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Clinical Trial News

EMA Recommends First EU Vaccine Against Swine Dysentery, Targeting Disease with 30-50% Mortality Rate

Drug Approval
  • The European Medicines Agency has issued a positive opinion for Biobhyo, the first vaccine authorized in the EU to protect pigs against swine dysentery disease.
  • Swine dysentery affects up to 90% of pigs in infected herds with a mortality rate of 30-50%, caused by the bacterium Brachyspira hyodysenteriae.
  • Clinical studies demonstrated vaccine efficacy when administered at five and eight weeks of age, showing reduced incidence of dysenteric diarrhea in commercial farm settings.
  • The Committee for Medicinal Products for Veterinary Use opinion will now proceed to the European Commission for final EU-wide marketing authorization.

European Commission Launches COMBINE Pilot Program to Streamline Combined Medicine and Medical Device Studies

  • The European Commission and EU Member States have launched a pilot project under the COMBINE programme to test a more efficient approval process for combined studies involving both clinical trials of medicines and performance studies of medical devices.
  • The pilot allows sponsors to submit a single application for studies testing both a medicine and companion diagnostic simultaneously, reducing administrative burden and promoting harmonized interactions with Member States.
  • This coordinated assessment procedure aims to enhance transparency and consistency in the evaluation process while accepting a limited number of studies to evaluate the effectiveness of this new approach.

First-in-Class CBP/p300 Inhibitor TT125-802 Shows Promise in Treatment-Resistant NSCLC

  • TT125-802, a novel oral CBP/p300 bromodomain inhibitor, demonstrated early clinical activity in advanced solid tumors with a favorable safety profile in an ongoing phase 1 trial.
  • Five out of seven NSCLC patients experienced tumor shrinkage following progression on prior therapy, with deep and durable responses observed in KRAS G12C- and EGFR-mutant NSCLC patients.
  • The treatment showed a best-in-class safety profile with 98% of treatment-related adverse events being grade 1 or 2 and reversible, notably without thrombocytopenia.
  • Seven patients experienced clinical benefit lasting at least 6 months, including one NSCLC patient who achieved a deep and durable partial response per RECIST 1.1 criteria.

A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors

NCT06403436RecruitingPhase 1
TOLREMO therapeutics AG
Posted 11/7/2023

Ellipsis Health Raises $45M Series A to Launch Sage, AI Care Manager with Emotional Intelligence

AI
  • Ellipsis Health secured $45 million in Series A funding led by Salesforce, Khosla Ventures, and CVS Health Ventures to advance AI-powered care management solutions.
  • The company unveiled Sage, an emotionally intelligent AI Care Manager that adjusts its tone and approach based on patient emotional states and mental health needs.
  • Sage leverages patented vocal biomarker technology trained on millions of clinical patient calls to support complex patients who drive majority of healthcare costs.
  • The AI platform integrates with Salesforce Health Cloud to address staffing shortages and reduce operating costs while maintaining high-quality patient engagement.

Serum Institute of India Partners with DNDi to Develop Affordable Dengue Monoclonal Antibody Treatment

Monoclonal Antibody
  • Serum Institute of India and DNDi have signed an MoU to co-develop a monoclonal antibody treatment for dengue that targets all four virus serotypes, focusing on affordability for low- and middle-income countries.
  • The collaboration will advance the drug candidate through Phase III clinical trials in India, Brazil, and other dengue-endemic countries, with SII having already completed pre-clinical and Phase I/II trials demonstrating safety and efficacy.
  • Dengue affects 3.9 billion people globally with cases more than doubling since 2021, yet no specific treatment currently exists for the disease.
  • The partnership leverages SII's manufacturing capabilities and DNDi's clinical trial leadership to address the urgent need for dengue therapeutics in vulnerable populations worldwide.

FAPI-Based PET Imaging Shows Superior Performance Over FDG-PET for Gastrointestinal Cancer Detection

  • Meta-analysis of 16 studies involving 597 patients demonstrates that (68Ga)Ga-FAPI-04 PET achieves 98% sensitivity and 93% specificity for primary gastric cancer detection, significantly outperforming (18F)FDG PET's 74% sensitivity and 48% specificity.
  • For lymph node metastases in gastric cancer, (68Ga)Ga-FAPI-04 PET shows double the sensitivity of (18F)FDG PET at 90% versus 45%, with higher specificity at 93% versus 83%.
  • FAPI-based imaging demonstrates particular advantage in gastric signet-ring-cell carcinoma detection, achieving 99% sensitivity compared to 46% for FDG-PET, attributed to increased FAP expression in tumor stroma.
  • Comparative analysis reveals both [18F]FAPI-74 and [68Ga]Ga-FAPI-04 show excellent diagnostic accuracy for metastatic colorectal cancer, with [18F]FAPI-74 offering superior tumor uptake and image contrast.

68Ga-FAPI-46 PET for Imaging of FAP Expressing Cancer

NCT05160051CompletedPhase 2
University Hospital, Essen
Posted 12/1/2021

Application of ⁶⁸Ga-FXX489 (NNS309) PET/CT Imaging in Diagnosis of Tumor Diseases.

NCT07144085Not Yet RecruitingNot Applicable
Yi Tian
Posted 9/1/2025

COVID-19 Vaccination Reduces Severe Kidney Damage Risk in Hospitalized Patients, UCLA Study Finds

  • UCLA Health researchers analyzed 3,500 hospitalized COVID-19 patients and found unvaccinated individuals were 16% more likely to require continuous renal replacement therapy during hospitalization.
  • Unvaccinated patients were more than 2.5 times as likely to need dialysis after discharge and faced higher mortality risk compared to vaccinated patients.
  • Experts suggest vaccination protects kidneys primarily by preventing severe COVID-19 illness that leads to multi-organ failure and systemic complications.
  • The study has limitations as researchers lacked baseline kidney function data, making it difficult to determine the full extent of vaccination benefits.

Johnson & Johnson's Dual-Targeting CAR-T Therapy Achieves 80% Complete Response Rate in Lymphoma Trial

CAR-TOncology
  • Johnson & Johnson's investigational dual-targeting CAR-T therapy JNJ-4496 demonstrated 75-80% complete response rates in patients with relapsed or refractory large B-cell lymphoma at the recommended Phase 2 dose.
  • The therapy targets both CD19 and CD20 antigens on malignant B-cells, potentially addressing resistance mechanisms that limit current single-antigen CAR-T treatments to 40% long-term remission rates.
  • Safety data showed no Grade 3 or 4 cytokine release syndrome cases, with neutropenia being the most common severe adverse event affecting 72% of patients.
  • The Phase 1b study results were presented at the 2025 European Hematology Association Congress, marking a significant advancement in treating the most common aggressive lymphoma type.

A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma

NCT05421663RecruitingPhase 1
Janssen Research & Development, LLC
Posted 8/12/2022

A Study of C-CAR039 in Subjects With Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma

NCT05149391RecruitingPhase 1
Peking University
Posted 7/20/2021

NextCell Pharma Completes Patient Dosing in Phase II ProTrans-Young Trial for Pediatric Type 1 Diabetes

  • NextCell Pharma has successfully completed treatment of all patients in the ProTrans-Young Phase II clinical trial, marking the completion of patient dosing in the company's largest clinical study to date.
  • The trial evaluates ProTrans, an allogeneic mesenchymal stromal cell therapy, in 66 pediatric and adolescent patients with recently diagnosed type 1 diabetes across three age cohorts.
  • One-year follow-up results from the 12-21 years age group showed a positive trend in preserved insulin production, with full study population data expected after summer 2026.
  • ProTrans is being developed as an off-the-shelf, single-dose infusion therapy aimed at modulating the immune system and preserving residual beta cell function in autoimmune diabetes.

Vial Doses First Participants in Phase 1 Trial of Half-Life Extended Anti-TL1A Antibody for IBD Treatment

Monoclonal Antibody
  • Vial has successfully dosed the first healthy volunteers in a Phase 1 trial of VIAL-TL1A-HLE, a novel subcutaneous monoclonal antibody targeting TL1A for inflammatory bowel disease treatment.
  • The first-in-human, single-ascending dose trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of the half-life extended antibody with interim data expected in H2 2025.
  • Preclinical studies demonstrate the antibody has potential for best-in-class dosing intervals compared to first and second-generation anti-TL1A candidates, offering improved patient convenience.
  • Vial plans to initiate a multi-region Phase 2 trial in IBD later in 2025 following the interim Phase 1 results.

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