Akari Therapeutics Initiates GMP Manufacturing for Novel ADC AKTX-101 with WuXi XDC Partnership
核心洞察
Akari Therapeutics has initiated GMP manufacturing for AKTX-101, its lead antibody drug conjugate featuring a novel PH1 (搜索) payload that targets RNA splicing modulation in cancer cells.
The company partnered with WuXi XDC (搜索), a leading ADC contract development and manufacturing organization, to support IND-enabling activities for clinical trial initiation.
AKTX-101 targets the Trop2 (搜索) receptor and has demonstrated significant activity and prolonged survival in preclinical studies compared to traditional ADC payloads.
Akari Therapeutics has reached a critical manufacturing milestone for its lead antibody drug conjugate (ADC) program, initiating GMP manufacturing activities for AKTX-101 in partnership with WuXi XDC (搜索). The collaboration represents a significant step toward clinical development of the company's novel spliceosome (搜索)-targeting payload technology.
Strategic Manufacturing Partnership
Akari selected WuXi XDC (搜索), described as the world's leading ADC contract development and manufacturing organization (CDMO), to support IND-enabling work for AKTX-101. WuXi XDC brings globally recognized end-to-end ADC development and manufacturing capabilities, with deep expertise in producing large numbers of ADCs currently in clinical development.
"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 (搜索) ADC payload in treating cancer patients," said Abizer Gaslightwala, President and CEO of Akari Therapeutics. "This key work lays the foundation for our planned Phase 1 first-in-human study in approximately 12 months."
Novel Payload Technology
AKTX-101 incorporates Akari's proprietary PH1 (搜索) payload, which represents a differentiated approach to ADC design through RNA splicing modulation. Unlike current ADCs that use tubulin inhibitors and DNA damaging agents as payloads, PH1 is a spliceosome (搜索) modulator designed to disrupt RNA splicing within cancer cells.
The PH1 (搜索) payload delivers what the company describes as a "1-2 punch of cytotoxicity and immuno-oncology action," potentially increasing therapeutic impact beyond current ADC options. In preclinical animal models, this splicing modulation has been shown to induce cancer cell death while activating immune cells to drive robust and durable activity.
Preclinical Efficacy Data
AKTX-101 targets the Trop2 (搜索) receptor on cancer cells and uses a proprietary linker to deliver the PH1 (搜索) payload directly into tumors. In preclinical studies, AKTX-101 demonstrated significant activity and prolonged survival relative to ADCs with traditional payloads.
The compound has shown potential for synergy with checkpoint inhibitors, demonstrating prolonged survival both as a single agent and in combination with checkpoint inhibitors compared to appropriate controls.
Clinical Development Timeline
The 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 timeline positions the manufacturing milestone as occurring approximately 12 months before clinical trial initiation.
Dr. Jimmy Li, CEO of WuXi XDC (搜索), emphasized the innovative nature of the collaboration: "The PH1 (搜索) 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."
Platform Potential
Akari's ADC discovery platform provides the ability to generate ADC candidates and optimize them based on desired applications to any target of interest. WuXi XDC (搜索) noted that this first project with Akari could lay the groundwork for multiple ADC programs utilizing the novel payload technology.
The strategic partnership combines Akari's innovative ADC design and payload technology with WuXi's global leadership in ADC development and manufacturing, potentially establishing a foundation for broader collaboration in developing differentiated ADC therapies.