Press Release
2026 - 05 - 21
PRINCETON, N.J. and SUZHOU, China, May 21, 2026 -- Transcenta Holding Ltd. (HKEX: 06628), a global clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announced that its partner Inhibrx Biosciences, Inc. ("Inhibrx") (Nasdaq: INBX) recently reported positive updated interim data from its Phase 1/2 study evaluating ozekibart (INBRX-109) in combination with FOLFIRI in patients with locally advanced or metastatic, unresectable colorectal cancer (CRC). Inhibrx also announced the submission of a Biologics License Application (BLA) to the FDA for ozekibart in conventional chondrosarcoma in April 2026.
Transcenta holds the exclusive rights to develop and commercialize ozekibart (INBRX-109) in mainland China, Hong Kong SAR, Macau SAR, and Taiwan region under a license agreement executed through HJB (Hangzhou) Co., Ltd * (杭州奕安济世生物药业有限公司) (“HJB”), a wholly owned subsidiary of the Company. In light of these positive developments for ozekibart, Transcenta is actively evaluating its plans in the Greater China region.
According to Inhibrx, the updated interim data demonstrated encouraging anti-tumor activity and a manageable safety profile in a heavily pretreated CRC patient population. As of April 10, 2026, the cutoff date, among the 45 evaluable patients, approximately 70% received ozekibart as a fourth-line therapy, and 80% had previously progressed on irinotecan-based regimens. The following data were observed:
l Objective Response Rate (ORR): Efficacy was assessed in 45 evaluable patients, resulting in an ORR of 20% per RECIST v1.1 criteria. Historically, the current standard of care has yielded limited response rates (ORR of 1-6% per RECIST v1.1 criteria). Nearly half of responses were durable with a duration of response exceeding 6 months. Responses were observed irrespective of RAS/RAF mutation status.
l Progression-Free Survival (PFS): The median PFS for the evaluable population was 5.5 months. Notably, 42% of patients remained progression-free at the 6-month landmark, with 9 patients remaining on therapy, suggesting that a significant portion of patients achieved durable disease control that extended well beyond the median PFS.
l Disease Control Rate (DCR): The overall disease control rate (partial responses and stable disease as best response) remained robust at 87%, further supporting the potential of ozekibart to control tumor growth in a heavily pre-treated population.
l Safety and tolerability: Ozekibart in combination with FOLFIRI continues to maintain a manageable safety profile. The most common treatment-related adverse events (TEAEs) were diarrhea, fatigue, and nausea, which were largely Grade 1 or 2 and consistent with the known side effects of FOLFIRI. Despite the majority of the patients (68%) presenting with liver metastases at baseline, no significant liver toxicity was observed.
Inhibrx stated that it plans to meet with the FDA in the second half of 2026 to discuss initiation of a first-line registrational trial in CRC, as well as potential accelerated regulatory pathways for ozekibart in fourth-line CRC and refractory Ewing sarcoma.
Beyond the CRC indication, Inhibrx announced a key regulatory milestone in chondrosarcoma. In April 2026, Inhibrx submitted a BLA to the FDA for ozekibart in conventional chondrosarcoma, a disease with no currently approved systemic treatment options.
These developments further validate the clinical and commercial potential of ozekibart across multiple indications and reinforce the value of Transcenta’s exclusive rights in mainland China, Hong Kong SAR, Macau SAR, and Taiwan region.
About Ozekibart (INBRX-109)
Ozekibart is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation. In January 2021, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to ozekibart for the treatment of patients with metastatic or unresectable conventional chondrosarcoma, and, in November 2021, the FDA granted orphan drug designation to ozekibart for chondrosarcoma.
In addition to the registrational trial, Inhibrx is advancing ongoing expansion cohorts, evaluating ozekibart in combination with irinotecan-based regimens in Ewing sarcoma and colorectal cancer. Encouraging early signals support further exploration of ozekibart's potential in these difficult-to-treat tumor types with high unmet medical need.
Cautionary statement: We cannot guarantee that we will be able to develop, or ultimately market ozekibart (INBRX-109) successfully. Shareholders and potential investors of the Company are advised to exercise caution when dealing in the shares of the Company.
About Transcenta Holding Ltd.
Transcenta Holding Ltd. (HKEX: 06628) is a global clinical stage biopharmaceutical company with fully integrated capabilities in antibody-based biotherapeutics discovery, research, development and manufacturing.
Transcenta has established global footprint, with Headquarters and Discovery, Clinical and Translational Research Center in Suzhou, Process and Product Development Center and Manufacturing Facility in Hangzhou, and Clinical Development Centers in China, U.S. and Europe. Transcenta is developing a diverse pipeline of more than a dozen novel biologic therapies for oncology and selected non-oncology indications including bone and kidney disorders.
For more information, please visit www.transcenta.com and https://www.linkedin.com/company/transcenta. For inquiries regarding Business Development opportunities, please contact us at bd@transcenta.com
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