ImmunityBio, Inc. (NASDAQ:IBRX), a clinical-stage biotechnology company with a market capitalization of $2.13 billion, announced early findings from its pilot study of a chemotherapy-free treatment regimen for recurrent glioblastoma brain tumors, reporting disease control in all five initial patients.
The experimental treatment combines ANKTIVA, an IL-15 agonist designed to enhance natural killer cell activity, with NK cell therapy and the Optune Gio Tumor Treating Fields device. According to the company, three of the five patients showed tumor response, with two achieving near complete response, while the remaining two patients maintained stable disease.
Dr. Simon Khagi, Medical Director of Neuro-Oncology at Hoag Family Cancer Institute and principal investigator for the study, noted the significance of these early results. "In my years of treating patients with glioblastoma I have never experienced these near complete responses as well as the rapidity of the response as seen in these patients to date," he stated in the press release.
Glioblastoma affects approximately 12,000 Americans annually and has a particularly poor prognosis, with five-year survival rates of just 9% for patients aged 45-54 and 6% for those aged 55-64, according to data cited by the company.
The company reported that ANKTIVA treatment increased absolute lymphocyte count in all five patients who had experienced lymphopenia following standard radiation and chemotherapy. Based on these preliminary findings, ImmunityBio plans to initiate a randomized Phase 2 trial targeting second-line glioblastoma patients with recurring disease. With revenue of $56.6 million in the last twelve months and projected sales growth of 6.34% for the current year, the company continues to invest heavily in its clinical programs.
ANKTIVA is currently FDA-approved in combination with BCG for treating patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
The small sample size of this initial cohort limits definitive conclusions about the treatment’s efficacy, and further studies will be needed to validate these early results.
In other recent news, ImmunityBio has initiated a Phase 2 clinical trial to evaluate ANKTIVA for treating long COVID. The trial aims to assess the safety of ANKTIVA in up to 40 participants, focusing on its impact on lymphocyte counts. Additionally, the company has reported promising results from its QUILT-106 Phase I trial, where its CD19 CAR-NK cell therapy achieved complete responses in two patients with late-stage Waldenstrom macroglobulinemia. These patients have maintained remission for six months, showcasing the potential of this novel cancer therapy.
Furthermore, ImmunityBio received FDA authorization for Expanded Access to ANKTIVA for treating lymphopenia in adults with refractory or relapsed solid tumors. This approval marks a significant milestone, as ANKTIVA is the first therapy with a defined mechanism to restore NK and T cells without increasing immunosuppressive Tregs. The company’s regulatory achievements have led H.C. Wainwright to maintain a Buy rating on ImmunityBio, with a price target of $8.00. These developments highlight ImmunityBio’s ongoing efforts to advance its therapeutic platforms in both cancer and long COVID treatment.
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