ImmunityBio Advances Pipeline with Novel Chemotherapy-Free Lymphoma Trial

ImmunityBio US45256X1037

ImmunityBio is accelerating its oncology development efforts with the initiation of a new mid-stage clinical study. The biopharmaceutical company has launched a Phase 2 trial designed to evaluate a cell therapy combination without traditional chemotherapy for an indolent form of B-cell non-Hodgkin lymphoma. This strategic move significantly broadens the company's clinical pipeline beyond its already FDA-approved ANKTIVA therapy.

This trial announcement comes amidst a period of notable updates from ImmunityBio's research and regulatory activities. Recent communications highlight a busy start to 2026:

• January 23, 2026: Updated glioblastoma data indicated the median overall survival for patients receiving ANKTIVA combined with CAR-NK therapy had not yet been reached.
• January 20, 2026: The company reported advanced discussions with the U.S. Food and Drug Administration regarding a potential pathway for the resubmission of ANKTIVA for BCG-unresponsive papillary bladder cancer.
• January 14, 2026: ANKTIVA received accelerated approval from the Saudi FDA for both non-small cell lung cancer (NSCLC) and BCG-unresponsive bladder cancer.

Market sentiment appears to reflect this heightened activity. Despite a softer performance in the most recent week, ImmunityBio shares have posted substantial gains over a 30-day period, closing yesterday at $5.64—a remarkable increase of +156.36%.

The ResQ215B Phase 2 Trial Design

On February 2, 2026, ImmunityBio formally announced the start of the ResQ215B study. This open-label Phase 2 investigation will examine a novel triple-combination regimen for indolent Non-Hodgkin Lymphoma (iNHL), including Waldenström macroglobulinemia.

The protocol will test three key components:

• CD19 t-haNK: An "off-the-shelf," allogeneic CAR-NK cell therapy
• ANKTIVA (nogapendekin alfa inbakicept): An IL-15 superagonist
• Rituximab: An anti-CD20 monoclonal antibody

A defining feature of this approach is its planned administration without lymphodepleting chemotherapy, a standard prerequisite in most CAR-T protocols. The treatment is scheduled in 21-day cycles on an outpatient basis, further eliminating the need for preconditioning chemo.

Foundation Built on Early Phase 1 Data

The new Phase 2 study is grounded in preliminary results from the earlier QUILT-106 (NCT06334991) Phase 1 trial. That study evaluated CD19 CAR-NK therapy plus Rituximab without ANKTIVA.

In an initial chemotherapy-free cohort of four patients with Waldenström macroglobulinemia, ImmunityBio reported the following outcomes:

• Clinical disease control was achieved in all 4 patients.
• Two patients attained complete remissions, which remained durable through 7 and 15 months of follow-up, respectively.
• Two patients maintained stable disease.

While the patient sample was limited, these early results provided a crucial proof-of-concept, justifying the broader evaluation of the combination in Phase 2 and the decision to now augment it with ANKTIVA.

Upcoming Catalyst: ASCO GU Symposium

Investors can anticipate a near-term clinical update. According to the company's investor relations calendar, ImmunityBio is scheduled to participate in the ASCO GU Symposium from February 26 to 28, 2026. The event may yield additional clinical details or presentations, offering new insights into the pace and potential of the ResQ215B trial as it progresses toward more robust efficacy and safety data.

@ boerse-global.de | US45256X1037 IMMUNITYBIO