Alastair Smith, Chief Executive Officer, commented:
“Selection of the Affimer PD-L1 inhibitor candidate for clinical development is an important milestone in our development of the Affimer therapeutic platform. The Group remains firmly on track to submit an application to the regulators for a first-time-in-human clinical study late in 2020.
Demonstration of appropriate safety and tolerability in humans is key to de-risking the platform overall for partners and therefore key to the number and value of licensing deals in the future.
Not only will the PD-L1 programme be used to demonstrate the safety of the Affimer platform in humans, but it will provide us with a proprietary inhibitor of the PD-1/PD-L1 checkpoint pathway which will be central to our ground-breaking TMAC drug conjugates and bispecifics. These novel programmes will allow us to build a clinically differentiated pipeline to address the lack of a durable response to single immune checkpoint therapies for most patients.
It is a hugely exciting period for Avacta and I look forward to keeping the market updated on our progress.”
Avacta Group plc (LON:AVCT), the developer of Affimer® biotherapeutics and research reagents, today announced 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.
The 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.
Avacta 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.
This 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.
The 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.
The cancer immunotherapy market is currently worth $60bn and is predicted to double by 2025. Avacta’s combinatorial approach to treatment through its TMAC and bispecific cancer immunotherapies, which build upon inhibition of PD-L1, are designed not only to compete strongly in this market through improved clinical benefit to patients, but also to expand the market to patients who do not respond to single checkpoint inhibitors.
Avacta will provide an on-line analyst briefing on the AVA004 in vitro and in vivo pharmacology data at 16:00 BST on Wednesday, 12 June 2019. To register for this analyst briefing please contact firstname.lastname@example.org.