– New data from the Phase 3 INDIGO open-label extension will include the longer-term flare protection and safety data of obexelimab in IgG4-RD –
– Additional analyses will assess glucocorticoid-associated toxicity and vaccine responses –
WALTHAM, Mass., Sept. 22, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company advancing therapies for patients living with autoimmune and inflammatory diseases, today announced that new data from the Phase 3 INDIGO trial evaluating obexelimab in immunoglobulin G4-related disease (IgG4-RD) will be presented at two upcoming scientific meetings: the 6th International Symposium on IgG4-Related Disease, taking place October 8-10, in Cambridge, Massachusetts, and American College of Rheumatology (ACR) Convergence 2026, taking place November 6-11, 2026, in Orlando, Florida.
Longer-term flare protection and safety data from the INDIGO open-label extension will be presented on October 10 at the 6th International Symposium on IgG4-Related Disease. Additional presentations across both meetings include analyses evaluating glucocorticoid-associated toxicity and vaccine responses among patients with IgG4-RD treated with obexelimab.
“Zenas is committed to advancing the scientific understanding of IgG4-RD and the potential role of obexelimab in addressing the needs of people living with this rare, chronic, immune-mediated disease,” said Lisa von Moltke, MD, Head of Research and Development and Chief Medical Officer of Zenas. “The upcoming presentations at the IgG4ward! 6th International Symposium on IgG4-RD and ACR Convergence 2026 build on the Phase 3 INDIGO results presented earlier this year and reflect our continued focus on advancing therapies that may help people living with IgG4-RD.”
Presentation Details
Details of 6th International Symposium on IgG4-Related Disease Presentations:
Title: Clinically Meaningful Influenza and SARS-CoV-2 Vaccine Responses Following Treatment-Free Window of Obexelimab in Patients with IgG4-RD
Presenting Author: Guy Katz, MD, MS – Massachusetts General Hospital
Session: Poster Viewing Session
Session Date & Time: Thursday, October 8; 5:00-7:00pm ET
Location: Charles Hotel-Boston
Title: Obexelimab Reduced Glucocorticoid-Associated Toxicity in Patients with IgG4-Related Disease: Results From the Phase 3 Randomized, Placebo-Controlled INDIGO Trial
Presenting Author: Matthew Baker, MD, MS – Stanford University
Session: Oral Presentation
Session Date & Time: Saturday, October 10; 9:00am ET
Location: Charles Hotel-Boston
Title: Longer-Term Efficacy and Safety of Obexelimab in IgG4-Related Disease: Results from the Phase 3 INDIGO Open-Label Extension
Presenting Author: Emma Culver, Dphil, MBChB – University of Oxford
Session: Oral Presentation
Session Date & Time: Saturday, October 10; 9:40am ET
Location: Charles Hotel-Boston
Details of ACR Convergence 2026 Presentations:
Title: Obexelimab Reduced Glucocorticoid-Associated Toxicity in Patients with IgG4-Related Disease: Results from the Phase 3 Randomized, Placebo-Controlled INDIGO Trial
Presenting Author: Matthew Baker, MD, MS – Stanford University
Session: Miscellaneous Rheumatic & Inflammatory Diseases I
Session Date & Time: Monday, November 9; 1:30pm-1:45pm ET
Abstract Number: 1882
Location: Oral presentation, W304 A-H
Title: Clinically Meaningful Influenza and SARS-CoV-2 Vaccine Responses Following Treatment-Free Window of Obexelimab in Patients with IgG4-RD
Presenting Author: Guy Katz, MD, MS – Massachusetts General Hospital
Session: Miscellaneous Rheumatic & Inflammatory Diseases; Poster Session C
Session Date & Time: November 10; 10:30am-12:30pm ET
Abstract Number: 2612
Location: Poster Hall
About Obexelimab
Obexelimab is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique inhibitory mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively modulate the pathogenic role of the B cell lineage in chronic autoimmune disease.
Obexelimab has been evaluated in nine clinical trials in a total of 667 subjects, including INDIGO. Obexelimab was well tolerated and demonstrated clinical activity across these clinical trials.
Phase 2 SunStone trial in Systemic Lupus Erythematosus (SLE) topline results expected in 4Q 2026.
About IgG4-RD
IgG4-related disease (IgG4-RD) is a rare, chronic immune-mediated disease that can cause inflammation and fibrosis in multiple organs throughout the body. Because symptoms can appear suddenly or develop gradually—and may be mistaken for other conditions—many people face a 5–7-year journey to diagnosis. IgG4-RD can worsen and cause irreversible damage if it is not diagnosed and managed properly. About 20,000 people in the United States have been diagnosed with IgG4-RD, but the true number of people living with the disease may be closer to 40,000 because some individuals remain undiagnosed.
About Zenas BioPharma
Zenas is a clinical-stage global biopharmaceutical company focused on the development and commercialization of therapies for autoimmune diseases and inflammatory conditions. Zenas combines our experienced leadership team with a disciplined global product candidate acquisition approach to identify, acquire and develop product candidates with the potential to deliver clinically meaningful benefits to patients. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind CD19 and FcγRIIb to inhibit the activity of B cells implicated in many autoimmune diseases without depleting them. Zenas believes that the unique mechanism of action of obexelimab and its self-administered, subcutaneous injection regimen may enable sustained control across multiple chronic autoimmune diseases. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule BTK inhibitor. Orelabrutinib’s mechanism of action targets pathogenic B cells not only in the periphery but also within the CNS. Additionally, it directly modulates macrophages and microglial cells in the CNS, with the potential to address compartmentalized inflammation and disease progression in MS. Zenas’ earlier stage programs include ZB021, a novel, clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor, ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor, and ZB014, a preclinical, half-life extended anti-CD19 and FcγRIIb monoclonal antibody. For more information about Zenas BioPharma, please visit https://zenasbio.com/ and follow us on LinkedIn.
Forward-Looking Statements
This press release contains “forward-looking statements.” In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward looking statements include, but are not limited to, the anticipated timing or likelihood of regulatory submissions and approvals, and the outcome of interactions with regulatory authorities; the therapeutic potential of the Company’s product candidates; the Company’s expectations regarding the potential commercialization, estimated market size and market opportunities of its product candidates; and the timing of reporting the topline results of obexelimab in SLE. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results, performance or achievements to differ materially from those anticipated in the forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development; potential competition, including from large and specialty pharmaceutical and biotechnology companies; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements; the Company’s ability to obtain regulatory approval to commercialize its product candidates; risks related to the manufacturing of the Company’s product candidates and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the its license obligations; significant political, trade, and regulatory developments, including changes in relations between the U.S. and China; risks related to the operations of the Company’s suppliers, many of which are located outside of the United States, including the Company’s current sole contract manufacturing organization for obexelimab drug substance and drug product, WuXi Biologics (Hong Kong) Limited, and our partner, InnoCare, both of which are located in China; the risk that the Company’s indebtedness could adversely affect the Company’s financial condition or restrict the Company’s future operations; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as supplemented from time to time by our subsequent filings with the Securities and Exchange Commission (the “SEC”), as well as other information we file with the SEC. The forward-looking statements in this press release are based upon information available to the Company as of the date of this press release and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete. Because forward-looking statements are inherently subject to risks and uncertainties, these forward-looking statements should not be relied upon as guarantees of future events. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
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Contacts:
Investors:
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Zenas@argotpartners.com
Media:
Kristin Ainsworth
SVP, U.S. Commercial Strategy & Corporate Affairs
612.839.6748
