ImmunityBio, a biotechnology company, has commenced a Phase II clinical trial named COVID-4.019-Long to investigate the safety and efficacy of Anktiva in patients suffering from long COVID. Long COVID is a condition characterized by persistent symptoms that linger for at least three months following a COVID-19 infection. The study aims to enroll up to 40 participants meeting the World Health Organization’s criteria for long COVID and will primarily focus on assessing the safety of Anktiva through subcutaneous administration. Additionally, the trial will explore the impact of Anktiva, an interleukin-15 agonist, on the absolute lymphocyte count and immune cell activity.
The onset of long COVID has raised concerns as it manifests as a chronic condition with various symptoms that can appear, disappear, and reappear over weeks to months. ImmunityBio’s founder, Patrick Soon-Shiong, MD, highlighted the significance of studying Anktiva for long COVID, emphasizing the virus’s ability to persist in the body long after the acute infection phase. Anktiva, already approved by the FDA for treating BCG-unresponsive non-muscle invasive bladder cancer, demonstrates a unique mechanism of action by enhancing the body’s immune response, potentially aiding in viral clearance and addressing underlying issues contributing to long COVID.
In addition to the current Phase II trial, ImmunityBio is supporting another Phase II study to evaluate the safety and tolerability of Anktiva for long COVID treatment. The company’s previous success with Anktiva in combination with Bacillus Calmette-Guérin (BCG) maintenance therapy for bladder cancer patients has paved the way for exploring its therapeutic potential in combating long COVID. The positive outcomes observed in the QUILT-3.032 trial, where Anktiva boosted the activity of various immune cells, have positioned it as a promising candidate for immune-related conditions like long COVID.
The Phase II trial for Anktiva in long COVID patients marks a significant step in ImmunityBio’s efforts to address the challenges posed by post-acute COVID-19 symptoms. By leveraging Anktiva’s unique immunotherapeutic properties, the company aims to provide a novel treatment option for individuals grappling with the long-term effects of COVID-19. As the trial progresses, researchers will closely monitor the safety profile of Anktiva and assess its impact on immune function and symptom management in patients with long COVID.
Key Takeaways:
– ImmunityBio has initiated a Phase II trial to evaluate Anktiva’s safety and efficacy in patients with long COVID, a condition characterized by persistent symptoms post-COVID-19 infection.
– Anktiva, an interleukin-15 agonist, has shown promise in enhancing immune responses and addressing underlying issues contributing to long COVID.
– The Phase II trial builds upon ImmunityBio’s successful use of Anktiva in BCG-unresponsive non-muscle invasive bladder cancer patients, highlighting its potential for immune-related conditions.
– By exploring Anktiva’s therapeutic effects in long COVID, ImmunityBio aims to provide a new treatment approach for individuals experiencing prolonged COVID-19 symptoms.
Tags: digital twins, clinical trials, gene therapy, regulatory, immunotherapy
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