A pivotal step toward Phase 1 clinical trials Akari Therapeutics has officially launched GMP (Good Manufacturing Practice) activities for its lead oncology candidate, AKTX-101. This next-generation antibody-drug conjugate (ADC) targets the Trop2 protein, which is highly expressed in aggressive cancers, including lung, breast, and K-Ras mutant pancreatic cancer.
Akari has exclusively partnered with WuXi XDC, a world-leading bioconjugate CDMO, to provide the essential IND-enabling work. This collaboration ensures high-quality production of materials required for regulatory filing, paving the way for a planned Phase 1 first-in-human clinical trial expected to initiate in late 2026 or early 2027.
The “1-2 Punch” of the proprietary PH1 payload The innovation behind AKTX-101 lies in its unique PH1 payload, which utilizes RNA splicing modulation. Unlike traditional ADCs that rely on standard tubulin inhibitors or DNA-damaging agents, PH1 offers a dual-action mechanism:
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Direct Cytotoxicity: Disrupting the essential RNA processing within cancer cells to induce cell death.
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Immuno-oncology Activation: Generating neoantigens that stimulate the body’s immune system to mount a durable anti-tumor response.
Preclinical models have demonstrated that AKTX-101 significantly outperforms traditional ADCs in survival rates and shows high synergy when combined with checkpoint inhibitors, suggesting potential as a powerful combination therapy.
Strategic partnership and future outlook By leveraging WuXi XDC’s integrated ADC platform, Akari aims to accelerate its path to the clinic. This partnership is expected to lay the groundwork for a broader portfolio of ADC programs utilizing the novel PH1 technology, potentially redefining treatment outcomes for patients with high unmet medical needs.