and type 2 diabetes in US adults doubled from 6% in 1999 to 12% in 2018, affecting approximately 12% of the population.
  • Individuals with both conditions face more than twice the risk of all-cause mortality and nearly three times the risk of cardiovascular death compared to those with neither condition.
  • Even co-existing prediabetes and elevated blood pressure increase mortality risk by up to 19%, suggesting risk begins before progression to full diabetes and hypertension.
  • The study analyzed nearly 49,000 adults over a median follow-up of 9.2 years, revealing that 31% of those with both conditions died during follow-up compared to just 6% with neither condition.

Seer Launches Next-Generation Proteomics Platform Enabling Unprecedented 20,000-Sample Cancer Study

  • Seer's new Proteograph ONE Assay and SP200 Automation Instrument can process over 1,000 samples per week, doubling throughput while reducing per-sample costs by approximately 60% compared to 2021.
  • Korea University will conduct the first large-scale plasma proteomics study of its kind, analyzing 20,000 samples from cancer patients and healthy controls to develop AI-driven diagnostics for early-onset cancers in young adults.
  • The three-year study, funded by Korea's K-Health MIRAE initiative, aims to identify novel blood-based biomarkers for cancer detection in patients in their 20s and 30s using samples from leading Korean cancer institutions.
  • The new workflow identifies up to 10 times more proteins than conventional mass spectrometry methods and completes 80-sample batches in under 5 hours of automated runtime.

Comprehensive Supportive Care Emerges as Critical Component in SMA Management Beyond Disease-Modifying Therapies

  • Supportive care for spinal muscular atrophy (SMA) encompasses rehabilitation, respiratory management, orthopedic interventions, and psychosocial support that extends beyond motor function improvement.
  • Adult patients with SMA face distinct challenges including independence maintenance, fatigue management, and reproductive concerns that differ significantly from pediatric patient needs.
  • Emerging evidence suggests properly designed exercise programs may have disease-modifying effects when combined with pharmacological treatments for SMA patients.
  • Critical life stages such as puberty, growth spurts, illness, and aging represent crisis points requiring heightened clinical vigilance due to potential acceleration of functional decline.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.