"The initial abstract data for these first set of 16 patients from the PIVOT study evaluating NKTR-214 in combination with nivolumab is very exciting," said
NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting CD8+ effector T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of PD-1 on these immune cells.
Details of the SITC presentations for Nektar's I-O portfolio are below.
Session Title: Clinical Trials: Novel Combinations
Presentation Title: PIVOT-02: Preliminary safety, efficacy and biomarker results from the Phase 1/2 study of CD-122-biased agonist NKTR-214 plus nivolumab in patients with locally advanced/metastatic solid tumors
Presenter: Dr. Adi Diab, MD Anderson Cancer Center
The online abstract for the oral clinical presentation includes preliminary data as of
Biomarkers and Immune Monitoring
Clinical Data Abstract #P77: The Novel IL-2 Cytokine Immune Agonist NKTR-214 Harnesses the Adaptive and Innate Immune System for the Treatment of Solid Cancers
Presenter: Salah Eddine Bentebibel,
Date and Time:
Preclinical Data Abstract #P140: NKTR-214 enhances anti-tumor T-cell immune responses induced by checkpoint blockade or vaccination
Date and Time:
Preclinical Data Abstract #P274: Combination of NKTR-214 and radiotherapy (RT) to reverse anergy and expand tumor-specific CD8 T Cells
Date and Time:
Preclinical Data Abstract #P275: Harnessing the innate and adaptive immune system to eradicate treated and distant untreated solid tumors
Date and Time:
Immune Modulation, Cytokines, and Antibodies
Preclinical Data Abstract #P332: Pre-clinical efficacy and tolerability of NKTR-255, a polymer-conjugated IL-15 for immuno-oncology
Date and Time:
Personalized Vaccines and Technologies/Personalized Medicines
Preclinical Data Abstract #P434: Great Apes Adenoviral vaccine encoding neoantigens synergizes with immunomodulators to cure established tumors in mice
Date and Time:
Analyst and Investor Event
NKTR-214 is a clinical-stage, immuno-stimulatory therapy designed to expand specific cancer-fighting CD8+ effector T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of PD-1 on these immune cells. NKTR-214 is a CD122-biased IL-2 pathway agonist that targets cancer-fighting immune cells to stimulate their proliferation and activation. In clinical and preclinical studies, treatment with NKTR-214 resulted in expansion of these cells and their mobilization into the tumor.1,2 NKTR-214 has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.
NKTR-255 is an immune-stimulating cytokine designed to engage all three IL-15 receptors and signal through all of these to activate the IL-15 pathway. NKTR-255 stimulates proliferation and survival of Natural Killer (NK) Cells, CD8+ T Cells and enhances long-term immunological memory which may lead to sustained anti-tumor immune response.
NKTR-262 is a first-in-class investigational small molecule intended to target toll-like receptors (TLRs) on innate immune cells in the body. NKTR-262 is designed to overcome the body's dysfunction of antigen-presenting cells (APC), and is being developed as a single intra-tumoral injection to be administered at the start of therapy with NKTR-214 to induce an abscopal response and achieve the goal of complete tumor regression in cancer patients treated with both therapies.
Nektar Therapeutics is a research-based, development stage biopharmaceutical company whose mission is to discover and develop innovative medicines to address the unmet medical needs of patients. Our R&D pipeline of new investigational medicines includes treatments for cancer, autoimmune disease and chronic pain. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new therapeutic candidates. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at www.nektar.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: "intend," "design," "expect," "believe," "should," "may," "will" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of immuno-oncology agents (such as NKTR-214, both alone and in combination with one or more other agents), the anticipated need for immuno-oncology combinations (such as NKTR-214 in combination with anti-PD1 and anti-PD-L1 agents) for use in patients whose tumors do not express PD-L1, and the potential of our technology and immuno-oncology drug candidates (such as NKTR-214, NKTR-255 and NKTR-262) in our research and development pipeline. 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 our immuno-oncology agents (such as NKTR-214, NKTR-255 and NKTR-262) are based on findings and observations from preclinical findings and, in some cases, ongoing clinical studies; (ii) NKTR-214, both alone and in combination with other agents (such as anti-PD1 and anti-PD-L1 agents) and our other immuno-oncology agents are in early stages of development and the risk of failure remains high and failure can unexpectedly occur due to efficacy, safety or other unpredictable factors prior to regulatory approval for numerous reasons, including negative safety and efficacy findings even after positive findings in previous clinical and preclinical studies; (iii) the timing of the commencement or end of clinical studies 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; (iv) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of applying our technology platform to potential new drug candidates (such as NKTR-214, NKTR-255 and NKTR-262) is therefore highly uncertain and unpredictable and one or more research and development programs could fail; (v) patents may not issue from our patent applications for our immuno-oncology drug candidates (including NKTR-214, NKTR-255 and NKTR-262), 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 Securities and Exchange Commission on August 9, 2017. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
- Charych, D., et al., Cancer Res. 2013;73(8 Suppl):Abstract nr 482 and Data on file. 2.
- Hoch U, at al. AACR; Mol Cancer Ther. 2013;12(11 Suppl):Abstract nr B296.
- PD-L1 = Expression of the programmed death-1 (PD-1) ligand 1 (PD-L1) is used to select patients and analyze responses to anti-PD-1/L1 antibodies. Ribas et. al. JEM
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