neoleukin clinical trials

2022.07.31
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neoleukin clinical trials

NL-201 is currently in a Phase 1 clinical trial for patients with relapsed and refractory solid tumors to assess safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity. For more information, please visit the Neoleukin website:www.neoleukin.com. The trial will enrol up to 132 subjects to analyse the efficacy of NL-201 plus Keytruda combination therapy. The archived audio webcast will be available on the Investor Relations section of the Neoleukin website approximately two hours after the event and will be available for replay for at least 30 days after the event. Neoleukins lead product candidate, NL-201, is a combined IL-2 and IL-15 agonist designed to improve tolerability and activity by eliminating the alpha receptor binding interface. Dose escalation is currently underway and will continue through 2022. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Patients will receive NL-201 as intravenous monotherapy to assess safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity. Previously presented preclinical data has demonstrated the ability ofNL-201 to stimulate and expand CD8+ and NK cells at low doses with minimal impact on immunosuppressive regulatory T cells. MediaJulie Rathbun206-769-9219jrathbun@neoleukin.com, InvestorsSolebury TroutAlexandra Roy617-221-9197aroy@soleburytrout.com, Neoleukin Therapeutics Announces Preclinical Data Highlighting Activity of NL-201 in Hematologic Malignancies at 63rd American Society of Hematology Annual Meeting (ASH 2021). The increase was partially offset by higher costs incurred in the second quarter of 2020 associated with the termination of its Vancouver, Canada office lease. Neoleukin Therapeutics has dosed the first subject with its NL-201 plus Keytruda (pembrolizumab), in a combination arm of Phase I clinical trial on relapsed or refractory solid tumour patients. NL-201 is a computationally designed de novo protein that is a mimetic of natural cytokines IL-2 and IL-15 designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without a bias toward cells expressing the IL-2 receptor alpha subunit (CD25). The increase was primarily due to increases in personnel-related costs. Choosing to participate in a study is an important personal decision. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. Keywords provided by Neoleukin Therapeutics, Inc.: Why Should I Register and Submit Results?

MediaJulie Rathbun206-769-9219jrathbun@neoleukin.com, InvestorsSolebury TroutAlexandra Roy617-221-9197aroy@soleburytrout.com, Condensed Consolidated Balance Sheet Data(In thousands of U.S. dollars), Condensed Consolidated Statements of Operations(In thousands of U.S. dollars, except per share and share amounts), Neoleukin Therapeutics Announces Year End 2021 Financial Results and Corporate Update, Net loss per common stock basic and diluted, Basic and diluted weighted average common shares outstanding. Neoleukin is a biopharmaceutical company creating next generation immunotherapies for cancer, inflammation and autoimmunity usingde novoprotein design technology. The increase in general and administrative expenses was primarily due to increases in personnel-related costs as Neoleukin continues to grow its operations. Patients will have tests and exams to see if they are eligible for the clinical trial. Furthermore, NL-201 treated mice had an increase in bone marrow T-cells expressing granzyme B and a decrease in the T-cell exhaustion phenotype. NL-201 is currently in a Phase 1 clinical trial for patients with solid tumors. NL-CVX1 is a de novo protein that binds to the spike protein of SARS-CoV-2, the virus that causes COVID-19 and blocks infection of human cells. Previously presented preclinical data has demonstrated the ability of NL-201 to stimulate and expand CD8+ and NK cells at low doses with minimal impact on immunosuppressive regulatory T cells. Neoleukin will evaluate NL-201 plus pembrolizumab as part of the companys ongoing Phase 1 trial in patients with advanced, relapsed or refractory solid tumors.

Earlier in his career, Mr. Palekar spent 16 years at Johnson & Johnson in various senior commercial and strategic management roles including worldwide VP of Immunology. G&A Expenses: General and administrative expenses for the year ended 2021 increased to $21.5 million from $17.2 million for the year ended 2020.

The trials combination arm will enrol up to 132 subjects. Neoleukin is a biopharmaceutical company creating next generation immunotherapies for cancer, inflammation and autoimmunity using de novo protein design technology. Part 3 and 4 Only: Known additional cancer that is progressing or has required active treatment within the past 2 years. Cash Position: Cash and cash equivalents totaled $164.2 million as of June 30, 2021, compared to $192.6 million as of December 31, 2020. About NL-201NL-201 is ade novo agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without any bias toward cells expressing the alpha receptor subunit (CD25). Neoleukin uses sophisticated computational methods to design proteins that demonstrate specific pharmaceutical properties that provide potentially superior therapeutic benefit over native proteins. The Phase 1 study, underway at clinical sites in the U.S. and Australia, is enrolling patients with advanced, relapsed, or refractory solid tumors. These data, generated by our collaborators at the Fred Hutchinson Cancer Research Center, demonstrate robust immune effects and anti-myeloma activity in a challenging setting, said Priti Patel M.D., Chief Medical Officer of Neoleukin. Tick the boxes of the newsletters you would like to receive. Keytruda is an anti-programmed death-1 (PD-1) therapy of Merck (known as MSD in North America). Details as follows: Time: 1:30 p.m. Pacific / 4:30 p.m. Eastern, Webcast URL: http://investor.neoleukin.com/events. These statements are subject to numerous risks and uncertainties, including risks and uncertainties related to the companys cash forecasts, the companys ability to advance its product candidates, the receipt and timing of potential regulatory submissions, designations, approvals and commercialization of product candidates, the timing and results of preclinical and clinical trials, the timing of announcements and updates relating to the companys clinical trials and related data market conditions and further impacts of COVID-19, that could cause actual results to differ materially from what Neoleukin expects.

Neoleukin uses sophisticated computational methods to design proteins that demonstrate specific pharmaceutical properties that provide potentially superior therapeutic benefit over native proteins. *KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the therapeutic properties and potential of the companys de novo protein design technology, the results of the clinical trial for NL-201, expectations regarding cash forecasts, and planned clinical and development activities and timelines. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday.

Mr. Palekar's career in the biopharmaceuticals industry spans more than 30 years, and he brings extensive strategic and operational experience spanning commercial and research and development functions. Furthermore, NL-201 has demonstrated both monotherapy and combination activity across a wide range of preclinical syngeneic tumor models. Neoleukin uses sophisticated computational methods to design proteins that demonstrate specific pharmaceutical properties that provide potentially superior therapeutic benefit over native proteins. Patients will be able to receive study treatment as long as it is tolerated and there is evidence of clinical benefit. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the therapeutic properties and potential of the companys de novo protein design technology, the results of the clinical trial for NL-201, expectations regarding cash forecasts, and planned clinical and development activities and timelines. Further information on potential risk factors that could affect Neoleukins business and its financial results are detailed under the heading Risk Factors in documents the company files from time to time with the Securities and Exchange Commission (SEC), and other reports as filed with the SEC. Experimental results indicate that anti-myeloma activity is mediated by expansion of cytotoxic memory CD8 T cells and a decrease in T-regulatory CD4 cells in the bone marrow. Information provided by (Responsible Party): NL-201 given as monotherapy by intravenous administration testing ascending doses and two different schedules. In December 2021, Neoleukin announced the presentation of preclinical data on NL-201 in multiple myeloma at the 63RDAmerican Society of Hematology (ASH) Annual Meeting and Exposition. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. The preclinical multiple myeloma data, demonstrate the ability of NL-201 to prevent relapse in murine myeloma models following autologous stem cell transplant. The design and characterization of NL-CVX1 in under three months underscores the speed and versatility of Neoleukin'sde novo protein platform.

Prespecified timepoints in serum before and after dosing with NL-201. Part 3 and 4 Only: History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. A de novo agonist of the IL-2 and IL-15 receptors, NL-201 can extend cancer-fighting CD8 T cells and natural killer (NK) cells without having a bias toward cells expressing the alpha receptor subunit (CD25). Parts 3 and 4 If eligible, the patient will receive NL-201 and pembrolizumab treatment by vein. Neoleukin undertakes no obligation to publicly 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.

Contract Research Organisation for Clinical Trials, Thank you for subscribing to Clinical Trials Arena, Hard data and deep insights on clinical trials strategy & operations, Receive our newsletter - data, insights and analysis delivered to you. Weve made significant strides in 2021 that will drive our efforts in 2022, including the start of clinical development for NL-201, the generation of preclinical findings supporting NL-201s activity in different indications and combinations, and highlighting new avenues for de novo protein design candidates and potential applications to expand our development pipeline, said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. Prior to Avanir, Mr. Palekar served as the Chief Commercial Officer of Medivation.

Furthermore, NL-201 has demonstrated both monotherapy and combination activity across a wide range of preclinical syngeneic tumor models. We expect to initiate a Phase 1 trial in 2022 to evaluate NL-201 in patients with these indications., Abstract number: 1609The IL-2/IL-15 Mimetic NL-201 Prevents Myeloma Relapse after ASCT by Expanding Highly Cytolytic T Cells in the Bone Marrow that are Resistant to Exhaustion, Abstract number: 4560NL-201, a De Novo Agonist of IL-2 and IL-15 Receptors, Demonstrates Synergistic Antitumor Activity with Anti-PD-1 Checkpoint Inhibitor Therapy in a Preclinical Non-Hodgkin Lymphoma Model, The ASH poster and abstract link are available on the Neoleukin website publications page:https://www.neoleukin.com/science/#pubs. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The open label Phase 1 trial of NL-201 is active at participating sites in the United States, Australia and Canada. Enrollment in the trial is progressing. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the therapeutic properties and potential of the companys de novo protein design technology, the results of the clinical trial for NL-201, and planned clinical and development activities and timelines. Up to 132 patients will be enrolled in the combination arm of the study.

Additionally, a published abstract in Blood reported on NL-201 antitumor activity in preclinical studies of non-Hodgkin lymphoma. Safety follow- up will occur within 7 days after the last dose of NL-201. Neoleukins lead product candidate, NL-201, is a combined IL-2 and IL-15 agonist designed to improve tolerability and activity by eliminating the alpha receptor binding interface. These statements are subject to numerous risks and uncertainties, including risks and uncertainties related to the companys cash forecasts, the companys ability to advance its product candidates, the receipt and timing of potential regulatory submissions, designations, approvals and commercialization of product candidates, the timing and results of preclinical and clinical trials, the timing of announcements and updates relating to the companys clinical trials and related data market conditions and further impacts of COVID-19, that could cause actual results to differ materially from what Neoleukin expects. For general information, Learn About Clinical Studies. The first patient was dosed in Australia.

Parts 3 and 4 The primary purpose of this study is to understand the safety of NL-201 in combination with pembrolizumab when both drugs are given intravenously in patients with advanced cancer to evaluate tolerability and to identify a recommended dose and schedule for further testing. The gain of $7.8 million recognized was the total consideration of $8.2 million, less transaction costs of $0.4 million. Prior to that, Mr. Palekar served as President and CEO of Avanir Pharmaceuticals after a series of leadership roles in commercial and operations. Interim data is expected to be reported in the second half of 2022. This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. U.S. Department of Health and Human Services. You have reached the maximum number of saved studies (100). NL-201 is a de novo agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without any bias toward cells expressing the alpha receptor subunit (CD25). SEATTLE, Dec. 11, 2021 (GLOBE NEWSWIRE) -- Neoleukin Therapeutics, Inc., Neoleukin (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to designde novoprotein therapeutics, today announced the presentation of preclinical data on NL-201 in multiple myeloma at the 63rdAmerican Society of Hematology (ASH) Annual Meeting and Exposition taking place virtually and in person December 11-14, 2021.

I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the, Introducing the Excellence Awards & Rankings 2022, The next chapter of clinical trial services. (Clinical Trial), A First-in-Human Phase 1 Study of NL-201 in Patients With Relapsed or Refractory Cancer, Experimental: Part 1: NL-201 Monotherapy Dose Escalation, Experimental: Part 2: NL201 Monotherapy Expansion Cohorts, Experimental: Part 3: NL-201 in Combination with Pembrolizumab Dose Escalation, Experimental: Part 4: NL-201 in Combination with Pembrolizumab Expansion Cohorts, 18 Years and older (Adult, Older Adult), Principal Investigator: Cassandra Moore, MD, Principal Investigator: Yan Xing, MD, PhD, Los Angeles, California, United States, 90095, Principal Investigator: Wanxing Chai-Ho, MD, San Diego, California, United States, 92037, Principal Investigator: Gregory Daniels, MD, PhD, University of Colorado-Cancer Center-PPDS, Principal Investigator: Theresa Medina, MD, Jacksonville, Florida, United States, 32224, Rochester, Minnesota, United States, 55905, Principal Investigator: Brian Costello, MD, Principal Investigator: Margaret Callahan, MD, PhD, Providence Cancer Center Oncology and Hematology Care Clinic, Principal Investigator: Brendan Curti, MD, University of Utah, Huntsman Cancer Institute, Salt Lake City, Utah, United States, 80045, Principal Investigator: Benjamin Maughan, MD, PharmD, Seattle, Washington, United States, 98109, Principal Investigator: Georgianna Long, MD, Principal Investigator: Anthony Joshua, MD, Olivia Newton-John Cancer Wellness & Research Centre, Principal Investigator: Andrew Weickhardt, MD, Principal Investigator: Gary Richardson, MD, Principal Investigator: Albiruni Razak, MD.