Roche announced on Thursday, September 17, 2026 that the Phase 3 CELESTIMO trial met its primary endpoint: Lunsumio (mosunetuzumab) plus lenalidomide produced a statistically significant improvement in progression-free survival versus rituximab plus lenalidomide in people with relapsed or refractory follicular lymphoma who had received at least one prior line of treatment. Overall survival data were immature at the interim analysis, and safety was consistent with the known profiles of both drugs, with no new signals. CELESTIMO is the confirmatory study required to convert the accelerated approval and conditional authorization of Lunsumio monotherapy for third-line or later follicular lymphoma into full approval. Roche will submit the data to health authorities and present them at an upcoming medical meeting.
Simcere Zaiming (a subsidiary of China's Simcere Pharmaceutical Group) announced Wednesday September 2, 2026 an exclusive global licensing agreement with Roche for SIM0660, a T-cell engager tri-specific antibody targeting CD79a, CD19, and CD3 for B-cell-mediated diseases. Deal terms: $75 million upfront plus up to $1.53 billion in total development, regulatory, and commercial milestone payments plus tiered royalties up to double-digits on future net sales. Roche acquires exclusive global rights to develop, manufacture, and commercialize SIM0660. The molecule combines a CD3-engaging arm with binding domains targeting the two B-cell antigens CD79a and CD19 to induce T-cell-mediated cytotoxicity while limiting cytokine release, positioned to compete with the emerging poly-specific antibody category (Amgen tarlatamab, Regeneron REGN5459, Janssen amivantamab). The transaction is the latest in a $60+ billion H1 2026 wave of China-to-multinational biotech licensing that continues to feed U.S. and European pharma pipelines.
Enara Bio presented ENA101 at AACR 2026 on April 20, a first-in-class bispecific T-cell engager targeting DARKFOX — a novel cancer-specific 'dark antigen' peptide presented by HLA-A*03:01 and expressed in multiple solid tumors. Preclinical data showed low-picomolar potency and complete tumor regression in xenograft models with once-weekly dosing. IND submission planned for 2H 2026.
Molecular Partners presents three posters at AACR 2026 announcing MP0632 as the first logic-gated Switch-DARPin T-cell engager candidate, targeting MSLN/EpCAM-expressing solid tumors. MP0632 showed tumor regression in dual-antigen preclinical models with limited activity on single-antigen tumors, supporting a favorable therapeutic window. The company also presented updated data for Radio-DARPin MP0712, currently in a US Phase 1/2a trial for DLL3-expressing tumors.