Cabaletta Bio, Inc.

PHILADELPHIA, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced two presentations at the upcoming American College of Rheumatology (ACR) Convergence 2024, which is being held at the Walter E. Washington Convention Center in Washington, D.C. from November 14-19, 2024. The presentations will feature new and updated clinical data on CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, which is being evaluated in multiple ongoing clinical trials in the RESET™ clinical development program. Details of the presentations are as follows: Oral Presentation: Title: Safety and Efficacy of CABA-201, a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Patients with Immune-Mediated Necrotizing Myopathy and Systemic Lupus Erythematosus from the RESET-Myositis™ and RESET-SLE™ Clinical TrialsAbstract ID: 1857177Date and Time: Sunday, November 17, 2024, 3:30 p.m. – 3:45 p.m. ETPresenter: David J. Chang, M.D., M.P.H, FACR, Chief Medical Officer, Cabaletta Bio Poster Presentation: Title: Correlative Studies of CABA-201, a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Patients with Immune-Mediated Necrotizing Myopathy and Systemic Lupus Erythematosus from the RESET-Myositis™ and RESET-SLE™ Clinical TrialsAbstract ID: 1866605Date and Time: Saturday, November 16, 2024, 10:30 a.m. – 12:30 p.m. ETPresenter: Daniel Nunez, Ph.D., Director, Computational Biology at Cabaletta Bio Additional information, including the accepted abstracts, can be accessed on the ACR Convergence 2024 website. Presentation materials will be made available on the Posters & Publications section of the Company’s website following the event. About CABA-201CABA-201 is designed to deeply and transiently deplete CD19-positive cells following a one-time infusion, which may enable an “immune system reset” with the potential for durable remission without chronic therapy in patients with autoimmune diseases. Cabaletta is evaluating CABA-201 in multiple autoimmune conditions within five disease-specific company sponsored INDs including myositis (idiopathic inflammatory myopathy, or IIM), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), generalized myasthenia gravis (gMG), and pemphigus vulgaris (PV; a sub-study to evaluate CABA-201 without preconditioning). About Cabaletta BioCabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in myositis, systemic lupus erythematosus, systemic sclerosis, generalized myasthenia gravis and in the RESET-PV™ sub-study within the DesCAARTes™ clinical trial in pemphigus vulgaris, along with the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK-associated myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. Contacts: Anup MardaChief Financial Officerinvestors@cabalettabio.com William GramigPrecision AQ william.gramig@precisionaq.com

Some of the most widely used drug contractors are based in China. But the U.S. biopharmaceutical industry may eventually be pushed to cut ties with those partners if the Biosecure Act, which passed in the House of Representatives last week, becomes law.The act would effectively prohibit U.S. companies from doing business with five Chinese firms, including WuXi AppTec, Complete Genomics and MGI Tech. In the Houses version, companies with existing contracts are given eight years to sever ties. The bill also allows Congress to add more companies to its list as it weighs perceived connections between the Chinese government and U.S. drug industry, as well as cybersecurity and intellectual property concerns.Still, the path forward for the bill isnt entirely secure. There were more no votes than in expected in the Houses 306-81 passage, which could suggest a tougher path in the Senate.It did not pass as overwhelmingly as it had passed out of committee, said Nielsen Hobbs, an analyst with Citeline. It's both an indication of some softness of support, as well as an invitation for folks [who] want to make modifications to try and do so.Its unclear if the Senate plans to vote on the bill or if theres enough time left in the year for the legislation to make its way into law. A lame duck Congress is less likely to push through substantive bills after the U.S. elections in November, too.This is probably not going to pass before the election, Hobbs predicted.Even with a murky future, U.S. biotechs are preparing for a potential disentanglement from some of their largest Chinese contractors.U.S. biotech exposureChina is a linchpin in pharmas global supply chain, making up about 13% of active pharmaceutical ingreident manufacturers. Two companies named in the Biosecure Act WuXi Apptec and WuXi Biologics are particularly well known as U.S. biotech partners. And if U.S. companies are forced to end their relationships with WuXi, there could be widespread ripple effects.Many U.S. companies are now disclosing their relationships with the target firms in securities filings. For example, Nuvalent, Viridian Therapeutics and Cabaletta Bio have each said they could see disruptions as a result of the Biosecure Act because they partner with one or more of the named Chinese companies.Iteos Therapeutics said in a securities filing that it has begun the process of transitioning from WuXi to other manufacturers. However, the biotech noted the process may take longer than expected due to difficulties with technology transfer.Sage Therapeutics, which gained an FDA approval for its postpartum depression med with Biogen last year, said the act could potentially disrupt its research activities and clinical trial partners.To some, any contract with a Chinese firm could be a risk. Liver and cardiometabolic-focused biotech 89bio, which contracted with Chinas BiBo Biopharma Engineering to build a plant for production of its MASH drug earlier this year, has said its exposed to the possibility of product supply disruption and increased costs as a result of the Biosecure Act. BiBo Biopharma was not named in the Houses bill.Amid this uncertainty, biotechs are preparing for changes.Everyone is wisely anticipating it will pass and that they're going to have less time than they might hope to make this kind of transition, Hobbs said. It's always difficult to create business plans in this climate of uncertainty.Large pharma companies also face risks. Eli Lilly has tapped WuXi Apptec to produce some of the ingredients in its blockbuster GLP-1 obesity medications, while GSK inked a licensing deal potentially worth nearly $1.5 billion with WuXi Biologics last year for up to four bi- and multi-specific TCE antibodies developed using WuXis platform.GSK and Lilly did not respond to a request for comment from PharmaVoice.The industrys largest trade association, PhRMA, aims to work with Congress to avoid any drug supply disruptions.Biopharmaceutical manufacturers are committed to working constructively with Congress to help protect national and economic interests and make sure patients are not unintentionally impacted with potential drug shortages or disruptions to medicine R&D, Megan Van Etten, deputy vice president of public affairs at PhRMA, said in an email.Biotechs prepareNot all biotechs expect the worst. Jonathan Kil, CEO of Seattle-based Sound Pharmaceuticals, has doubts the bill will pass in the Senate and views WuXi as a safe partner after collaborating with the Chinese company for 18 years.WuXi has been inspected by the FDA hundreds of times, he said.Still, for Kil, the timing isn't ideal. Sound recently completed a study for its lead candidate, an anti-inflammatory drug for Mnire's disease. Sound plans to release study results later this year and pursue FDA approval soon after. Cutting ties with WuXi would be a major hurdle to commercialization, should Sounds drug reach market.The cost of switching contractors would be high for a small biotech like Sound. Even exploring partnerships with other CROs has been costly in one case, the company sunk $500,000 into making sure a partnership would have worked in the first place.After that initial time, money and effort, you still wont know if the new CRO can scale pre-commercially yet thats another $500,000 to $1,000,000 and another nine to 12 months, Kil said. Its a stepwise process with a lot of internal controls.WuXi, for its part, has denied any wrongdoing and stated it does not collect genomic data, a top concern cited by lawmakers.We firmly believe that WuXi AppTec has not posed, does not pose, and will not pose a security risk to the United States or any other country and it has not been subject to any sanction by the U.S. government agencies, the company said in a statement last week. '

PHILADELPHIA, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in the following investor conferences in September: Morgan Stanley 22nd Annual Global Healthcare Conference: Fireside chat on Wednesday, September 4, 2024 at 4:50 p.m. ET in New York, NY.2024 Wells Fargo Healthcare Conference: Fireside chat on Thursday, September 5, 2024 at 8:00 a.m. ET in Boston, MA.H.C. Wainwright 26th Annual Global Investment Conference: Fireside chat on Wednesday, September 11, 2024 at 9:00 a.m. ET in New York, NY.2024 Cantor Fitzgerald Global Healthcare Conference: Fireside chat on Tuesday, September 17, 2024 at 11:30 a.m. ET in New York, NY. A live webcast of each presentation will be available on the News and Events section of the Company’s website at www.cabalettabio.com. Replays will be available on the website for 30 days. About Cabaletta BioCabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in myositis, systemic lupus erythematosus, systemic sclerosis, generalized myasthenia gravis and in the RESET-PV™ sub-study within the DesCAARTes™ clinical trial in pemphigus vulgaris, along with the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK-associated myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. Contacts: Anup MardaChief Financial Officerinvestors@cabalettabio.com William GramigPrecision AQ william.gramig@precisionaq.com