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Clinical Trial News

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

NCT05149391RecruitingPhase 1
Peking University
Posted 7/20/2021

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

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

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.

Panavance Therapeutics Reports Promising Phase 1 Results for Misetionamide in Pancreatic Cancer

Oncology
  • Panavance Therapeutics announced interim Phase 1 results for misetionamide (GP-2250) combined with gemcitabine in advanced pancreatic cancer patients.
  • The combination demonstrated a 42% response rate with partial response or stable disease in 55 enrolled patients across seven US sites.
  • Misetionamide showed excellent tolerability with no new toxicities compared to gemcitabine alone, targeting multiple oncogenic transcription factors including c-MYC and NFκB.
  • The company plans additional trials in platinum-resistant ovarian cancer and first-line maintenance therapy for non-BRCA mutated pancreatic cancer patients.

UCB Announces $5 Billion U.S. Biologics Manufacturing Investment to Strengthen Supply Chain

FDA Approval
  • UCB plans to invest $5 billion in a new state-of-the-art biologics manufacturing facility in the United States, creating 300 permanent high-skilled jobs and over 500 construction positions.
  • The investment reflects UCB's commitment to serving its growing U.S. patient base and building a more resilient supply chain for immunology and central nervous system disease treatments.
  • Since 2017, UCB has expanded its U.S. workforce by 73% to around 2,000 employees and achieved 15 FDA approvals, with eight coming in the past two years alone.

FDA Places Clinical Hold on Rocket Pharmaceuticals' Gene Therapy Trial After Patient Death

Rare Disease
  • The FDA placed a clinical hold on Rocket Pharmaceuticals' Phase 2 pivotal trial for RP-A501, a gene therapy for Danon disease, following a patient death from a serious adverse event.
  • Rocket Pharmaceuticals' stock price crashed over 60% on May 27, 2025, after the company disclosed the FDA's clinical hold and revealed undisclosed protocol amendments.
  • A securities class action lawsuit has been filed alleging the company failed to properly disclose safety risks and protocol changes, including the addition of a novel immunomodulatory agent.
  • The lawsuit claims Rocket Pharmaceuticals made materially false statements about RP-A501's safety profile and trial protocol while knowing serious adverse events were at risk.

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