Akari Therapeutics Initiates GMP Manufacturing For AKTX-101 ADC To Support First-In-Human Clinical Study

Akari Therapeutics, Plc, an oncology biotechnology company focused on developing antibody-drug conjugates (ADCs) with novel payloads, announced the start of GMP manufacturing activities to support the development of its lead ADC program, AKTX-101. The company has partnered with WuXi XDC, a globally recognized ADC contract development and manufacturing organization (CDMO), to conduct this essential IND-enabling work in preparation for clinical trials. WuXi XDC is known for its comprehensive ADC development and manufacturing capabilities, including experience producing large numbers of ADCs currently in clinical development.

The initiation of GMP manufacturing marks a significant step forward for AKTX-101, which features Akari’s proprietary PH1 payload. This innovative payload works through RNA splicing modulation, representing a differentiated approach to ADC design. The PH1 payload combines cytotoxic and immuno-oncology mechanisms, offering the potential to enhance the therapeutic impact of ADCs beyond what current treatments can achieve. Abizer Gaslightwala, President and CEO of Akari Therapeutics, noted that starting GMP production is an important milestone, demonstrating confidence in the science behind AKTX-101 and supporting the company’s plan to initiate a Phase 1 first-in-human study within approximately 12 months.

Dr. Jimmy Li, CEO of WuXi XDC, emphasized the significance of the collaboration, highlighting the innovative nature of the PH1 payload and its potential to make a meaningful impact in the ADC field. He expressed enthusiasm for leveraging WuXi’s integrated ADC platform to produce high-quality GMP material and help advance the program toward clinical trials. WuXi XDC anticipates that this collaboration could lay the foundation for additional ADC programs utilizing the PH1 payload in the future.

The strategic partnership between Akari and WuXi XDC combines Akari’s novel ADC design and payload technology with WuXi’s expertise in global ADC development and manufacturing. The GMP-grade drug product generated through this collaboration will support Akari’s planned Phase 1 first-in-human clinical trial, expected to begin in late 2026 or early 2027, pending regulatory approval. This manufacturing milestone reflects Akari’s continued progress in advancing its pipeline and executing its strategy to develop differentiated ADC therapies using innovative payloads, with the goal of significantly improving outcomes for patients with cancer.