TIDMAVCT
RNS Number : 6699U
Avacta Group PLC
20 January 2017
20 January 2017
Avacta Group plc
("Avacta" or "the Group" or "the Company")
AGM business update and notice of results
Substantial progress in therapeutic programme
Multiple third party technology evaluations ongoing
Avacta Group plc (AIM: AVCT), the developer of Affimer(R)
biotherapeutics and research reagents, is today holding its Annual
General Meeting at 10.00 am GMT. In conjunction with this meeting
the Company is pleased to provide a business and trading update
ahead of its results for the six months ending 31 January 2017,
which the Company expects to announce in full on Monday 3 April
2017.
Highlights
-- Custom Affimer order book grown 70% YOY.
-- Half year revenue, operating losses and cash balances are in line with market forecasts.
-- Multiple paid-for technology evaluations and collaborations now ongoing with:
o 4 out of the top 10 global large pharma and more than 10 other
biotech and pharma companies
o 8 research tools companies
o Several diagnostics companies including 1 of the top 3
-- Several technology evaluations underway that could lead to
the first reagents license deals during 2017.
-- Excellent progress being made with in-house immuno-oncology
therapeutic programme: still targeting the clinic in 2019.
o Multiple therapeutic lead Affimers identified
o First animal efficacy study completed with positive
results
o First PK studies completed with positive results
o Expansion of immuno-oncology pipeline underway
o Ongoing immunogenicity studies expected to conclude in next
few months
-- Research partnership with Moderna continues to progress.
-- Collaboration agreement with Memorial Sloan Kettering Cancer
Centre NY to generate Affimer CAR-T proof-of-concept data later in
2017.
-- Affimer technology patent granted in Europe.
The presentation to shareholders at today's AGM is available on
the Company's web site (www.avacta.com).
Dr Alastair Smith, Avacta Group Chief Executive Officer,
commented:
"We have made substantial progress over the past year in
demonstrating the performance and differentiation of our Affimer
technology in key applications. It is pleasing that this is now
translating into a custom Affimer order book and paid-for
commercial evaluations that could ultimately lead to licensing
deals. While it will take time for these evaluations to conclude,
it is reasonable to expect to see the first of these in 2017.
Our in-house therapeutic development programme continues apace
and we are delighted to have seen positive results from the first
in vivo studies that demonstrate efficacy, tolerability and
suitable pharmacokinetics properties of Affimer molecules. These
are huge steps forward that we believe de-risks the platform
considerably. Our collaborations with partners such as Moderna,
Glythera and the Memorial Sloan Kettering Cancer Centre provide
additional opportunities to develop therapeutic applications of the
Affimer technology.
With our expectation of strong news flow to underpin increasing
shareholder value this year, we start 2017 with great
enthusiasm."
Avacta Life Sciences
Avacta's principal focus is on its proprietary Affimer(R)
technology which is a novel engineered alternative to antibodies
that has wide application in a multi-billion life sciences market
for diagnostics, therapeutics and as general research tools.
Avacta's strategy is to build a profitable business unit licensing
Affimer technology into third parties' diagnostic and research
product development pipelines, whilst generating valuable
therapeutic assets both in-house and with partners.
Licensing deals are secured through technology evaluations.
Successful evaluations have a good likelihood of leading to royalty
bearing commercial licenses to develop and market products powered
by Affimers. Multiple Affimer technology evaluations and
collaborations are ongoing with four out of the top ten large
pharma, over 20 other biotech and research tools companies and
several diagnostics companies including one of the top three.
The order book for evaluations and other custom Affimer projects
has grown 70% compared with the same period last year, which is an
encouraging sign of increasing awareness of the technology and the
positive effects of building solid technical marketing data to
support business development.
The evaluation process may take six months to a year, or longer,
depending on the nature of the application. Some of the many
paid-for evaluations/collaborations that are now underway could
lead to licensing for product development which is the principal
objective. Others may lead to third party internal use only via a
supply arrangement, or to repeated custom Affimer orders. Therefore
it is essential to build the pipeline of evaluations and focus
efforts on those third parties most likely to develop royalty
bearing products for sale. Several of these ongoing evaluations are
with third parties that could lead to first reagents license deals
during 2017.
The Company is collaborating with Mologic, a UK developer of
rapid point-of-care tests - one of the three areas of commercial
focus for the Company. This collaboration aims to demonstrate the
benefits of Affimer technology in lateral flow tests and to develop
novel Affimer-based diagnostic assays for human healthcare. Basic
proof of concept in this application has been demonstrated and
Avacta is now generating Affimer binders to a number of
commercially valuable diagnostic targets, as well as making its
Zika virus binders available, to support the development of
commercial products. Work remains to fully demonstrate the
performance of Affimer based lateral flow devices which will be
carried out during 2017. Both companies will share in the future
revenues from the commercialisation of the marketed
diagnostics.
A number of early custom Affimer evaluations have concluded
successfully and have now led to multiple repeat orders of Affimer
reagents by those customers. For example, the Company is now
working on the fifth Affimer tool for one such customer with a
sixth in discussion. The Company anticipates that some of these
customers may agree to disclose details of these projects during
2017. Such independent endorsement is a powerful business
development tool for a technology in the early stages of
commercialisation. Other longer established collaborations with
smaller partners have generated useful validation data but are now
on-hold due to the funding requirements of the partner or changes
in their priorities.
The Company continues to work with a small number of partners
with interests in ubiquitination, generating data that plays an
important role in demonstrating that Affimer reagents can be
generated to targets that are difficult for antibodies to hit. This
data is powerful in supporting other business development
activities focused on generating Affimer licensing deals. The
Company expects to be able to present new and compelling data from
one of its academic collaborators targeting the K6 di-ubiquitin
linkage within the next few months showcasing the Affimer
technology. The pharma sector is only very slowly turning its
attention to targeting the ubiquitin system. Therefore, whilst this
activity in pharma grows, the Company has focused its development
efforts on larger immediate opportunities in affinity separation,
immunoassays and rapid diagnostics, and the Company is well placed
to provide tools for drug development in the ubiquitination field
as it grows.
Therapeutic Update
Substantial progress has been made in the Company's in-house
immuno-oncology programme.
Multiple Affimer inhibitors of PD-L1 (one of the better
understood drug targets in immuno-oncology and therefore one of the
lowest risk in terms of progression into the clinic) have been
rapidly identified and characterised. The first animal studies
(with any Affimer), of pharmacokinetics and efficacy in a mouse
tumour model, have been completed with positive results and the
expansion of the portfolio of immuno-oncology Affimer binders
beyond PD-L1 is well underway. It is a notable achievement, and an
indication of the ease with which Affimer therapeutics can be
developed, that data from these animal models was obtained within
nine months of screening the library with the target.
The efficacy data set is the single most important Affimer
therapeutic data set to be generated by the Company to date because
it demonstrates that for an appropriately formatted Affimer
therapeutic, the serum residence time in the circulation was
sufficient to see a clinical effect which means that the Affimer
proteins reached the site of action and were functional in vivo.
This is a major step in demonstrating the potential of Affimer
technology per se as a therapeutic platform.
The Company expects to provide the market with more information
about the build-out of the immuno-oncology portfolio and the
strategy for expanding the in-house pipeline in the next few months
as well as report on key data from immunogenicity studies - the
first such data indicating whether the Affimer technology and
individual Affimers show immunogenicity in human models.
The collaboration with Phoremost, a UK drug discovery company,
has long term goals to discover and commercialise new drug targets,
Affimer reagents and therapeutics. PhoreMost is using Affimers in
tandem with its SiteSeeker technology to discover new drug targets
and screen for small molecule therapeutics that act on these
targets. In addition, this discovery programme will generate novel
Affimers which could be used as reagents to assist in the drugs'
development, or as therapeutics themselves. Under the terms of the
agreement, Avacta is entitled to a royalty on all PhoreMost's
revenues that are generated using Affimers. Early proof of concept
with the Affimer library is promising showing Affimers clearly
generating phenotypic effects in cell lines. We anticipate being
able to update the market in more detail in the next twelve
months.
The research partnership with Glythera, a UK biotech, to
evaluate the use of Glythera's PermaLink(TM) conjugation chemistry
in combination with Avacta's Affimer technology with the aim of
developing a new class of highly targeted bio-therapeutics as a
superior alternative to the established class of antibody drug
conjugates (ADCs) is also progressing well. Initial work has
focused on optimising the PermaLink attachment of cytotoxic agents
to Affimer proteins that will be used in the early part of 2017 in
cell killing assays to determine potency. As part of the
collaboration Affimer technology has now been shown to withstand
the harsh solvent environments required to optimise such
conjugation chemistries and give tight control of the drug-Affimer
ratio. Work is ongoing to demonstrate cell killing capability of
Affimer drug conjugates. The Company will update the market further
when this collaboration concludes mid-2017.
During the reporting period the Company signed a collaboration
agreement with the Memorial Sloan Kettering Cancer Centre NY to
generate Affimer CAR-T proof-of-concept data. CAR-T immunotherapy
is a form of cancer treatment in which the patient's own immune
system T cells are modified to give them greater potency with which
to attack cancer cells. The simple structure and biophysical
properties of Affimers potentially provide significant advantages
over antibody fragment technology currently used in CAR-T cell
modification and the collaboration is intended to demonstrate a new
class of CAR-T cell therapy that incorporate Affimer molecules
which could lead to future licensing deals for Affimer technology
into the CAR-T space. The Company expects to report on the progress
with this collaboration later in 2017.
The Company's established Research partnership with Moderna
continues to progress but the Company is restricted from providing
any detailed progress updates at this time.
Good progress is being made in the Company's second programme in
coagulation in collaboration with Dr Ramzi Ajjan at the Leeds
General Infirmary. A range of Affimer molecules has been generated
which modulate the clotting of blood and the breakdown of the clots
via two different targets. These Affimer molecules are being
characterised in Dr Ramzi's laboratory in vitro prior to planned
use in in vivo models later in 2017 and 2018 with the objective of
licensing these assets or taking them into phase 1 clinical trials
in-house. The data show that different Affimer molecules affect
blood clotting and clot breakdown to varying degrees in pure
samples, in serum and in whole human and mouse blood. Work is
ongoing to select the best candidates to take forwards for in vivo
testing.
The Company also strengthened its immuno-oncology Scientific
Advisory Board with the appointment of Professor Gerard Evan during
the reporting period. Professor Evan's research focuses on the
molecular basis of cancer. He is the Sir William Dunn Chair of
Biochemistry and Head of Biochemistry in the University of
Cambridge.
Avacta Animal Health
Avacta Animal Health has traded in line with expectations and
ahead of last year. This improvement has been driven by improved
sales in the core allergy business, including the recently-launched
equine allergy test, and reflects strong sales and marketing
efforts.
Development work, primarily of algorithm-based tests, is
expected to lead to product launches in the second half of this
financial year which we anticipate will contribute to next year
financially.
For further information from Avacta Group plc, please
contact:
Avacta Group plc Tel: +44 (0)
Alastair Smith, Chief Executive 844 414 0452
Officer www.avacta.com
Tony Gardiner, Chief Financial
Officer
finnCap Ltd Tel: +44 (0)
Geoff Nash / Giles Rolls - Nominated 207 220 0500
Adviser www.finncap.com
Tim Redfern / Alice Lane - Corporate
Broking
Tel: +44 (0)
WG Partners 203 705 9318
Nigel Birks / Nigel Barnes Tel: +44 (0)
David Wilson / Claes Spang 203 705 9217
www.wgpartners.co.uk
Zyme Communications (Trade and Tel: +44 (0)7787
Regional Media) 502 947
Katie Odgaard katie.odgaard@zymecommunications.com
FTI Consulting (Financial Media Tel: +44 (0)
and IR) 203 727 1000
Simon Conway / Natalie Garland-Collins avacta@fticonsulting.com
About Avacta Group plc (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 $50bn 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 and bleeding disorders as well as
partnered development programmes. Avacta is commercialising
non-therapeutic Affimer reagents through licensing to developers of
life sciences research tools and diagnostics.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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