Transcenta Announces Positive Ozekibart Clinical Data and U.S. BLA Submission by Inhibrx
Key Highlights for Investors
- Positive Updated Data: Transcenta’s partner, Inhibrx Biosciences (Nasdaq: INBX), has released encouraging updated interim results from its ongoing Phase 1/2 study of ozekibart (INBRX-109) in combination with FOLFIRI for patients with advanced, unresectable colorectal cancer (CRC).
- U.S. Regulatory Milestone: Inhibrx has announced the submission of a Biologics License Application (BLA) to the U.S. FDA for ozekibart in conventional chondrosarcoma, a rare bone cancer with no approved systemic treatments, as of April 2026.
- Exclusive Regional Rights: Transcenta holds the exclusive rights to develop and commercialize ozekibart in mainland China, Hong Kong SAR, Macau SAR, and Taiwan via its wholly owned subsidiary HJB (Hangzhou) Co., Ltd.
Detailed Clinical Results
- Patient Profile: The data cutoff was April 10, 2026, covering 45 evaluable patients with heavily pretreated CRC. About 70% received ozekibart as fourth-line therapy, and 80% had progressed on irinotecan-based regimens.
- Objective Response Rate (ORR): The ORR reached 20% per RECIST v1.1 criteria—substantially higher than the 1-6% for current standard of care treatments. Nearly half of the responses were durable, lasting over 6 months. Importantly, responses were observed regardless of RAS/RAF mutation status.
- Progression-Free Survival (PFS): Median PFS was 5.5 months. At the 6-month mark, 42% of patients remained progression-free; 9 patients were still on therapy, indicating potential for prolonged disease control.
- Disease Control Rate (DCR): DCR, including partial responses and stable disease, was 87%, underscoring ozekibart’s potential to control tumor growth in a challenging patient population.
- Safety Profile: The combination of ozekibart and FOLFIRI was well-tolerated. The most common side effects were diarrhea, fatigue, and nausea (mainly Grade 1-2). Even though 68% had liver metastases, no significant liver toxicity was detected.
Regulatory and Commercial Implications
- Upcoming FDA Discussions: Inhibrx plans to meet with the FDA in the second half of 2026 to discuss the initiation of a first-line registrational trial in CRC and explore accelerated pathways for fourth-line CRC and refractory Ewing sarcoma.
- Chondrosarcoma BLA Submission: The April 2026 BLA filing for ozekibart in conventional chondrosarcoma is a critical regulatory milestone, as there are currently no approved systemic therapies for this cancer.
- Expansion Opportunities: Ongoing trials are further evaluating ozekibart in combination with irinotecan-based regimens for Ewing sarcoma and CRC, with early signals supporting broader development.
Potential Impact on Shareholders and Share Price Sensitivity
- The positive efficacy and safety results, combined with a robust DCR and ORR in a heavily pretreated CRC population, position ozekibart as a potentially best-in-class asset.
- The U.S. BLA submission for chondrosarcoma may open the door for the first approved systemic treatment in this indication, representing a significant commercial opportunity.
- Transcenta’s exclusive rights in Greater China could become increasingly valuable if U.S. regulatory approval is secured, potentially leading to accelerated development and commercialization in the region.
- Investors should closely monitor upcoming FDA engagements and regulatory decisions that may serve as major share price catalysts.
About Ozekibart (INBRX-109)
Ozekibart is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody, designed to trigger tumor-selective cell death through DR5 activation. The FDA granted ozekibart Fast Track designation in January 2021 and orphan drug designation in November 2021 for chondrosarcoma.
Management and Board
The announcement was signed on behalf of the Board by Dr. Xueming Qian, Executive Director, Chairman, and CEO. The Board also includes Dr. Li Xu (Non-executive Director), and four Independent Non-executive Directors: Mr. Jiasong Tang, Mr. Zhihua Zhang, Dr. Kumar Srinivasan, and Ms. Helen Wei Chen.
Disclaimer
Cautionary Statement: There is no assurance that Transcenta will be able to successfully develop or ultimately market ozekibart (INBRX-109). Shareholders and potential investors are advised to exercise caution when dealing in the shares of the Company.
Transcenta 宣佈合作夥伴 Inhibrx 公佈 Ozekibart 正面臨牀數據及美國 BLA 申請
投資者重點資訊
- 正面臨牀數據：Transcenta 合作夥伴 Inhibrx Biosciences（納斯達克：INBX）發佈 Ozekibart（INBRX-109）聯合 FOLFIRI 治療晚期、不可切除結直腸癌（CRC）患者的第一/二期臨牀研究正面中期結果。
- 美國監管里程碑：Inhibrx 已於 2026 年 4 月向美國 FDA 提交 Ozekibart 用於常規軟骨肉瘤的生物製劑許可申請（BLA），該病種目前尚無獲批系統性治療。
- 大中華獨家權利：Transcenta 透過全資子公司 HJB（杭州）有限公司，持有 Ozekibart 在中國內地、香港、澳門和台灣的獨家開發及商業化權利。
臨牀數據詳情
- 患者特點：截至 2026 年 4 月 10 日，數據涵蓋 45 名重度治療後的 CRC 患者。約 70% 為四線治療，80% 曾於伊立替康方案失效。
- 客觀緩解率（ORR）： 按 RECIST v1.1 評估，ORR 達 20%，遠高於現有標準治療的 1-6%。近半數反應持續超過 6 個月，且不受 RAS/RAF 基因突變狀態影響。
- 無惡化生存期（PFS）： 中位 PFS 為 5.5 個月，42% 患者於 6 個月時仍無疾病進展，9 名患者持續治療中，顯示疾病控制具持久性。
- 疾病控制率（DCR）： 包括部分緩解及疾病穩定，DCR 為 87%，證明 Ozekibart 在難治患者群中具高度抑瘤潛力。
- 安全性： Ozekibart 聯合 FOLFIRI 具有良好耐受性，常見副作用為腹瀉、疲勞及噁心（多為 1-2 級），68% 患者基線時有肝轉移，仍未見顯著肝毒性。
監管及商業前景
- 美國 FDA 溝通：Inhibrx 計劃於 2026 年下半年與 FDA 商討 CRC 一線註冊性試驗及四線 CRC 和難治性尤文氏肉瘤的加速審批路徑。
- 軟骨肉瘤 BLA 申請：2026 年 4 月已向 FDA 提交 Ozekibart 用於常規軟骨肉瘤的 BLA 申請，該病種目前無獲批系統性治療。
- 拓展機會： 現正開展更多聯合伊立替康方案的擴展試驗，早期信號顯示於尤文氏肉瘤及 CRC 潛力巨大。
對股東及股價的潛在影響
- Ozekibart 在重度治療後 CRC 患者中展現出色療效與安全性，有望成為同類最佳藥物。
- 軟骨肉瘤 BLA 申請如獲批，將填補該領域治療空白，開啟重大商業機遇。
- 若取得美國註冊，Transcenta 的大中華區獨家權利價值有望顯著提升，推動區內加速研發及上市。
- 投資者應密切關注 FDA 相關進展，因其有望成為重要股價催化劑。
關於 Ozekibart（INBRX-109）
Ozekibart 屬高精度四價 DR5 受體激動劑抗體，通過活化 DR5 觸發腫瘤細胞凋亡。2021 年 1 月獲 FDA 授予快速通道資格，11 月獲孤兒藥資格（軟骨肉瘤）。
管理層與董事會
公告由執行董事、董事長兼行政總裁錢學明博士簽署。董事會成員包括：非執行董事徐力博士及四位獨立非執行董事：湯家松先生、張志華先生、Kumar Srinivasan 博士、陳慧玲女士。
免責聲明
風險提示：Transcenta 未必能成功開發或最終上市 Ozekibart（INBRX-109）。股東及潛在投資者於買賣公司股份時須審慎行事。
