Akari Therapeutics Plc, an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel RNA splicing modulating payloads, has entered a strategic partnership with WuXi XDC, a global leader in ADC development and manufacturing, to accelerate the development of Akari’s novel PH1 payload.

Akari’s lead program AKTX-101 is initially targeting metastatic urothelial cancer, where there continues to be significant unmet medical need particularly in the second-line treatment setting. Patients with metastatic disease that progress following first-line therapies often have limited options beyond standard chemotherapy, which offers only modest clinical benefit in this setting. Akari believes that AKTX-101 with its novel PH1 payload may provide a promising new therapeutic approach for urothelial cancer patients, while also demonstrating the broader potential of Akari’s PH1 payload platform.

AKTX-101 features Akari’s proprietary PH1 payload, a novel spliceosome modulator designed to disrupt RNA splicing in cancer cells. By targeting RNA splicing, PH1 represents a new direction for next-generation ADC therapies. Unlike traditional ADC payloads that are microtubule inhibitors or DNA-damaging agents, PH1 offers a differentiated mechanism of direct cytotoxicity as well as the unique activation of the innate and adaptive immune systems to attack cancer.

In preclinical studies, AKTX-101 has demonstrated superior anti-tumor regression and complete remissions relative to other ADCs. Akari believes this differentiated mechanism positions PH1 as part of a new wave of ADC payload innovation aimed at significantly improving the therapeutic potential of antibody-drug conjugates.

“This strategic partnership with WuXi XDC represents a major milestone for Akari and a powerful validation of our novel PH1 payload technology,” said Abizer Gaslightwala, President and CEO of Akari Therapeutics. “WuXi XDC is widely recognized as a global leader in ADC innovation, and with this partnership, we believe Akari can rapidly advance and further validate our PH1 payload on AKTX-101 in future clinical studies.”

WuXi XDC’s CEO, Jimmy Li, Ph.D., said, “There is a strong need for ADC payload innovation to improve on current therapies, and WuXi XDC wants to be at the forefront working with partners like Akari to bring novel ADCs to cancer patients.”

Akari is working to advance AKTX-101 into a Phase 1 clinical trial expected to start in late 2026 or early 2027 subject to regulatory clearance.