Peak Bio, Akari Therapeutics announce portfolio prioritization plan

Akari Therapeutics (AKTX) and Peak Bio (PKBO) announced completion of a joint portfolio prioritization review pursuant to which the combined entity, following completion of the previously announced merger of Akari and Peak, will focus on Peak’s ADC platform technology and Akari’s PAS-nomacopan Geographic Atrophy program. Peak’s ADC platform technology is a proprietary technology using antibody plus linker plus Peak Bio toxin with immune modulation and includes a novel pre-clinical ADC candidate targeting TROP-2. Akari’s PAS-nomacopan is a bispecific complement and leukotriene B4 inhibitor with prolonged duration of action being developed for GA. Key Elements of Program Prioritization: ADC toolkit: Oncology platform includes a novel pre-clinical ADC candidate targeting TROP-2; Strategy includes continued IND enabling development; Strategy includes developing and progressing our novel toxin including our lead toxin, PH-1 which can be used in multiple important cancer targets including our TROP-2 candidate; Ongoing and continued business development activities with significant market interest in ADC candidates. PAS-nomacopan for Geographic Atrophy: Complement only inhibitors recently approved for treatment of GA; PAS-nomacopan has been shown in animal models to have prolonged biologic residence in the eye, suggesting ability for q2 to q4 month dosing, a potentially important competitive advantage; PAS-nomacopan, with its unique, non-pegylated bispecific inhibition of leukotriene B4 and complement may offer safety and/or efficacy advantages over traditional complement inhibitors; Continued IND enabling development including full scale manufacturing of drug for clinical use with a pre-IND meeting expected 1H 2024. Programs for Further Evaluation: HSCT-TMA: Akari’s HSCT-TMA program will be suspended, with enrollment in its currently active pediatric clinical study discontinued due to cost and timeline; The post-closing combined company will work closely with FDA to define the best path forward for this technology; Based upon cost and timeline will consider the opportunity for partnership and licensing, specifically as it relates to the Priority Review Voucher. PHP 303: Peak Bio’s Phase II ready PHP 303 program for Alpha 1 anti trypsin deficiency, a rare orphan condition, will be discontinued; The post-closing combined company will continue ongoing business development discussions around this technology. Nomacopan: Continue to seek partnership opportunities for licensing, proof of concept studies, and clinical trials