Synthekine, Inc.

MENLO PARK, Calif.--( BUSINESS WIRE )-- 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. SYNCAR-001 + STK-009 is a cytokine-inducible cell therapy regimen built on Synthekine’s proprietary ortho IL-2 technology. It is a two-component therapy consisting of SYNCAR-001, an autologous 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 IL-2 cytokine. SYNCAR-001 + STK-009 has been administered to patients with CD19+ hematologic malignancies in an ongoing Phase 1 study ( NCT05665062 ). The FDA recently cleared an IND application for a Phase 1 study ( NCT06544330 ) of SYNCAR-001 + STK-009 in non-renal SLE and lupus nephritis (LN). “Recent clinical studies have shown CD19 targeted cell therapies can be a potentially effective treatment option for SLE. However, these therapies typically require lymphodepleting chemotherapy that introduce a wide range of toxicities, including cytopenias and infections, for this patient population,” said Debanjan Ray, chief executive officer of Synthekine. “Fast Track designation from the FDA allows us to more rapidly advance our cytokine-inducible CD19 CAR-T cell therapy. Eliminating lymphodepletion and its associated risks opens the door to a broader population of patients with lupus and other autoimmune diseases, and we look forward to accelerating our efforts to bringing SYNCAR-001 + STK-009 to those individuals in need.” The multi-center, dose escalation clinical trial will assess the safety and clinical activity of SYNCAR-001 + STK-009 in patients with non-renal SLE and LN. Patients will be treated with a one-time, fixed dose of SYNCAR-001 cells and a defined course of STK-009 via weekly subcutaneous injection. Fast Track designation is intended to aid the development and expedite the review of drugs to treat serious and life-threatening conditions with unmet medical needs, with the goal of reaching patients earlier. A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the therapeutic candidate’s clinical trial designs and development plans. About Systemic Lupus Erythematosus (SLE) Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that causes inflammation and potentially irreversible damage to affected organs. SLE manifests a wide range of symptoms with varying degrees of severity in about 200,000 U.S. adults, making it difficult to diagnose. Currently, there is no known cure for SLE and commonly used treatments including nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and other immunosuppressants have limited benefit. About Lupus Nephritis (LN) Up to 50% of patients with SLE can develop lupus nephritis, a type of kidney disease that often starts at the same time or shortly after non-kidney related SLE symptoms. Between 10 to 30 percent of people who have lupus nephritis develop kidney failure. Current treatment options aim to reduce inflammation in the kidneys, however less than half of affected patients using these therapies achieve complete responses. About Synthekine Synthekine is harnessing the potential of cytokine therapeutics to develop selective immunotherapies designed to improve the treatment paradigm of cancer and inflammatory disease. Using insights on cytokine structure and function, the company engineers therapeutics designed to unlock the full efficacy potential of cytokines while avoiding their associated toxicities. Synthekine is applying principles of cytokine partial agonism and immunological specificity across multiple protein engineering platforms to create a broad and deep pipeline of product candidates. These novel immunotherapies include modified cytokines, cytokine-enhanced cell therapies and surrogate cytokine agonists. For more information, visit www.synthekine.com , and follow us on Twitter @ synthekine and LinkedIn .

The emerging pipeline of CAR-T in NHL includes late-stage, mid-stage, and early-stage drugs in different lines of therapies and different indications, mainly including B- cell Lymphoma such as DLBCL, FL, MCL, MZL, CLL/SLL, and others, with one of them being developed for a T-cell Lymphoma, PTCL. LAS VEGAS, April 15, 2024 /PRNewswire/ -- DelveInsight's CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Insights report includes a comprehensive understanding of current treatment practices, CAR T-Cell Therapy for NHL emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan]. Key Takeaways from the CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Report According to DelveInsight's analysis, the market size for CAR T-Cell therapy for NHL reached USD 1,200 million in 2023 across the US. DelveInsight's analysis reveals that the total incident cases of selected indications for CAR-T in NHL in the 7MM comprised ~155,200 in 2023. Leading CAR T-Cell therapy for NHL companies such as Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Mustang Bio, CRISPR Therapeutics, 2seventy Bio, Imugene, and others are developing novel CAR T-Cell therapies for NHL drugs that can be available in the CAR T-Cell therapy for NHL market in the coming years. Other promising CAR T-Cell therapies for NHL in the pipeline include Cemacabtagene Ansegedleucel, Rapcabtagene Autoleucel, Zamtocabtagene Autoleucel, MB-106, CTX110, BBT369, Azercabtagene Zapreleucel , and others. BREYANZI is poised to dominate the CAR-T market in NHL in the forthcoming years, with potential approvals anticipated across two indications: CLL/SLL, follicular lymphoma and MCL. Notably, it has already secured approval for DLBCL in 3L+, 2L+ TE, and NTE. Novartis is progressing with its additional CD-19 CAR-T therapy, Rapcabtagene autoleucel, with expectations of a significantly reduced turnaround time for availability compared to KYMRIAH. Companies are leveraging the strength of dual and triple targeting in CAR-T therapies. Miltenyi Biomedicine, ImmPACT Bio, 2seventy bio, and Novartis are developing CD19/20 Bispecific CAR-T, CD79a/CD20 Bispecific CAR-T, and CD2xCD3xCD19 CAR-T, enhancing treatment efficacy by targeting multiple antigens simultaneously. Discover which therapies are expected to grab the major CAR T-Cell therapy for NHL market share @ CAR T-Cell Therapy for NHL Market Report CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Overview CAR-T cell therapy represents a groundbreaking advancement in cancer immunotherapy, especially for specific types of NHL that have shown resistance to traditional therapies. Through the manipulation of genetically modified T cells, this state-of-the-art treatment boosts the immune system's capacity to locate and eliminate cancerous cells. Essentially, CAR-T cell therapy modifies a patient's T cells genetically to carry chimeric antigen receptors (CARs) on their surface. These engineered CARs are tailored to identify and attach to particular proteins found on cancer cells' surfaces, thereby directing the immune system to effectively combat the malignancy. CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Epidemiology Segmentation In 2023, DLBCL had the highest number of cases among all selected indications for CAR-T therapy, followed by Follicular lymphoma. The total incident cases of MZL in the 7MM were around 13,800 in 2023 and are projected to increase during the forecasted period. The CAR T-Cell therapy for NHL market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Incident Cases of Selected Indications for CAR-T in NHL (Mantle cell lymphoma, DLBCL, Follicular lymphoma, Marginal Zone Lymphoma, Primary mediastinal large B-cell lymphoma, Chronic lymphocytic leukemia/small-cell lymphocytic lymphoma) and Total Indication-wise Eligible Cases of CAR-T in NHL. CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Treatment Market The treatment landscape for NHL is complex, influenced by factors such as the type of NHL, the stage of the disease, the patient's overall health, and their preferences. CAR-T cell therapy has emerged as a promising option within this landscape, especially for aggressive B-cell NHLs that have not responded to standard treatments. Previously, such cases posed significant challenges, often resulting in poor outlooks despite attempts with salvage chemotherapy and autologous stem cell transplants. However, the introduction of CAR-T cell therapy has drastically changed this scenario, showing impressive response rates and the potential for long-lasting remissions even in patients with advanced disease after multiple prior treatments. The approval of various CAR-T therapies for NHL by the FDA highlights the importance of this advancement. YESCARTA, KYMRIAH, BREYANZI, and TECARTUS have all proven effective across different types of NHL, including DLBCL, follicular lymphoma, and mantle cell lymphoma. Ongoing research aims to improve CAR-T cell therapy for NHL further, seeking to increase effectiveness, decrease side effects, and expand the range of target antigens beyond CD19. Additionally, studies are looking into the combined use of CAR-T cell therapy with other treatments like checkpoint inhibitors or targeted therapies, with the ultimate goal of optimizing treatment outcomes for NHL patients. To know more about CAR T-Cell therapy for Non-Hodgkin's Lymphoma treatment guidelines, visit @ CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Management Emerging CAR T-Cell Therapies for NHL and Key Companies Cemacabtagene Ansegedleucel: Allogene Therapeutics Rapcabtagene Autoleucel: Novartis Zamtocabtagene Autoleucel: Miltenyi Biomedicine MB-106: Mustang Bio CTX110: CRISPR Therapeutics BBT369: 2seventy Bio Azercabtagene Zapreleucel: Imugene Learn more about the FDA-approved CAR T-Cell therapy for NHL @ Drugs for CAR T-Cell Therapy for NHL Treatment CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Dynamics The dynamics of the CAR T-Cell therapy for the NHL market are expected to change in the coming years. The market for CAR T-cell therapy in NHL is characterized by a surge in research and development activities, as pharmaceutical companies race to bring new therapies to the market. With several CAR T-cell therapies receiving FDA approval, competition among manufacturers is intense, driving innovation and investment in the field. As a result, we witness a dynamic landscape with ongoing clinical trials, collaborations, and strategic partnerships aiming to expand the reach and efficacy of CAR T-cell therapies for NHL. Moreover, the market dynamics of CAR T-cell therapy for NHL are influenced by patient accessibility and reimbursement challenges. Despite the remarkable efficacy of these therapies, their high cost poses a significant barrier to widespread adoption. Healthcare systems and insurers grapple with the economic implications of CAR T-cell therapy, leading to negotiations on pricing and reimbursement models. Efforts are underway to make these life-saving treatments more accessible to patients, including discussions on value-based pricing and outcome-based reimbursement. As the field continues to evolve, the CAR T-cell therapy for NHL market dynamics will be shaped by a delicate balance between the clinical benefits of CAR T-cell therapy and the economic considerations surrounding its widespread implementation in the treatment of Non-Hodgkin's lymphoma. Scope of the CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Report Therapeutic Assessment: CAR T-Cell Therapy for Non-Hodgkin's Lymphoma current marketed and emerging therapies CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Dynamics: Key Market Forecast Assumptions of Emerging CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis, Conjoint Analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Market Access and Reimbursement Discover more about CAR T-Cell therapy for NHL drugs in development @ CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Clinical Trials Table of Contents Related Reports CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Pipeline CAR T-Cell Therapy for Non-Hodgkin's Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CAR T-Cell therapy for NHL companies, including Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Mustang Bio, CRISPR Therapeutics, 2seventy Bio, Imugene, among others. CAR T-Cell Therapy Market CAR T-Cell Therapy Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CAR T-cell therapy companies, including CytoAgents, Genentech, Incyte Corporation, Caribou Biosciences, Chimeric Therapeutics, Allogene Therapeutics, Kyverna Therapeutics, iCell Gene Therapeutics, Synthekine, Janssen Research & Development, SecuraBio, ImmPACT Bio, A2 Biotherapeutics, Gracell Biopharmaceuticals, Wugen, Sana Biotechnology, Oncternal Therapeutics, Vor Biopharma, CARsgen Therapeutics, Autolus Limited, Arcellx, Kite, Novartis, Lyell Immunopharma, ImmPACT Bio, Tmunity Therapeutics, Poseida Therapeutics, Precigen, AffyImmune Therapeutics, 2seventy bio, Takeda, Cartesian Therapeutics, Cabaletta Bio, Legend Biotech, Miltenyi Biomedicine, Beam Therapeutics, among others. CAR T-Cell Therapy Competitive Landscape CAR T-cell Therapy Competitive Landscape – 2024 report provides comprehensive insights about the pipeline and current landscape, pipeline and marketed drug profiles, and the key CAR T-cell therapy companies, including Alnylam Pharmaceuticals, JW Therapeutics, Gilead Sciences, Janssen Pharmaceuticals, Innovent Biologics, Sorrento Therapeutics, Cartesian Therapeutics, CASI Pharmaceuticals, Juventas Cell Therapy, Novartis, Poseida Therapeutics,Shanghai Unicar-Therapy Bio-medicine Technology, Sinobioway Cell Therapy, Tessa Therapeutics, Wuhan Bio-Raid Biotechnology, Miltenyi Biomedicine, Bristol-Myers Squibb, Autolus Limited, Beijing Immunochina Medical Science and Technology, Carsgen Therapeutics, Cellular Biomedicine Group, Chongqing Precision Biotech, Eureka Therapeutics, Formula Pharmaceuticals, Guangzhou Bio-gene Technology, Hebei Senlang Biotechnology, Mustang Bio, MolMed, Aurora BioPharma, Atara Biotherapeutics, Autolus, Bellicum Pharmaceuticals, Kecellitics Biotech Company, Yake Biotechnology, Minerva Biotechnologies, Allogene Therapeutics, PersonGen BioTherapeutics (Suzhou), Precision BioSciences, Pregene (ShenZhen) Biotechnology Company, Shanghai GeneChem, Shanghai Longyao Biotechnology, Shenzhen BinDeBio, among others. CAR T-Cell Therapy for Multiple Myeloma Market CAR T-Cell Therapy for Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CAR T-cell therapy for multiple myeloma companies, including Cartesian Therapeutics, Arcellx, Novartis, Bristol-Myers Squibb, CARsgen Therapeutics, Poseida Therapeutics, Juno Therapeutics, CRISPR Therapeutics, bluebird bio, Cellectis SA, Caribou Biosciences, Luminary Therapeutics, Celyad Oncology, Allogene Therapeutics, Gadeta, Nanjing IASO Biotherapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Responding to some of the challenges of its peers, Synthekine built a molecule called an IL-2 alpha/beta, dubbed STK-012. IL-2 medicines have shown the ability to kill tumors. Unfortunately, they aren’t very specific and have come to be associated with toxicities. Synthekine is hoping to avoid activating lymphocytes such as natural killer cells that can cause these issues, creating a safer and more tolerable medicine. That’s what early data from a phase 1a/1b trial of STK-012 seem to show, CEO Debanjan Ray told Fierce Biotech on the sidelines of the American Association for Cancer Research annual meeting Monday. The results are very early, with just a handful of partial responses. And Ray is well aware of the struggles of other IL-2s in the clinic—see Sanofi’s many challenges with the target. Responding to some of the hurdles faced by his peers, Ray said that with STK-012, Synthekine has built a molecule called an IL-2 alpha/beta that is meant to stimulate CD25+ antigen-activated T cells but avoid the same reaction with the NK cells that can drive toxicity in IL-2 meds. The early-stage trial tested the med in 47 patients with advanced solid tumors including non-small cell lung cancer, renal cell carcinoma and ovarian cancer. Most of the patients had three or more lines of therapy prior to entering the trial, which tested seven dose levels on two dosing schedules. Of the 40 evaluable patients, three had a partial response as of data cutoff and 12 had stable disease. In a group of 15 patients who had not previously responded to immune checkpoint inhibitors and were minimally pretreated, three had a best overall response of partial response and six had stable disease. “The promise of IL-2 in the treatment of solid tumors has yet to be realized as IL-2 analogues developed to date have had limited efficacy and an unacceptable toxicity profile,” said Naiyer Rizvi, M.D., Synthekine’s chief medical officer, in a Tuesday statement. The therapy was associated with favorable safety, pharmacokinetics and pharmacodynamics, with a profile that was different from aldesleukin and non-alpha IL-2 analogues. The early data suggest that STK-012 is selective for T cells that express CD25. Ray also noted that the response was durable in multiple subjects, with some continuing to benefit for as much as a year after the data cutoff. Synthekine’s presentation included one patient case study of a 72-year-old female who had stage 4 clear cell renal cell carcinoma and had previously had two prior lines of therapy. The patient had “innumerable lung metastases and a large primary renal mass.” At Week 12, the photos show a reduction in tumors. “You don't need to be a radiologist to really see this difference,” Ray said. Synthekine has selected the every-three-weeks schedule to go forward. Ray said next steps include focusing on the ongoing dose expansion, monotherapy arm including one cohort focusing on renal cancer. While early, Synthekine’s work has attracted some Big Pharma partners, including Sanofi. The French pharma signed a $40 million deal with Synthekine in January to work on IL-10 receptor agonists designed to treat inflammatory diseases. Merck & Co. has also linked up with the biotech but for autoimmune diseases, signing a deal that could be worth up to $525 million in biobucks in November 2021. Editor's note: This story was updated at 5 p.m. ET to clarify details about the dose expansion and Synthekine's partnership with Sanofi.