AKTX-101

August 18, 2026: Akari Therapeutics plc (NASDAQ: AKTX) reported new preclinical data for AKTX-101, a TROP2-targeted ADC with a PH1 RNA spliceosome-modulating payload, in urothelial cancer. In the UM-UC-14 advanced urothelial carcinoma model, AKTX-101 showed statistically significant tumor growth inhibition versus vehicle, while Padcev (enfortumab vedotin) had limited responsiveness in the same model. In a separate model, tumors that acquired resistance after initial treatment with Trodelvy (sacituzumab govitecan) resumed growth, but switching to AKTX-101 again slowed tumor growth, supporting potential activity after resistance to a first-generation TROP2 ADC and suggesting resistance may be linked to the topoisomerase I payload rather than loss of TROP2.

The company said the findings support a differentiated ADC payload/sequencing strategy in settings where currently approved ADCs may have limited benefit, including relapse after prior ADC exposure. Akari is advancing IND-enabling activities for AKTX-101 and plans to initiate a Phase 1 clinical trial in mid-2027. The release also notes AKTX-102, a CEACAM5-targeted ADC using the same PH1 payload platform, is in development, but no new data were reported for that program.