ImmunityBio, Inc. (IBRX) has received FDA Expanded Access authorization for its Cancer BioShield platform, anchored by ANKTIVA, to treat lymphopenia in patients with relapsed or refractory solid tumors. The company is also broadening its pipeline, including a Phase 2 trial of ANKTIVA for Long COVID and a randomized trial combining N-803 with a PD-1 inhibitor for second-line non-small cell lung cancer.
ImmunityBio, Inc. (IBRX), a leading biotechnology company focused on immunotherapy, has received significant milestones in its quest to revolutionize cancer treatment. The company has obtained FDA Expanded Access authorization for its Cancer BioShield platform, anchored by ANKTIVA, to treat lymphopenia in patients with relapsed or refractory solid tumors. This authorization represents a critical step forward in addressing the unmet needs of patients with these challenging conditions.
The Cancer BioShield platform, which includes ANKTIVA, is designed to bolster the natural immune system to defeat cancers and infectious diseases. ANKTIVA, a first-in-class IL-15 agonist IgG1 fusion complex, has shown promising results in early clinical trials, including a recent pilot study where all five patients with recurrent glioblastoma achieved 100% disease control [1].
In addition to this authorization, ImmunityBio is broadening its pipeline with several exciting developments. The company is planning a Phase 2 trial of ANKTIVA for Long COVID, a condition that has gained significant attention due to its long-term effects on patients. This trial aims to evaluate the potential of ANKTIVA in activating the immune system to combat the lingering symptoms of COVID-19.
Furthermore, ImmunityBio is conducting a randomized trial combining N-803 with a PD-1 inhibitor for second-line non-small cell lung cancer. This trial seeks to determine if the combination of these agents can improve outcomes for patients with advanced lung cancer who have already received standard treatments.
These developments underscore ImmunityBio's commitment to advancing innovative immunotherapies that address critical unmet medical needs. The company's ability to secure regulatory approvals and expand its pipeline positions it as a leader in the rapidly evolving field of immunotherapy.
References:
[1] https://www.marketscreener.com/news/initial-data-shows-100-disease-control-in-5-out-of-5-patients-with-recurrent-glioblastoma-with-two-ce7c50dedf81f72d
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