New Data Featuring Nektar Therapeutics' Wholly-Owned Immuno-Oncology Pipeline to be Presented at the 2017 Society for Immunotherapy of Cancer 32nd Annual Meeting

Tuesday, November 7, 2017 Cancer News
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Company to host Investor & Analyst Event on Saturday, November 11th following an oral presentation of data from PIVOT Phase 1/2 study of NKTR-214 with nivolumab

SAN FRANCISCO, Nov. 7, 2017 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that new clinical data

will be presented for NKTR-214, Nektar's lead immuno-oncology candidate, a CD122-biased agonist, at the Society for Immunotherapy of Cancer (SITC) Annual Meeting at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.  Data from the ongoing PIVOT Phase 1/2 study, which is evaluating NKTR-214 in combination with the checkpoint inhibitor nivolumab, will be presented in an oral presentation on Saturday, November 11th.  Six additional presentations for immuno-oncology (I-O) candidates in Nektar's pipeline will also be presented at the meeting; specifically, one additional clinical and three preclinical presentations on NKTR-214; one preclinical presentation on NKTR-255, an IL-15 memory T-cell stimulating cytokine; and one preclinical presentation on NKTR-262, a novel toll-like receptor (TLR) agonist. The abstracts published in advance of the SITC Annual Meeting were made available at 8 a.m. Eastern Time today on the Journal for ImmunoTherapy of Cancer's website at https://www.sitcancer.org/2017/abstracts/titles.

"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 Mary Tagliaferri, M.D., Senior Vice President of Clinical Development at Nektar Therapeutics.  "We look forward to presenting additional new data from all of the 38 patients enrolled in the dose escalation cohort of the study in Dr. Diab's oral presentation at SITC on Saturday afternoon, including the first efficacy data for patients with PD-L1 negative non-small cell lung cancer who had progressed on prior chemotherapy. We believe there is tremendous need for more efficacious and better tolerated I-O combination treatment regimens, particularly treatments that can be used for the majority of cancer patients whose tumors don't express PD-L1 as these patients can't currently benefit from treatment with checkpoint inhibitors."

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.

Oral Presentation

Date: Saturday, November 11, 2017, Presentation Time: 5:00 p.m. Eastern TimeSession Title: Clinical Trials: Novel CombinationsPresentation 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 CenterLocation: Gaylord National Hotel & Convention Center, Maryland Ballroom A

The online abstract for the oral clinical presentation includes preliminary data as of July 25, 2017 for 16 patients with Stage IV melanoma and renal cell carcinoma enrolled in the dose-escalation phase of the PIVOT study of NKTR-214 in combination with nivolumab (NCT02983045). New and updated interim data for a total of 38 patients with Stage IV melanoma, renal cell carcinoma and non-small cell lung cancer which were enrolled in the dose-escalation phase of the PIVOT study, will be presented at the SITC Annual Meeting.  A copy of the slides from Dr. Diab's presentation will be made available on Nektar's corporate website on Saturday, November 11th at 6:00 p.m. Eastern Time, in accordance with the embargo policies set forth by SITC.

Poster Presentations

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 CancersPresenter: Salah Eddine Bentebibel, University of Texas MD Anderson Cancer CenterDate and Time: Friday, November 10, 2017, 12:30-2:00 p.m. Eastern Time

Cancer Vaccines

Preclinical Data Abstract #P140: NKTR-214 enhances anti-tumor T-cell immune responses induced by checkpoint blockade or vaccinationPresenter: Meenu Sharma, University of Texas MD Anderson Cancer CenterDate and Time: Saturday, November 11, 2017, 12:30-2:00 p.m. Eastern Time

Combination Therapy

Preclinical Data Abstract #P274Combination of NKTR-214 and radiotherapy (RT) to reverse anergy and expand tumor-specific CD8 T Cells Presenter: Joshua Walker, Oregon Health & Science University Date and Time: Saturday, November 11, 2017,12:30-2:00 p.m. Eastern Time

Preclinical Data Abstract #P275: Harnessing the innate and adaptive immune system to eradicate treated and distant untreated solid tumorsPresenter: Saul Kivimae, Nektar Therapeutics Date and Time: Friday, November 10, 2017, 12:30-2:00 p.m. Eastern 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-oncologyPresenter: Peiwen Kuo, Nektar Therapeutics Date and Time: Saturday, November 11, 2017, 12:30-2:00 p.m. Eastern 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 micePresenter: Anna Morena D'Alise, Nouscom srl Date and Time: Saturday, November 11, 2017, 12:30-2:00 p.m. Eastern Time

Analyst and Investor Event Nektar Therapeutics will webcast an analyst and investor event with clinical investigators during the SITC Annual Meeting beginning on Saturday, November 11, 2017 at 6:15 p.m. Eastern Time. Featured speakers include Dr. Patrick Hwu of MD Anderson Cancer Center, Dr. Adi Diab of MD Anderson Cancer Center, Dr. Michael E. Hurwitz of Yale Cancer Center, Dr. Antoni Ribas of UCLA Medical Center and Dr. Nizar M. Tannir of MD Anderson Cancer Center. The webcast is accessible from the investor relations page of Nektar's website at www.nektar.com.

About NKTR-214NKTR-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.

About NKTR-255NKTR-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.

About NKTR-262NKTR-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.

About NektarNektar 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 StatementsThis 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.

Contact:

For Investors: Jennifer Ruddock of Nektar Therapeutics415-482-5585

Jodi Sievers of Nektar Therapeutics415-482-5593

For Media:Jennifer Paganelli 347-658-8290 [email protected]

  1. Charych, D., et al., Cancer Res. 2013;73(8 Suppl):Abstract nr 482 and Data on file. 2.
  2. Hoch U, at al. AACR; Mol Cancer Ther. 2013;12(11 Suppl):Abstract nr B296.
  3. 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 Dec 2016

 

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SOURCE Nektar Therapeutics



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