uBriGene Biosciences , a China-based advanced therapy medicinal product (ATMP) CDMO , has entered a strategic partnership with BriSTAR Immunotech , a clinical-stage cell therapy company , to provide full-process CDMO services for universal STAR-T therapy targeting severe autoimmune diseases . The collaboration integrates uBriGene’s AAV vector manufacturing expertise with BriSTAR’s STAR-T cell technology to overcome autologous therapy bottlenecks and accelerate clinical translation of this next-generation cell therapy platform .
Partnership Structure
Element Detail CDMO Partner uBriGene Biosciences (ATMP-focused CDMO) Cell Therapy Partner BriSTAR Immunotech (clinical-stage, China) Modality Universal STAR-T therapy (allogeneic cell therapy) Target Indications Severe autoimmune diseases; oncology (future expansion) uBriGene Services AAV vector process development, GMP manufacturing, Sino-US IND filing support Strategic Goal Clinical translation and industrialization of STAR-T platform
Technology Integration & Innovation
Component Technology Strategic Value STAR-T Cells Synthetic T-cell receptor and antigen receptor platformEnhanced specificity and potency vs. conventional CAR-T; universal/off-the-shelf capability AAV Vectors Adeno-associated viral delivery for genetic modificationEfficient, stable gene transfer; established safety profile Universal (Allogeneic) Format Off-the-shelf vs. patient-specific autologousManufacturing scalability , reduced cost , immediate availability for acute autoimmune flaresCombination Rationale AAV-mediated genetic engineering of STAR-T cells Streamlined manufacturing ; consistent product quality; regulatory pathway clarity
Target Indications & Market Context
Therapeutic Area Application Unmet Need Severe Autoimmune Diseases Systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis Refractory patients failing biologics; autologous CAR-T too slow/costly for acute managementOncology (Future) Solid tumors, hematologic malignancies Allogeneic CAR-T limitations (GvHD, persistence); STAR-T safety and efficacy potential
Autoimmune Cell Therapy Gap: Autologous CAR-T (Kymera, Cabaletta) demonstrates efficacy but 3-4 week manufacturing delays treatment; universal STAR-T offers immediate administration for life-threatening autoimmune crises China ATMP Ecosystem: Partnership exemplifies vertical integration —BriSTAR innovation + uBriGene manufacturing —reducing reliance on foreign CDMOs (Lonza, Catalent) and accelerating domestic clinical timelines
Development & Regulatory Strategy
Phase Activity Timeline Current Partnership execution; tech transfer and process development Q1 2026 Manufacturing GMP batch production for IND-enabling studies 2026 Regulatory Sino-US IND submissions (parallel China NMPA and US FDA) 2026-2027 Clinical Phase I/II initiation in severe autoimmune indication 2027 Expansion Oncology pipeline advancement; manufacturing scale-up 2027-2028
Forward‑Looking Statements -Fineline Info & Tech
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