By Fineline Cube 
Imugene Ltd (ASX: IMU) and JW Therapeutics (Shanghai) Co., LTD (HKG: 2126) announced a co‑development collaboration to evaluate the combination of Imugene’s oncolytic virus CF33‑CD19 (onCARlytics) and JW’s Carteyva—a CD19‑directed autologous CAR‑T cell therapy—for patients with advanced solid tumors.
Collaboration Overview
| Element | Detail |
|---|---|
| Partners | Imugene Ltd (ASX:IMU) + JW Therapeutics (HKEX:2126) |
| Imugene Asset | CF33‑CD19 (onCARlytics) – oncolytic virus engineered to express CD19 |
| JW Asset | Carteyva – anti‑CD19 autologous CAR‑T cell therapy |
| Indication | Advanced solid tumors (multiple histologies) |
| Strategy | Mark and Kill: Virus induces CD19 on tumor cells → CAR‑T mediated clearance |
| Territory | China‑only clinical development |
Mechanism of Action & Innovation
- Transformative Approach: onCARlytics infects solid tumor cells, forcing ectopic CD19 expression that is normally absent in non‑hematologic cancers.
- Dual‑Agent Synergy: Carteyva CAR‑T cells recognize de novo CD19 epitopes, triggering potent T‑cell cytotoxicity while the virus continues oncolytic replication.
- Preclinical Validation: In vivo models show >80 % tumor regression versus monotherapy controls; enhanced T‑cell persistence at tumor sites.
- IP Position: Imugene holds global patents on CD19‑transgene‑armed oncolytic poxviruses; JW contributes proprietary CAR‑T manufacturing know‑how.
Clinical Development Roadmap
| Phase | Activities | Timeline | Key Endpoints |
|---|---|---|---|
| Preclinical | In vitro co‑culture killing assays; orthotopic mouse models | Q1 2026 | Synergy confirmation, dosing schema |
| Phase 1 | Investigator‑initiated trial (IIT) at premier Chinese CAR‑T centers | H2 2026 – H2 2027 | Safety, CD19 induction rates, ORR, DLTs |
| Next Steps | Expansion cohorts; potential registrational path in China | 2028+ | PFS, OS, biomarker‑driven patient selection |
Strategic Context & Market Implications
- China CAR‑T Leadership: JW Therapeutics is the first company to commercialize a CAR‑T product in China (relma-cel); dominates the domestic cell‑therapy infrastructure.
- Solid Tumor Unmet Need: Current CAR‑T therapies show limited efficacy in solid tumors due to antigen heterogeneity; the Mark and Kill paradigm could unlock a >US$10 billion global market.
- Revenue Upside: If Phase 1 succeeds, JW gains exclusive China rights; Imugene eligible for milestones + double‑digit royalties. Analysts estimate peak China sales potential of ¥2.5 billion (≈ US$350 million) for the combination.
- Competitive Moat: No approved oncolytic‑CAR‑T combos exist; first‑mover advantage in China could set the global standard.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding preclinical results, trial initiation timelines, and commercial potential. Actual outcomes may vary due to regulatory, clinical, and competitive risks.-Fineline Info & Tech