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Clinical Trial News

Adolore BioTherapeutics Reports Positive Preclinical Data for Gene Therapy Targeting Chronic Knee Pain

  • Adolore BioTherapeutics published preclinical data in Molecular Therapy demonstrating biosafety and efficacy of its rdHSV-CA8* gene therapy for chronic knee pain from osteoarthritis.
  • The gene therapy delivered via intra-articular injection showed profound analgesia lasting over 6 months without functional impairments or toxicity in mouse models.
  • The therapy works by activating Kv7 voltage-gated potassium channels to reduce nerve excitability, offering a potential non-opioid alternative for chronic pain treatment.
  • The company's lead program ADB-102 is fully funded by NIH/NINDS HEAL program with first-in-human studies expected to commence in 2026.

Samsung Biologics Expands Into Preclinical Research with Launch of Samsung Organoids Drug Screening Platform

  • Samsung Biologics launched Samsung Organoids, an advanced drug screening service utilizing three-dimensional cell culture systems that closely mimic human organs to provide clinically relevant insights for drug discovery and development.
  • The new platform supports precision screening to predict patient responses and accelerate timelines toward investigational new drug (IND) filings through data-driven analysis of candidate molecules.
  • This launch marks Samsung Biologics' expansion into preclinical research, with services now spanning target discovery, lead selection, preclinical development, and clinical trial planning to support the entire drug lifecycle.
  • The organoid technology is emerging as a new research model due to its high similarity to live tissues and potential applications in biomarker discovery and drug efficacy prediction.

NHS App to Feature Clinical Trial Matching System as UK Targets 150-Day Setup Times

  • The NHS App will introduce a new "Be Part of Research" feature that automatically matches patients with clinical trials based on their health data and interests, sending push notifications for relevant studies.
  • The UK government aims to reduce clinical trial setup times from the current 250 days to 150 days by March 2026, compared to Spain's 100-day benchmark.
  • The initiative includes making trial performance data public for NHS trusts and prioritizing funding for top-performing sites, while introducing standardized national contracts to reduce bureaucracy.
  • The program specifically encourages participation from under-represented communities including young, Black, and South Asian populations to improve diversity in clinical research.

Hengrui and Kailera Present Phase 2 Data for Dual GLP-1/GIP Agonist and Oral GLP-1 Therapies at ADA 2025

  • Jiangsu Hengrui Pharmaceuticals and Kailera Therapeutics will present six abstracts at the American Diabetes Association 85th Scientific Sessions showcasing clinical progress of their metabolic disease portfolio.
  • The presentations include Phase 2 data for injectable dual GLP-1/GIP receptor agonist HRS9531 (KAI-9531) in type 2 diabetes and obesity, with trials extending up to 52 weeks.
  • Clinical results will also cover oral small molecule GLP-1 receptor agonist HRS-7535 (KAI-7535) and an oral formulation of the dual agonist HRS9531.
  • The data demonstrates the companies' advancement in next-generation therapies for obesity and diabetes, including both injectable and oral delivery mechanisms.

Axcelead and A2 Healthcare Form Strategic Partnership to Accelerate Drug R&D in Japan

Drug Discovery
  • Axcelead and A2 Healthcare announced a strategic partnership to establish an integrated support framework covering drug discovery, non-clinical studies, clinical trials, regulatory submissions, and manufacturing in Japan.
  • The collaboration combines Axcelead's drug discovery services and mRNA CDMO capabilities with A2 Healthcare's clinical development expertise to address drug loss and strengthen Japan's pharmaceutical R&D ecosystem.
  • The partnership will provide comprehensive support to academia, biotech ventures, and pharmaceutical companies from Japan and abroad advancing drug development in the Japanese market.
  • A2 Healthcare's J-STEP initiative and Boston office expansion complement the alliance's goal of enhancing Japan's drug discovery capabilities and facilitating international pharmaceutical market entry.

Novel BTK Degrader BGB-16673 Achieves 84.8% Response Rate in Heavily Pretreated CLL/SLL Patients

Targeted Therapy
  • BGB-16673, a novel BTK protein degrader, demonstrated an 84.8% overall response rate in 66 heavily pretreated patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma in the phase 1/2 CaDAnCe-101 trial.
  • The treatment showed efficacy across high-risk patient subgroups, including those with BTK mutations and prior exposure to multiple BTK and BCL2 inhibitors, with responses observed regardless of baseline mutations and unfavorable biological features.
  • At a median follow-up of 15.6 months, the drug was well-tolerated with manageable safety profile, and achieved a one-year progression-free survival rate of 77.4% in this challenging patient population.
  • The 200-mg dose level, selected for expansion, showed particularly promising results with a 93.8% overall response rate and median duration of exposure of 16.2 months.

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716RecruitingPhase 1
BeiGene
Posted 9/13/2021

Intellia's CRISPR Gene Therapy Shows 98% Reduction in HAE Attacks After Three Years

Gene EditingOrphan DrugRare Disease
  • Intellia Therapeutics reported three-year follow-up data showing lonvoguran ziclumeran achieved a 98% mean reduction in monthly hereditary angioedema attack rates across all 10 Phase 1 patients.
  • All patients remained attack-free and treatment-free for a median of 23 months, demonstrating the potential for lonvo-z to become the first one-time therapy for HAE patients.
  • The company's Phase 3 HAELO trial completed screening ahead of schedule, with results expected in the first half of 2026 and a planned U.S. launch in 2027.
  • The CRISPR-based therapy targets the KLKB1 gene to prevent HAE attacks and has received multiple regulatory designations including FDA Orphan Drug and RMAT status.

HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)

NCT06634420Active, Not RecruitingPhase 3
Intellia Therapeutics
Posted 1/15/2025

NTLA-2002 in Adults With Hereditary Angioedema (HAE)

NCT05120830Active, Not RecruitingPhase 1
Intellia Therapeutics
Posted 12/10/2021

Adalimumab Biosimilars Show High Acceptance and Long-Term Durability in IBD Patients Across Age Groups

Monoclonal AntibodyReal World Evidence
  • A French observational study found 92% of adult IBD patients accepted switching from adalimumab reference product to biosimilars, with 71% remaining on biosimilar therapy at 12 months.
  • Real-world data from European pediatric IBD centers demonstrated high durability rates for adalimumab biosimilars, with 67% of patients continuing treatment after median 26-month follow-up.
  • Both studies confirm cost-effectiveness of adalimumab biosimilars, with pediatric study estimating savings of 5,030 Euro per patient per year compared to reference product.
  • Clinical remission rates remained stable or improved in both populations, with 85% of adult switchers and 72% of pediatric patients achieving remission at 12 months.

Socioeconomic Disparities Drive Worse Outcomes in Multiple Myeloma Patients Despite Treatment Advances

  • Patients with relapsed/refractory multiple myeloma from lower socioeconomic backgrounds report significantly worse quality of life and higher prevalence of clinically important symptoms that limit daily activities.
  • Multiple myeloma mortality rates remain nearly twice as high among patients from households earning less than $40,000 annually compared to those earning over $120,000, with rural patients also experiencing higher mortality rates.
  • Chronic kidney disease emerges as a significant comorbidity that increases risk of high-risk multiple myeloma diagnosis, advanced disease stage, and mortality in affected patients.

EHA 2025 Showcases Breakthrough Therapies for Hematologic Malignancies

  • The 2025 European Hematology Association Congress featured promising clinical trial results across multiple hematologic cancers, with novel trispecific and bispecific antibodies showing exceptional response rates in challenging patient populations.
  • JNJ-5332, a trispecific antibody targeting CD3, BCMA, and GPRC5D, achieved 70.4% complete response rates in BCMA/GPRC5D-naïve multiple myeloma patients, comparable to CAR-T therapy but as an off-the-shelf outpatient treatment.
  • The combination of talquetamab and teclistamab demonstrated a 78.9% overall response rate in multiple myeloma patients with extramedullary disease, a historically difficult-to-treat population with poor outcomes.
  • POLARGO trial results showed polatuzumab vedotin-based therapy reduced death risk by 40% in relapsed/refractory diffuse large B-cell lymphoma, offering new treatment options for transplant-ineligible patients.

A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04586426Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/15/2020

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

NCT06034002RecruitingPhase 1
Incyte Corporation
Posted 12/4/2023

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis

NCT05652335RecruitingPhase 1
Janssen Research & Development, LLC
Posted 11/22/2022

Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance

NCT04285086Active, Not RecruitingPhase 3
PharmaEssentia
Posted 8/25/2020

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

NCT05936359RecruitingPhase 1
Incyte Corporation
Posted 9/25/2023

A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

NCT04182204CompletedPhase 3
Hoffmann-La Roche
Posted 2/7/2020

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