Transcenta's partner Inhibrx announced positive new data for ozekibart in colorectal cancer and disclosed that it has submitted a Biologics License Application (BLA) to the FDA for chondrosarcoma.

Princeton, New Jersey and Suzhou, China – May 21, 2026 – Transcenta Holding Limited (HKEX: 06628), a clinical-stage global biopharmaceutical company with integrated capabilities in biologic discovery, research and development, process development, and manufacturing, announced that its partner, Inhibrx Biosciences, Inc. (“Inhibrx,” Nasdaq: INBX), recently released positive interim data from a Phase 1/2 clinical study evaluating ozekibart (INBRX-109) in combination with FOLFIRI for the treatment of patients with locally advanced or metastatic, unresectable colorectal cancer (CRC). Inhibrx also announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in April 2026 for ozekibart for the treatment of conventional chondrosarcoma.

Under a license agreement executed through its wholly owned subsidiary Hangzhou Y-Antibody BioPharma Co., Ltd. ("HJB"), Transcenta holds exclusive development and commercialization rights to ozekibart (INBRX-109) in mainland China, the Hong Kong Special Administrative Region, the Macau Special Administrative Region, and Taiwan. In light of the positive progress achieved with ozekibart, Transcenta is actively evaluating its development strategy in the Greater China region.

According to information disclosed by Inhibrx, the latest interim data showed that ozekibart demonstrated encouraging anti-tumor activity and a manageable safety profile in a heavily pre-treated CRC patient population. Among 45 evaluable patients, 70% received the combination regimen as fourth-line therapy, and 80% had previously been treated with an irinotecan-based regimen and experienced disease progression. As of the data cutoff date of April 10, 2026, the following observations were made:

Objective Response Rate (ORR):

Efficacy was assessed in 45 evaluable patients according to RECIST v1.1 criteria, yielding an ORR of 20%. By comparison, historical ORR rates for current standard-of-care regimens range from only 1% to 6% (per RECIST v1.1). Nearly half of the responses were durable, lasting longer than six months. Clinical benefit was observed regardless of RAS or RAF mutation status.

Progression-Free Survival (PFS):

The median PFS in the evaluable patient population was 5.5 months. Notably, at the 6-month timepoint, 42% of patients remained free of disease progression, with nine patients still continuing treatment, indicating that a substantial proportion of patients achieved long-term disease control beyond the median PFS.

Disease Control Rate (DCR):

The overall disease control rate (defined as best response of partial response or stable disease) remained high at 87%, further supporting the potential of ozekibart to control tumor progression in heavily pretreated patients.

Safety and Tolerability:

The combination of ozekibart with the FOLFIRI regimen continued to demonstrate a manageable safety profile. The most common treatment-emergent adverse events (TEAEs) included diarrhea, fatigue, and nausea, most of which were grade 1 or 2 and consistent with the known adverse reaction profile of FOLFIRI. Despite the majority of patients (68%) having liver metastases at baseline (at enrollment), no significant hepatotoxicity was observed.

Inhibrx plans to hold a meeting with the U.S. Food and Drug Administration (FDA) in the second half of 2026 to discuss initiating a registrational clinical trial of ozekibart for first-line treatment of colorectal cancer, as well as to explore potential accelerated approval pathways for ozekibart in fourth-line colorectal cancer and refractory Ewing sarcoma.

Beyond its colorectal cancer indication, Inhibrx also announced a significant regulatory milestone in chondrosarcoma. In April 2026, Inhibrx submitted a Biologics License Application (BLA) to the FDA for ozekibart in conventional chondrosarcoma—a disease for which no systemic therapies are currently approved.

These developments further validate the clinical and commercial potential of ozekibart across multiple indications and underscore the value of Transcenta’s exclusive rights in mainland China, the Hong Kong Special Administrative Region, the Macao Special Administrative Region, and Taiwan.

About Transcenta

Transcenta is a clinical-stage biopharmaceutical company with comprehensive capabilities in biologic drug discovery, research and development, process development, and production.

Headquartered in Suzhou, Transcenta has successfully established a global business presence: it operates drug discovery, clinical, and translational research centers in Suzhou, a process and product development center and manufacturing facility in Hangzhou, and clinical development centers in China, the United States, and Europe. Transcenta is developing a diversified pipeline of dozens of novel biologics covering oncology and non-oncology indications, including orthopedics, autoimmune diseases, and kidney diseases.

For more information about Transcenta, please visit the company website: www.transcenta.com or the LinkedIn page: Transcenta Therapeutics. If you are interested in exploring capital partnership opportunities with us, please reach out via ir@transcenta.com to connect and discuss potential collaborations.

About ozekibart (INBRX-109)

Ozekibart is a precisely engineered tetravalent agonistic antibody targeting Death Receptor 5 (DR5), designed to harness DR5 activation-induced tumor-selective cell death mechanisms for anti-tumor efficacy. In January 2021, the U.S. Food and Drug Administration (FDA) granted ozekibart Fast Track designation for the treatment of patients with metastatic or unresectable conventional chondrosarcoma; in November of the same year, the FDA further granted ozekibart Orphan Drug designation for chondrosarcoma.

In addition to its registrational clinical trial, Inhibrx is also advancing expansion cohorts of ozekibart to evaluate its combination with irinotecan-based regimens for the treatment of Ewing sarcoma and colorectal cancer. Early results have shown encouraging signals, supporting further exploration of ozekibart’s potential in these difficult-to-treat tumors with significant unmet medical needs.

Cautionary Statement: We cannot guarantee that we will successfully develop and ultimately commercialize Ozekibart (INBRX-109). Shareholders and prospective investors should exercise caution when buying or selling our shares.

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