Zenas BioPharma Secures Global Rights for Three Autoimmune Candidates, Including Orelabrutinib for Progressive MS
Wednesday, October 08, 2025
Zenas BioPharma, Inc. and InnoCare Pharma Limited have announced a licence agreement granting Zenas global development and commercialisation rights to orelabrutinib for multiple sclerosis (MS) and rights to develop the therapy across all non-oncology indications. Zenas also acquired rights to an oral IL-17AA/AF inhibitor and an oral, brain-penetrant TYK2 inhibitor.
Orelabrutinib is a selective, CNS-penetrant, oral BTK inhibitor designed to address compartmentalised inflammation and disease progression in MS. A global Phase 3 trial evaluating orelabrutinib 80 mg once daily in patients with primary progressive MS (PPMS) is underway. Zenas plans a second Phase 3 study for secondary progressive MS (SPMS) in the first quarter of 2026.
In a previous Phase 2 trial involving relapsing-remitting MS (RRMS) patients, orelabrutinib demonstrated significant reductions in new Gd+ T1 lesions versus placebo at 12 and 24 weeks, with sustained reduction of inflammatory activity through week 96. Its safety and tolerability profile aligns with other BTK inhibitors under development and has been well characterised in prior autoimmune and haematologic cancer studies.
The agreement strengthens Zenas’ autoimmune pipeline by adding two potentially best-in-class candidates alongside orelabrutinib: an oral IL-17AA/AF inhibitor and an oral, brain-penetrant TYK2 inhibitor, both planned for clinical development in 2026, with initial patient data from the IL-17AA/AF programme expected in 2027.
The expanded portfolio now positions Zenas to pursue complementary mechanisms across multiple autoimmune diseases. The company continues to advance its two franchise programmes: obexelimab, concluding Phase 3 development for IgG4-related disease (IgG4-RD), and orelabrutinib for progressive forms of MS. Topline results from the Phase 2 MoonStone trial for RMS with obexelimab are expected early in the fourth quarter of 2025, with 24-week data in the first quarter of 2026, which will inform the next programme decision.
Orelabrutinib’s demonstrated CNS penetration and efficacy in Phase 2 studies underline its potential to transform the treatment paradigm for progressive MS, where few treatment options exist. The agreement also leverages combined expertise to accelerate development and maximise the clinical and commercial potential of these autoimmune candidates globally.
Source: globenewswire.com
