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
“Fast Track designation in lung cancer represents an important milestone for TRE-515 and further validates our strategy of combining dCK inhibition with targeted cancer therapies,” said Dr. Ken Schultz, Trethera Chairman and CEO. “KRAS G12C inhibitors have transformed the NSCLC treatment landscape, but resistance and incomplete responses remain major challenges.
“AvenCell has built a differentiated cell therapy platform that brings together CRISPR-engineered allogeneic CAR-T technology with a unique switchable CAR approach designed to provide greater control over CAR-T activity,” said Todd Davis, CEO of Ligand. “We believe the combination of these technologies, together with the encouraging clinical data generated to
“Advanced gastric cancer is characterized by substantial biological and clinical heterogeneity. Previous studies have shown that the magnitude of benefit from PD-1 inhibitor therapy is closely associated with PD-L1 expression, and that there remains room to further improve outcomes, particularly in patients with low PD-L1 expression. How to broaden the
“The evERA results represent an important step forward for people with ER-positive advanced breast cancer and underscore the potential for giredestrant to help address the challenge of disease progression in this setting,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Together with the