Avacta Group PLC Avacta hits Clinical Candidate Selection Milestone (5969B)
June 10 2019 - 1:00AM
UK Regulatory
TIDMAVCT
RNS Number : 5969B
Avacta Group PLC
10 June 2019
10 June 2019
Avacta Group plc
("Avacta", the "Company" or the "Group")
Avacta hits Clinical Candidate Selection Milestone for Affimer
PD-L1 Inhibitor
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(R)
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(TM)) 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[1]. 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
avacta@yellowjerseypr.com.
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."
- Ends -
For further information from Avacta Group plc, please
contact:
Avacta Group plc Tel: +44 (0) 844 414 0452
Alastair Smith, Chief Executive www.avacta.com
Officer
Tony Gardiner, Chief Financial
Officer
finnCap Ltd (Nominated Adviser Tel: +44 (0) 207 220 0500
and Joint Broker) www.finncap.com
Geoff Nash / Giles Rolls - Corporate
Finance
Tim Redfern - ECM Tel: +44 (0) 203 705 9318
Tel: +44 (0) 203 705 9217
WG Partners (Joint Broker) www.wgpartners.co.uk
Nigel Birks / Nigel Barnes
David Wilson / Claes Spang
Turner Pope Investments Tel: +44 (0) 203 621 4120
James Pope / Ben Turner www.turnerpope.com
Yellow Jersey PR (Financial Media
and IR) Tel: +44 (0)7764 947 137
Sarah Hollins Tel: +44 (0)7544 275 882
Harriet Jackson avacta@yellowjerseypr.com
Zyme Communications (Trade and Tel: +44 (0)7787 502 947
Regional Media) katie.odgaard@zymecommunications.com
Katie Odgaard
About Avacta Group plc - https://www.avacta.com
Avacta's principal focus is on its proprietary Affimer(R)
technology which is a novel engineered alternative to antibodies
that has wide application in Life Sciences for diagnostics,
therapeutics and general research and development.
Antibodies dominate markets worth in excess of $100bn despite
their shortcomings. Affimer technology has been designed to address
many of these negative performance issues, principally; the time
taken to generate new antibodies, the reliance on an animal's
immune response, poor specificity in many cases, and batch to batch
variability. Affimer technology is based on a small protein that
can be quickly generated to bind with high specificity and affinity
to a wide range of protein targets.
Avacta has a pre-clinical biotech development programme with an
in-house focus on immuno-oncology as well as partnered development
programmes. Avacta is commercialising non-therapeutic Affimer
reagents through licensing to developers of life sciences research
tools and diagnostics.
To register for news alerts by email go to
www.avacta.com/investor-news-email-alerts
[1]
https://www.grandviewresearch.com/industry-analysis/cancer-immunotherapy-market
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END
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