The company will hold an analyst and investor conference call this morning,
BEMPEG is an investigational CD122-preferential IL-2 pathway agonist that stimulates the immune system through the proliferation of lymphocytes. It is currently being evaluated in six separate late-stage clinical studies in patients diagnosed with melanoma, renal cell carcinoma and bladder cancer.
"Decreased levels of lymphocytes have been associated with increased mortality in hospitalized COVID-19 patients. Providing these patients with an agent like BEMPEG that can drive anti-viral adaptive immunity has the potential to improve these outcomes," said
The Phase 1b, randomized, double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetic/pharmacodynamic profile of BEMPEG in adult patients with mild COVID-19. Eligibility criteria include symptoms such as fever, cough, sore throat, malaise, headache, and muscle pain without evidence of severe dyspnea or acute respiratory distress syndrome. Patients who meet the eligibility criteria will be randomized and treated with either a single dose of BEMPEG or placebo in combination with current standard of care treatment for patients with mild COVID-19. Primary and secondary endpoints include change over time in absolute lymphocyte counts and measurements of clinical progression based upon the WHO Clinical Progression Scale. The trial will enroll up to three cohorts of ten patients each, who will receive increasing doses of BEMPEG with the aim of evaluating safety and tolerability and to identify the recommended dose for future studies. The clinical trial will be conducted at various investigator sites in
"After many months of evaluating the emerging body of data on the correlation of decreased lymphocyte levels and the severity of disease in patients with COVID-19, Nektar and our scientific and clinical advisors made the decision to proceed with this important study of our cytokine investigational therapy BEMPEG," said Dr.
Analyst Call Details
Date and Time:
Dial-in: (877) 881-2183 (toll-free) or (970) 315-0453 (Conference ID: 1418007)
Investors and analysts can also view slides and listen to the live audio webcast of the presentation at https://edge.media-server.com/mmc/p/tc46muyj. The event will also be available for replay for two weeks on the company's website, www.nektar.com.
Dr. Robert Gallo
About Bempegaldesleukin (BEMPEG; NKTR-214)
BEMPEG is an investigational, first-in-class, CD122-preferential IL-2 pathway agonist designed to provide rapid activation and proliferation of cytotoxic immune cells, known as CD8+ effector T cells and natural killer (NK) cells, without over activating the immune system. The agent is designed to stimulate these immune cells in the body by targeting CD122 specific receptors found on the surface of these immune cells. CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling receptor that is known to increase proliferation of these effector T cells.1 In clinical and preclinical studies, treatment with BEMPEG resulted in expansion of these cells and mobilization into the tumor micro-environment.2,3 Bempegaldesleukin has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines being used to treat a range of cancers.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: "may," "design," "potential," "evaluate," "plan," "will," and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of, and future development plans for, bempegaldesleukin, and the timing of the initiation of clinical studies for bempegaldesleukin. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of bempegaldesleukin in patients who have been diagnosed with COVID-19 infection are based on data that is evolving and does not include clinical testing of bempegaldesleukin for this intended patient population, and there is no guarantee that the clinical evaluation of bempegaldesleukin in COVID-19 patients will support the use of bempegaldesleukin in this patient population; (ii) bempegaldesleukin is an investigational agent and continued research and development for this drug candidate is subject to substantial risks, including negative safety and efficacy findings in ongoing clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) as bempegaldesleukin is currently in clinical development, the risk of failure is high and failure can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (v) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vi) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the
1. Boyman, J., et al., Nature Reviews Immunology, 2012, 12:180-90.
2. Charych, D., et al.,
3. Diab, A., et al.,
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