Akari Therapeutics, Plc, an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel payloads, announced the initiation of GMP manufacturing activities to support the development of AKTX-101, the company’s lead ADC program.

Akari has selected WuXi XDC, a contract development and manufacturing organization (CDMO), as its partner to provide necessary IND-enabling work to support the initiation of clinical trials. 

The initiation of manufacturing activity marks a significant advancement for AKTX-101, which incorporates Akari’s novel payload PH1 that works through RNA splicing modulation. The PH1 payload represents a differentiated approach to ADC design and brings a 1-2 punch of cytotoxicity and immuno-oncology action that has the potential to significantly increase the therapeutic impact of ADCs beyond today’s current options.

“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,” said Abizer Gaslightwala, President and CEO of Akari Therapeutics. “Advancing this critical project with WuXi XDC reflects our confidence in the science behind AKTX-101 and our path to the clinic. This key work lays the foundation for our planned Phase 1 first-in-human study in approximately 12 months.”

“We are excited to work with Akari Therapeutics on the manufacturing of AKTX-101,” said Dr. Jimmy Li, CEO of WuXi XDC. “The PH1 payload represents a novel and potentially high impact innovation in the ADC field, and we look forward to leveraging our integrated ADC platform to support the production of high-quality GMP material and help advance this promising program toward the clinic. We believe this first project with Akari could lay the groundwork for multiple ADC programs that utilize this novel payload.”