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ESMO 2023 – BioNTech still has work to do on Claudin6

On the face of it a 59% response rate with BioNTech’s Claudin6-targeting Car-T therapy BNT211 seems promising. But a closer look at the results presented at ESMO yesterday, from a phase 1/2 trial in Claudin6-positive solid tumours, shows that this was achieved with a dose of 1x108 Car-T cells that “seems to be toxic”, according to the discussant, Centre Léon Bérard’s Dr Philippe Cassier. 15 of 27 patients receiving this dose experienced cytokine release syndrome. Across the whole trial, the ORR was 45% among 38 evaluable patients – still a respectable result in a study population dominated by ovarian and germ cell cancers. The investigators are now “backfilling” doses to find a recommended phase 2 dose. After last year’s ESMO update covered a manual manufacturing process yesterday's data involved automation, which adds potency and toxicity alike. Some patients also received a mRNA vaccine, called CarVac, designed to boost BNT211. The ESMO presentation didn’t break out responses according to who had received CarVac, although biomarker data suggested that the vaccine could improve BNT211’s persistence. BioNTech still has much to iron out ahead of its phase 2 trial of BNT211, set to begin next year. Still, the company is ahead in the Claudin6 arena.

 

ProjectCompanyDescriptionStatusNote
BNT211BioNTechCLDN6 CAR-TPh1/2 trial +/- CARVac in CLDN6+ solid tumours (NCT04503278)ESMO 2023 with automated manufacturing: 45% ORR (17/38) across all doses; 59% ORR (13/22) at dose level 2 (1x108 Car-T cells)
TORL-1-23TORL BiotherapeuticsAnti-CLDN6 ADCPh1 in solid tumours (NCT05103683)ASCO 2023: 28% ORR (7/25) across all doses
DS-9606Daiichi SankyoAnti-CLDN6 ADCPh1 in tumours known to express CLDN6 (NCT05394675)Primary completion Nov 2023
BNT142BioNTechAnti-CLDN6/CD3 mRNA-encoded bispecific MAbPH1/2 in CLDN6+ solid tumours (NCT05262530)Primary completion Oct 2025
AMG 794AmgenAnti-CLDN6/CD3 BiTEPh1 in CLDN+ NSCLC, epithelial ovarian cancer & other solid tumours (NCT05317078)Primary completion Apr 2026
SAIL66Roche/ ChugaiAnti-CLDN6/CD3 bispecific antibodyPh1 in CLDN+ solid tumours (NCT05735366)Primary completion Dec 2028

Source: OncologyPipeline.

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