TransThera Sciences (Nanjing), Inc. Announces Pivotal Phase II Data for Tinengotinib at ASCO 2026
Key Highlights and Investor-Relevant Details
TransThera Sciences (Nanjing), Inc. has released a voluntary announcement detailing a significant milestone in its clinical program for Tinengotinib (TT-00420), a novel multi-kinase inhibitor. The company will present pivotal Phase II trial data for Tinengotinib monotherapy targeting FGFR2-altered cholangiocarcinoma (CCA) patients who have failed prior chemotherapy and FGFR inhibitor treatments at the prestigious 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
- Poster Presentation: May 30, 2026, 9:00 AM-12:00 PM CDT. Poster Board: 116
- Study Title: “Tinengotinib (TT-00420) in Advanced/Metastatic FGFR2-Altered Cholangiocarcinoma Following Prior Chemotherapy and FGFR inhibitor treatment: Results from a Phase II Study (FIRST-08)”
- Patient Population: Advanced, FGFR inhibitor refractory/relapsed CCA; all had at least one line of chemotherapy and FGFR inhibitor, with a high proportion (40%) having received three or more prior systemic regimens, and 66% having prior immunotherapy.
Clinical Data and Results
The Phase II study enrolled 50 patients in China, with a median follow-up of 12 months. Tinengotinib was administered at 10 mg once daily. The results are promising for a heavily pre-treated patient group:
- Objective Response Rate (ORR): 28.0% (14 confirmed partial responses), as assessed by blinded independent central review.
- Median Duration of Response (DoR): 8.5 months (range 5.6-12.5 months).
- Disease Control Rate (DCR): 82.0%.
- Median Progression-Free Survival (PFS): 6.1 months (range 4.4-8.3 months).
- Median Overall Survival (OS): 20.7 months (lower bound 11.8 months, upper bound not reached); 18 months survival rate is 51.8%.
- Safety: Tinengotinib demonstrated a manageable safety profile.
Advancement to Phase III and Regulatory Designations
Global Phase III pivotal study is currently open to further evaluate Tinengotinib in FGFR2-altered CCA patients who have progressed on chemotherapy and FGFR inhibitors (NCT05948475). Additionally, a domestic Phase III confirmatory trial is underway in China to compare Tinengotinib against chemotherapy in unresectable advanced or metastatic intrahepatic CCA with FGFR2 fusion/rearrangement or mutation after first-line systemic therapy (CTR20255200).
Tinengotinib has garnered multiple regulatory designations, underscoring its potential market impact:
- FDA: Orphan Drug Designation (ODD) and Fast Track Designation (FTD) for CCA
- EMA: Orphan Drug Designation for biliary tract cancer
- China NMPA: Priority Review and Approval Procedure, Breakthrough Therapy Designation (BTD) for CCA
Investor Impact and Share Price Sensitivity
The announcement is potentially price-sensitive for shareholders due to the following factors:
- Positive Phase II results in a hard-to-treat population with limited options after chemotherapy and FGFR inhibitor failure, supporting Tinengotinib’s efficacy and safety profile.
- Advancement to global and domestic Phase III pivotal trials increases the likelihood of regulatory approval and commercialization, which may significantly drive future revenues.
- Multiple regulatory designations (ODD, FTD, BTD) enhance market access and potential exclusivity, reinforcing Tinengotinib’s commercial prospects.
However, the company warns that there is no assurance the relevant products will ultimately be successfully developed and marketed.
Corporate Governance
The announcement is authorized by Dr. Frank Wu, Chairman and CEO. As of May 31, 2026, the Board comprises executive, non-executive, and independent directors, maintaining robust corporate governance.
About Tinengotinib
Tinengotinib is an internally discovered, NDA-stage, multi-kinase inhibitor targeting FGFRs/VEGFRs, Aurora A/B, and Janus kinases. It has shown efficacy in various solid tumors including cholangiocarcinoma, prostate, breast, and liver cancers.
Disclaimer
This article is for informational purposes only. It does not constitute investment advice. There is no assurance that Tinengotinib or any related products will be successfully developed, approved, or marketed. Investors should conduct their own research and consult professional advisors before making any investment decisions.
TransThera Sciences（南京）有限公司公佈Tinengotinib在ASCO 2026關鍵II期數據（粵語版）
重點及投資者須知
TransThera Sciences（南京）有限公司自願公告其創新型多靶點激酶抑制劑Tinengotinib（TT-00420）在治療FGFR2基因異常膽管癌（CCA）患者的關鍵II期臨床進展。公司將於2026年美國臨床腫瘤學會（ASCO）芝加哥年會公佈數據。
- 海報展示：2026年5月30日，上午9:00至中午12:00（CDT）。展板116號。
- 研究標題：「Tinengotinib（TT-00420）於化療及FGFR抑制劑治療後進展的晚期FGFR2異常膽管癌——II期研究（FIRST-08）結果」
- 患者群：晚期、FGFR抑制劑耐藥/復發CCA，全部曾接受化療及FGFR抑制劑，40%曾接受三種或以上系統方案，66%接受過免疫治療。
臨床數據及結果
- 入組患者：50名中國患者，隨訪中位數12個月，Tinengotinib每日10mg。
- 客觀緩解率（ORR）：28.0%（14例確認部分緩解），經盲法中央評審。
- 緩解持續時間（DoR）:中位數8.5個月（5.6-12.5月範圍）。
- 疾病控制率（DCR）：82.0%。
- 無進展生存期（PFS）：中位數6.1個月（4.4-8.3月）。
- 總生存期（OS）：中位數20.7個月（下限11.8月，上限未達），18個月生存率51.8%。
- 安全性：Tinengotinib安全性可控，耐受性良好。
III期研究及監管動態
- 全球III期關鍵研究（NCT05948475）現正開展，評估Tinengotinib於化療及FGFR抑制劑失敗後的療效與安全。
- 中國III期確認性試驗（CTR20255200）亦進行中，對比Tinengotinib與化療於不可切除晚期或轉移性FGFR2異常膽管癌患者的療效。
Tinengotinib獲得多項監管認證，提升市場競爭力：
- FDA：孤兒藥認證（ODD）、快速通道（FTD）
- 歐洲藥監局（EMA）：膽道癌孤兒藥認證
- 中國NMPA：優先審批、突破性治療（BTD）
對投資者及股價敏感事項
- II期數據於難治患者中取得明顯療效及安全性，支持Tinengotinib後續發展。
- III期研究啟動及多項監管認證，增加獲批及商業化機會，或帶來重大收入增長。
- 監管認證加強市場進入及排他性，提升產品價值。
- 警告：產品能否最終成功開發及上市，尚無保證。
公司治理
公告由董事長兼CEO Dr. Frank Wu授權，董事會組成包括執行、非執行及獨立董事，治理完善。
關於Tinengotinib
Tinengotinib屬自主研發、申請新藥階段的多靶點激酶抑制劑，靶向FGFR/VEGFR、Aurora A/B及JAK。全球多項臨床研究顯示其對膽管癌、前列腺癌、乳癌及肝癌具療效。
免責聲明
本文章僅供資訊參考，不構成投資建議。Tinengotinib及相關產品最終能否成功開發、獲批或上市，無法保證。投資者應自行研究並諮詢專業意見。
