SAN FRANCISCO, May 16, 2018 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that new clinical and
Preliminary clinical data from the ongoing PIVOT Phase 1/2 study that is evaluating NKTR-214, a CD122-biased agonist, in combination with the checkpoint inhibitor nivolumab, were accepted for an oral presentation in the Developmental Therapeutics - Immunotherapy Session on June 2, 2018.
"We are extremely pleased that six separate abstracts for Nektar programs were accepted for presentation at this year's ASCO meeting, including preliminary clinical data from the ongoing PIVOT study evaluating NKTR-214 in combination with nivolumab," said Mary Tagliaferri, M.D., Senior Vice President of Clinical Development, and Chief Medical Officer at Nektar Therapeutics. "Cancer immunotherapy holds great promise, but most patients lack the cancer-fighting immune cells for these treatments to be effective. NKTR-214 is designed to selectively target the IL-2 pathway to drive the proliferation of cancer-fighting CD8+ effector T cells and natural killer cells in the tumor without expanding unwanted suppressive regulatory T cells. Our ASCO presentations highlight how NKTR-214's unique and non-overlapping mechanism synergizes with multiple mechanisms of action including checkpoint inhibition, SYK/FLK3 inhibition, DPP inhibition and PARP inhibition. We believe NKTR-214 has the potential to emerge as a backbone therapy in immuno-oncology."
In addition to the oral presentation, researchers will also present new preclinical data for NKTR-214, with the following small molecules: TAK-659, a Spleen Tyrosine Kinase / FMS-like tyrosine kinase 3 (SYK/FLT3) inhibitor; BXCL701, a dipeptidyl peptidase (DPP) inhibitor; and rucaparib, a poly ADP ribose polymerase (PARP) inhibitor.
Details of the oral presentation are as follows:
Abstract Title: NKTR-214 (CD122-biased agonist) plus nivolumab in patients with advanced solid tumors: Preliminary phase 1/2 results of PIVOTAbstract: #3006Presenter: Dr. Adi Diab, MD Anderson Cancer CenterSession Title: Developmental Therapeutics – ImmunotherapyDate: Saturday, June 2, 2018, 5:00 - 5:12 p.m. Central Daylight Time Location: McCormick Place, Hall B1
The oral abstract for PIVOT was also selected for presentation as part of the Best of ASCO Program, which presents the scientific and educational highlights of the ASCO Annual Meeting selected from the year's notable abstracts.
Details of the poster presentations by session are as follows:
Developmental Therapeutics - Immunotherapy
Abstract #3085/ Poster Board #299: "Efficacy and immune modulation by BXCL701 a dipeptidyl peptidase inhibitor, NKTR-214 a CD122-biased immune agonist with PD1 blockade in murine pancreatic tumors", Rastelli, L., et al.Session Date and Time: Monday, June 4, 2018, 8:00 a.m. - 11:30 a.m. Central Daylight Time
Abstract #TPS3115/Poster Board #322a: "PROPEL: A phase 1/2 trial of NKTR-214 (CD122-biased agonist) combined with anti-PD-1 (pembrolizumab) or anti-PD-L1 (atezolizumab) in patients (pts) with advanced solid tumors", Vaena, D., et al.Session Date and Time: Monday, June 4, 2018, 8:00 a.m. - 11:30 a.m. Central Daylight Time
Developmental Therapeutics - Clinical Pharmacology and Experimental Therapeutics
Abstract #2567/Poster Board #393: "TAK-659 in Combination with NKTR-214 and anti-PD-1 Therapy Leads to Complete and Sustained Tumor Regression and Immune Memory In Pre-Clinical Syngeneic Models", Huck, J., et al.Session Date and Time: Monday, June 4, 2018, 8:00 a.m. - 11:30 a.m. Central Daylight Time
Abstract #5582/Poster Board #309: "Efficacy and immune modulation of the tumor microenvironment in murine ovarian tumor with the PARP inhibitor rucaparib and CD122-biased immune agonist NKTR-214", Simmons, A., et al.Session Date and Time: Monday, June 4, 2018, 1:15 p.m. - 4:45 p.m. Central Daylight Time
Breast Cancer - Metastatic
Abstract #TPS1111/Poster Board #186b: "ATTAIN: Phase 3 study of etirinotecan pegol (EP) vs. treatment of physician's choice (TPC) in patients (pts) with metastatic breast cancer (MBC) who have stable brain metastases (BM) previously treated with an anthracycline, a taxane, and capecitabine (ATC)", Tripathy, D., et al. Session Date and Time: Saturday, June 2, 2018, 8:00 a.m. - 11:30 a.m. Central Daylight Time
Analyst and Investor EventNektar Therapeutics will webcast an analyst and investor event with clinical investigators during the ASCO Annual Meeting beginning on Saturday, June 2, 2018 at 6:45 p.m. Central Daylight Time. Featured speakers include Dr. Adi Diab, Assistant Professor, Melanoma Medical Oncology at the University of Texas MD Anderson Cancer Center, Dr. Scott N. Gettinger, Associate Professor, Medical Oncology at the Yale Cancer Center and Dr. Nizar M. Tannir, Professor, Genitourinary Medical Oncology at the University of Texas MD Anderson Cancer Center. The webcast is accessible from the Investor Events page of Nektar's website at http://ir.nektar.com/events-and-presentations/events.
About NKTR-214NKTR-214 is an experimental therapy designed to stimulate cancer-killing immune cells in the body by targeting CD122 specific receptors found on the surface of these immune cells, known as CD8+ effector T cells and Natural Killer (NK) cells. Growing these tumor-infiltrating lymphocytes (TILs) in vivo and replenishing the immune system is critically important as many patients battling cancer lack sufficient TIL populations to benefit from approved checkpoint inhibitor therapies. In preclinical studies, treatment with NKTR-214 resulted in a rapid expansion of these cells and mobilization into the tumor micro-environment.1,2 NKTR-214 has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.
About the PIVOT Phase 1/2 ProgramThe PIVOT Phase 1/2 program is a dose escalation and expansion study of NKTR-214 when administered in combination with nivolumab in patients with melanoma, renal cell carcinoma, non-small cell lung cancer (NSCLC), urothelial carcinoma, or triple negative breast cancer. The dose escalation stage of the study enrolled 38 patients and evaluated the safety and efficacy profile of the combination and the recommended phase 2 dose was established. The expansion stage of the PIVOT program is underway to evaluate the safety and efficacy of combining NKTR-214 with nivolumab in approximately 330 patients who are either immuno-oncology (I-O) therapy naïve or anti-PD-1 or anti-PD-L1 relapsed/refractory. The expansion cohorts in the PIVOT program include five tumor types and thirteen indications, including first and second/third-line melanoma, first and second/third-line renal cell carcinoma, first and second/third-line NSCLC, first and third-line urothelial carcinoma, and first and second-line triple negative breast cancer. For more information, please visit clinicaltrials.gov and search NCT02983045.
About Nektar 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, auto-immune 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 http://www.nektar.com.
Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements which can be identified by words such as: "will," "believe," "designed" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential NKTR-214 in combination with other therapeutic agents, and the availability of results and outcomes from clinical and preclinical studies of our new drug candidates. 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, 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 NKTR-214 are based on pre-clinical and clinical findings and observations; (ii) NKTR-214 is in early stage clinical development and the risk of failure remains high and failure can unexpectedly occur at any stage for one or more of the cancer indications being studied prior to regulatory approval due to lack of sufficient efficacy, safety considerations or other factors that impact drug development; (iii) data reported from ongoing clinical trials is necessarily interim data only and the final results will change based on continuing observations from patients that currently remain enrolled in the trials and/or new observations from patients enrolling in the trials; (iv) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of potential new drug candidates (such as NKTR-214 and NKTR-102) is therefore very uncertain and unpredictable; (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 Nektar's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2018. 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.
For Investors: Jennifer Ruddock of Nektar Therapeutics415-482-5585
Jodi Sievers of Nektar Therapeutics415-482-5593
For Media: Dan Budwick of 1AB973firstname.lastname@example.org
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SOURCE Nektar Therapeutics
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