SAN FRANCISCO - Nektar Therapeutics (NASDAQ:NKTR) revealed clinical data from a Phase 1 study of NKTR-255, an IL-15 receptor agonist, used in conjunction with CD19-22 CAR-T cell therapy for patients with B-cell acute lymphoblastic leukemia (B-ALL). The study, published in the journal Blood, indicated that NKTR-255 doubled the 12-month relapse-free/progression-free survival rate compared to historical controls, achieving 67% versus 38%.
The trial, conducted by Stanford Medicine, assessed the safety and efficacy of NKTR-255 combined with a bispecific CAR-T therapy targeting CD19 and CD22 in nine relapsed or refractory B-ALL patients. Eight participants achieved complete remission with no measurable residual disease (MRD) detected. The median relapse-free survival (RFS) for patients treated with the combination therapy has not been reached after more than 14 months of follow-up, suggesting a potential for durable treatment outcomes.
No dose-limiting toxicities were observed, and the most common side effects included fevers, chills, and myelosuppression, which were either self-limiting or manageable. Cytokine profiling showed significant increases in proinflammatory cytokines and chemokines, indicating enhanced lymphocyte trafficking to tissues.
Dr. Mary Tagliaferri, Senior Vice President and Chief Medical Officer at Nektar, expressed optimism about the data, highlighting the potential of NKTR-255 to potentiate CAR-T cell therapy. Dr. David Miklos from Stanford Medicine underscored the need for more durable treatment outcomes in B-cell malignancies, despite advances made by CAR-T cell therapies.
NKTR-255 is designed to activate the body's immune response against cancer by targeting the IL-15 pathway. It is being evaluated in other clinical trials, including a Phase 1 study in metastatic non-small cell lung cancer and a study in combination with avelumab for urothelial carcinoma.
The information in this article is based on a press release statement from Nektar Therapeutics. The company cautions that statements regarding the therapeutic potential of NKTR-255 are forward-looking and subject to change as research progresses. NKTR-255 is still in clinical development, and its efficacy and safety must be established in larger, more definitive clinical trials.
In other recent news, Nektar Therapeutics has been in the spotlight following BTIG's upgrade of its stock. The firm's bullish stance is based on the potential of Nektar's investigational drug, rezpegaldesleukin (Rezpeg), especially in treating inflammatory and autoimmune diseases such as atopic dermatitis (AD) and alopecia areata (AA). BTIG's analysis indicates a significant gap between Nektar's market valuation and Rezpeg's potential, suggesting that the market has yet to fully adjust to the drug's prospects.
The firm also highlighted that Nektar's previous partnership with Eli Lilly (NYSE:LLY), which ended on terms unrelated to Rezpeg's efficacy, left the stock underappreciated. Since regaining the rights to Rezpeg, Nektar has clarified previous inaccuracies in Phase 1b data reported by Eli Lilly.
BTIG's positive outlook on Nektar is based on the expectation that Rezpeg's value will be increasingly recognized, particularly if litigation surrounding the termination of the Eli Lilly collaboration sheds light on the actual reasons for the dissolution, potentially validating Rezpeg's merits. These are among the recent developments that have drawn attention to Nektar Therapeutics.
InvestingPro Insights
As Nektar Therapeutics (NASDAQ:NKTR) reports promising clinical data for NKTR-255, investors may find additional context from InvestingPro's financial metrics and tips valuable.
The company's market capitalization stands at $254.03 million, reflecting its current position in the biotechnology sector. Despite the positive clinical results, InvestingPro data shows that Nektar is not profitable over the last twelve months, with an operating income of -$135.1 million. This aligns with an InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year.
However, Nektar's financial position isn't entirely bleak. An InvestingPro Tip reveals that the company holds more cash than debt on its balance sheet, which could provide some financial flexibility as it continues to develop NKTR-255 and other pipeline candidates. Additionally, Nektar's liquid assets exceed short-term obligations, potentially offering a buffer against immediate financial pressures.
Interestingly, despite the lack of profitability, Nektar has seen a significant price return of 146.43% over the past year. This suggests that investors may be optimistic about the company's future prospects, possibly influenced by developments like the NKTR-255 study results.
For those seeking a more comprehensive analysis, InvestingPro offers 7 additional tips for Nektar Therapeutics, providing a deeper understanding of the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.