Zenas BioPharma Announces Upcoming Presentations of Orelabrutinib Data in Relapsing Remitting Multiple Sclerosis, Clinical Trial Designs in Progressive Multiple Sclerosis and Other Multiple Sclerosis Portfolio Data at MSToronto2026
WALTHAM, Mass., Oct. 07, 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 it will present seven posters at the 10th Joint ACTRIMS-ECTRIMS Meeting (MSToronto2026) taking place October 21-23, 2026, in Toronto, Canada.
The Company will also host a Symposium featuring a panel of Multiple Sclerosis (MS) experts discussing the evolving science and clinical potential of BTK inhibition in progressive MS.
Symposium Details:
Title: BTK Inhibition in MS: An Emerging Approach to Disability Progression
Participants: Amit Bar-Or, MD, FRCPC, Maria Pia Sormani, PhD, Robert Fox, MD, Benjamin Greenberg, MD, MHS
Date & Time: Wednesday, October 21; 5:30-6:30pm ET
Location: Lecture Hall 718
Poster Presentation Details:
Title: Pharmacokinetics of Orelabrutinib in a Phase 2 Study in Relapsing Remitting Multiple Sclerosis
Presenting Author: Mary Hughes, MD, MBA – Neurologist, University of South Carolina School of Medicine Greenville
Session: ePoster
Poster Number: EP2593
Title: Orelabrutinib in Non-Active Secondary Progressive Multiple Sclerosis: Design of the Monarch Phase 3 Randomized Controlled Trial
Presenting Author: Robert J. Fox, MD – Neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic
Session: ePoster
Poster Number: EP2594
Title: Orelabrutinib in Primary Progressive Multiple Sclerosis: Design of the PriMroSe Phase 3 Randomized Controlled Trial
Presenting Author: Robert J. Fox, MD – Neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic
Session: ePoster
Poster Number: EP2602
Title: Effect of Obexelimab on Serum Biomarkers and MS Disease Activity Score: Results from the Phase 2 MoonStone Trial in Relapsing Multiple Sclerosis
Presenting Author: Annette Okai, MD, FAAN - Director of Neuroimmunology and Multiple Sclerosis Research at North Texas Institute of Neurology, Rheumatology & Headache
Session: Paper Poster Session 2: Therapy – Immunomodulation/Immunosuppression
Session Date & Time: Thursday, October 22; 4:30pm-6:30pm ET
Poster Number: P1411
Location: Exhibit Hall DE
Title: Obexelimab Demonstrated Reduction in Disease Activity in Relapsing Multiple Sclerosis: 24-Week Results from the MoonStone Phase 2 Trial
Presenting Author: Darin Okuda, MD – Professor in the Department of Neurology at UT Southwestern Medical Center
Session: Paper Poster Session 2: Therapy – Immunomodulation/Immunosuppression
Session Date & Time: Thursday, October 22; 4:30pm-6:30pm ET
Abstract Number: P1417
Location: Exhibit Hall DE
Title: Pharmacokinetics and Pharmacodynamics of Obexelimab in Patients with Relapsing Multiple Sclerosis: Results from the Phase 2 MoonStone Trial
Presenting Author: Regina Berkovich, MD, PhD – Assistant Professor of Clinical Neurology at Keck School of Medicine of USC
Session: Paper Poster Session 2: Therapy – Immunomodulation/Immunosuppression
Session Date & Time: Thursday, October 22; 4:30pm-6:30pm ET
Abstract Number: P1455
Location: Exhibit Hall DE
Title: Efficacy and Safety of Orelabrutinib in Relapsing-Remitting Multiple Sclerosis: 24-Week Results of the 80 mg Dose from a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study
Presenting Author: Mary Hughes, MD, MBA – Neurologist, University of South Carolina School of Medicine Greenville
Session: Paper Poster Session 2: Therapy – Immunomodulation/Immunosuppression
Session Date & Time: Thursday, October 22; 4:30pm-6:30pm ET
Abstract Number: P1446
Location: Exhibit Hall DE
About Multiple Sclerosis
Multiple Sclerosis (MS) is a chronic, autoimmune-mediated disorder of the Central Nervous System (CNS). According to the Multiple Sclerosis International Federation, approximately 2.9 million people worldwide are currently living with MS. The disease disproportionately affects females, and its highest prevalence is observed in North America, Europe and Australia. MS onset typically occurs between 20 and 40 years of age, making MS the leading cause of non-traumatic neurological disability in young adults. MS is categorized into three main subtypes, Relapsing Multiple Sclerosis (RMS), Secondary Progressive Multiple Sclerosis (SPMS) and Primary Progressive Multiple Sclerosis (PPMS); all three subtypes are associated with ongoing neuroaxonal loss from the earliest stages of the disease, even in the absence of overt clinical progression. Delays in diagnosis and treatment accelerate disability accumulation, reduce quality of life and increase socioeconomic burden. Consequently, early intervention with highly effective therapies is a key objective in disease management to slow or halt inflammatory and neurodegenerative processes and stop disability progression.
Approximately 85% of patients are initially diagnosed with RMS, and approximately 20-30% of those treated patients transition to SPMS, defined by continuous disability progression with or without relapses. Currently, there are no approved therapies for non-relapsing SPMS in the U.S. PPMS represents 10-15% of all MS diagnoses and is characterized by a steady increase in disability without relapses from disease onset. Currently there is only one approved therapy for PPMS.
About Orelabrutinib
Orelabrutinib is a late-stage, potentially best-in-class, highly selective central nervous system (CNS)-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor. Orelabrutinib’s mechanism of action targets pathogenic B cells in both the periphery and the CNS. Additionally, it directly modulates macrophages and microglial cells in the CNS, with the potential to address compartmentalized inflammation and disease progression in multiple sclerosis (MS). In MS, Zenas is advancing PriMroSe, a Phase 3 trial in Primary Progressive MS (PPMS), and Monarch, a Phase 3 trial in non-active Secondary Progressive MS (naSPMS). Orelabrutinib is approved for B cell malignancies in mainland China and Singapore, marketed by our partner InnoCare.
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 MoonStone. 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 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, including the potential of BTK inhibition in progressive MS; 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:
Argot Partners
Zenas@argotpartners.com
Media:
Kristin Ainsworth
SVP, U.S. Commercial Strategy & Corporate Affairs
612.839.6748
