Partner Inhibrx Biosciences, Inc. has reported positive interim data from a Phase 1/2 study evaluating ozekibart in combination with FOLFIRI for patients with locally advanced or metastatic, unresectable colorectal cancer. Inhibrx also announced the submission of a Biologics License Application to the FDA in April 2026 for ozekibart for the treatment of conventional chondrosarcoma.
Under a license agreement through its wholly-owned subsidiary, TRANSCENTA-B holds exclusive rights to develop and commercialize ozekibart in Mainland China, Hong Kong, Macau, and Taiwan. Given these positive developments for ozekibart, TRANSCENTA-B is actively evaluating its plans for the Greater China region.
According to Inhibrx, the updated interim data shows encouraging anti-tumor activity and a manageable safety profile in a heavily pre-treated CRC patient population. As of the cutoff date of April 10, 2026, among 45 evaluable patients, approximately 70% received ozekibart as a fourth-line therapy, and 80% had progressed after prior irinotecan-based regimens. The following data were observed:
* Objective Response Rate: The ORR was 20% per RECIST v1.1 criteria. Historically, current standard-of-care therapies have limited response rates of 1-6%. Nearly half of the responses were durable, lasting over 6 months. Responses were observed regardless of RAS/RAF mutation status. * Progression-Free Survival: The median PFS for the evaluable population was 5.5 months. Notably, 42% of patients remained progression-free at the 6-month timepoint, with 9 patients still on treatment, indicating a significant portion achieved durable disease control beyond the median PFS. * Disease Control Rate: The overall DCR, defined as partial response or stable disease as the best response, remained robust at 87%, further supporting ozekibart's potential to control tumor growth in this heavily pre-treated population. * Safety and Tolerability: Ozekibart in combination with FOLFIRI continued to demonstrate a manageable safety profile. The most common treatment-emergent adverse events were diarrhea, fatigue, and nausea, mostly Grade 1 or 2, consistent with the known side effects of FOLFIRI. Despite most patients having liver metastases at baseline, no significant hepatotoxicity was observed.
Inhibrx stated it plans to meet with the FDA in the second half of 2026 to discuss initiating a first-line CRC registrational trial and the potential for accelerated regulatory pathways for ozekibart in fourth-line CRC and refractory Ewing sarcoma.
In addition to the CRC indication, Inhibrx announced a significant regulatory milestone for ozekibart in chondrosarcoma. In April 2026, Inhibrx submitted a BLA to the FDA for ozekibart for conventional chondrosarcoma, a disease for which there are currently no approved systemic treatment options.
These developments further validate the clinical and commercial potential of ozekibart across multiple indications and enhance the value of the exclusive rights held by TRANSCENTA-B in Mainland China, Hong Kong, Macau, and Taiwan.
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