ImmunityBio's ANKTIVA and Optune Gio: A Dual-Immunotherapy Breakthrough in Recurrent Glioblastoma and Long COVID

In the race to address two of the most challenging medical conditions—recurrent glioblastoma (GBM) and Long COVID—ImmunityBio, Inc. (NASDAQ: IBRX) has positioned itself at the forefront of innovation. By leveraging its dual-breakthrough therapies, ANKTIVA (an IL-15 agonist) and Optune Gio (a tumor-treating fields device), the company is redefining the boundaries of immunotherapy. This strategic combination not only targets the biological underpinnings of these diseases but also taps into a high-growth, underserved therapeutic space with significant unmet medical needs.

The Dual-Immunotherapy Synergy: A New Paradigm for GBM

Recurrent glioblastoma remains one of the most lethal cancers, with a median survival of just 6–12 months despite aggressive treatments. ImmunityBio's pilot study (NCT06061809) combining ANKTIVA, PD-L1 t-haNK (engineered NK cells), and Optune Gio has delivered unprecedented results: 100% disease control in five patients, including two near-complete responses and two cases of stable disease. This chemotherapy-free regimen leverages ANKTIVA's ability to activate NK and CD8+ T cells, which Optune Gio's TTFields enhance by disrupting tumor cell division. The synergy here is profound—while Optune Gio creates a localized immune-boosting environment, ANKTIVA amplifies systemic immune memory, potentially overcoming tumor resistance mechanisms.

For investors, the implications are clear: a dual-immunotherapy approach that could redefine GBM treatment. The Phase 2 trial planned for 2025 will be critical, but the early data already suggest a paradigm shift. With 60% revenue growth in Q2 2025 and $153.7 million in cash reserves, ImmunityBio is well-positioned to advance this pipeline.

ANKTIVA's Multi-Indication Potential: From Cancer to Long COVID

ANKTIVA's mechanism—mimicking IL-15 receptor alpha to activate NK and T cells—extends beyond oncology. In Long COVID, where persistent viral antigens and immune dysfunction are hallmarks, ANKTIVA's Phase 2 trial (NCT07123727) aims to restore immune balance. Early hypotheses suggest that boosting lymphocyte counts and NK cell activity could clear residual viral elements and alleviate symptoms like fatigue and brain fog. With 40 participants enrolled under WHO criteria, this trial could unlock a $100+ billion market for Long COVID treatments, a space currently devoid of FDA-approved therapies.

The multi-indication potential of ANKTIVA is a masterstroke. Approved for bladder cancer, it is now being tested in NSCLC, lymphoma, ovarian cancer, and HIV, with RMAT designation for lymphopenia. This diversification reduces risk and accelerates revenue streams, a critical factor for a biotech navigating regulatory hurdles.

Strategic Advantages: Durable Responses and Regulatory Momentum

ImmunityBio's BioShield™ platform is designed for durable immune memory, a key differentiator in an era of short-lived checkpoint inhibitors. Preclinical data on N-803 (another IL-15 superagonist) showed long-term survival in murine GBM models, suggesting ANKTIVA's potential to deliver lasting remissions. For Long COVID, the focus on immune restoration rather than symptom management aligns with a growing emphasis on root-cause therapies in post-viral conditions.

Regulatory engagement is equally robust. ANKTIVA's Breakthrough Therapy designation and Optune Gio's FDA approval for GBM underscore the company's credibility. Discussions with the FDA on lymphopenia endpoints and trial designs further highlight a proactive approach to regulatory pathways.

Investment Thesis: High-Risk, High-Reward in a $100B+ Market

The dual-immunotherapy narrative is not just scientific—it's financial. GBM and Long COVID represent $50 billion and $100+ billion markets, respectively, with minimal competition. ImmunityBio's first-mover advantage in combining biologics and devices creates a moat that is difficult to replicate.

However, risks remain. The Phase 2 trial for Long COVID is exploratory, and GBM's Phase 2 results must be validated in larger cohorts. Yet, the company's $26.4 million Q2 2025 revenue and strong cash position provide a buffer for setbacks.

Conclusion: A Dual-Immunotherapy Catalyst for Long-Term Value

ImmunityBio's ANKTIVA and Optune Gio represent more than a pipeline—they embody a vision of next-generation immunotherapy. By targeting both the tumor microenvironment and systemic immune dysfunction, the company is addressing the root causes of disease in ways that traditional therapies cannot. For investors, the dual-breakthrough narrative offers a compelling case: a high-growth, underserved space with durable responses and multi-indication potential.

Investment Recommendation: Buy for long-term growth, with a focus on Phase 2 trial outcomes in 2025. Position as a speculative play with high upside, given the transformative potential of dual-immunotherapy in GBM and Long COVID.