- The company launched a Phase 2 Long COVID study to evaluate whether immune activation with Anktiva can improve recovery by restoring NK and CD8 T cells.
- The open-label study plans to enroll about 20 participants and is expected to be completed in October.
- The platform has expanded beyond cancer into severe pneumonia, sepsis and acute respiratory distress syndrome, among others.
Shares of ImmunityBio, Inc. (IBRX) are tracking their strongest quarter in roughly six years as the company expands its lead therapy, Anktiva, into a new Phase 2 study in long COVID and signals plans for broader international rollout.
Momentum in IBRX stock has eased since late January after shares hit fresh highs following a 14-session winning streak. The stock has surged over 270% this year, far outperforming the SPDR S&P Biotech ETF (XBI), which has dipped nearly 2% over the same period.
Phase 2 Long COVID Trial Launches
The newly registered open-label Phase 2 study will evaluate the safety and tolerability of Anktiva in adults experiencing persistent symptoms following COVID-19 infection. Participants will receive up to two doses of the therapy and undergo follow-up clinical testing, laboratory monitoring, and symptom assessments as researchers evaluate whether immune activation improves recovery.
The study is expected to enroll about 20 participants, with completion projected in October. Rather than targeting individual symptoms separately, the trial will test whether restoring natural killer (NK) cells, immune cells that kill virus-infected cells, and CD8 T cells, immune cells that help the body clear lingering infection, can help correct the underlying immune imbalance.
Meanwhile, founder and executive chairman Patrick Soon-Shiong said on X that he had been invited by a European health minister to discuss establishing “immunotherapy 2.0,” as part of a broader push to expand NK-cell and T-cell-based therapies globally.
Anktiva Advances Across Multiple Diseases
Originally developed as an immune-activating cancer therapy to stimulate NK cells and CD8 T cells, Anktiva reached its first major milestone with FDA approval in 2024 for non-muscle-invasive bladder cancer in patients whose disease did not respond to standard BCG therapy.
Anktiva then expanded into combination programs across solid tumors, including non-small cell lung cancer, pancreatic cancer, colorectal cancer and glioblastoma, most recently including a new pre-surgery pancreatic cancer study registered last week.
The platform has since moved beyond oncology into HIV functional-cure research and, last week, new Phase 2 and Phase 3 trials in severe pneumonia, sepsis and acute respiratory distress syndrome.
Guideline Support Strengthens Anktiva Case
Momentum around Anktiva has also been supported by recent regulatory progress. The therapy was added to Macau’s approved drug list for bladder cancer, placing it alongside treatments from Bristol Myers Squibb, Eli Lilly, Vertex Pharmaceuticals, Gilead Sciences and Moderna.
In the U.S., the National Comprehensive Cancer Network (NCCN) added Anktiva with BCG as an “other recommended” option for papillary bladder cancer that no longer responds to standard BCG therapy, extending its positioning beyond carcinoma in situ in treatment guidelines.
The company has also resubmitted its application seeking label expansion into papillary disease after previously receiving a refusal-to-file letter from regulators.
How Do Retail Traders Feel About IBRX?
On Stocktwits, retail sentiment for IBRX jumped to ‘bullish’ over the past day from ‘bearish’ levels a month ago amid over a 90% decline in message volumes over the past month.
One user said, “Europe is positioning itself as an early adopter of Immunotherapy 2.0, and Dr. Pat just made it clear: the door isn’t simply open.”
Another user said European policymakers reviewing the data are seeing higher lymphocyte counts as linked to better outcomes across infectious disease, cancer and sepsis, calling the approach “a no-brainer win-win, good for government and good for the masses,” and suggesting successful implementation could “force the FDA here to do the same.”
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