The FDA has issued a ‘safe to proceed’ for the investigational new drug application enabling a phase 1 study evaluating NY-ESO-1 TCR/IL-15 NK, a first-in-class engineered T-cell receptor natural killer cell therapy for patients with relapsed/refractory multiple myeloma.
Now that positive phase 1 results have been reported for PHE855, a phase 2 study of PHE855 is currently underway in patients with relapsed and refractory multiple myeloma.
Findings from a phase 1 study showed that the fully humanized IgG4 antibody IO-108 was well tolerated and displayed durable responses when given as a monotherapy as well as in combination with pembrolizumab, supporting further development of the agent alone or with PD-1/PD-L1 targeted therapy for patients with advanced solid tumors.