- Akari Therapeutics has initiated GMP manufacturing activities for its lead antibody-drug conjugate candidate, AKTX-101.
- The company has selected WuXi XDC as its CDMO partner to support IND-enabling manufacturing ahead of planned clinical trials.
Akari Therapeutics has begun GMP manufacturing to support the development of AKTX-101, its lead antibody-drug conjugate (ADC) programme, as the company prepares for investigational new drug (IND)-enabling activities. The work is intended to support the initiation of clinical trials for the oncology candidate.
The company has selected WuXi XDC as its contract development and manufacturing organisation (CDMO) partner for the programme. WuXi XDC will provide end-to-end ADC development and GMP manufacturing services to produce clinical-grade material for AKTX-101.
AKTX-101 incorporates Akari’s proprietary PH1 payload, which is designed to act through RNA splicing modulation. According to the company, the payload combines cytotoxic and immuno-oncology mechanisms and is intended to differentiate the ADC from existing approaches.
“Initiating GMP manufacturing of AKTX-101 is an important milestone for Akari and for AKTX-101 as we look to demonstrate the potential of our PH1 ADC payload in treating cancer patients.”
Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics
The resulting GMP drug product is expected to support a planned Phase 1 first-in-human clinical trial, which Akari anticipates initiating in late 2026 or early 2027, subject to regulatory clearance. The collaboration reflects Akari’s strategy to advance novel ADC payload technologies through CDMO and contract manufacturing partnerships.
