FDA clears IND application for EVOLVE104 for the treatment of solid tumors
“This IND clearance represents a transformational milestone for our company, as it paves the way for our advancement into a clinical-stage developer of next-generation trispecific T cell engagers,” said Stephen Bloch, M.D., chief executive officer of EvolveImmune. “We have long believed that the integrated CD2 costimulation strategy underpinning EVOLVE has differentiated potential to deliver best-in-class T cell engagers that offer meaningful clinical benefits to patients with cancer. We are excited to evaluate this hypothesis in a clinical setting. We expect to initiate our first-in-human clinical trial for EVOLVE104 in the coming months.”
Share:
More News
“The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for Parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy
“Patients with non-muscle invasive bladder cancer continue to face a significant risk of disease recurrence despite available treatment options,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “UGN-501 is an investigational next-generation oncolytic virus designed to selectively destroy tumor cells while generating an anti-tumor immune response. FDA clearance of
“Whitehawk has established strong expertise in ADC technology and oncology drug development,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “This collaboration further expands the application of Biocytogen’s fully human bispecific antibodies in ADC development. We look forward to supporting the efficient advancement of multiple programs by contributing high-quality
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “The AZUR-1 results support the potential for dostarlimab to transform treatment for dMMR/MSI-H locally advanced rectal cancer. For many patients today, rectal cancer treatment comes with the tolerability burden and lasting impacts from chemotherapy, radiation and surgery. These data