Cabaletta Bio, Inc. is a clinical-stage biotechnology company, which engages in the discovery and development of engineered T cell therapies for B cell-mediated autoimmune diseases. Its proprietary technology utilizes chimeric autoantibody receptor to selectively bind and eliminate B cells that produce disease-causing autoantibodies. The company was founded by Michael C. Milone, Steven Nichtberger, and Aimee Payne in April 2017 and is headquartered in Philadelphia, PA.
相关临床试验
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成立时间
2017
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招募中
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- The FDA has cleared the IND application for IASO208, a CD20-targeted in vivo CAR-T therapy developed on IASO Bio's InTelliCAR platform. - IASO208 is the first China-originated lentiviral vector-based in vivo CAR-T therapy to receive FDA IND clearance, and will advance directly to a US Phase 1b study. - The therapy generates anti-CD20 CAR-T cells inside the patient without leukapheresis or lymphodepleting chemotherapy, given as a single intravenous infusion. - Early data from a Chinese investigator-initiated trial show 11 patients dosed with favorable tolerability and encouraging anti-tumor activity in relapsed/refractory B-cell malignancies.
- Novartis paused trials of its CAR-T therapy rap-cel across lupus, myasthenia gravis, multiple sclerosis and other autoimmune indications after three cases of immune effector cell-associated hemophagocytic syndrome (IEC-HS). - Bristol Myers Squibb voluntarily paused enrollment in autoimmune trials of zola-cel after detecting transient and reversible inflammatory events during routine safety surveillance. - Both companies are reviewing clinical and safety data, with Novartis engaged with regulators and Bristol Myers aiming to resume testing as quickly as possible. - Analysts note the fast-manufacturing technology behind both therapies could be driving increased cell expansion and reported toxicities, warranting monitoring for future market adoption.
- Cellares, a South San Francisco cell therapy manufacturing specialist, plans to lay off 100 employees following the loss of a partnership with an unspecified large pharmaceutical customer. - CEO Fabian Gerlinghaus said the loss "requires us to resize the company," with affected roles primarily in software engineering, quality control, design, and manufacturing. - The company says it has more than doubled its customer base since the start of the year and that its Cell Shuttle technology is "proven in the clinic." - Cellares retains partnerships with Bristol Myers Squibb, Gilead's Kite Pharma, Sonoma Biotherapeutics, and Cabaletta Bio, and recently won FDA PreCheck Pilot Program designation.
- Cabaletta Bio's investigational CAR-T therapy rese-cel received FDA clearance for an IND amendment enabling automated manufacturing using Cellares' Cell Shuttle and Cell Q platforms. - This marks the first time Cellares' fully automated platforms are supporting an active clinical program, with initial patient dosing expected in the first half of 2026. - The automated manufacturing capability addresses scalability challenges for autoimmune disease applications where larger patient populations require consistent and efficient production. - Cabaletta Bio's stock has surged 44.55% over seven days and 45.21% over 30 days following the FDA clearance announcement.
- Experimental CAR-T therapies from Cabaletta Bio and Bristol Myers Squibb have induced complete remissions in patients with severe inflammatory muscle disease, according to dual clinical trial results presented this week. - The treatments effectively targeted and eliminated specific immune cells responsible for driving the autoimmune condition, with some patients achieving full remission of symptoms. - These findings represent significant progress in expanding CAR-T cell therapy applications beyond blood cancers into autoimmune disorders, potentially offering curative one-time treatments. - The results could transform treatment paradigms for patients who currently require multiple daily medications with significant health and financial burdens.
- Cabaletta Bio has appointed Steve Gavel as Chief Commercial Officer to lead the global commercial strategy for rese-cel, the company's lead CAR-T cell therapy for autoimmune diseases. - Gavel brings extensive CAR-T commercialization experience from Legend Biotech, where he successfully led the launch of CARVYKTI for multiple myeloma from 2018 to 2025. - The company anticipates its first Biologics License Application submission for rese-cel in myositis in 2027, marking a potential milestone in autoimmune disease treatment. - As part of his appointment, Gavel received stock options to purchase 275,000 shares at $2.49 per share, vesting over four years.
- Cabaletta Bio's rese-cel CAR-T therapy achieved complete B cell depletion and meaningful clinical responses in pemphigus vulgaris patients without requiring preconditioning chemotherapy. - Two of three patients experienced near-complete resolution of clinical symptoms, with all patients remaining off immunomodulators since treatment infusion. - The simplified no-preconditioning regimen could expand treatment access while maintaining similar CAR-T cell expansion compared to over 30 patients who received preconditioning in other trials. - Results support continued exploration of the approach in pemphigus vulgaris and potential evaluation in other autoimmune diseases within the RESET program.
- DelveInsight's 2025 pipeline report reveals over 35 companies are actively developing more than 40 investigational therapies for lupus nephritis treatment. - Hoffmann-La Roche leads with obinutuzumab in Phase III trials, while other promising candidates include ADX-097 from Q32 Bio and NKX019 from Nkarta Therapeutics. - The FDA granted Fast Track designation to AlloNK from Artiva Biotherapeutics in February 2024 for combination therapy with rituximab or obinutuzumab. - Lupus nephritis affects patients with systemic lupus erythematosus and can progress to chronic kidney disease or end-stage renal disease without effective treatment.
- The FDA approved nipocalimab (Imaavy) in May 2025 as the first therapy targeting the underlying cause of generalized myasthenia gravis in patients aged 12 and older with specific antibodies. - Over 20 companies are developing 22+ novel myasthenia gravis therapies, including promising candidates like Descartes-08, Telitacicept, and batoclimab showing sustained efficacy in Phase 2b and Phase 3 trials. - Recent clinical developments include Cartesian Therapeutics reporting 12-month sustained improvement with Descartes-08 and RemeGen sharing positive Phase 3 results for Telitacicept at the 2025 AAN Annual Meeting.
- Cabaletta Bio announced an underwritten public offering of common stock and warrants on June 11, 2025, with expected closing on June 12, 2025. - The clinical-stage biotechnology company is developing the first curative targeted cell therapies specifically designed for patients with autoimmune diseases. - The company's lead therapy rese-cel is a fully human CD19-CAR T cell investigational treatment being evaluated in the RESET clinical program. - The RESET program spans multiple therapeutic areas including rheumatology, neurology, and dermatology for autoimmune disease treatment.
