Transcenta Updates: Partner Inhibrx Posts 20% ORR for Ozekibart in Late-Line Colorectal Cancer, Files U.S. BLA for Chondrosarcoma

Bulletin Express
05/21

Transcenta Holding Limited (Transcenta) released a voluntary announcement highlighting two milestones from its U.S. partner, Inhibrx Biosciences (Inhibrx, Nasdaq: INBX): positive interim efficacy data for ozekibart (INBRX-109) in colorectal cancer (CRC) and the April 2026 submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration for conventional chondrosarcoma. Transcenta retains exclusive development and commercial rights to ozekibart in mainland China, Hong Kong SAR, Macau SAR and Taiwan region and is assessing regional development plans in light of the new results.

Ozekibart + FOLFIRI in CRC • Study design: Phase 1/2 trial in locally advanced or metastatic unresectable CRC; data cutoff 10 April 2026. • Patient profile: 45 evaluable patients; 70% on fourth-line therapy; 80% previously progressed on irinotecan. • Objective Response Rate: 20% per RECIST v1.1, compared with historical 1–6% for current standards. Nearly half of responses lasted beyond six months; efficacy observed across RAS/RAF mutation statuses. • Progression-Free Survival: Median 5.50 months; 42% progression-free at the six-month landmark, with nine patients still on treatment. • Disease Control Rate: 87% (partial responses + stable disease). • Safety: Manageable profile; diarrhea, fatigue and nausea were the most common treatment-related adverse events, mainly Grade 1–2. No significant liver toxicity despite 68% baseline liver metastases.

Regulatory and development outlook Inhibrx intends to meet the FDA in 2H26 to discuss a first-line registrational trial in CRC and possible accelerated pathways for fourth-line CRC and refractory Ewing sarcoma.

Chondrosarcoma progress A BLA for ozekibart in conventional chondrosarcoma was submitted to the FDA in April 2026, addressing a disease with no approved systemic therapies. Ozekibart previously received Fast Track (January 2021) and Orphan Drug (November 2021) designations for this indication.

Mechanism of action Ozekibart is a precision-engineered tetravalent agonist antibody targeting death receptor 5 (DR5), designed to induce tumor-biased apoptosis. Expansion cohorts are also evaluating combinations with irinotecan-based regimens in Ewing sarcoma and CRC.

Cautionary note Development and commercialization outcomes are not guaranteed; shareholders and potential investors are advised to exercise caution when dealing in Transcenta shares.

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