On December 23, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel payloads reported the initiation of GMP manufacturing activities to support the development of AKTX-101, the Company’s lead ADC program.
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Akari has selected WuXi XDC, the world’s leading ADC contract development and manufacturing organization (CDMO), as its partner for this critical and necessary IND-enabling work to support the initiation of clinical trials. WuXi XDC is globally recognized for its end-to-end ADC development and manufacturing capabilities and deep expertise in producing large numbers of ADCs that are currently in clinical development.
The initiation of this key manufacturing activity marks a significant advancement for AKTX-101, which incorporates Akari’s novel proprietary 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. To have WuXi XDC as our key partner adds to our confidence of reaching the clinical trials quickly and efficiently and with the highest quality. This key work lays the foundation for our planned Phase 1 first-in-human study in approximately 12 months."
WuXi XDC also highlighted the importance of the collaboration with Akari and the innovative nature of Akari’s ADC payload, PH1:
"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."
Akari and WuXi XDC are building a strategic partnership around AKTX-101, combining Akari’s innovative ADC design and payload technology with WuXi’s global leadership in ADC development and manufacturing. The resulting GMP-grade drug product is intended to support Akari’s planned Phase 1 first-in-human clinical trial, which the Company expects to initiate in late 2026 or early 2027, subject to regulatory clearance.
This manufacturing milestone underscores Akari’s continued progress in advancing its pipeline and executing on its strategy to develop differentiated ADC therapies using novel payloads that have the potential to significantly improve outcomes for cancer patients.
(Press release, Akari Therapeutics, DEC 23, 2025, View Source [SID1234661605])