TIDMAVCT
RNS Number : 1809P
Avacta Group PLC
16 February 2021
16 February 2021
Avacta Group plc
("Avacta" or "the Group" or "the Company")
Results of Initial Evaluation of SARS-CoV-2 Lateral Flow Antigen
Test with Clinical Samples
Avacta Group plc (AIM: AVCT), the developer of Affimer(R)
biotherapeutics and reagents, announces that it has received the
first data for its SARS-CoV-2 rapid antigen test from ongoing
clinical studies in Europe and the UK. These data show excellent
performance of the test in identifying patients with an infectious
viral load and no false positive results.
Avacta's SARS-CoV-2 rapid antigen test has been developed to
identify infectious individuals so that they can isolate promptly
and reduce the spread of COVID-19. A recent report from the
Liverpool Covid SMART Pilot Study(1) indicates that individuals
with COVID-19 infection had a significant chance of infecting their
contacts if they had a viral load measured by PCR, called the Ct
value (cycle threshold value), of approximately 25 or lower. The Ct
value indicates how many PCR cycles are required to amplify the
viral RNA so that it can be detected and a lower Ct value indicates
a higher viral load.
The initial evaluation of Avacta's lateral flow rapid antigen
test with clinical samples has been carried out at two sites, one
in EU and one in the UK using patient samples with viral loads
confirmed by PCR. 30 positive samples were tested with Ct values of
26 and below, with half of those in the range 22-26, and the
lateral flow test identified 29/30 of these correctly as positive.
This indicates a clinical sensitivity of 96.7% for samples with a
Ct value below 26. Importantly, out of a total of 26 negative
samples tested with the lateral flow device, the test correctly
identified all 26 as negative, giving a clinical specificity of
100%. High specificity is critical for a lateral flow test for mass
screening so that large numbers of false positives are not
generated which would create a major burden on follow-on testing
resources, and result in a significant socio-economic cost of
unnecessarily isolating people.
On the basis of these excellent initial data, the Company will
now progress to a full clinical validation with a larger number of
patient samples to CE mark the test for professional use, aiming to
bring the test to market in Europe around the end of the first
quarter of this year.
Dr Alastair Smith, Chief Executive Officer of Avacta Group,
commented:
"I am delighted with the performance of the test with clinical
samples which is extremely encouraging.
On the basis of these initial clinical studies, the lateral flow
test shows very good sensitivity in the infectious range of viral
loads including at the lower infectious loads with Ct values of
23-26 which compares very favourably with the data reported in the
Liverpool Covid SMART Pilot Study report.
These data from the first clinical studies will allow us to
quickly progress with confidence into the full clinical validation
of the test, manufactured at scale, at our clinical trial sites in
the UK and the EU. I am confident that these data will accelerate
our commercial discussions regarding the roll-out of the test when
it is approved for professional use.
I look forward to updating the market on clinical and commercial
progress in due course."
This announcement contains information which, prior to its
disclosure, was considered inside information for the purposes of
Article 7 of Regulation (EU) No 596/2014 (MAR).
Disclaimer: The AffiDx(TM) SARS-Cov-2 rapid antigen test is not
currently available for sale in the United States.
- Ends-
1
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/950695/s0958-liverpool-covid-smart-evaluation.pdf
For further information from Avacta Group plc, please
contact:
Avacta Group plc Tel: +44 (0) 844 414 0452
Alastair Smith, Chief Executive Officer www.avacta.com
Tony Gardiner, Chief Financial Officer
finnCap Ltd (Nominated Adviser and Joint Broker) Tel: +44 (0) 207 220 0500
Geoff Nash / Giles Rolls - Corporate Finance www.finncap.com
Tim Redfern - ECM
Stifel Nicolaus Europe Limited (Joint Broker) Tel: +44 (0) 207 710 7600
Nicholas Moore / Nick Adams / Fred Walsh / Ben Maddison www.stifel.com
FTI Consulting (Financial Media and IR) Tel: +44 (0) 203 727 1000
Simon Conway / Stephanie Cuthbert Avacta.LS@fticonsulting.com
Zyme Communications (Trade and Regional Media) Tel: +44 (0) 7787 502 947
Katie Odgaard katie.odgaard@zymecommunications.com
About Avacta Group plc - https://www.avacta.com
Avacta Group is developing novel cancer immunotherapies and
powerful diagnostics based on its two proprietary platforms -
Affimer(R) biologics and pre|CISION(TM) tumour targeted
chemotherapies.
The Affimer platform is an alternative to antibodies derived
from a small human protein. Despite their shortcomings, antibodies
currently dominate markets, such as diagnostics and therapeutics,
worth in excess of $100bn. Affimer technology has been designed to
address many of these negative performance issues, principally: the
time taken to generate new antibodies and the reliance on an
animal's immune response; poor specificity in many cases; their
large size, complexity and high cost of manufacture.
Avacta's pre|CISION targeted chemotherapy platform releases
active chemotherapy in the tumour, which limits the systemic
exposure that causes damage to healthy tissues, and thereby
improves the overall safety and therapeutic potential of these
powerful anti-cancer treatments.
The Group comprises two divisions: The therapeutics development
activities are based in Cambridge, UK and the Group is generating
near-term revenues from Affimer reagents for diagnostics,
bioprocessing and research, through a separate diagnostics business
unit based in Wetherby, UK.
Avacta's Diagnostics Division works with partners world-wide to
develop bespoke Affimer reagents for third party products. The
Company is also developing an in-house pipeline of Affimer-based
diagnostic assays including the AffiDX(TM) SARS-CoV-2 Lateral Flow
Rapid Antigen Test and a BAMS(TM) SARS-CoV-2 Assay in partnership
with Adeptrix Inc.
Avacta's Therapeutics Division is addressing a critical gap in
current cancer treatment - the lack of a durable response to
current immunotherapies experienced by most patients. By combining
its two proprietary platforms the Company is building a wholly
owned pipeline of novel cancer therapies deigned to be effective
for all cancer patients. In 2021 Avacta will commence a phase 1
first-in-human, open label, dose-escalation and expansion study of
AVA6000 Pro-doxorubicin, the Company's lead pre|CISION(TM) prodrug,
in patients with locally advanced or metastatic selected solid
tumours.
Avacta has established drug development partnerships with pharma
and biotech, including a research collaboration with Moderna
Therapeutics Inc., a multi-target deal with LG Chem worth up to
$400m, a joint venture in South Korea with Daewoong Pharmaceutical
focused on cell and gene therapies incorporating Affimer
immune-modulators, a partnership with ADC Therapeutics to develop
Affimer-drug conjugates and a collaboration with Point Biopharma to
develop radiopharmaceuticals based on the pre|CISION(TM) platform.
Avacta actively seeks to license its proprietary platforms in a
range of therapeutic areas.
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