Cure.
Overview
Scientists are striving for therapies that wipe out disease-causing cells in autoimmune disease, resetting the immune system, and aiming ultimately to cure patients.
Autoimmune diseases affect an more than 25 million Americans, or 8% of the population—and for most of them, treatment still means a lifetime of broad immune suppression, trading one set of risks for another. There are over 100 known types of autoimmune diseases, affecting various parts of the body, including rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, multiple sclerosis, type 1 diabetes, and the muscular disorder myasthenia gravis.
Current therapies generally work by dampening the immune system. Drugs such as rituximab and infliximab can put the disease into remission in many patients, but they must be taken chronically and often put patients at risk of serious infection. Scientists are now striving for therapies that target disease-causing cells while allowing healthy cells to recover, effectively resetting the immune system.
"Our understanding of how the immune system might inadvertently attack oneself is accelerating, and targeting cells that play a role is now possible," says Jill Buyon, MD, Director of Rheumatology Division and Lupus Center at NYU Langone Health.
One promising approach is to destroy the disease-causing B cells that produce autoantibodies targeting the body's own tissue, using cell therapies such as chimeric antigen receptor T cells (CAR-T cells). CAR-T cell therapies are best known for their cancer-fighting abilities, yet the B cells these drugs target are the same ones that malfunction in autoimmune disease, albeit in a different way. Several CAR-T cell therapies are now in clinical trials for autoimmune disorders.
"Preliminary clinical data are promising. We are awaiting final data from pivotal trials to know what the durability and ultimate risk–benefit profile is," says Aimee Payne, MD, PhD, Professor and Chair of Dermatology at Columbia University. Payne co-founded Philadelphia-based Cabaletta Bio, which is developing CAR-T cell therapy for autoimmune diseases, and she now acts as a scientific advisor to the company. "I'm hoping that CAR-T cell therapies and similar technologies ultimately can bring cures to patients," she says.
The field has already seen remarkable early results, including a patient with an ultra-rare combination of three autoimmune diseases who has had no symptoms since receiving a single dose of CAR-T cells directed at disease-causing B cells.
Beyond CAR-T, the therapeutic landscape is broadening. Other approaches in clinical trials include regulatory T cell therapies, which dampen inflammation to restore immune balance; natural killer cell therapies, which detect and destroy abnormal cells; T-cell engagers, bispecific antibodies that redirect T cells to target antibody-producing B cells; and tolerance-inducing therapies designed to retrain the immune system to stop attacking healthy tissue.
"The explosion of trials to rebalance the immune system is exciting," says Buyon. "There's always caution as very new concepts in therapy are brought forward, but there's no time like now to change the trajectory of autoimmune diseases."
The following companies represent the breadth of approaches currently in clinical development, from CAR-T and NK cell therapies to T-cell engagers and immune tolerance platforms.
Kyverna Therapeutics
Sector: Cell therapy
HQ: Emeryville, CA
Year Founded: 2018 (as Bait Therapeutics, renamed in 2019)
Origin Story: The company was founded by immunologist and transplant surgeon Dominic Borie and Fred Cohen of Vida Ventures.
Key Leaders: Warner Biddle, Chief Executive Officer; Naji Gehchan, MD, Chief Medical and Development Officer; Mayo Pujols, Chief Technology Officer
Number of Employees: ~130
Stage: Public (KYTX)
Financial Snapshot: An upsized IPO in 2024 raised $319 million, and in December 2025, the company announced a $100 million public offering of common stock; the company had a market cap of $564 million in April 2026
Key Products: Kyverna’s lead product is mivocabtagene autoleucel (MivCel), a CAR-T cell therapy that targets CD19 on B cells that’s in clinical trials for stiff person syndrome, generalized myasthenia gravis, progressive multiple sclerosis, rheumatoid arthritis, lupus nephritis, and systemic sclerosis.
Recent Highlights: Topline data released in December 2025 showed that a single dose of MivCel improved overall disability, mobility, and stiffness in people with stiff person syndrome, and enabled all patients to remain free of immunotherapy treatments. Kyvena intends to use this data to support a BLA submission, which is anticipated in 1H 2026. If approved, MivCel will be one of the first cell therapies for treating autoimmune disease.
Cartesian Therapeutics
Sector: Cell therapy
HQ: Frederick, MD
Year Founded: 2016
Origin Story: Founded by life-sciences founders and physician–scientists Murat Kalayoglu, Michael Singer, and Metin Kurtoglu
Key Leaders: Carsten Brunn, PhD, President and CEO; Miloš Miljković, MD, Chief Medical Officer; Emily English, PhD, Chief Operations Officer
Number of Employees: ~75
Stage: Public (RNAC)
Financial Snapshot: The company reversed-merged with Selecta in 2023, with Selecta raising $60.25 million in financing led by board member Timothy Springer to support clinical trials; Cartesian’s market cap was about $186 million in April 2026.
Key Products: Cartesian’s lead candidate is Descartes-08, an mRNA CAR-T cell therapy that targets B-cell maturation antigen on B cells. The CAR-T cells are made in the patient’s body and only transiently expressed, negating the need for gruelling lymphodepletion and hospital stays. Descartes-08 is in clinical trials for myasthenia gravis, systemic lupus erythematosus (SLE), and myositis.
Recent Highlights: Initial data released in November 2025 from three patients with SLE showed that Descartes-08 was well-tolerated, and two of the patients had disease remission at month three. The company intends to start a phase 2 trial of Descartes-08 in people with dermatomyositis and antisynthetase syndrome in 1H26
Sonoma Biotherapeutics
Sector: Cell therapy
HQ: San Francisco, CA
Year Founded: 2019
Origin Story: Sonoma was co-founded by immunologist Jeff Bluestone, a pioneer in research on regulatory T cells (Tregs). Other co-founders were Qizhi Tang, Alexander Rudensky, and Fred Ramsdell.
Key Leaders: Stephen Dilly, MBBS, PhD, President and CEO; Lisa Taylor Ash, JD, Chief Operating Officer; Joshua Beilke, PhD, Chief Scientific Officer
Number of Employees: ~112
Stage: Private, Series B
Financial Snapshot: The company, in 2021 raised $265 million in an oversubscribed Series B round, and in March 2023, it entered a collaboration with Regeneron to develop Treg cell therapies for inflammatory bowel disease and other indications, worth $75 million upfront; In September 2024, Sonoma received a $45 million milestone payment as part of this collaboration
Notable Investors: Ally Bridge Group and over 20 other investors, including Vertex Ventures HC, Mirae Asset Capital, Regeneron Pharmaceuticals, ArrowMark Partners, and Avidity Partners
Key Products: SBT-77-7101 is a CAR-Treg cell therapy that recognizes citrullinated proteins found in the joints of people with rheumatoid arthritis and is in phase 1 trials.
Recent Highlights: Data released at the 2025 American College of Rheumatology Conference showed that SBT-77-7101 had a favorable safety profile without immune-mediated side effects. The product reduced the level of swollen and tender joints in four of six patients with refractory disease and lowered disease scores. In October 2025, co-founder Jeff Bluestone won the 2025 Nobel Prize in Physiology or Medicine for discovering Treg cells.
Nkarta
Sector: Cell therapy
HQ: South San Francisco, CA
Year Founded: 2015
Origin Story: Founded by Dario Campana, who pioneered CAR-T and natural killer (NK) cell therapies at St. Jude Children's Research Hospital and the National University of Singapore.
Key Leaders: Paul Hastings, Chief Executive Officer; Nadir Mahmood, PhD, President; Shawn Rose, MD, Chief Medical Officer and Head of Research and Development
Number of Employees: ~108
Stage: Public (NKTX)
Financial Snapshot: The company’s market cap was $165 million in April 2026; an upsized IPO in 2020 raised $289.8 million
Key Products: Nkarta’s lead product is NKX109, a CAR-NK cell therapy directed to CD19 on B cells that’s in phase 1 clinical trials for lupus nephritis, systemic sclerosis, inflammatory myopathy, antineutrophil cytoplasmic antibody-associated vasculitis, systemic lupus erythematosus, and myasthenia gravis
Recent Highlights: Preclinical data presented at the American College of Rheumatology 2025 meeting showed that NKX019 depletes pathogenic B cells in in vivo autoimmune disease models. The company intends to release its first clinical data this year.
Abcuro
Sector: Therapeutic antibodies
HQ: Newton, MA
Year Founded: 2015
Origin Story: Founded by scientist–entrepreneur Stefano Gullà and Steven Greenberg, a neurologist at Brigham and Women’s Hospital, whose research into KLRG1-expressing T cells formed the basis of Abcuro
Key Leaders: Alex Martin, MBA, Chief Executive Officer; Steven Greenberg, MD, Chief Scientific Advisor and Co-founder; H. Jeffrey Wilkins, MD, Chief Medical Officer; Karen Tubridy, PharmD, Chief Operating Officer
Number of Employees: ~55
Stage: Private, Series C
Financial Snapshot: A series C round in February 2025 raised $200 million, and previous rounds combined raised $197 million
Notable Investors: BlackRock, Aberdeen Investments, Bain Capital Life Sciences, New Enterprise Associates, Foresite Capital, Sanofi Ventures, RA Capital, Mass General Brigham Ventures
Key Products: The company’s lead product is ulviprubart, a monoclonal antibody that selectively depletes cytotoxic CD8+ KLRG1+ T cells, the cells that drive T-cell attacks on muscle fibers in inclusion-body myostitis, causing loss of hand function and ability to walk.
Recent Highlights: March 2026 phase 2/3 results showed that ulviprubart slowed disease progression in some patients with inclusion-body myostitis; the results were not significant in the overall population, but progression was slowed by 50% in people with less severe disease. Abcuro plans to meet with FDA to discuss the next steps in advancing ulviprubart in this indication.
Cour Pharmaceuticals
Sector: Immune tolerance therapies
HQ: Skokie, IL
Year Founded: 2012
Origin Story: Founded on research conducted by Stephen Miller and Lonnie Shea at Northwestern University, who invented Cour’s nanoparticle technology platform
Key Leaders: Dannielle Appelhans, President and CEO; Paul Peloso, MD, Chief Medical Officer; Adam Elhofy, PhD, Chief Scientific Officer
Number of Employees: ~65
Stage: Private, Series A
Financial Snapshot: The company raised $105 million In Series A in 2024
Notable Investors: Lumira Ventures, Alpha Wave Ventures, Angelini Ventures, Bristol-Meyers Squibb, Chimera Capital
Key Products: Cour’s platform technology uses nanoparticles expressing disease-specific antigens (dubbed Navacims) that promote immune tolerance by reprogramming disease-causing T cells into disease-regulating Treg cells. The company has four programs in phase 2 trials for primary biliary cholangitis, type 1 diabetes, myasthenia gravis, and celiac disease (the latter trial partnered with Takeda)
Recent Highlights: Cour released data in March 2026 showing that CNP-104 improved markers of liver function and disease progression in people with the autoimmune liver disorder primary biliary cholangitis. The company received Orphan Drug designation for CNP-106 in generalized myasthenia gravis in October 2025.
Cullinan Therapeutics
Sector: T cell engagers
HQ: Cambridge, MA
Year Founded: 2016 (formerly called Cullinan Oncology)
Origin Story: Founded by molecular biologist, immunologist, and biopharmaceutical entrepreneur Patrick Baeuerle, who also co-founded TCR2 Therapeutics, Harpoon Therapeutics, and Maverick Therapeutics, alongside Owen Hughes, managing director at MPM Capital
Key Leaders: Nadim Ahmed, President and Chief Executive Officer; Jeffrey Jones, MD, Chief Medical Officer; Jennifer Michaelson, PhD, Chief Scientific Officer
Number of Employees: ~109
Stage: Public (CGEM)
Financial Snapshot: The company’s market cap was $921 million in April 2026; an IPO in 2021 raised $287.4 million
Key Products: CLN-978, a CD19-directed T-cell engager that triggers the lysis of CD19-expressing B cells, which is in clinical trials for patients with rheumatoid arthritis, Sjögren’s disease, and systemic lupus erythematosus.
Recent Highlights: Preclinical data presented in October 2025 showed that CLN-978 depleted target B cells and activated T cells in samples from patients with autoimmune disease. And in a mouse model of SLE, CLN-978 had a disease-modifying effect in affected tissues. The company plans to release initial clinical data in Q2 2026.
Forte Biosciences
Sector: Therapeutic antibodies
HQ: Dallas, TX
Year Founded: 2007
Origin Story: Founded by chemist Paul Wagner, who previously held roles at CANBridge Life Sciences, Pfenex, several investment firms, and was Vice President at Lehman Brothers.
Key Leaders: Paul Wagner, PhD, Chief Executive Officer; Christopher Roenfeldt, Chief Operating Officer; Barbara Finck, MD, Senior Medical Clinician
Number of Employees: ~19
Stage: Public (FBRX)
Financial Snapshot: The company’s market cap was approximately $674 million in April 2026
Key Products: The company’s lead product is FB102. This monoclonal antibody targets CD122, a molecule that mediates immune responses. It is in trials for celiac disease, vitiligo, and alopecia areata.
Recent Highlights: In June 2025, data from FB102’s phase 1 trial in people with celiac disease showed that the therapy improved characteristics of the disorder and improved patients’ gastrointestinal symptoms. A recent public offering in April 2026 raised $150 million.
Odyssey Therapeutics
Sector: Small-molecule immunomodulators
HQ: Boston, MA
Year Founded: 2018
Origin Story: Founded by chemist and serial biotech entrepreneur Gary Glick, who also founded IFM Therapeutics, Scorpion Therapeutics, and Lycera Corporation
Key Leaders: Gary Glick, PhD, Founder, President, and Chief Executive Officer; Natalie Dales, PhD, Chief of Research Operations; Anthony Opipari, MD, Interim Chief Medical Officer
Number of Employees: ~118
Stage: Private (Series D)
Financial Snapshot: An oversubscribed Series D round in September 2025 raised $213 million. Previous funding rounds together raised $478 million. The company announced its plans to go public in April 2026.
Notable Investors: Affinity Asset Advisors, Lightspeed Ventures, Sanofi Ventures, Dimension Capital, TPG Life Sciences Innovations, Jeito Capital, and others
Key Products: The company’s lead product is OD-001, an oral, small-molecule inhibitor of receptor-interacting protein kinase 2 (RIPK2) scaffolding. The molecule blocks the downstream activation of proinflammatory cells that release cytokines and drive the pathology of inflammatory bowel disease. OD-001 is in phase 2 trials for ulcerative colitis and Crohn’s disease.
Recent Highlights: The company presented preclinical data of OD-101 in patient samples at the American College of Gastroenterology 2024 Meeting, showing that RIPK2 drives intestinal inflammation, IBD severity, and responsiveness to biologic therapies.
Annexon Biosciences
Sector: Complement cascade inhibitors
HQ: Brisbane, CA
Year Founded: 2011
Origin Story: Annexon was founded in 2011 by the late Ben Barres, Professor of Neurobiology at Stanford University School of Medicine, and Arnon Rosenthal, who also founded Alector and Rinat Neurosciences.
Key Leaders: Douglas Love, Esq, President and Chief Executive Officer; Ted Yednock, PhD, Chief Innovation Officer; Rick Artis, PhD, Chief Scientific Officer; Jamie Dananberg, MD, Chief Medical Officer
Number of Employees: ~100
Stage: Public (ANNX)
Financial Snapshot: The company’s market cap was approximately $1 billion in April 2026.
Key Products: The company’s products include antibody and small-molecule inhibitors. Tanruprubart is a monoclonal antibody that blocks the C1q protein to treat Guillain-Barré syndrome. ANX1502 is an oral, small-molecule inhibitor that targets the active C1 molecules that propagate classical pathway activation.
Recent Highlights: The company filed an MAA for tanruprubart in January 2026; data supporting the application were presented at J.P. Morgan 2026, and if approved, it will be the first targeted rapid-acting treatment for Guillain-Barré syndrome.
