Avacta Group plc Hits Clinical Candidate Selection Milestone for Affimer PD-L1 Inhibitor
10 June 2019 - 7:40PM
Business Wire
- Selection of its first-time-in-human
clinical candidate for the Affimer platform confirmed
- Group remains on track to submit an
IND/CTA application by the end of 2020
Avacta 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.
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 20251. 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
harriet.jackson@yellowjerseypr.com.
Dr Alastair Smith, Chief Executive Officer, Avacta Group plc,
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.”
1.
https://www.grandviewresearch.com/industry-analysis/cancer-immunotherapy-market
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190610005282/en/
Zyme CommunicationsKatie OdgaardTel: +44 (0)7787 502
947katie.odgaard@zymecommunications.com
Avacta (LSE:AVCT)
Historical Stock Chart
From Apr 2024 to May 2024
Avacta (LSE:AVCT)
Historical Stock Chart
From May 2023 to May 2024