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PatientSeek Identifies Genetic Signature for Vedolizumab Response in Ulcerative Colitis

  • C4X Discovery's PatientSeek platform has identified a genetic signature that distinguishes responders from non-responders to vedolizumab in ulcerative colitis patients.
  • The genetic signature is based on variations in non-coding regions of DNA and offers a stable, time-independent biomarker for patient selection.
  • This precision medicine approach could lead to smaller, more efficient clinical trials by targeting the right patients for a4b7 integrin therapies.
  • The discovery marks a significant advancement in immuno-inflammation precision medicine, potentially guiding clinical practice for IBD treatment.

Certa Therapeutics' GPR68 Inhibitor FT011 Receives International Non-Proprietary Name: Asengeprast

  • Certa Therapeutics' lead drug candidate FT011 has been granted the International Non-Proprietary Name (INN) 'asengeprast' by the World Health Organization.
  • Asengeprast is a first-in-class oral GPR68 antagonist being developed for treating chronic fibrosis in multiple organs, demonstrating efficacy in preclinical models.
  • Clinical studies have shown favorable efficacy, safety, and pharmacokinetics of asengeprast in systemic sclerosis (SSc) patients, with plans for a Phase IIb trial.
  • Certa Therapeutics is also developing biomarkers and gene signatures to identify patients most likely to respond to asengeprast treatment.

AstraZeneca's Imfinzi Shows Promise in Extending Lives of Bladder Cancer Patients

  • AstraZeneca's Imfinzi, combined with standard care, significantly reduced the risk of disease recurrence by 32% in muscle-invasive bladder cancer patients.
  • The late-stage trial involving 1,063 patients demonstrated that Imfinzi also lowered the risk of death by 25% when used with treatments like chemotherapy.
  • Positive data from the Imfinzi trial has boosted AstraZeneca's shares, potentially increasing annual revenue by $500 million if approved for this new patient group.
  • The study's findings, presented at the European Society for Medical Oncology Congress, mark the first instance of an immunotherapy drug improving survival in this cancer type.

FDA Approves Dupixent as First Treatment for CRSwNP in Adolescents

  • The FDA has approved Dupixent (dupilumab) for adolescents aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
  • This marks the first approved treatment option for CRSwNP in this younger age group, addressing a significant unmet need in upper airway inflammatory diseases.
  • The approval was based on data from adult trials (SINUS-24 and SINUS-52) and pharmacokinetic data from adolescent asthma studies, demonstrating efficacy and safety.
  • Dupixent, a monoclonal antibody targeting interleukin-4 and interleukin-13, has now been approved in over 60 countries for various type 2 inflammation-related diseases.

MEDSIR Presents Promising Results in Breast and Thymic Cancer Trials at ESMO

  • The ABIGAIL study showed that abemaciclib with endocrine therapy achieved a 59% overall response rate at 12 weeks in HR+/HER2- advanced breast cancer, versus 40% with chemotherapy.
  • The PECATI study demonstrated an 88% progression-free rate at 5 months using lenvatinib and pembrolizumab in advanced thymic tumors, offering a potential new standard of care.
  • MEDSIR also hosted MEDTalks, focusing on advancing research in brain metastasis, a critical unmet need in solid tumors like lung, breast, and skin cancers.

Deep Learning Identifies Behavioral Risk Profiles for Ventricular Arrhythmias

  • A new study uses deep learning to analyze physical behavior data from wearable accelerometers to predict the risk of malignant ventricular arrhythmias.
  • The study identified distinct behavioral profiles associated with varying risks of ICD therapy and death in patients with ICDs.
  • Findings suggest that behavioral patterns, captured through wearable technology and analyzed with AI, can improve risk stratification for ventricular arrhythmias.
  • This approach offers a novel way to personalize management strategies for patients at risk of life-threatening arrhythmias.

Elicio Therapeutics to Present mKRAS Vaccine Data at Multiple Conferences

  • Elicio Therapeutics will present Phase I AMPLIFY-7P trial updates at the AACR Special Conference on Pancreatic Cancer, highlighting clinical actionability.
  • The company will also present at the RAS-Targeted Drug Development Summit, focusing on the clinical translation of its RAS-targeted Amphiphile vaccines.
  • Elicio will share Phase I experience with ELI-002 2P and ELI-002 7P at the Advances in Cancer Vaccines Summit, detailing lymph node-targeted mKRAS-specific amphiphile vaccine in gastrointestinal tumors.

Pfizer's Ponsegromab Shows Promise in Treating Cancer Cachexia in Phase 2 Trial

  • Pfizer's ponsegromab met its primary endpoint in a Phase 2 trial, demonstrating a statistically significant increase in body weight compared to placebo in cancer cachexia patients.
  • The highest dose of ponsegromab (400 mg) led to a 5.61% mean increase in body weight at 12 weeks, along with improvements in appetite, cachexia symptoms, physical activity, and muscle mass.
  • The study included patients with non-small cell lung cancer, pancreatic cancer, or colorectal cancer, showing the drug was generally safe and well-tolerated across all dose levels.
  • Pfizer plans to initiate registration-enabling studies in 2025 based on these positive Phase 2 results, with ponsegromab also under investigation for heart failure.

A Study of Ponsegromab in People With Heart Failure

NCT05492500TerminatedPhase 2
Pfizer
Posted 9/26/2022

Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15

NCT05546476CompletedPhase 2
Pfizer
Posted 11/21/2022

IO Biotech's IO102-IO103 Plus Pembrolizumab Shows Promise in Head and Neck Cancer

  • IO Biotech's Phase 2 trial of IO102-IO103 with pembrolizumab demonstrates a 44.4% overall response rate in PD-L1 high recurrent or metastatic SCCHN patients.
  • The combination therapy shows an encouraging median progression-free survival of 6.6 months and a disease control rate of 66.7% in SCCHN.
  • The safety profile of IO102-IO103 with pembrolizumab is consistent with previous studies, showing no new systemic toxicity concerns.
  • These results support further investigation of IO102-IO103 plus pembrolizumab as a first-line treatment for advanced head and neck cancer.

IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)

NCT05155254Active, Not RecruitingPhase 3
IO Biotech
Posted 5/17/2022

IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC

NCT05077709Active, Not RecruitingPhase 2
IO Biotech
Posted 2/14/2022

Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors

NCT05280314RecruitingPhase 2
IO Biotech
Posted 12/21/2023

FDA Approves Ocrevus ZUNOVO: First Subcutaneous Injection for Multiple Sclerosis

  • The FDA has approved Ocrevus ZUNOVO as the first and only twice-yearly, 10-minute subcutaneous injection for relapsing and primary progressive multiple sclerosis.
  • Ocrevus ZUNOVO offers an alternative administration method, potentially expanding treatment access to centers with IV constraints or limited infrastructure.
  • Backed by a decade of safety and efficacy data from Ocrevus IV, the new formulation demonstrated consistent suppression of relapse activity and MRI lesions in trials.
  • The approval provides multiple sclerosis patients with more flexible treatment options tailored to individual needs, enhancing convenience and accessibility.

A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis

NCT05232825Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 5/3/2022

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