FDA provides IND requirements for the development of ALA-101 in first-inhuman clinical trials for lymphoma and leukaemia
Arovella’s Chief Executive Officer and Managing Director, Dr Michael Baker, commented, “The valuable and positive feedback we received from the FDA was excellent and aligns clearly with our development plans for ALA-101. For a complex therapeutic like off-the-shelf CAR-iNKT cells, our team has done a commendable job reaching this key milestone. We look forward to receiving acceptance for our IND and executing our plan to advance ALA-101 into the clinic over the coming months. Due to the platform nature of Arovella’s CAR-iNKT cells, the learnings for ALA-101 throughout the IND application process can be applied to our additional solid tumour programs, such as ALA-105.”
Share:
More News
“Giredestrant represents the first major endocrine therapy advance in early-stage ER-positive breast cancer in decades, where the chance for cure is highest,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “The FDA’s filing acceptance brings us closer to delivering a new standard-of-care with the
“Orphan Drug Designation for SOT106 underscores both the urgent need for new treatment options in osteosarcoma and the strength of our ADC platform,” said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. “Osteosarcoma is a devastating disease that has seen little therapeutic innovation over the past four decades. Treatment
“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”
“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two