ImmunityBio launches phase 2 study of ANKTIVA for long COVID

CULVER CITY, Calif. - ImmunityBio, Inc. (NASDAQ:IBRX), a $2.29 billion biotech company currently undervalued according to InvestingPro analysis, announced on Tuesday the initiation of a new Phase 2 clinical trial to evaluate its ANKTIVA therapy for patients suffering from long COVID, a condition affecting approximately one in five American adults who previously contracted COVID-19.

The exploratory, single-arm study (NCT07123727) aims to recruit up to 40 participants who meet the World Health Organization’s criteria for long COVID. The trial’s primary objective is to assess the safety of ANKTIVA when administered subcutaneously, with secondary objectives focusing on its effect on absolute lymphocyte count. The company maintains strong liquidity with a current ratio of 4.11, though InvestingPro data indicates rapid cash consumption in recent quarters.

Long COVID encompasses over 200 identified symptoms including fatigue, brain fog, respiratory issues, and heart palpitations that can persist for months or years after initial infection. Despite its significant public health impact, there are currently no established treatments for the condition.

"We are excited to study ANKTIVA for the treatment of long COVID, a substantial public health concern," said Dr. Patrick Soon-Shiong, Founder and Executive Chairman of ImmunityBio, in the press release.

ANKTIVA (nogapendekin alfa inbakicept-pmln) is an IL-15 agonist that activates natural killer cells and T cells. The company believes this mechanism may enhance immune function and facilitate viral clearance in long COVID patients, addressing the persistence of viral nucleic acid and proteins that can remain in the gut mucosa months after infection.

A separate Phase 2 study evaluating ANKTIVA for long COVID is also underway at the University of California - San Francisco, with both studies supported by ImmunityBio.

ANKTIVA received FDA approval in 2023 for use with Bacillus Calmette-Guérin (BCG) in treating patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.

The announcement represents an expansion of ImmunityBio’s research beyond cancer applications, as the company is currently evaluating ANKTIVA in multiple oncology indications as well as HIV and lymphopenia.

In other recent news, ImmunityBio has reported promising results from its QUILT-106 Phase I trial. The company’s CD19 CAR-NK cell therapy achieved complete responses in the first two patients with late-stage Waldenstrom macroglobulinemia, a type of non-Hodgkin lymphoma. These patients have maintained remission for six months, with one responding to monotherapy and the other to a combination with rituximab. Additionally, ImmunityBio received FDA authorization for Expanded Access to ANKTIVA, a treatment for lymphopenia in patients with refractory or relapsed solid tumors. This development marks ANKTIVA as the first therapy with a defined mechanism to restore NK and T cells without increasing immunosuppressive regulatory T cells.

In analyst updates, H.C. Wainwright reaffirmed a Buy rating for ImmunityBio, citing recent regulatory achievements, while Piper Sandler upgraded the stock to Overweight, raising the price target to $5.00. Piper Sandler highlighted the company’s progress with ANKTIVA and other cell therapies, projecting significant sales in the coming years. Despite an FDA Refusal to File letter for ANKTIVA in a specific cancer type, ImmunityBio is advancing with a Phase III trial, with data expected next year. These developments reflect ImmunityBio’s ongoing efforts to enhance cancer treatment options.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.