New Medicines

Solid tumours


New molecular entity
Takeda & Turnstone Biologics
Takeda & Turnstone Biologics

Development and Regulatory status

Phase II Clinical Trials
Apr 21Takeda anticipates the approval of RIVAL 01 in 2025/2026 [2].
Dec 19Takeda enters into licensing agreement with Turnstone Biologics for RIVAL 01, and will co-develop and co-commercialise RIVAL 01 [2].


A vaccinia virus based oncolytic virus immunotherapy, engineered to encode fms-like tyrosine kinase 3 (Flt3) ligand, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody and interleukin 12. Once inside the body, the viruses enter and replicate inside the tumour cells resulting in local production of Flt3 ligand, IL-12 and anti-CTLA-4 antibody. Booster injections of TBio-6517 are permitted for up to 24 months, after injection of 4 initial doses.
Variable depending on tumour type.
Solid tumours

Trial or other data

Mar 22PI/IIa RAPTOR is recruiting [1].
Jun 20Jun 20: PI/IIa RAPTOR dose-escalation trial of RIVAL 01 administered by intratumoural injection(s) alone and in combination with pembrolizumab, in patients with advanced solid tumours starts (NCT04301011; TBio-6517-ITu-001). The non-randomised, open-label trial intends to recruit 84 patients in the US and Republic of Korea (no UK sites). The Phase 1 portion has 4 arms; the first arm (Arm A) will determine the RP2D of TBio-6517 alone when directly injected into tumor(s), and the second arm (Arm B) will determine the RP2D of TBio-6517 when combined with pembrolizumab. The third and fourth arms will determine the RP2D of TBio-6517 when given intravenously alone and with pembrolizumab, respectively. In the Phase 2a portion, the clinical benefit of TBio-6517 combined with pembrolizumab will be further explored in patients with Microsatellite Stable Colorectal Cancer (MSS-CRC), Cholangiocarcinoma (CCA), Cutaneous Melanoma, and Cutaneous Squamous Cell Carcinoma of the Skin (cSCC), as assessed by overall response rate (ORR) from central radiology review. Booster injections of TBio-6517 are permitted for up to 24 months. Primary outcomes include adverse events, maximum tolerated dose and overall response rate; collection of these data is due to complete Dec 24 [1].