CRANBURY, N.J. — Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for AC0676 for the treatment of patients with relapsed/refractory B-cell malignancies. AC0676 is an orally bioavailable, chimeric degrader molecule designed to target and degrade Bruton’s Tyrosine Kinase (BTK) with high potency, selectivity, and broad mutant coverage. BTK plays a crucial role in the B-cell receptor (BCR) signaling pathway, and its constitutive activation is essential to…
Tag: Trial
Tevogen Bio Announces Positive Proof-of-Concept Clinical Trial Results of Its Off-The-Shelf, Allogeneic Cytotoxic CD8+ T Cell Therapy for Treatment of Acute High-Risk COVID Patients, First Clinical Product of Company’s Precision Cell Therapy Platform
WARREN, N.J. — Tevogen Bio today announced positive topline results from its Proof-of-Concept (POC) clinical trial designed to evaluate the safety and feasibility of TVGN 489, the company’s first clinical product of its precision T Cell therapy platform, for the treatment of acute high-risk COVID-19 patients. TVGN 489 is a genetically unmodified, off-the-shelf, allogeneic cytotoxic CD8+ T lymphocyte (CTL) product with precise targets across the SARS-CoV-2 genome, not just the Spike protein. To date, TVGN 489 targets, identified early in the pandemic, persist in the most recent SARS-CoV-2 variants. The open label comparative trial…
Drug Combination Meets Survival Endpoint in Phase III Pivotal Trial Involving Participants With Refractory Metastatic Colorectal Cancer
PARIS — Servier, Taiho Oncology, Inc., and Taiho Pharmaceutical Co., Ltd., announced today that the investigational combination of trifluridine/tipiracil plus bevacizumab showed a statistically significant improvement in the primary endpoint of overall survival (OS) compared to trifluridine/tipiracil alone in a Phase III clinical trial of participants with refractory metastatic colorectal cancer (mCRC) following two chemotherapy regimens. Further details about the OS benefit and other results from the primary analysis of the global SUNLIGHT trial will be presented at an upcoming international scientific conference. “Findings from the SUNLIGHT trial could potentially…