A Phase 2/3, Randomized, Open-label Study to Compare Bempegaldesleukin Combined With Pembrolizumab Versus Pembrolizumab Alone in First-Line Treatment of Patients With Metastatic or Recurrent Head and Neck Squamous-Cell Carcinoma With PD-L1 Expressing Tumors (PROPEL-36)

This is a multicenter, randomized, open-label, Phase 2/3 study that will evaluate the efficacy and safety of bempegaldesleukin (BEMPEG; NKTR-214) combined with pembrolizumab compared with pembrolizumab monotherapy in patients with recurrent or metastatic HNSCC with positive PD-L1 expression (CPS ≥ 1).

Start Date09 Mar 2022

Sponsor / Collaborator

Nektar Therapeutics

[+2]

NCT04936841

/ TerminatedPhase 2IIT

Phase II Study of Bempegaldesleukin (NKTR-214) Together With Palliative Radiation and Anti-PD-1 Checkpoint Blockade in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

This trial will evaluate safety and efficacy of the combination of anti-PD1, NKTR-214, and palliative radiation therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Twenty-four participants will be enrolled to evaluate the efficacy of this combination.

Start Date05 Aug 2021

Sponsor / Collaborator

University of Wisconsin Madison

[+1]

NCT04730349

/ TerminatedPhase 1/2

Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)

The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children, adolescents and young adults with recurrent or treatment-resistant cancer.

Start Date03 Jun 2021

Sponsor / Collaborator

Bristol Myers Squibb Co.

[+1]

100 Clinical Results associated with Bempegaldesleukin

100 Translational Medicine associated with Bempegaldesleukin

100 Patents (Medical) associated with Bempegaldesleukin

Literatures (Medical) associated with Bempegaldesleukin

01 Oct 2024·UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS

Bempegaldesleukin plus nivolumab in first-line advanced/metastatic urothelial carcinoma: Results from a phase II single-arm study (PIVOT-10)

Article

Author: De Giorgi, Ugo ; Siefker-Radtke, Arlene O ; Sridhar, Srikala S ; Qureshi, Anila ; Bilen, Mehmet A ; Järvinen, Riikka ; Peer, Avivit ; Balar, Arjun ; Koshkin, Vadim S ; Harputluoğlu, Hakan ; Loriot, Yohann ; Wang, Tianhua ; Zalevsky, Jonathan ; Poushnejad, Shermeen ; Tagliaferri, Mary A. ; Vasiliev, Aleksandr ; Bilen, Mehmet A. ; Penkov, Konstantin ; Castellano, Daniel ; Tagliaferri, Mary A ; Huddart, Robert A. ; Koshkin, Vadim S. ; Huddart, Robert A ; Siefker-Radtke, Arlene O.

BACKGROUND:

In PIVOT-02, bempegaldesleukin (BEMPEG), a pegylated interleukin-2 cytokine prodrug, in combination with nivolumab (NIVO), a Programmed cell death protein 1 inhibitor, demonstrated the potential to provide additional benefits over immune checkpoint inhibitor monotherapy in patients with urothelial carcinoma, warranting further investigation. We evaluated BEMPEG plus NIVO in cisplatin-ineligible patients with previously untreated locally advanced or metastatic urothelial carcinoma.

METHODS:

This open-label, multicenter, single-arm, phase II study enrolled patients with locally advanced/surgically unresectable or metastatic urothelial carcinoma and who were ineligible for cisplatin-based treatment. Patients received BEMPEG plus NIVO were administered intravenously every 3 weeks for ≤2 years or until progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) by blinded independent central review (BICR) in patients with low programmed death ligand-1 (PD-L1) expression. Secondary endpoints included ORR and duration of response in the overall population. Progression-free survival (PFS) and overall survival (OS) were exploratory endpoints.

RESULTS:

One hundred and eighty-eight patients were enrolled; 123 patients were PD-L1 low (combined positive score [CPS] <10; 65.4%), 59 were PD-L1 high (31.4%; CPS ≥10), and 6 had PD-L1 status unknown (3.2%). ORR per blinded independent central review in patients with PD-L1-low tumors was 17.9% (95% confidence interval [CI] 11.6-25.8) while in all treated patients was 19.7% (95% CI 14.3-26.1). Median PFS and OS in the overall population were 3.0 months and 12.6 months, respectively. BEMPEG plus NIVO combination was well tolerated, with a safety profile similar to previously reported trials; no new or unexpected safety signals were reported.

CONCLUSIONS:

BEMPEG plus NIVO did not meet the efficacy threshold for ORR in patients with previously untreated locally advanced or metastatic urothelial carcinoma and low PD-L1 expression.

10 Aug 2024·JOURNAL OF CLINICAL ONCOLOGY

Bempegaldesleukin Plus Nivolumab Versus Sunitinib or Cabozantinib in Previously Untreated Advanced Clear Cell Renal Cell Carcinoma: A Phase III Randomized Study (PIVOT-09)

Article

PURPOSE:

Bempegaldesleukin (BEMPEG) is a pegylated interleukin (IL)-2 cytokine prodrug engineered to provide controlled and sustained activation of the clinically validated IL-2 pathway, with the goal of preferentially activating and expanding effector CD8+ T cells and natural killer cells over immunosuppressive regulator T cells in the tumor microenvironment. The open-label, phase III randomized controlled PIVOT-09 trial investigated the efficacy and safety of BEMPEG plus nivolumab (NIVO) as first-line treatment for advanced/metastatic clear cell renal cell carcinoma (ccRCC) with intermediate-/poor-risk disease.

METHODS:

Patients with previously untreated advanced/metastatic ccRCC were randomly assigned (1:1) to BEMPEG plus NIVO, or investigator's choice of tyrosine kinase inhibitor (TKI; sunitinib or cabozantinib). Coprimary end points were objective response rate (ORR) by blinded independent central review and overall survival (OS) in patients with International Metastatic RCC Database Consortium (IMDC) intermediate-/poor-risk disease.

RESULTS:

Overall, 623 patients were randomly assigned to BEMPEG plus NIVO (n = 311) or TKI (n = 312; sunitinib n = 225, cabozantinib n = 87), of whom 514 (82.5%) had IMDC intermediate-/poor-risk disease. In patients with IMDC intermediate-/poor-risk disease, ORR with BEMPEG plus NIVO versus TKI was 23.0% (95% CI, 18.0 to 28.7) versus 30.6% (95% CI, 25.1 to 36.6; difference, –7.7 [95% CI, –15.2 to –0.2]; P = .0489), and median OS was 29.0 months versus not estimable (hazard ratio, 0.82 [95% CI, 0.61 to 1.10]; P = .192), respectively. More frequent all-grade treatment-related adverse events (TRAEs) with BEMPEG plus NIVO versus TKI included pyrexia (32.6% v 2.0%) and pruritus (31.3% v 8.8%). Grade 3/4 TRAEs were less frequent with BEMPEG plus NIVO (25.8%) versus TKI (56.5%).

CONCLUSION:

First-line BEMPEG plus NIVO for advanced/metastatic ccRCC did not improve efficacy in patients with intermediate-/poor-risk disease but led to fewer grade 3/4 TRAEs versus TKI.

20 Oct 2023·Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Bempegaldesleukin Plus Nivolumab in Untreated Advanced Melanoma: The Open-Label, Phase III PIVOT IO 001 Trial Results.

Article

Author: Muñoz Couselo, Eva ; Franke, Fabio ; Yang, Haisu ; Lebbe, Celeste ; Zhou, Ming ; Schenker, Michael ; Statkevich, Paul ; Pereira, Caio ; Khushalani, Nikhil I ; Rojas, Carlos ; Gogas, Helen ; Meier, Friedegund ; Quéreux, Gaëlle ; Bronzon Damian, Fernanda ; Diab, Adi ; Curti, Brendan D ; Sznol, Mario ; Arriaga, Yull ; Perfetti, Aldo ; Tagliaferri, Mary A ; Ravimohan, Shruthi ; Sandhu, Shahneen ; Long, Georgina V ; Ciuleanu, Tudor E ; Larkin, James ; Ascierto, Paolo A

PURPOSE:

Despite marked advances in the treatment of unresectable or metastatic melanoma, the need for novel therapies remains. Bempegaldesleukin (BEMPEG), a pegylated interleukin-2 (IL-2) cytokine prodrug, demonstrated efficacy in the phase II PIVOT-02 trial. PIVOT IO 001 (ClinicalTrials.gov identifier: NCT03635983) is a phase III, randomized, open-label study that builds on the PIVOT-02 results in first-line melanoma.

METHODS:

Patients with previously untreated, unresectable, or metastatic melanoma were randomly assigned 1:1 to receive BEMPEG plus nivolumab (NIVO) or NIVO monotherapy. Primary end points were objective response rate (ORR) and progression-free survival (PFS) by blinded independent central review and overall survival (OS). Secondary and exploratory end points included additional efficacy measures, safety, and pharmacokinetics (PKs) and pharmacodynamics analyses.

RESULTS:

In 783 patients (n = 391, BEMPEG plus NIVO; n = 392, NIVO monotherapy), the median follow-up was 11.6 months in the intent-to-treat population. The ORR with BEMPEG plus NIVO was 27.7% versus 36.0% with NIVO (two-sided P = .0311). The median PFS with BEMPEG plus NIVO was 4.17 months (95% CI, 3.52 to 5.55) versus 4.99 months (95% CI, 4.14 to 7.82) with NIVO (hazard ratio [HR], 1.09; 97% CI, 0.88 to 1.35; P = .3988). The median OS was 29.67 months (95% CI, 22.14 to not reached [NR]) with BEMPEG plus NIVO versus 28.88 months (95% CI, 21.32 to NR) with NIVO (HR, 0.94; 99.929% CI, 0.59 to 1.48; P = .6361). Grade 3-4 treatment-related adverse events (AEs) and serious AE rates were higher with the combination (21.7% and 10.1%, respectively) versus NIVO (11.5% and 5.5%, respectively). BEMPEG PK exposure and absolute lymphocyte count changes after BEMPEG plus NIVO were comparable between PIVOT IO 001 and PIVOT-02.

CONCLUSION:

The PIVOT IO 001 study did not meet its primary end points of ORR, PFS, and OS. Increased toxicity was observed with BEMPEG plus NIVO versus NIVO.

News (Medical) associated with Bempegaldesleukin

21 Feb 2024

·www.biospace.com

Ikena Oncology Appoints Caroline Germa, M.D. as Chief Medical Officer

Caroline Germa, M.D., an accomplished senior executive and medical oncologist, brings over 25 years of pharmaceutical and drug development expertise Dr. Germa will drive clinical development strategy and oversee the execution of targeted oncology programs, IK-930 and IK-595 Sergio Santillana, M.D., MSc., MBA resigned from current role as Chief Medical Officer BOSTON, Feb. 21, 2024 (GLOBE NEWSWIRE) -- Ikena Oncology, Inc. (Nasdaq: IKNA, “Ikena,” “Company”), a targeted oncology company forging new territory in patient-directed cancer treatment, today announced the resignation of Dr. Sergio Santillana and the appointment of Dr. Caroline Germa as Chief Medical Officer. Her addition comes at a pivotal time with the Company’s focus on its clinical programs, IK-930 and IK-595, underscoring Ikena’s commitment to driving innovation in the targeted oncology space. “Our clinical team is firing on all cylinders to bring the right patients into our ongoing IK-930 and IK-595 studies, and to collaborate with our investigators to learn as much as we can from these two novel Phase I programs. Dr. Germa’s leadership and experience in clinical drug development, in both the biotech space and the large pharma world, will be instrumental to our development effort and strategy, as we set both of our programs up for success,” said Mark Manfredi, Ph.D., Chief Executive Officer of Ikena. “We are confident that Dr. Germa’s contributions will continue to broaden patient access to our programs and, in turn, drive value for our investors and stakeholders, as we remain on track to deliver a clinical update in the second half of this year.” Dr. Germa is an accomplished medical oncologist and clinical development leader with over 25 years of pharmaceutical experience across the spectrum of drug development, from early clinical trials to late phase and registrational studies. Prior to Ikena, Dr. Germa served as the EVP, Global Medicine Development, and Chief Medical Officer at Transcenta Therapeutics, where she played a pivotal role in shaping strategic goals for the company’s oncology and non-oncology portfolio, ensuring successful execution across all clinical development functions. Previously, Dr. Germa held senior leadership positions at global pharmaceutical companies such as AstraZeneca as Vice President and Head of Oncology Early Development Clinical Group, Bristol Myers Squibb as Development Team Lead for NKTR214, and Novartis where in particular she led the development and registration of KISQALI®, solidifying her reputation as a trailblazer in advancing oncology care in the relentless pursuit of a cure for cancer. Dr. Germa earned her Medical Doctor degree and board certification in medical oncology at the University of Lille, a degree in immunology from the University of Lille and a degree in health economics from Paris Diderot University in France. Dr. Germa added, “I am thrilled to be joining Ikena at a time when it is primed for clinical inflection across the pipeline. The opportunity to work in a first-in-class program like IK-930, in a novel pathway like Hippo, is one that does not come often. In addition to that, I am deeply motivated by the work the team has done to solve what is missing for RAS and RAF mutant cancer patients who are unaddressed by the current available treatments with IK-595. I am looking forward to collaborating with this team on both of these novel targeted oncology programs for patients with great unmet needs.” Dr. Sergio Santillana will resign from his role as Chief Medical Officer upon Dr. Germa’s appointment and will continue to consult for the Company to ensure a smooth transition of clinical responsibilities and activities to Dr. Germa. Dr. Manfredi continued, “We would like to thank Sergio for his dedication and contributions to Ikena. Dr. Santillana’s leadership was integral to bringing our programs into the clinic, and we wish him well in his future endeavors.” About Ikena Oncology Ikena Oncology® is focused on developing differentiated therapies for patients in need that target nodes of cancer growth, spread, and therapeutic resistance in the Hippo and RAS onco-signaling network. The Company’s lead targeted oncology program, IK-930, is a TEAD1 selective Hippo pathway inhibitor, a known tumor suppressor pathway that also drives resistance to multiple targeted therapies. The Company’s second clinical stage program targets the RAS signaling pathway with IK-595, a novel MEK-RAF molecular glue. Ikena aims to utilize their depth of institutional knowledge and breadth of tools to efficiently develop the right drug using the right modality for the right patient. To learn more, visit or follow us on X and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding: the timing and advancement of our targeted oncology programs, including the timing of updates; our expectations regarding the therapeutic benefit of our targeted oncology programs; our ability to efficiently discover and develop product candidates; our ability to obtain and maintain regulatory approval of our product candidates; expectations with respect to year end cash and projected cash runway; the anticipated results of our organizational changes; the implementation of our business model; and strategic plans for our business and product candidates. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of our targeted oncology programs; our expectations regarding the therapeutic benefit of our targeted oncology programs; our ability to efficiently discover and develop product candidates; the implementation of our business model, and strategic plans for our business and product candidates, the sufficiency of the Company’s capital resources to fund operating expenses and capital expenditure requirements and the period in which such resources are expected to be available, and other factors discussed in the “Risk Factors” section of Ikena’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, which is on the Securities and Exchange Commission (SEC), as updated by any subsequent SEC filings. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements. Investor Contact: Rebecca Cohen Ikena Oncology rcohen@ikenaoncology.com Media Contact: Luke Shiplo LifeSci Communications lshiplo@lifescicomms.com

Executive ChangePhase 1

29 Jan 2024

·medcitynews.com

Sanofi Tries Again With Cytokines, Inking R&D Alliance With Startup Synthekine

Sanofi’s work with engineered cytokines has stumbled in the clinic, but the company isn’t throwing in the towel yet on such therapies, which hold potential for treating autoimmune diseases and cancer. The French pharmaceutical giant is now partnering with a clinical-stage startup whose technologies for engineering these protein therapies could avoid limitations that have stymied some research efforts. Per deal terms announced Monday, Sanofi is paying Synthekine $40 million up front. Depending on the progress of the research, Menlo Park, California-based Synthekine will be eligible for an unspecified sum in milestone payments. Cytokines are signaling proteins that modulate immune responses. While these proteins are already in our bodies, leveraging them for therapeutic effect presents challenges. A cytokine’s effects can vary on different types of cells or even on the same cell types. Cytokine therapies can also spark broad responses that have toxic effects. The Sanofi partnership is focused on one particular cytokine called interleukin-10, or IL-10. While this cytokine has drawn research interest for potential immunosuppressive applications, dose-limiting toxicity has been a problem. Synthekine’s version of IL-10 is engineered to dial out the protein’s immunostimulatory effects, which the company says separates the drug’s therapeutic efficacy from potential toxic effects. The inflammatory disease targets for the partnered research were not disclosed. But the deal calls for Synthekine and Sanofi to work together up to a defined but undisclosed point of preclinical development. After that, Sanofi will take responsibility for developing the IL-10 therapeutic candidates. The companies said the collaboration will focus on using Synthekine’s technologies to optimize IL-10 with the goal of developing drugs that are more selective to their targets while offering a wider therapeutic index, the dose range that balances safety and efficacy. “We look forward to working with Synthekine, a leader in targeted cytokine engineering with outstanding technologies and scientific team,” John Bertin, global head of inflammation and immunology research at Sanofi, said in a prepared statement. “IL-10 plays a key role in immune regulation, and this collaboration aimed at developing precisely tailored IL-10 therapies reaffirms our commitment to deliver the next wave of novel therapies to treat inflammatory diseases.” Sanofi previously placed a big bet on cytokines when it acquired engineered cytokines developer Synthorx for $2.5 billion in 2019. Synthorx’s lead program was an IL-2 therapy in development for cancers and autoimmune diseases. In 2022, Sanofi disclosed Phase 2 results showing this cytokine therapy did not achieve the desired efficacy. No safety issues were reported for the therapy, which now bears the name pegenzileukin. But the disappointing results led the company to return the therapy to early-stage testing to sort out what it described as dosing issues. Sanofi aims to develop this therapy for treating solid tumors. Lack of efficacy was also cited in the disappointing clinical trial outcomes for bempegaldesleukin, an IL-2 therapy that Nektar Therapeutics was developing in partnership with Bristol Myers Squibb. In 2022, this therapy ran into successive failures, first in a Phase 3 test in melanoma and then two Phase 2 trials in kidney and bladder cancers. The mid-stage failures led to the end of the alliance, which began in 2018 with a $1.8 billion financial commitment from BMS. Synthekine has another big pharma research partner. In 2021, Merck and Synthekine struck up an alliance on the development of cytokine drugs for two autoimmune and inflammation targets that remain undisclosed. The sum of the upfront payment was also not disclosed, but Merck is providing Synthekine with research funding and the startup could earn up to $525 million in milestone payments. Synthekine’s internal pipeline is led by an IL-12 therapy currently in Phase 1 testing for cancer. The startup last raised money in 2023, a $100 million Series C round of financing.

Phase 2AcquisitionPhase 1

07 Nov 2023

·www.prnewswire.com

Nektar Therapeutics Reports Third Quarter 2023 Financial Results

SAN FRANCISCO, Nov. 7, 2023 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported financial results for the third quarter ended September 30, 2023. Cash and investments in marketable securities at September 30, 2023, were $372.7 million as compared to $505.0 million at December 31, 2022. Nektar's cash and marketable securities are expected to support strategic development activities and operations into the middle of 2026. "We've made significant progress across our pipeline, including initiating a Phase 2b atopic dermatitis study in October and completing plans to start a Phase 2b alopecia areata study in early 2024," said Howard W. Robin, President and CEO of Nektar. "These two studies position us for important and transformative data readouts for rezpegaldesleukin in the first half of 2025. In September, we signed a new clinical study collaboration with cell therapy leader, Cellular Biomedicine Group, who will evaluate NKTR-255 in combination with CBMG's tumor-infiltrating lymphocyte therapy in advanced non-small cell lung cancer. This study is an example of the potential of NKTR-255 in combination with a range of cell therapies in liquid and solid tumors. Finally, we will end this year in a strong financial position with at least $320 million in cash and investments which provides us with a cash runway into the middle of 2026." Summary of Financial Results Revenue in the third quarter of 2023 was $24.1 million as compared to $23.6 million in the third quarter of 2022. Revenue for the first nine months of 2023 was $66.2 million as compared to $70.0 million in the first nine months of 2022. Total operating costs and expenses in the third quarter of 2023 were $69.0 million as compared to $77.9 million in the third quarter of 2022. Total operating costs and expenses in the first nine months of 2023 were $296.4 million as compared to $393.7 million in the first nine months of 2022. The reduction in operating costs and expenses for both the third quarter and the first nine months of 2023 were due to decreases in research and development expenses, general and administrative expense and restructuring, impairment and costs of terminated program. For the first nine months of 2023, these decreases were partially offset by $76.5 million in non-cash goodwill impairment. R&D expense in the third quarter of 2023 was $24.1 million as compared to $33.6 million for the third quarter of 2022. For the first nine months of 2023, R&D expense was $84.2 million as compared to $183.6 million in the first nine months of 2022. R&D expense decreased for both the third quarter and first nine months of 2023 due to the wind down of the bempegaldesleukin program. G&A expense was $21.1 million in the third quarter of 2023 as compared to $22.5 million in the third quarter of 2022. For the first nine months of 2023, G&A expense was $60.1 million as compared to $70.4 million in the first nine months of 2022. G&A expense decreased for both the third quarter and first nine months of 2023 due to the wind down of the bempegaldesleukin program. Restructuring, impairment and costs of terminated program were $11.4 million in the third quarter of 2023 as compared to $16.8 million in the third quarter of 2022. The amount for the third quarter of 2023 includes $10.2 million in non-cash lease and equipment impairment charges, $0.7 million for the wind down of the bempegaldesleukin program and $0.5 million in severance. The amount for the third quarter of 2022 includes $8.5 million for the wind down of the bempegaldesleukin program, $5.0 million for contract termination and other restructuring costs, $2.1 million in severance and $1.2 million in non-cash lease impairment charges. For the first nine months of 2023, restructuring, impairment and costs of terminated program were $49.1 million. This amount includes $36.6 million in non-cash lease and equipment impairment charges, $8.0 million in severance and $3.6 million for the wind down of the bempegaldesleukin program. For the first nine months of 2022, restructuring, impairment and costs of terminated program were $124.4 million. This amount includes $58.5 million in non-cash lease and equipment impairment charges, $29.8 million in severance, $28.9 million for the wind down of the bempegaldesleukin program and $7.1 million in contract termination and other restructuring costs. Net loss for the third quarter of 2023 was $45.8 million or $0.24 basic and diluted loss per share as compared to a net loss of $59.0 million or $0.31 basic and diluted loss per share in the third quarter of 2022. Net loss in the first nine months of 2023 was $234.0 million or $1.23 basic and diluted loss per share as compared to a net loss of $308.5 million or $1.65 basic and diluted loss per share in the first nine months of 2022. Excluding the $10.2 million in non-cash impairment charges, net loss, on a non-GAAP basis, for the third quarter of 2023 was $35.7 million or $0.19 basic and diluted loss per share. Excluding the $113.1 million in non-cash goodwill and other impairment charges, net loss, on a non-GAAP basis, for the first nine months of 2023 was $120.8 million or $0.64 basic and diluted loss per share. Third Quarter 2023 and Recent Business Updates In September 2023, Nektar announced a clinical study collaboration with Cellular Biomedicine Group Inc. (CBMG) to evaluate NKTR-255 in combination with C-TIL051 in advanced non-small cell lung cancer (NSCLC) patients that are relapsed or refractory to anti-PD-1 therapy. Under the collaboration, CBMG will add NKTR-255 to its ongoing Phase 1 clinical trial being conducted at Duke Cancer Institute. Enrollment for this trial is ongoing. In October 2023, Nektar presented final data from the Phase 1b study of rezpegaldesleukin in patients with atopic dermatitis at the 2023 European Academy of Dermatology and Venereology (EADV) Congress. Patients with moderate-to-severe AD that were treated with rezpegaldesleukin showed dose-dependent improvements in Eczema Area and Severity Index (EASI), Validated Investigator Global Assessment (vIGA), Body Surface Area (BSA), and Itch Numeric Rating Scale (NRS) over 12 weeks of treatment compared to placebo, which were sustained post-treatment over an additional 36 weeks. At the highest studied dose, the proportion of Daily Life Quality Index (DLQI) responders was 75% and the proportion of Patient Oriented Eczema Measure (POEM) responders was 65% at week 12. rezpegaldesleukin was well tolerated with no patients in the rezpegaldesleukin groups experiencing severe, serious, or fatal adverse events, and no anti-rezpegaldesleukin antibodies were detected. In October 2023, Nektar initiated a Phase 2b study of rezpegaldesleukin in patients with atopic dermatitis. Conference Call to Discuss Third Quarter 2023 Financial Results Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, November 7, 2023. This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: . The web broadcast of the conference call will be available for replay through December 8, 2023. To access the conference call, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call. About Nektar Therapeutics Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in immunology and oncology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional manufacturing operations in Huntsville, Alabama. Further information about the company and its drug development programs and capabilities may be found online at . Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements which can be identified by words such as: "will," "could," "develop," "potential," "advance" 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, rezpegaldesleukin and 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 rezpegaldesleukin and NKTR-255 are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin and NKTR-255 are investigational agents and continued research and development for these drug candidates 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) rezpegaldesleukin and NKTR-255 are in various stages of 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 challenges caused by the COVID-19 pandemic, 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) we may not achieve the expected cost savings we expect from our 2022 corporate restructuring and reorganization plan or our 2023 cost restructuring plan and we may undertake additional restructuring and cost-saving activities in the future, (vi) 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 (vii) certain other important risks and uncertainties set forth in our Annual Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2023. 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: Vivian Wu of Nektar Therapeutics 628-895-0661 For Media: David Rosen of Argot Partners (212) 600-1902 [email protected] SOURCE Nektar Therapeutics

Clinical ResultPhase 1Financial StatementPhase 2Cell Therapy

100 Deals associated with Bempegaldesleukin

External Link

KEGG	Wiki	ATC	Drug Bank
D11669	Bempegaldesleukin	-	DB15140

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Head and neck cancer metastatic	Phase 3	United States	Merck Sharp & Dohme Corp.	09 Mar 2022
Head and neck cancer metastatic	Phase 3	United States	SFJ Pharmaceuticals, Inc.	09 Mar 2022
Head and neck cancer metastatic	Phase 3	United States	Nektar Therapeutics	09 Mar 2022
Head and neck cancer metastatic	Phase 3	Austria	Merck Sharp & Dohme Corp.	09 Mar 2022
Head and neck cancer metastatic	Phase 3	Austria	Nektar Therapeutics	09 Mar 2022
Head and neck cancer metastatic	Phase 3	Austria	SFJ Pharmaceuticals, Inc.	09 Mar 2022
Head and neck cancer metastatic	Phase 3	Greece	SFJ Pharmaceuticals, Inc.	09 Mar 2022
Head and neck cancer metastatic	Phase 3	Greece	Nektar Therapeutics	09 Mar 2022
Head and neck cancer metastatic	Phase 3	Greece	Merck Sharp & Dohme Corp.	09 Mar 2022
Head and neck cancer metastatic	Phase 3	Italy	Nektar Therapeutics	09 Mar 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03729245 (PIVOT-09, Pubmed \| J Clin Oncol)	Phase 3	Locally Advanced Clear Cell Renal Cell Carcinoma First line	623	Bempegaldesleukin plus Nivolumab	kbolnnhohe(rkqhtugpzf) = ckpcfchjpp ejszhpvyrs (lyznnufaix, 18.0 - 28.7) View more	Negative	10 Aug 2024
				Sunitinib or Cabozantinib	kbolnnhohe(rkqhtugpzf) = nyxcmajvkh ejszhpvyrs (lyznnufaix, 25.1 - 36.6) View more
NCT03835533 (PORTER, CTgov)	Phase 1	Metastatic castration-resistant prostate cancer	43	Nivolumab+NKTR-214 (Cohort A) (Cohort A: NKTR-214 + Nivolumab)	tiecionlri = jczmnoeygm hgisbvtuan (qkrdkyeijq, pjxfrbrluf - lkockcjuod) View more	-	12 Apr 2024
				Stereotactic body radiation therapy (SBRT) (Cohort B)+Poly-ICLC (Cohort B)+Nivolumab+CDX-301 (Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab)	tiecionlri = pvnslcpgei hgisbvtuan (qkrdkyeijq, aecuxfzuye - ygcyxmnzet) View more
NCT04410445 (PIVOT-12, CTgov)	Phase 3	Melanoma, Cutaneous Malignant	765	Nivolumab (Nivolumab)	djmqegfmuj(bjozznogpf) = cmdeeajxlx ocldbtdphi (fkesmwzonl, glifbvmrzu - xczzasvvjg) View more	-	21 Apr 2023
				Nivolumab+Bempegaldesleukin (Combination of Bempegaldesleukin (NKTR-214) + Nivolumab)	uvmhkmqqrf(cbehkxrnlt) = tyfrzjjpvr chorgdvuqj (lwnfhvqvfz, vrzzhxppog - dacupwnlyc) View more
NCT03729245 (PIVOT-09, CTgov)	Phase 3	Metastatic Renal Cell Carcinoma \| Advanced Renal Cell Carcinoma	623	nivolumab+bempegaldesleukin (Combination of Bempegaldesleukin + Nivolumab)	fhegmswsiq = mtatctbmxq kxdenkldag (oiaumyqkga, wijoeknszy - tuvctrnult) View more	-	11 Apr 2023
				cabozantinib+Sunitinib (Sunitinib or Cabozantinib)	fhegmswsiq = yfedrreyaa kxdenkldag (oiaumyqkga, kbnlckazkq - cddtslfkmd) View more
NCT04730349 (PIVOT IO 020, CTgov)	Phase 1/2	Ependymoma \| Rhabdomyosarcoma \| High grade glioma ... View more	15	Nivolumab+Bempegaldesleukin (Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg))	hjejoyefpq = nxmbzmfixz fcvxwcsang (crxjgzruuq, xlllyxvmjg - hnioiwesau) View more	-	24 Mar 2023
				Nivolumab+Bempegaldesleukin (Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg))	hjejoyefpq = molibaxytf fcvxwcsang (crxjgzruuq, zqvclomitu - htchqasbwk) View more
NCT04969861 (CTgov)	Phase 2/3	Squamous cell carcinoma of head and neck metastatic \| Recurrent Head and Neck Carcinoma \| Head and neck cancer metastatic	1	Bempegaldesleukin+pembrolizumab (BEMPEG + Pembrolizumab)	xjzznyqhhe(tcwfjjzfau) = fpopkwvhxx codwaeuqlx (rjzqryvtrt, lmurixyfod - vwupzqbtrc) View more	-	15 Dec 2022
				pembrolizumab (Pembrolizumab Monotherapy)	xjzznyqhhe(tcwfjjzfau) = dxprrxmyvz codwaeuqlx (rjzqryvtrt, xxqyvyzhit - hekmutxtaf) View more
NCT03635983 (PIVOT IO-001, SITC2022)	Phase 3	Unresectable Melanoma Tregs \| IFNÎ³	-	BEMPEG 0.006 mg/kg+NIVO 360 mg IV Q3W	omdlzlhaag(vchnkmesod) = jrbwpfsixs henofbjzna (gotllmbcpa ) View more	Negative	07 Nov 2022
				NIVO 360 mg IV Q3W	omdlzlhaag(vchnkmesod) = gmmoffccay henofbjzna (gotllmbcpa ) View more
NCT03729245 (PIVOT-09, ESMO2022) Manual	Phase 3	Advanced Renal Cell Carcinoma First line	623	Bempegaldesleukin 0.006 mg/kg+Nivolumab 360 mg	uulpzmpkjd(ehyvwnxsqy) = whnwrahlsy rikisizhea (tcqdfmndjt ) View more	Negative	12 Sep 2022
				Sunitinib 50 mg or Cabozantinib 60 mg	uulpzmpkjd(ehyvwnxsqy) = lvovarrpki rikisizhea (tcqdfmndjt ) View more
NCT03635983 (PIVOT IO 001, ESMO2022) Manual	Phase 3	Melanoma First line BRAF Mutation	783	Bempegaldesleukin 0.006 mg/kg+Nivolumab 360 mg	dgyxwqrhra(gcaazuojws) = vlxqatscpm dnaylokoht (hdndeuvhfd ) View more	Negative	10 Sep 2022
				Nivolumab 360 mg	dgyxwqrhra(gcaazuojws) = iqnwpoigws dnaylokoht (hdndeuvhfd ) View more
NCT02983045 (PIVOT-02, Pubmed)	Phase 1/2	Metastatic urothelial carcinoma First line	41	Bempegaldesleukin plus Nivolumab	abgsgxpfnb(mcpzqjfjja) = nyvophenkl ifcllgyuhh (yemrnnbfrh ) View more	Positive	25 May 2022

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