- The founder said that 50% of enrolled patients in the Phase 3 bladder cancer study reached an evaluable efficacy endpoint, triggering a review by an independent monitoring committee.
- The trial is testing a combination of Anktiva and BCG versus BCG alone in patients newly starting standard bladder cancer therapy.
- One of the trials will test whether the combination can reduce 28-day mortality versus standard treatment alone.
Shares of ImmunityBio, Inc. (IBRX) staged a rebound on Wednesday after the drugmaker flagged fresh progress in its randomized Anktiva bladder cancer study and opened new trials in severe pneumonia patients.
Shares of IBRX jumped about 9% on Wednesday, recovering from a sharp selloff in the previous session that marked the stock’s worst day in over a year after the U.S. Food and Drug Administration (FDA) issued a warning letter over statements promoting Anktiva beyond its approved use.
Anktiva Bladder Cancer Trial Hits Key Mid-Study Checkpoint
Founder and executive chairman Patrick Soon-Shiong said on X that half of the patients in the Quilt-2.005 bladder cancer study, testing the therapy in people newly starting standard BCG treatment, have now reached a key stage at which its effectiveness can be assessed.
The milestone has triggered a review by an independent monitoring committee to determine whether the trial’s current enrollment of 366 patients is sufficient to clearly show whether Anktiva works better than BCG alone when added to standard BCG treatment. “Our hypothesis that IL-15 is a key immunotherapy cytokine and the quest continues,” Soon-Shiong said.
ImmunityBio Opens New Severe Pneumonia Studies
Separately, ImmunityBio registered two new studies on Wednesday evaluating Anktiva in combination with off-the-shelf invariant natural killer T (iNKT) cell therapy in critically ill adults with severe community-acquired pneumonia, including patients with sepsis or acute respiratory distress syndrome (ARDS).
One study is a Phase 2 trial enrolling up to 20 intensive care patients with lymphopenia, a condition marked by low immune cell levels, to evaluate safety and look for early signs that Anktiva and the off-the-shelf immune cell therapy to standard treatment, may help restore immune function and improve survival.
The second study is a randomized, blinded Phase 3 trial designed to determine whether adding the combination therapy to standard treatment can reduce deaths within 28 days compared with standard treatment alone.
According to the trial filing, current treatment for severe community-acquired pneumonia in critically ill patients focuses on controlling infection with antibiotics and providing organ support, but often does not directly address the underlying immune dysfunction seen in patients with lymphopenia or immunoparalysis.
Platform Momentum Builds Across Cancer Programs
The developments add to ImmunityBio’s broader effort to position Anktiva as a platform immunotherapy across cancer and immune-driven diseases.
Earlier this month, Soon-Shiong highlighted early immune data from the randomized 138-patient study evaluating Anktiva with the company’s adenovirus-based cancer vaccine, saying results from the first 20 participants showed increases in absolute lymphocyte counts.
Meanwhile, Anktiva was recently added to Macau’s approved bladder cancer drug list and included by the National Comprehensive Cancer Network (NCCN) as an “other recommended” option for papillary bladder cancer that no longer responds to standard BCG treatment. ImmunityBio has also resubmitted its application to expand the therapy’s label to include papillary disease after previously receiving a refusal-to-file letter from regulators.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment for IBRX has jumped to ‘bullish’ from ‘bearish’ levels over the past week amid nearly a 2,500% surge in message volumes over the past three months.
One user flagged the new trial filings and said, “This isn’t about immediate revenue — it’s about optionality and narrative. Cutting-edge immunotherapy + high short interest = explosive setup if sentiment flips.”
Another user added to views on the new trials, saying, “No downside. Very inexpensive Trial. They should do these for all kinds Lymphopenia conditions.”
IBRX stock has nearly tripled over the past year.
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