Shares of ImmunityBio (NASDAQ:IBRX) traded more than 30% higher after the company reported updated clinical data showing durable complete responses in patients treated with its off-the-shelf CD19 CAR-NK cell therapy in Waldenström non-Hodgkin’s lymphoma, adding to recent momentum driven by strong sales growth for its approved immunotherapy Anktiva.
ImmunityBio said on Friday that follow-up from its ongoing Phase 1/2 QUILT-106 study demonstrated sustained complete responses lasting up to 15 months in evaluable patients, with 100% disease control observed to date.
The data reflect outcomes in patients who had failed standard treatments and were treated in an outpatient setting without chemotherapy or lymphodepletion.
The QUILT-106 trial is evaluating an allogeneic CD19 CAR-NK therapy, known as CD19 t-haNK, in combination with rituximab for Waldenström lymphoma, a rare B-cell malignancy. To date, four patients have been enrolled in the study, all of whom remain in clinical disease control. Two patients are evaluable for long-term follow-up and continue to show complete remission at seven and 15 months, respectively, after completing treatment.
According to the company, patients received a total of eight doses of CAR-NK cells administered over four cycles, along with six doses of rituximab, with no additional therapy following completion. Responses were assessed after two cycles, with complete remissions observed as early as that point in treatment.
ImmunityBio highlighted that the therapy is the first reported CAR-NK approach in this setting to demonstrate chemotherapy-free and lymphodepletion-free administration with full disease control in early patients.
The off-the-shelf design is intended to address some of the limitations associated with CAR-T therapies, including the need for intensive conditioning regimens and inpatient hospitalization, the company noted.
“This updated follow-up reinforces the central thesis that restoring and activating the immune system can deliver durable control of disease without chemotherapy or lymphodepletion,” said Dr Patrick Soon-Shiong, founder, executive chairman, and global chief medical and scientific officer of ImmunityBio.
He added that complete responses persisting more than a year after treatment cessation in heavily pretreated patients represent a meaningful advance and support CAR-NK as a potential next-generation immunotherapy platform.
ImmunityBio said enrollment and follow-up in the QUILT-106 study are ongoing, with additional updates expected as more patients become evaluable and longer-term durability data mature
The latest clinical update follows a sharp increase in ImmunityBio’s shares earlier this week after the company reported a significant rise in Anktiva revenue and disclosed regulatory approvals in Saudi Arabia. The stock traded hands at $5.25 on Friday morning, up more than 125% this week.