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Highlights
- Zenas gains global rights for orelabrutinib and two early-stage autoimmune candidates.
- Pivotal Phase 3 trials initiated Primary Progressive MS, Secondary Progressive MS to start 1Q 2026.
- Zenas announces 120.0 million USD private placement financing to support pipeline development.
Zenas BioPharma, Inc. (Nasdaq:ZBIO) and InnoCare Pharma Limited announced a license agreement granting Zenas global development and commercialization rights for orelabrutinib in Multiple Sclerosis (MS) and rights to two additional oral autoimmune candidates: an IL-17AA/AF inhibitor and a brain-penetrant TYK2 inhibitor. Zenas holds non-oncology rights outside Greater China and Southeast Asia, while InnoCare retains oncology rights globally.
Under the agreement, Zenas will make upfront and near-term milestone payments totaling up to 100 million USD in cash, including milestone-related shares of Zenas common stock. Additional potential development, regulatory, and commercial milestone payments across all three programs could exceed 2 billion USD. InnoCare will also receive tiered royalties of up to high teens percentages on annual net sales of the licensed products.
Orelabrutinib Development
Orelabrutinib is an oral, CNS-penetrant, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor in Phase 3 development for progressive MS. A global, multicenter, randomized, double-blind, placebo-controlled trial for Primary Progressive MS (PPMS) has been initiated, with dosing at 80 mg once daily. A similar Phase 3 trial for Secondary Progressive MS (SPMS) is expected to start in 1Q 2026.
In prior Phase 2 trials in Relapsing-Remitting MS (RRMS), orelabrutinib showed reductions in new Gd+ T1 lesions at weeks 12 and 24, with sustained reductions through week 96. The safety and tolerability profile aligns with other BTK inhibitors studied in MS and prior autoimmune disease and hematologic cancer trials.
Management Comments:
“InnoCare is a globally recognized company with a successful track record of drug discovery, development and commercialization. This transformative collaboration with InnoCare further positions Zenas to execute on its vision to become a global, fully integrated development and commercial-stage autoimmune-focused biopharmaceutical company. With global rights to orelabrutinib, we are advancing a potential blockbuster franchise for progressive MS. Orelabrutinib, with its best-in-class potential, is strongly positioned to address disease progression independent of relapse activity, the highest unmet medical need in MS, and to improve the lives of patients living with progressive MS. We are also excited to add two potentially best-in-class molecules, a novel, oral, IL-17AA/AF inhibitor and an oral, brain-penetrant, TYK2 inhibitor, to our pipeline. We plan to advance each of these programs to human clinical trials in 2026 and expect to have initial patient data from the oral IL-17AA/AF clinical program in 2027,” said Lonnie Moulder, Founder and CEO of Zenas.
Pipeline and Clinical Programs
- Obexelimab: Phase 3 trial in IgG4-RD (INDIGO), Phase 2 trials in RMS and SLE (SunStone).
- Orelabrutinib: Phase 3 PPMS trial initiated; SPMS trial expected 1Q 2026.
- Oral IL-17AA/AF inhibitor & TYK2 inhibitor: IND enabling studies; Phase 1 trials expected in 2026.
Private Placement Financing
Zenas entered a private placement agreement expected to raise gross proceeds of approximately 120.0 million USD through the sale of ~6.3 million shares of common stock. Institutional and accredited investors will purchase shares at 19.00 USD each, while directors and officers will purchase at 20.85 USD per share.
Company Profiles
Zenas BioPharma: Clinical-stage biopharma company developing therapies for autoimmune diseases, advancing late-stage programs obexelimab and orelabrutinib, along with preclinical IL-17AA/AF and TYK2 inhibitors.
InnoCare Pharma: Commercial-stage biopharma company focused on oncology and autoimmune therapeutics, with a pipeline of approved drugs, clinical-stage candidates, and preclinical programs.
