Part of cambridge equities lp
ImmunityBio, Inc. is a clinical stage immunotherapy company. It develops next generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases. The company's immunotherapy platform activates both the innate and adaptive immune systems to create long term immunological memory. ImmunityBio was founded by Patrick Soon-Shiong in 2014 and is headquartered in San Diego, CA.
Clinical Trials
83
16 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2014
Active, not recruiting
9
10.8%
Available
2
2.4%
Completed
17
20.5%
Not yet recruiting
7
8.4%
Recruiting
7
8.4%
Terminated
15
18.1%
Unknown
2
2.4%
Withdrawn
24
28.9%
No approval data available
- ImmunityBio has appointed Dr. Jim Yong Kim, former World Bank President, as Vice Chairman to lead international partnerships and global access efforts through a newly created Office of the Executive Chairman. - Dr. Kim brings decades of experience at the intersection of medicine, public health, and global finance, including co-founding Partners In Health and leading the WHO's HIV/AIDS department. - He will focus on building relationships with governments, health ministries, and multilateral institutions to expand access to ImmunityBio's immunotherapy platform and approved therapies outside the United States. - ImmunityBio's core platform, Cancer BioShield™, is anchored by ANKTIVA® (nogapendekin alfa inbakicept), a proprietary IL-15 receptor agonist designed to stimulate NK cells, cytotoxic T cells, and memory T cells.
- Curebound, a San Diego-based cancer research accelerator, announced three executive hires: Mary Meyer as Chief Advancement Officer, Scotty Cadet, Ph.D. as Chief Scientific Officer, and Leena Gupta as Chief Financial Officer. - Dr. Cadet brings 17+ years spanning drug discovery through late-stage clinical development, including immuno-oncology work at ImmunityBio that produced an FDA-approved drug. - The new leaders will apply expertise in philanthropy, artificial intelligence, and financial strategy to sharpen Curebound's selection and funding of high-impact cancer research. - CEO Robin Toft stated the hires will help Curebound fund bold science and deliver treatments and cures that give patients and families more time.
- ImmunityBio has agreed to a revised lease with New York State for the Dunkirk pharmaceutical facility, increasing annual rent from $1 to $525,000 and committing to $40 million in capital improvements. - The company must hire at least 100 employees by the end of 2028 and scale to 450 employees by 2032, representing a more realistic timeline compared to the failed Athenex agreement. - The new one-year renewable lease structure allows annual compliance assessments, with stricter accountability measures following nearly a decade of uncertainty at the state-funded facility.
- ImmunityBio secured $75 million in non-dilutive financing from Oberland Capital and converted $25 million in debt to equity, strengthening its balance sheet for global expansion. - ANKTIVA, the company's IL-15 receptor superagonist immunotherapy, has achieved regulatory approval across 34 countries in under two years since initial FDA approval. - The financing will support commercial scaling and pipeline advancement following recent approvals for BCG-unresponsive bladder cancer and lung cancer indications. - Saudi Arabia became the first jurisdiction globally to authorize ANKTIVA for metastatic non-small cell lung cancer in combination with checkpoint inhibitors.
- The FDA issued a warning letter to ImmunityBio after biotech billionaire Patrick Soon-Shiong made misleading claims about Anktiva, stating it could cure all cancers and prevent radiation-induced cancer. - Anktiva is currently approved only for hard-to-treat bladder cancer, but Soon-Shiong promoted it as a universal cancer treatment during a podcast appearance. - The FDA cited violations of federal drug marketing rules for creating misleading impressions and failing to provide balanced risk-benefit information. - ImmunityBio shares fell more than 24% following the FDA warning, and the company has 15 days to respond and correct the violations.
- ImmunityBio successfully established a scalable manufacturing pathway for its M-ceNK cell therapy, producing up to 5 billion highly pure NK cells from a single apheresis collection within 12 days. - The company completed Phase I safety studies across 74 subjects, demonstrating zero serious adverse events and successful cryopreservation of NK cells with retained cytotoxicity against multiple tumor types. - Preclinical data from the National Cancer Institute showed statistically significant tumor volume reductions in small cell lung cancer models when M-ceNK cells were combined with ANKTIVA. - The manufacturing process enables production of 8-10 therapeutic doses per patient and positions the company to establish what it calls a "World Bank of NK Cells" for universal patient access.
- ImmunityBio's off-the-shelf CD19 CAR-NK cell therapy combined with rituximab demonstrated 100% disease control rate across four patients with relapsed/refractory Waldenström lymphoma in the phase 1 QUILT-106 trial. - One patient with 95% bone marrow infiltration by tumor cells achieved complete response after only four doses, maintaining remission for 15 months without additional treatment. - The chemotherapy-free and lymphodepletion-free regimen was administered entirely in outpatient settings with no serious adverse events reported to date. - This represents the first immunotherapy combination to demonstrate such efficacy in Waldenström non-Hodgkin lymphoma without requiring cytotoxic conditioning or hospitalization.
- The Saudi Food and Drug Authority granted conditional approval for Anktiva (nogapendekin alfa inbakicept) for advanced lung and bladder cancers, making Saudi Arabia the first country to approve this IL-15-based immunotherapy for non-small cell lung cancer. - Anktiva works by activating natural killer cells and memory CD8+ T cells to target cancer cells, representing a distinct immunologic strategy compared to conventional chemotherapy or checkpoint inhibitors. - The approval is based on clinical evidence showing potential survival improvements in lung cancer patients whose disease progressed after prior therapies, including immune checkpoint inhibitors. - In bladder cancer trials, Anktiva demonstrated a 62% complete response rate when combined with BCG therapy, with 58% of responders remaining disease-free at 12 months or longer.
- The European Medicines Agency has recommended conditional marketing authorization for Anktiva (nogapendekin alfa inbakicept) combined with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. - Clinical trial data showed a 71% complete response rate in 100 patients, with responses lasting an average of 27 months and ranging up to 54+ months. - The conditional approval pathway facilitates early access to medicines addressing unmet medical needs, with the decision now moving to the European Commission for final authorization. - Approximately 150,000 of the 200,000 patients expected to be diagnosed with bladder cancer in Europe in 2025 will have non-muscle invasive disease, representing a significant patient population.
- The European Medicines Agency has recommended conditional EU marketing authorization for ANKTIVA in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ. - This marks the first EMA-recommended immunotherapy for this bladder cancer form that activates NK cells, T cells, and memory T cells, potentially offering an alternative to radical surgery. - The approval is based on a single-arm trial in 100 adults and opens the door to EU pricing and reimbursement discussions for ImmunityBio. - ImmunityBio reported strong Q3 2025 results with ANKTIVA driving 434% year-over-year product revenue growth, though the company maintains a limited cash runway of 3-4 quarters.
