ImmunityBio Advances Pipeline with Chemotherapy-Free Trial and Regulatory Progress

ImmunityBio US45256X1037

ImmunityBio has initiated a new clinical trial, focusing on a combination cell therapy approach that is garnering significant interest in oncology: treatments that avoid traditional chemotherapy. Concurrently, the company continues efforts to clarify the regulatory pathway for its key drug, ANKTIVA, with the U.S. Food and Drug Administration (FDA). This dual focus on clinical development and regulatory strategy is central to the company's near-term outlook.

A primary strategic focus remains ANKTIVA. Following a Type‑B End‑of‑Phase meeting held on January 20, the FDA provided guidance for a potential resubmission of the supplemental Biologics License Application (sBLA) for ANKTIVA in BCG‑unresponsive papillary bladder cancer. Critically, the agency's requested additional information is not expected to necessitate any new clinical studies. This represents a potentially streamlined path forward for the therapy.

Further bolstering its oncology pipeline, ImmunityBio provided updates on two other key programs:
- For the QUILT‑2.005 trial in BCG‑naive, non-muscle invasive bladder cancer, patient recruitment surpassed 85% as of January 16, progressing faster than anticipated. The company is targeting a BLA submission by the end of 2026.
- In the QUILT‑3.078 trial for recurrent glioblastoma, the median overall survival for patients receiving ANKTIVA combined with CAR‑NK cell therapy had not yet been reached as of the January 23 update.

Launch of a Chemotherapy-Free Phase 2 Study

Building on this regulatory momentum, the company announced the start of a Phase 2 trial named ResQ215B on Monday. This study will evaluate a chemotherapy-free and lymphodepletion-free combination regimen. It involves an "off-the-shelf" CD19-targeted natural killer (NK) cell therapy (CD19 t-haNK) administered alongside ANKTIVA and the anti-CD20 antibody Rituximab.

The trial is enrolling adult patients with CD19-positive/CD20-positive indolent B‑cell non‑Hodgkin lymphoma, including Waldenström macroglobulinemia, who have relapsed or become refractory after at least two prior lines of therapy. Treatment will be administered in 21‑day cycles on an outpatient basis, explicitly excluding pre-treatment chemotherapy.

Early Data Provides Rationale for New Trial

The ResQ215B study is informed by earlier results from the Phase 1 QUILT‑106 trial. That earlier study tested a CD19‑CAR‑NK cell therapy with Rituximab but without ANKTIVA. In a preliminary, chemotherapy-free cohort of four patients with Waldenström macroglobulinemia, all achieved disease control, according to the company. Within that group, two patients attained complete remissions that were ongoing at follow-up (at 7 and 15 months, respectively).

While these early results are encouraging, the very small patient population clearly positions them as a promising signal rather than conclusive proof. The new Phase 2 study is designed to build upon these preliminary findings with more robust data.

Market Performance Reflects Volatile Sentiment

Recent news flow has been reflected in substantial stock price movement. Over the past 30 days, ImmunityBio shares have surged approximately 204% (year-to-date gain of 213%). The stock currently trades around $6.33, which is about 14% below its 52‑week high of $7.34.

Key Upcoming Catalysts

The coming weeks and months will be pivotal for ImmunityBio on two main fronts. First, market observers will watch for the company's timely submission of the ANKTIVA resubmission package and the clarity of the subsequent FDA feedback. Second, progress in the ResQ215B trial will be monitored to see if the early Phase 1 signals translate into robust data within a larger patient cohort. The company's next scheduled financial report is expected on March 2, 2026.