Synthekine Appoints Biotechnology and Pharmaceutical Industry Veteran John A. Orwin as Chair of its Board of Directors
Synthekine Inc., an engineered cytokine therapeutics company, today announced the appointment of John A. Orwin as Chair of its Board of Directors. Mr. Orwin succeeds Srinivas Akkaraju, M.D., Ph.D., Founder and Managing General Partner at Samsara BioCapital, who has served as Chair since the company’s early days and will continue to serve as an active member of the Board.
First Patient Dosed in SYNERGY-101, a Global, Randomized Phase 2 Clinical Trial of STK-012 in First-Line, PD-L1 Negative Nonsquamous Non-Small Cell Lung Cancer
Synthekine Inc., an engineered cytokine therapeutics company, today announced that the company has dosed the first patient in the SYNERGY-101 study. SYNERGY-101 is a global, randomized Phase 2 clinical trial evaluating STK-012 combined with pembrolizumab and chemotherapy (PCT) vs. PCT in first-line, PD-L1 negative nonsquamous non-small cell lung cancer (NSCLC).
Synthekine Presents Positive Initial Results from Phase 1a/1b Clinical Trial of STK-012 Plus Pembrolizumab and Chemotherapy in First-Line, PD-L1 Negative Nonsquamous Non-Small Cell Lung Cancer
Synthekine Inc., an engineered cytokine therapeutics company, today announced positive initial results from a Phase 1a/1b clinical trial of STK-012 in first-line, PD-L1 negative nonsquamous (NSQ) non-small cell lung cancer (NSCLC) in combination with standard of care (SoC) pembrolizumab and chemotherapy (PCT). The data will be presented by Adam J. Schoenfeld, M.D., Memorial Sloan Kettering Cancer Center, New York, as a late-breaking oral presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2025 in National Harbor, MD, on Saturday, November 8.
Synthekine Announces Late-Breaking Oral Presentation of Initial Clinical Data of STK-012 Plus Pembrolizumab and Chemotherapy in First-Line, PD-L1 Negative Nonsquamous NSCLC at SITC 2025 Annual Meeting
Synthekine Inc., an engineered cytokine therapeutics company, today announced that data from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, will be presented in a late-breaking oral presentation at the upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting 2025 taking place in National Harbor, MD., from November 7-9, 2025. In this study, STK-012 is being evaluated in combination with standard-of-care pembrolizumab + chemotherapy in first-line, PD-L1 negative nonsquamous non-small cell lung cancer (NSCLC) patients. The company will also present new preclinical data on combinations of STK-012 and T cell engagers.
Synthekine Presents Positive Initial Results from Phase 1 Clinical Trial of CD19 CAR-T (SYNCAR-001) and Orthogonal IL-2 (STK-009) Combination Therapy for Treatment of Hematologic Malignancies at ASH 2024 Annual Meeting
Synthekine Inc., an engineered cytokine therapeutics company, today announced positive initial results from a first-in-human Phase 1 study (NCT05665062) of SYNCAR-001 + STK-009 for the treatment of relapsed or refractory CD19+ hematologic malignancies. In the results presented from 8 patients treated in the dose escalation portion of the study with a fixed SYNCAR-001 infusion of 30M cells and STK-009 doses ranging from 1.5 to 6 mg, this combination therapy was well tolerated with no dose-limiting toxicities (DLTs) or IL-2-related toxicities observed. This regimen also demonstrated durable responses, including complete responses in all 4 patients with non-Hodgkin lymphoma (NHL).
Synthekine to Present Preclinical Data for CD19 CAR-T (SYNCAR-001) Empowered by Orthogonal IL-2 (STK-009) Without Lymphodepletion at American College of Rheumatology (ACR) Convergence 2024
Synthekine Inc., an engineered cytokine therapeutics company, today announced promising preclinical results with the murine version of its STK-009 + SYNCAR-001 program will be presented at the American College of Rheumatology (ACR) Convergence 2024 in Washington, D.C. This regimen demonstrated potential to treat autoimmune diseases, such as systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), without requiring lymphodepletion.
Synthekine Announces Presentation of New Translational Data from Phase 1a/1b Clinical Trial of α/β Biased IL-2, STK-012, at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting
Synthekine Inc., an engineered cytokine therapeutics company, today presented positive translational results from the Phase 1a dose escalation portion of a Phase 1a/1b clinical trial of its first-in-class α/β-IL-2R biased partial agonist, STK-012, at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting in Houston. STK-012 is engineered to selectively stimulate CD25+ antigen-activated T cells, which are associated with potent anti-tumor activity, and avoid broad stimulation of other lymphocytes, such as natural killer (NK) cells, which are associated with IL-2 toxicity. The Phase 1b dose expansion portion of the study in adults with advanced solid tumors remains ongoing (NCT05098132) and will include treating patients with STK-012 in combination with standard of care therapy in first line PD-L1 negative non-small cell lung cancer (NSCLC).
Synthekine Granted U.S. FDA Fast Track Designation for CD19 CAR-T and Orthogonal IL-2 Investigational Therapy, SYNCAR-001 + STK-009, for the Treatment of Lupus Without Lymphodepletion
Synthekine Inc., an engineered cytokine therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SYNCAR-001 + STK-009, its CD19 CAR-T and orthogonal IL-2 investigational therapy, for the treatment of patients with severe, refractory systemic lupus erythematosus (SLE), without the use of lymphodepletion.
Synthekine Presents Positive Initial Results from Phase 1a/1b Clinical Trial of α/β Biased IL-2, STK-012, for Treatment of Advanced Solid Tumors
Synthekine Inc., an engineered cytokine therapeutics company, today announced positive initial results from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, for the treatment of advanced solid tumors. The data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego. STK-012 is a first-in-class α/β-IL-2R biased partial agonist engineered to selectively stimulate CD25+ antigen-activated T cells, which are associated with potent anti-tumor activity, and avoid broad stimulation of other lymphocytes, such as natural killer (NK) cells, which are associated with IL-2 toxicity. In the results presented, which included 47 patients treated in Phase 1a dose escalation, STK-012 monotherapy demonstrated a favorable safety, efficacy, pharmacokinetic and pharmacodynamic profile.
Synthekine Announces U.S. FDA Clearance of IND Application for CD19 CAR-T and Orthogonal IL-2 Combination Therapy, SYNCAR-001 + STK-009, for Treatment of Lupus Without Lymphodepletion
Synthekine Inc., an engineered cytokine therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to evaluate SYNCAR-001 + STK-009, its orthogonal IL-2 and CD19 CAR-T combination therapy, in patients with non-renal systemic lupus erythematosus (SLE) and lupus nephritis (LN), without the use of any lymphodepletion.
Synthekine Announces Presentation of Initial Results from Phase 1a/1b Clinical Trial of STK-012 at AACR 2024 Annual Meeting
Synthekine Inc., an engineered cytokine therapeutics company, today announced that data from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2024 taking place in San Diego, from April 5-10, 2024. The company will also present new preclinical data for its orthogonal IL-2 (orthoIL-2) technology for cytokine-inducible cell therapies, currently being investigated in a Phase 1 study with the STK-009 + SYNCAR-001 combination therapy.
Synthekine Appoints Geoff Nosrati, Ph.D., as Chief Business Officer and Announces Executive Leadership Changes
Synthekine Inc., an engineered cytokine therapeutics company, today announced the appointment of Geoff Nosrati, Ph.D., as chief business officer. The company also announced additional changes in the executive leadership team, with Martin Oft, M.D., assuming the role of chief scientific officer and Greg Yedinak promoted to chief technical officer.
Synthekine Announces Strategic Collaboration with Sanofi to Develop Selective IL-10 Agonists for Treatment of Inflammatory Diseases
Synthekine Inc., an engineered cytokine therapeutics company, today announced a worldwide collaboration with Sanofi (EURONEXT: SAN and NASDAQ: SNY) to develop and commercialize IL-10 receptor agonists for the treatment of inflammatory diseases. The collaboration will focus on advancing Synthekine’s multiple approaches to optimizing IL-10, with the goal of developing selective agonists that expand therapeutic index.
Synthekine Presents Preclinical Data at SITC 38th Annual Meeting Demonstrating its IL-12 Partial Agonist, STK-026, Significantly Expands Therapeutic Window
Synthekine Inc., an engineered cytokine therapeutics company, today presented new data from preclinical studies of STK-026, its biased IL-12 partial agonist program, during the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego. STK-026 is designed to retain the potent antitumor activity of IL-12 while avoiding its systemic toxicities and is currently in IND-enabling studies.
First Patient Dosed in Phase 1b Clinical Trial of Synthekine’s α/β Biased IL-2, STK-012, for Treatment of Solid Tumors
Synthekine Inc., a leader in engineered cytokine therapeutics, today announced that the company has completed phase 1a dose escalation and dosed the first patient in the Phase 1b portion of a clinical trial evaluating its α/β biased IL-2, STK-012, for the treatment of solid tumors.
Synthekine Doses First Patient in Phase 1 Clinical Trial of Orthogonal IL-2 and CD19 CAR-T Combination Therapy, STK-009 + SYNCAR-001, for Treatment of CD19+ Hematologic Malignancies
Synthekine Inc., a leader in engineered cytokine therapeutics, today announced that the first patient has been dosed in a Phase 1 clinical trial of its orthogonal IL-2 and CD19 CAR-T combination therapy, STK-009 + SYNCAR-001, in adults with relapsed or refractory CD19+ hematologic malignancies. STK-009 + SYNCAR-001 is a two-component therapy consisting of SYNCAR-001, a CD19-targeting chimeric antigen receptor T cell (CAR-T) which expresses an engineered IL-2 receptor allowing it to selectively receive a signal from STK-009, an engineered pegylated IL-2 cytokine.
Synthekine Secures $100 Million Series C Financing to Advance Pipeline of Engineered Cytokine Therapeutics
Synthekine Inc., an engineered cytokine therapeutics company, today announced the closing of a $100 million Series C financing led by The Column Group, with participation from both new and existing investors. Debanjan Ray, Synthekine’s chief executive officer, will present a corporate overview at the 41st Annual J.P. Morgan Healthcare Conference at 1:30 p.m. PT on Tuesday, January 10.
Fierce Biotech Names Synthekine as One of Its “Fierce 15” Biotech Companies of 2022
Synthekine Inc., an engineered cytokine therapeutics company, today announced that Fierce Biotech has named it as one of 2022’s Fierce 15 biotechnology companies, designating it as one of the most promising early-stage biotechnology companies in the industry.
Synthekine Announces Multiple Poster Presentations Showcasing Its Three Distinct Cytokine Engineering Platforms at American Association for Cancer Research (AACR) 2022 Annual Meeting
Synthekine Inc., an engineered cytokine therapeutics company, today announced five poster presentations based on research spanning each of its three distinct cytokine engineering platforms at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2022 taking place in New Orleans, LA from April 8-13, 2022.
Synthekine Doses First Patient in Phase 1 Clinical Trial of IL-2 Partial Agonist, STK-012, for Treatment of Solid Tumors
Synthekine Inc., an engineered cytokine therapeutics company, today announced the dosing of the first patient in a Phase 1a/1b clinical trial of its IL-2 partial agonist, STK-012, for the treatment of solid tumors. STK-012 is designed as an alpha/beta-biased IL-2 partial agonist to selectively stimulate antigen-activated T cells, which are associated with potent anti-tumor activity, and avoid stimulation of toxicity causing immune cells, such as natural killer cells.
Synthekine Announces Publication of Preclinical Data Demonstrating In Vivo Control of CD19 CAR-T Cells with its Orthogonal IL-2 System
Synthekine Inc., an engineered cytokine therapeutics company, today announced the publication of preclinical data for its lead cell therapy program using the orthogonal IL-2 receptor/ligand system in Science Translational Medicine. This system uses a lock and key approach, wherein an orthogonal IL-2 receptor (the “lock”) is engineered into an adoptive T cell therapy (ACT) so that it can be selectively stimulated by an orthogonal IL-2 ligand (the “key”). This creates the ability to employ IL-2 signaling completely independent of the endogenous IL-2 receptor/ligand, allowing for controlled and enhanced in vivo expansion of ACTs without toxicities emerging from the indiscriminate activation of the endogenous immune system. The published data shows STK-009, the orthogonal IL-2 ligand, enables the control of cell expansion and activation of a CD19 CAR-T cell therapy which expresses the orthogonal IL-2 receptor (SYNCAR-001) in preclinical models of human lymphoma. The publication, titled “An Orthogonal IL-2 and IL-2Rß System Drives Persistence and Activation of CAR-T Cells and Clearance of Bulky Lymphoma” can be accessed here.
Synthekine Establishes Collaboration with Merck to Develop Therapeutic Candidates Using its Proprietary Surrogate Cytokine Agonist Platform
Synthekine Inc., an engineered cytokine therapeutics company, today announced it has entered into a worldwide research collaboration and license agreement with Merck, known as MSD outside the United States and Canada. The collaboration will leverage Synthekine’s proprietary surrogate cytokine agonist platform to discover, develop, and commercialize novel cytokine therapeutics.
Synthekine Advances IL-2 Partial Agonist, STK-012, into Clinical Investigation for Treatment of Solid Tumors
Synthekine Inc., an engineered cytokine therapeutics company, today announced it is advancing its IL-2 partial agonist, STK-012, into clinical investigation following clearance of its investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA).
Synthekine Announces $107.5 Million Oversubscribed Series B Financing to Support Lead Programs to Clinical Proof of Concept, Advance Preclinical Programs and Platform
Synthekine Inc., an engineered cytokine therapeutics company, today announced that it has closed an oversubscribed $107.5 million Series B financing. The round was co-led by Deerfield Management and Janus Henderson Investors, with participation from RA Capital Management, Rock Springs Capital, Omega Funds, TCG X, Lilly Asia Ventures, and an undisclosed leading healthcare investor. Existing investors The Column Group, Samsara BioCapital, Canaan Partners, and Emerson Collective also participated in the round.
Synthekine Expands Board of Directors, Management Team and Scientific Advisory Board with New Key Appointments
Synthekine Inc., an engineered cytokine therapeutics company, today announced that it has appointed Mardi Dier to its board of directors, Robin Knifsend as senior vice president of finance and operations and Antoni Ribas, M.D., Ph.D., to its scientific advisory board.
Synthekine Appoints Internationally Recognized Cancer Immunotherapy Leader Naiyer Rizvi, M.D., as Chief Medical Officer
Synthekine Inc., an engineered cytokine therapeutics company, announced that it has appointed Naiyer Rizvi, M.D., as Chief Medical Officer, effective today. Dr. Rizvi is an internationally recognized leader in cancer immunotherapy drug development whose clinical research has helped deliver FDA approvals of several landmark immunotherapies, including nivolumab in squamous lung cancer and pembrolizumab in non-small cell lung cancer. He will lead Synthekine’s efforts in advancing its maturing pipeline through clinical investigation.
Synthekine Licenses Additional Cytokine Programs
Synthekine Inc., an engineered cytokine therapeutics company, today announced a new agreement with Stanford University to license cytokine partial agonist programs for IL-10, IL-12 and IL-22. These programs augment a growing pipeline of selective cytokine partial agonists at Synthekine that is maturing toward clinical development.
Synthekine Presents Data at AACR Annual Meeting 2021 Demonstrating Selective IL-2 Partial Agonist, STK-012, Promotes Anti-Tumor Response without Related Toxicities
Synthekine Inc., an engineered cytokine therapeutics company, today announced preclinical data presented at the American Association of Cancer Research Annual Meeting 2021 demonstrating its alpha/beta selective IL-2 partial agonist, STK-012, induced potent anti-tumor activity while avoiding the toxicities that have hindered the development of IL-2 therapeutics, including vascular leak syndrome (VLS). Synthekine also presented new data on its orthogonal IL-2 and CD-19 CAR-T system (STK-009 and SYNCAR-001).
