ImmunityBio Eyes Sepsis Trials for Anktiva
Founder Patrick Soon-Shiong highlighted plans to test the bladder-cancer drug Anktiva in patients with sepsis.
Updated on Nov. 3, 2026 in Biotech
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ImmunityBio founder Patrick Soon-Shiong highlighted plans to test Anktiva in sepsis, and ClinicalTrials.gov lists two Phase 2 sepsis studies sponsored by the company. The company's IBRX stock fell 4% to $7.95 on Monday, its third straight session of losses.
Why it matters
Anktiva is approved in the U.S. with BCG for adults whose non-muscle-invasive bladder cancer has not responded to BCG, and the sepsis studies would test whether it can help patients with persistent lymphopenia, a prolonged shortage of infection-fighting immune cells. The planned work would extend the drug beyond its current cancer indication.
Two ClinicalTrials.gov-listed Phase 2 sepsis studies would each enroll about 50 patients and track deaths from any cause over 28 days, but both are listed as not yet recruiting. No results have been reported, and the trials' outcomes remain unknown.
The players
ImmunityBio
A biopharmaceutical company that developed Anktiva and is sponsoring the sepsis studies and bladder-cancer trial.
Patrick Soon-Shiong
The founder of ImmunityBio, who highlighted the plans to test Anktiva in sepsis.
The details
The two sepsis studies compare Anktiva plus standard care against either standard care alone or a placebo-controlled comparison. Researchers aim to determine whether the drug can help sepsis patients with persistent lymphopenia.
Timeline
Last month: FDA broadened Anktiva's bladder-cancer approval to include high-grade papillary-only tumors.
Last month: ImmunityBio announced database lock for a randomized trial of 366 patients.
Monday: IBRX stock fell 4% to $7.95 for its third straight session of losses.
November: Topline results from the randomized bladder-cancer trial are expected.
Fourth quarter: A supplemental FDA application for the bladder-cancer combination is planned.
Big Picture
Anktiva, ImmunityBio's IL-15 superagonist approved with BCG for non-muscle-invasive bladder cancer, is now being explored in sepsis, extending the drug well beyond its current oncology indication. Whether the sepsis studies succeed will determine if the approved bladder-cancer use becomes a platform for other immune-related conditions.
For patients with bladder cancer who have not responded to BCG, Anktiva is already an approved option in the U.S. The sepsis studies are not yet recruiting, so they will not affect treatment access for patients in the near term.
The takeaway
Investors and patients should treat the sepsis plans as early-stage, since no trial has begun recruiting and no efficacy data exist yet. Watching the November bladder-cancer topline results will offer a clearer signal of the drug's broader potential.
What happens next
Topline results from the randomized bladder-cancer trial are expected in November, and a supplemental FDA application for the bladder-cancer combination is planned for the fourth quarter.
Further reading
Explore more Biotech coverage for context on drug development pipelines.
More information
Search the ClinicalTrials.gov sepsis study registry for listings of the two ImmunityBio-sponsored Phase 2 studies.
Source note: This article includes information reported by Asianet News Network Pvt Ltd.
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