Viridian Therapeutics announces positive topline results from veligrotug (VRDN-001) phase 3 THRIVE clinical trial in patients with active thyroid eye disease
- Viridian Therapeutics reported positive topline data from the THRIVE phase 3 trial of veligrotug (VRDN-001) in patients with active thyroid eye disease (TED).
- The trial met primary and all secondary endpoints at 15 weeks, showing significant improvements in proptosis, clinical activity score, and diplopia.
- Veligrotug demonstrated a rapid onset of action, with 53% of patients achieving a proptosis response after just one infusion.
- The safety profile was favorable, with most adverse events being mild and a low rate of discontinuations.
Read more
Reveal Genomics announces positive top-line results for HER2DX in CLEOPATRA phase III trial
- Reveal Genomics released positive results for HER2DX, a genomic test for HER2+ breast cancer, from the CLEOPATRA phase III trial.
- The HER2DX ERBB2 mRNA score showed a strong association with progression-free survival (PFS) and overall survival (OS) in 214 patients.
- The CLEOPATRA trial compared docetaxel-trastuzumab with and without pertuzumab, leading to FDA approval of pertuzumab in 2012.
- Detailed results will be presented at an upcoming medical congress and submitted for publication.
Read more
Incendia Therapeutics enrolls first patient in Phase 1c clinical trial of PRTH-101
- Incendia Therapeutics has enrolled the first patient in the Phase 1c study of PRTH-101 for advanced or metastatic solid tumors.
- The study will evaluate the safety, tolerability, and anti-tumor activity of PRTH-101 as a monotherapy and in combination with pembrolizumab.
- PRTH-101 targets DDR1, a collagen binding protein, to disrupt tumor-associated collagen alignment and permit immune cell access.
- The trial aims to enroll up to 270 patients in the US and will inform the design of the Phase 2/3 program.
Read more
Delta-Fly Pharma initiates phase I/II combo-study of DFP-10917 with Venetoclax in AML patients
- Delta-Fly Pharma has initiated a Phase I/II clinical trial of DFP-10917 in combination with Venetoclax (VEN) for AML patients.
- The trial targets patients who had one prior treatment with a VEN-involved regimen.
- The first patient was enrolled at the University of Virginia Hospital.
- The study aims to enroll up to 39 patients, with endpoints including complete remission (CR) rate and progression-free survival (PFS).
Read more
Pfizer highlights diverse oncology portfolio and combination approaches at ESMO 2024
- Pfizer will present data from over 50 research abstracts at ESMO 2024, including more than 10 oral and mini-oral presentations.
- Key presentations include updated results from the Phase 2 PHAROS study of BRAFTOVI + MEKTOVI in BRAF V600E-mutant metastatic NSCLC.
- Pfizer will share early results for two novel investigational antibody-drug conjugates and a novel combination of next-generation CDK inhibitors.
- Additional presentations will cover the efficacy and safety of ponsegromab for cancer-associated cachexia and early clinical-stage research for several priority pipeline areas.
Read more
Avistone announces results from a sponsored clinical research program studying the combination of two small-molecule c-MET and EGFR inhibitors in NSCLC patients at the 2024 World Conference on Lung Cancer (WCLC)
- Avistone Biotechnology presented results at the IASLC 2024 World Conference on Lung Cancer.
- The study involved 44 NSCLC patients with EGFR mutation-positive, MET amplified, or MET overexpression.
- Objective responses were observed in 59.4% of response-evaluable patients, with a 75% ORR in patients with brain metastases.
- The most common treatment-related adverse events (TRAEs) were rash and paronychia, with no treatment discontinuations due to TRAEs.
Read more
Scholar Rock completes enrollment in Phase 2 EMBRAZE proof-of-concept trial of apitegromab in obesity
- Scholar Rock has completed enrollment in the Phase 2 EMBRAZE trial for apitegromab, targeting obesity.
- The trial aims to evaluate the efficacy, safety, and pharmacokinetics of apitegromab in adults on GLP-1 RA therapy.
- Primary endpoint: change in lean mass at 24 weeks, with results expected in Q2 2025.
- Data from this trial will inform the development of SRK-439, a novel myostatin inhibitor for cardiometabolic disorders.
Read more
Basking Biosciences doses first patients in phase 2 clinical trial of reversible thrombolytic BB-031 for acute ischemic stroke
- Basking Biosciences has initiated patient enrollment in the RAISE Phase 2 clinical trial for BB-031.
- The trial will evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, and pharmacodynamics of BB-031 in 156 patients.
- RAISE is a multicenter, double-blind, placebo-controlled, randomized single ascending dose study.
- BB-031 targets von Willebrand Factor (vWF) and aims to offer a safer, more effective thrombolytic option for acute ischemic stroke patients.
Read more
Stoke Therapeutics presents zorevunersen data showing substantial reductions in seizures and improvements in cognition and behavior
- Stoke Therapeutics presented data at the 15th European Epilepsy Congress showing zorevunersen's potential as a disease-modifying treatment for Dravet syndrome.
- Phase 1/2a ADMIRAL study showed significant reductions in seizures and improvements in cognition and behavior within the first year of treatment.
- Two-year natural history study indicated high seizure rates and developmental plateau despite standard anti-seizure medications.
- Plans for a Phase 3 registrational study are underway, focusing on dose regimen and clinical endpoints.
Read more
Inflammasome Therapeutics completes enrollment in study for first oral dual inflammasome inhibitor for ophthalmic and neuroinflammatory diseases
- Inflammasome Therapeutics has completed enrollment for a Phase I PK/Safety study of K9, a brain- and retina-penetrant drug.
- K9 targets multiple neuroinflammatory and degenerative diseases, including Alzheimer's, MS, ALS, Parkinson's, and autoimmune diseases like lupus.
- The drug blocks two specific inflammasomes, showing superior results compared to single inflammasome inhibitors.
- The successful completion of this study paves the way for further clinical trials expected to commence later this year.
Read more
