By Fineline Cube 
TransThera Sciences (Nanjing) Inc. (HKG: 2617) announced the first patient dose in an open‑label, multi‑center Phase II clinical trial evaluating its flagship product Tinengotinib (TT‑00420) in combination with Akeso Bio’s bispecific antibodies AK‑112 (cadonilimab) and AK‑102 (ivonescimab) for advanced hepatocellular carcinoma (HCC).
Study Design
- Population – Patients with advanced, therapy‑refractory HCC.
- Intervention – Oral Tinengotinib plus either AK‑112 (PD‑1/CTLA‑4) or AK‑102 (PD‑1/VEGF).
- Endpoints – Objective response rate, progression‑free survival, overall survival, and safety.
- Phase – Open‑label, multi‑center, global enrollment.
Tinengotinib – A Multi‑Kinase Inhibitor
| Target | Therapeutic Rationale |
|---|---|
| FGFR / VEGFR | Inhibits angiogenesis and tumor proliferation. |
| JAK | Modulates cytokine signaling and immune evasion. |
| Aurora kinases | Suppresses mitotic progression in cancer cells. |
- Clinical Status – In global Phase III registration studies for solid tumors.
- Regulatory Designations – FDA: Orphan Drug & Breakthrough Therapy; EMA: Orphan Drug.
- Efficacy Portfolio – Demonstrated activity in cholangiocarcinoma, metastatic castration‑resistant prostate cancer (mCRPC), and other solid tumors.
Strategic Rationale
- Synergy with Bispecifics – Combining kinase inhibition with dual checkpoint/angiogenesis blockade may overcome resistance mechanisms in HCC.
- Accelerated Pathway – Phase II data will inform dosing and safety for the upcoming Phase III program.
- Portfolio Expansion – Positions TransThera as a leader in oncology drug combinations, enhancing its valuation and investor appeal.
Market Implications
- HCC Landscape – Rising incidence and limited effective options; combination therapies are a focus of regulatory agencies and payers.
- Competitive Edge – Tinengotinib’s broad kinase inhibition combined with Akeso’s bispecific platform offers a unique mechanism profile versus existing TKIs and immunotherapies.
- Commercial Potential – Successful trial outcomes could unlock significant revenue streams in the >$3 B HCC market.-Fineline Info & Tech