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Avacta hits Clinical Candidate Selection Milestone
Avacta hits Clinical Candidate Selection Milestone.
About this update from Avacta Group Plc
[{"type":"text","content":"\n \nRNS Number : 5969B Avacta Group PLC 10 June 2019 \n\n10 June 2019\nAvacta Group plc\n(\"Avacta\", the \"Company\" or the \"Group\")\n \nAvacta hits Clinical Candidate Selection Milestone for Affimer PD-L1 Inhibitor \n \nSelection of its first-time-in-human clinical candidate for the Affimer platform confirmed\nGroup remains on track to submit an IND/CTA application by the end of 2020 \n \nAvacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and research reagents, announces that it has selected the clinical development candidate for first-time-in-human clinical trials of the Affimer platform. This important milestone means that the Group remains on track to submit an IND/CTA application for an Affimer PD-L1 inhibitor by the end of 2020. \nThe Group has generated a wide range of Affimer inhibitors of PD-L1, a well known cancer immunotherapy target. This target was chosen to demonstrate safety and tolerability of the Affimer platform in human and, importantly, to provide a proprietary basis for its novel tumour microenvironment activated drug conjugate (TMAC™) and bispecific cancer immunotherapies. \nAvacta has selected a specific Affimer molecule (AVA004) as its clinical candidate because of its excellent in vitro and in vivo pharmacological properties. This Affimer has been shown to have equivalent tumour growth inhibition to three approved monoclonal antibody inhibitors of PD-L1 (Tecentriq, Imfinzi and Bavencio) in several in vivo animal efficacy models.\nThis molecule will therefore now be taken forwards into clinical manufacturing and IND/CTA enabling studies allowing the Group to remain on track for an IND/CTA application in late 2020 and dosing of first patients shortly afterwards. \nThe planned phase I study will be in patients with advanced PD-L1 positive solid tumours. This study will explore both intra-venous and sub-cutaneous routes of administration to provide proof-of-concept with primary endpoints of safety, tolerability and appropriate pharmacokinetics/pharmacodynamics, and with a secondary efficacy endpoint. The study will include 20-30 patients in at least two sites in North America and Europe.\nThe cancer immunotherapy market is currently worth $60bn and is predicted to double by 2025[1]. Avacta's combinatorial approach ...