Idiopathic Inflammatory Myopathies

Designations Follow Recent Investigational New Drug (IND) Application Clearance for the RESOLUTION Basket Study of ALLO-329 in Rheumatology Dual CD19/CD70 CAR T Specifically Designed to Enhance Therapeutic Benefit, Expanding Treatment Potential Across a Range of Autoimmune Indications Leverages Proprietary Dagger® Technology to Reduce or Eliminate Lymphodepletion, Potentially Expanding Access to a Broader Patient Population Phase 1 RESOLUTION Trial Initiation Planned for Mid-2025 with Initial Proof-of-Concept by Year-End 2025 April 07, 2025 -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T, has received three Fast Track Designations (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with: active refractory moderate-to-severe systemic lupus erythematous (SLE); active severe/refractory idiopathic inflammatory myopathy (IIM), specifically dermatomyositis, immune mediated necrotizing myopathy and anti-synthetase syndrome; and active refractory diffuse systemic sclerosis (SSc). "Receiving these designations for ALLO-329 underscores the versatility and transformative promise of this next-generation allogeneic CAR T investigational product in redefining the autoimmune treatment landscape," said Zachary Roberts, M.D., Ph.D., EVP of Research and Development and Chief Medical Officer of Allogene. "Leveraging our extensive expertise, we've developed this off-the-shelf CAR T specifically for autoimmune diseases, prioritizing both scalability and the reduction or elimination of lymphodepletion – a key barrier in this patient population." The Company expects to initiate the Phase 1 RESOLUTION basket trial in mid-2025. The trial is designed to evaluate the safety and preliminary efficacy of ALLO-329 in patients with SLE, IIM, and SSc. This innovative trial design, which leverages the clinically validated Dagger® technology to drive CAR T cell expansion and prevent rejection, includes two distinct lymphodepletion arms: one using a dose of cyclophosphamide alone, which is used by rheumatologists, and another that eliminates lymphodepletion entirely. Proof-of-concept from the RESOLUTION trial is expected by year-end 2025, aiming to provide critical insights into the potential of ALLO-329 to transform the treatment landscape for autoimmune diseases. FDA's Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs. ALLO-329 is a CD19/CD70 dual AlloCAR T™ investigational product being developed for the treatment of autoimmune diseases. ALLO-329 utilizes CRISPR-based site-specific integration for dual CAR expression. This approach targets both CD19+ B cells and CD70+ T cells, which play a role in autoimmune disease pathogenesis. Additionally, ALLO-329 incorporates Allogene's clinically validated Dagger® technology, designed to reduce or eliminate the need for lymphodepletion, a pre-treatment regimen that may be a significant barrier to CAR T cell therapy adoption in autoimmune indications. Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. The content above comes from the network. if any infringement, please contact us to modify.

EYSINS, Switzerland, April 3, 2025 /PRNewswire/ -- Today, AliveDx announces it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex® Connective Tissue Diseases (CTDplus) microarray. The MosaiQ AiPlex CTDplus multiplex assay, which received IVDR-CE mark certification in February 2025, is designed to improve the accuracy and speed of systematic connective tissue disease diagnosis while simplifying laboratory workflows. Systemic autoimmune Rheumatic Diseases such as Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus, Systemic Sclerosis (also known as Scleroderma), Sjögren's syndrome, idiopathic inflammatory Myopathies and mixed connective tissue diseases affect millions worldwide and are associated with autoantibody production. Diagnosing these conditions is complex due to overlapping clinical symptoms and high rates of co-occurrence among a range of connective tissue diseases1. Fast, Easy, Comprehensive The MosaiQ solution has been designed to provide simple workflow and fast results. Combining multiple relevant markers into one single test enables actionable insights for better patient care, as well as reducing significant hands-on time and minimizing consumable usage. For connective tissue diseases, the multiplex assay is designed to rapidly detect and identify up to 1275 disease markers per hour. Seamless, microarray-internal calibration and quality control as well as multi-constituent, external quality controls can further help simplify laboratory workflows. All reagents and multiplex microarray magazines are equipped with RFID tags to save time while avoiding manual errors. Unique combination of tests The MosaiQ AiPlex CTDplus assay enables a syndromic approach and accurate serological evaluation of Rheumatoid Arthritis (RA) and systematic connective tissue diseases (CTD) for healthcare providers. Its unique combination of autoantibody tests offers a sensitive and specific diagnostic solution, assisting clinicians with actionable insights for improved patient care. It can generate these results with only 10 μl patient in one single step. MosaiQ AiPlex CTDplus microarray includes 15 markers in one panel for each patient, including the majority of autoantibodies recommended by the relevant clinical guidelines (ACR/EULAR)*2-6. The MosaiQ AiPlex CTDplus solution enables the simultaneous detection of autoantibodies directed to DFS70/LEDGF, CCP, dsDNA, Sm, Sm/RNP, U1RNP, Chromatin, Ribosomal P, SS-A 60 (Ro60), SS-B (La), TRIM21 (Ro52), Jo-1, CENP-B, Scl-70 and RNA Polymerase III. Significant step to deliver value to our customers Manuel O. Méndez, CEO of AliveDx: "We are thrilled to submit the MosaiQ AiPlex® CTDplus microarray to the FDA for 510(k) clearance. With autoimmune disease diagnoses often taking more than four years, there is a critical need for a multiplexed and syndromic approach to accelerate the process. The MosaiQ AiPlex CTDplus microarray addresses this challenge by enabling early disease detection and supporting more targeted, effective treatments—ultimately providing much-needed relief to patients. With our MosaiQ AiPlex Celiac Disease microarray already under review by the FDA, today's submission brings us a significant step closer to delivering clinical and economical value to customers in the USA." About AliveDx At AliveDx, our mission is to empower diagnostic insights, transform patient care, and innovate for life. With over 30 years in in-vitro diagnostics, we are dedicated to shaping the future of global diagnostics in autoimmune, allergy, and beyond. Our innovative solutions empower laboratories and clinicians to accelerate diagnosis, improving patients' lives while fostering a positive and sustainable work environment for healthcare providers. Our portfolio includes the Alba, MosaiQ and LumiQ brands. These solutions aim to generate both economic and clinical value by simplifying laboratory workflows and providing fast, accurate results that enhance clinical decision-making. At AliveDx, we innovate for life. About the MosaiQ solution The MosaiQ solution is a state-of-the-art IVD solution for autoimmune diseases, allergies and beyond. The multiplexed, fully automated planar microarray platform enables syndromic testing for complex conditions. This intuitive platform offers high throughput with continuous random access, delivers fast and accurate results addressing evolving expectations for laboratory efficiency. For more information about AliveDx and its IVD solutions, please visit and connect with us on LinkedIn and X. ©AliveDx Suisse SA. 2025. The AliveDx logo, AliveDx, MosaiQ, MosaiQ AiPlex, and LumiQ are trademarks or registered trademarks of AliveDx group companies in various jurisdictions. Menus and capabilities are subject to change. Not all methods may be available in all territories. Subject to regulatory clearance. 1. Nathalie Conrad et al. Lancet 2023; 401: 1878–90 *ACR: American College of Rheumatology. EULAR: European Alliance of Associations for Rheumatology. 2. Aringer M et al. Ann Rheum Dis. 2019;78(9):1151-9. 3. Shiboski CH et al. Arthritis Rheumatol. 2017;69(1):35-45. 4. van den Hoogen F et al. Arthritis Rheum. 2013;65(11):2737-47. 5. Lundberg IE et al. Arthritis Rheumatol. 2017;69(12):2271-82. 6. Aletaha D et al. Arthritis Rheum. 2010;62(9):2569-81. 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Century Therapeutics has decided it\'s time to join a burgeoning trend, discarding a cancer trial to jump on the autoimmune bandwagon.\n Century Therapeutics has joined the onslaught of cell therapy biotechs taking hits, discontinuing a phase 1 cancer study to turn its focus toward autoimmune diseases.The move isn’t shocking, as it follows Century’s acquisition of autoimmune cell therapy biotech Clade Therapeutics last year and mirrors an industrywide pattern as numerous other companies turn from cancer to autoimmune.For Century, the change means ending a study of CNTY-101, the company’s first allogeneic cell therapy candidate that was being tested among patients with late-stage relapsed-refractory non-Hodgkin lymphoma, according to an annual financial report shared after market close March 19.The program, dubbed Elipse-1, launched in the beginning of 2023 and had an estimated enrollment of 75 patients, according to ClinicalTrials.gov. While Century called the therapy’s clinical activity and tolerability profile encouraging, the data didn’t meet the company’s standard to be considered “transformational” for the patient population, according to the release.The Philadelphia-based biotech said it was “committed to providing continued treatment access in the Elipse-1 trial for patients showing benefit.”Century is pointing to the Elipse-1 data as reason to move CNTY-101 into autoimmune diseases, citing deep B-cell depletion and evidence of the therapy trafficking to lymph nodes. The company plans to share more data from the trial later this year, it said in a statement.  The cell therapy company is now launching a new trial for its sole clinical asset, this time for patients with B-cell-mediated autoimmune diseases. The early-stage study, called Calipso-1, is slated to start dosing this month at U.S. sites, with plans to expand to certain European countries later this year.“We believe CNTY-101 is well-positioned to potentially impact the standard of care meaningfully in B-cell-mediated autoimmune diseases,” Century CEO Brent Pfeiffenberger said in the release.The company also expects further insights on the CD19 CAR-iNK cell therapy candidate to come from a phase 1/2 investigator-initiated clinical trial, dubbed Caramel.The study will be sponsored by the Friedrich-Alexander University Erlangen-Nürnberg in Germany and will enroll patients with systemic lupus erythematosus, lupus nephritis, idiopathic inflammatory myopathy and diffuse cutaneous systemic sclerosis. The study is expected to launch in mid-2025.Analysts with William Blair view the discontinuation as \"as unfortunate but necessary,\" citing a competitive treatment landscape for non-Hodgkin lymphoma in a March 20 note. Leerink Partners echoed the sentiment, citing a challenging financing environment for early-stage cell therapy companies. The analyst said it supported Century\'s decision to continue development of CNTY-101 in autoimmune diseases. Meanwhile, the biotech is prioritizing its preclinical pipeline to feature four programs, led by CNTY-308, a CD19-targeted CAR-iT cell therapy. The therapy is being developed for B-cell-mediated autoimmune diseases and malignancies.Another of Century’s candidates is CNTY-341, a CD19/CD22 dual-targeted CAR-iT cell therapy. The prioritized preclinical programs all use induced-pluripotent-stem-cell-derived “tunable” CD4+/CD8+ ab T cells, according to Century.“In the case of CNTY-308 and CNTY-341 in B-cell-mediated diseases, we are aiming for comparable or better performance to approved autologous CAR-T therapies,” Century Chief Scientific Officer Chad Cowan, Ph.D., said in the release. “With our combined expertise in protein engineering, cell differentiation and manufacturing, we aim to launch allogeneic cell therapies at antibody-like scale and cost. For our solid tumor and non-immune cell programs, this brings the potential to expand access to cell therapies much more broadly.”The company will host a live webcast April 22 to discuss each of the programs in more detail. The biotech’s pipeline pivot follows Bristol Myers Squibb’s own “portfolio prioritization efforts” that eliminated a pact with Century in December.Century had entered a collaboration with BMS back in 2022 in which the partners were working to develop stem-cell-derived, engineered natural killer cell and gamma delta T-cell candidates for blood cancers. The Big Pharma paid out $150 million in cash and an equity investment and offered up more than $3 billion in biobucks.After reviewing its own portfolio, BMS axed the entire deal “without cause,” a dissolution that became effective March 12.Century still lists two preclinical cancer candidates—named CNTY-104 and CNTY-106—that were being developed with BMS on its site.As of Dec. 31, 2024, Century had $220 million in cash and marketable securities, a runway expected to bring the biotech into the final quarter of 2026.  Editor\'s note: This story was updated at 10 a.m. ET on March 20 to include analyst commentary.