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

“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 Chief Executive Officer 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., added, “We are pleased to work with Akari to advance the novel PH1 payload into more advanced studies. WuXi XDC has a proven record of advancing novel ADC payloads and strives to remain at the forefront of ADC innovation. We believe we are the trusted and best partner to help Akari advance this first-in-kind RNA splicing modulating ADC payload for its use in its lead program, as well as other future ADC molecules. 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’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. The Company 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.

Akari is working to advance its lead program, AKTX-101, into a Phase 1 clinical trial expected to initiate in late 2026 or early 2027 subject to regulatory clearance. This key clinical milestone reinforces Akari’s ongoing progress to advance its novel payload and execute its strategy to develop ADC therapies with novel payloads that have the potential to improve outcomes for cancer patients.