NKTR-255

73% of the NKTR-255 treatment group compared to 50% of the placebo group achieved a complete response at 6 months NKTR-255 enhanced CAR T-cell kinetics with improved CD8+ CAR-T area under the curve (AUC) 0-15 days post-administration being 5.8-fold greater than placebo-controls SAN FRANCISCO, Dec. 7, 2024 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced results of its Phase 2 proof-of-concept study evaluating NKTR-255 as an adjuvant treatment to enhance complete response rate (CRR) and durability following CD19-directed CAR-T therapy in patients with relapsed/refractory (R/R) Large B-cell Lymphoma (LBCL) at the 66th ASH Annual Meeting and Exposition in San Diego, California. NKTR-255 is an investigational polymer-conjugated IL-15 agonist, that activates, proliferates and expands natural killer (NK) and CD8+ T-cells in vivo, as well as promotes the survival and expansion of memory CD8+ T cells intended to increase duration and level of response for CAR-T and cellular therapies.1,2 In this multicenter, double-blind Phase 2 study, patients were randomized to receive one of three dose regimens of NKTR-255 or placebo intravenously starting 14 days after CAR-T infusion. In the fifteen-person clinical trial, the NKTR-255 combined treatment group demonstrated an improved CRR at six months, achieving 73% compared to 50% for the placebo, as assessed by a blinded independent central radiology review. Additionally, two patients treated with NKTR-255 converted from stable disease or partial response to complete responses at six months. No conversions from stable disease or partial response to complete response were observed in the placebo arm of the trial. "The majority of patients currently receiving CAR-T therapies fail to achieve durable disease remission," said Sairah Ahmed, M.D., Associate Professor, Director of CAR-T Program at the Department of Lymphoma/Myeloma, Division of Cancer Medicine at University of Texas MD Anderson Cancer Center. "The results of this study demonstrated that NKTR-255 enhanced CAR T-cell counts and increased the number of patients who achieve a CR at 6 months post infusion. This finding is highly significant since, in multiple pivotal trials, patients who achieved complete response at 6 months were highly likely to remain in complete response beyond 2 years translating to improved progression-free survival." The reported clinical benefit surpasses the published historical benchmark data from multiple pivotal trials and real-world meta-analyses of currently available commercial CD19 CAR-T cell therapies, which demonstrate 6-month complete response rates of 41% to 44%. "This study is the first randomized trial demonstrating adjuvant treatment with NKTR-255 can enhance the durability of response to standard-of-care commercial CAR T-cell therapy by modifying CAR T-cell kinetics," said Mary Tagliaferri, M.D., Chief Medical Officer of Nektar. "These results contribute to the growing body of evidence demonstrating the broad applicability of NKTR-255 in combination with cellular therapies, and, as new data emerge, we continue to explore the best path forward for this program." NKTR-255 was safe and well-tolerated in patients with relapsed/refractory LBCL in combination with FDA-approved CD19 CAR T-cell products. Details of the presentation can be found on Nektar's website at under Scientific Posters, Presentations and Publications. Title: 2068 NKTR-255 Vs Placebo to Enhance Complete Responses and Durability Following CD19-Directed CAR-T Therapy in Patients with Relapsed/ Refractory (R/R) Large B-Cell Lymphoma (LBCL) Poster: 2068 Program: Oral and Poster Abstracts Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I Hematology Disease Topics & Pathways: Research, Clinical trials, Clinical Research Time & Date: Saturday, December 7, 2024, 5:30 PM-7:30 PM About NKTR-255 NKTR-255 is a biologic that targets the IL-15 pathway in order to activate the body's innate and adaptive immunity. Through optimal engagement of the IL-15 receptor complex, NKTR-255 is designed to enhance functional NK cell populations and formation of long-term immunological memory, which may lead to sustained and durable anti-tumor immune response. In addition to studies in combination with CAR T cell therapies, NKTR-255 is being studied in a Phase 1 clinical trial sponsored by AbelZeta Pharma, Inc., which is evaluating C-TIL051, a tumor-infiltrating lymphocyte therapy, in anti-PD1 resistant metastatic non-small cell lung cancer (NCT05676749). The JAVELIN Bladder Medley study (NCT05327530), sponsored by Merck KGaA, is also ongoing to evaluate NKTR-255 in combination with avelumab as a maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma (NCT05327530). About Nektar Therapeutics Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. Nektar's lead product candidate, rezpegaldesleukin (REZPEG, or NKTR-358), is a novel, first-in-class regulatory T cell stimulator being evaluated in two Phase 2b clinical trials, one in atopic dermatitis and one in alopecia areata. Nektar's pipeline also includes a preclinical bivalent tumor necrosis factor receptor type II (TNFR2) antibody and bispecific programs, NKTR-0165 and NKTR-0166, and a modified hematopoietic colony stimulating factor (CSF) protein, NKTR-422. Nektar, together with various partners, is also evaluating NKTR-255, an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer, in several ongoing clinical trials. Nektar is headquartered in San Francisco, California. For further information, visit and follow Nektar on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements which can be identified by words such as: "will," "expect," "develop," "potential," "advance," "anticipate," "can," and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the therapeutic potential of, and future development plans for, NKTR-255. 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 NKTR-255 are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) NKTR-255 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 future clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) NKTR-255 is in clinical development, and the risk of failure is high and 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 Securities and Exchange Commission on November 8, 2024. 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: Vivian Wu of Nektar Therapeutics 628-895-0661 For Media: Madelin Hawtin LifeSci Communications 603-714-2638 [email protected] Shah, N., Perales, M. A., Turtle, C. J., Cairo, M. S., Cowan, A. J., Saeed, H., … Patel, K. K. (2021). Phase I Study Protocol: NKTR-255 as Monotherapy or Combined with Daratumumab or Rituximab in Hematologic Malignancies. Future Oncology, 17(27), 3549–3560. Miyazaki T, Maiti M, Hennessy M, et al. NKTR-255, a novel polymer-conjugated rhIL-15 with potent antitumor efficacy. Journal for ImmunoTherapy of Cancer 2021;9:e002024. doi:10.1136/jitc-2020-002024 SOURCE Nektar Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BOSTON and HUNTSVILLE, Ala., Dec. 2, 2024 /PRNewswire/ -- Ampersand Capital Partners, a private equity firm specializing in growth equity investments in the life sciences and healthcare sectors, today announced the successful closing of its previously announced acquisition of Nektar Therapeutics' PEGylation reagent manufacturing business. The new Ampersand portfolio company will be branded Gannet BioChem and will continue to operate out of its state-of-the-art facility in Huntsville, Alabama. Continue Reading Gannet BioChem With over 30 years of expertise, Gannet BioChem is a proven specialty CDMO leader in developing, scaling, and manufacturing polyethylene glycol (PEG) reagents - critical components in advanced biopharmaceutical and therapeutic products. Gannet BioChem combines industry-leading expertise and cutting-edge infrastructure to deliver unparalleled capabilities: End-to-End GMP Production: From raw material sourcing to manufacturing and packaging, ensuring exceptional quality and reliability across every stage of the supply chain. FDA-Approved Applications: Development and production of PEG reagents used in nine FDA-approved therapeutics over facility's history. Commercial Impact: Supplying PEG reagents for several currently marketed drugs. Flexible Facility: Designed to efficiently handle small-scale and commercial-scale production needs. Expert Team: An experienced workforce with an average tenure of 13 years, ensuring consistent quality and innovation. Expansion-Ready Infrastructure: A 124,000 sq. ft. manufacturing facility with dedicated small and large-scale production areas and operational capacity for future growth. Strategic Location: Situated in Huntsville, Alabama, Gannet BioChem benefits from its proximity to the USA's second-largest life sciences research park, providing a robust ecosystem for collaboration and innovation in biotechnology. Legacy of Quality: Gannet BioChem's FDA-inspected facility maintains an exceptional compliance record, underlining its commitment to quality and reliability for customers worldwide. "We are thrilled to introduce Gannet BioChem as a new, independent PEG reagents CDMO," said David Anderson, General Partner at Ampersand Capital Partners. "The PEG reagent manufacturing team at Gannet BioChem has a well-established track record and long history of delivering high-quality, specialized PEG reagents for commercial and clinical stage biologic therapeutics. We are well-equipped to build on that legacy with the support of Ampersand's resources and expertise in life sciences partnerships. Gannet BioChem is poised for continued success and strategic growth as a trusted partner to biopharmaceutical innovators globally." About Ampersand Capital Partners Ampersand Capital Partners, founded in 1988, is a middle-market private equity firm with $3 billion of assets under management, dedicated to growth-oriented investments in the healthcare sector. With offices in Boston, MA, and Amsterdam, Netherlands, Ampersand leverages a unique blend of private equity and operating experience to build value and drive long-term performance alongside its portfolio company management teams. Ampersand has helped build numerous market-leading companies across each of the firm's core healthcare sectors. For additional information, visit AmpersandCapital.com or follow us on LinkedIn. About Gannet BioChem With over 30 years of expertise, Gannet BioChem is a leading specialty CDMO specializing in the development, scaling, and manufacturing of polyethylene glycol (PEG) reagents—essential components in advanced biopharmaceutical and therapeutic products. Operating from a state-of-the-art 124,000 sq. ft. FDA-inspected facility in Huntsville, Alabama, Gannet BioChem delivers end-to-end GMP production, supporting clinical and commercial therapeutics. With a highly experienced team, flexible production capabilities, and a commitment to quality, Gannet BioChem provides reliable, innovative solutions to meet the evolving needs of the global biopharmaceutical industry. For additional information, please visit GannetBioChem.com or follow us on LinkedIn. About Nektar Therapeutics Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. Nektar's lead product candidate, rezpegaldesleukin (REZPEG, or NKTR-358), is a novel, first-in-class regulatory T cell stimulator being evaluated in two Phase 2b clinical trials, one in atopic dermatitis and one in alopecia areata. Nektar's pipeline also includes a preclinical bivalent tumor necrosis factor receptor type II (TNFR2) antibody and bispecific programs, NKTR-0165 and NKTR-0166, and a modified hematopoietic colony stimulating factor (CSF) protein, NKTR-422. Nektar, together with various partners, is also evaluating NKTR-255, an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer, in several ongoing clinical trials. Nektar is headquartered in San Francisco, California. For further information, visit and follow Nektar on LinkedIn. SOURCE Ampersand Capital Partners WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED