Akari Therapeutics, Plc (Nasdaq: AKTX) yesterday announced that it has initiated GMP manufacturing of its lead antibody-drug conjugate (ADC), AKTX-101, marking a pivotal step toward its planned Phase 1 first-in-human clinical trial.
Cancer treatment is entering a new era where innovation often lies in the payload attached to antibodies. Akari's proprietary PH1 payload, designed to disrupt RNA splicing inside tumor cells, represents a fresh approach that combines direct cytotoxicity with immune activation. This "one-two punch" could potentially expand the therapeutic impact of ADCs beyond current options.
The company has partnered exclusively with WuXi XDC, a global leader in ADC development and manufacturing, to produce GMP-grade material for AKTX-101. WuXi's integrated platform and track record in advancing ADCs provide Akari with confidence in moving swiftly and efficiently toward the clinic.
Akari's lead candidate, AKTX-101, is designed to target Trop2, a receptor commonly expressed on cancer cells, and deliver the novel PH1 payload through a proprietary linker directly into tumors. Unlike conventional ADCs that rely on tubulin inhibitors or DNA-damaging agents, PH1 acts as a spliceosome modulator, disrupting RNA splicing to induce cancer cell death while simultaneously activating immune cells.
In preclinical animal models, the candidate has demonstrated significant activity and prolonged survival compared to ADCs with traditional payloads, and has also shown synergy with checkpoint inhibitors, suggesting potential for combination therapy.
Akari expects to initiate its Phase 1 first-in-human trial in late 2026 or early 2027, pending regulatory clearance.
The initiation of GMP manufacturing is more than a technical milestone; it signals Akari's confidence in its science and its path to the clinic.
WuXi XDC's CEO, Dr Jimmy Li, emphasized the innovative nature of the PH1 payload, noting that the collaboration could pave the way for multiple ADC programs built on this novel approach. For Akari, the partnership represents both scientific validation and strategic alignment, combining its proprietary payload technology with WuXi's global leadership in ADC development and manufacturing. Upcoming milestones include:
•Completion of GMP manufacturing to support IND submission.
•Planned initiation of Phase 1 first-in-human study within 12 months.
•Continued validation of PH1 payload across undisclosed targets in Akari's pipeline.
As Akari advances toward clinical testing, the company is positioning itself as a differentiated player in the oncology space, focusing on next-generation ADCs that combine precision targeting with innovative payload design.
The broader implications of this work are significant: if successful, AKTX-101 could represent a new class of ADCs capable of delivering improved outcomes for patients by harnessing both cytotoxic and immuno-oncology mechanisms. In a crowded ADC landscape, Akari's bet on spliceosome modulation may well redefine what antibody-drug conjugates can achieve in cancer therapy.
AKTX has traded between $0.21 and $1.73 over the past year. The stock closed yesterday's trading at $0.24, down 7.08 %, and rose in the overnight trading at $0.26, up 9.66%.
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