Akari Therapeutics Initiates GMP Manufacturing of AKTX-101 ADC Program to Support Phase 1 First-in-Human Clinical Trial

Core Viewpoint - Akari Therapeutics has initiated GMP manufacturing activities for its lead ADC program, AKTX-101, in partnership with WuXi XDC, aiming to support clinical trials and advance cancer treatment options [1][2][4]. Group 1: Partnership and Manufacturing - Akari has selected WuXi XDC, a leading ADC contract development and manufacturing organization, for critical IND-enabling work to support clinical trials [2][4]. - The collaboration aims to leverage WuXi XDC's expertise in ADC development and manufacturing to produce high-quality GMP material for AKTX-101 [4][5]. Group 2: Product Development - AKTX-101 incorporates Akari's novel proprietary payload, PH1, which modulates RNA splicing and offers a differentiated approach to ADC design, potentially enhancing therapeutic impact [3][6]. - The manufacturing milestone is a significant step in advancing Akari's pipeline of differentiated ADC therapies, which aim to improve outcomes for cancer patients [5][6]. Group 3: Future Plans - The company plans to initiate a Phase 1 first-in-human clinical trial for AKTX-101 in approximately 12 months, pending regulatory clearance [4][5]. - Akari's innovative ADC design and payload technology, combined with WuXi's manufacturing capabilities, are expected to lay the groundwork for multiple ADC programs utilizing the PH1 payload [4][6].