REG - Avacta Group PLC - Update on AffiDX and detection of Omicron variant

AvactaAnnouncement

10/01/2022 07:05

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RNS Number : 8873X  Avacta Group PLC  10 January 2022

 

10 January 2022

 

Avacta Group plc

 

("Avacta" or "the Group" or "the Company")

 

Update on AffiDX(®) SARS-CoV-2 antigen lateral flow test and detection of the
Omicron variant

 

Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company
developing innovative cancer therapies and powerful diagnostics based on its
proprietary Affimer(®) and pre|CISION™ platforms, provides an update on the
performance of the AffiDX(®) SARS-CoV-2 antigen lateral flow test (LFT) with
the Omicron variant.

 

The performance of all rapid antigen tests has come under recent scrutiny in
light of the large number of mutations in the Omicron variant of the
SARS-CoV-2 virus and the US Food and Drug Administration, as well as other
sources, has indicated that antigen tests generally will detect the Omicron
variant but may have reduced sensitivity. 1 

 

As reported on 15 December 2021, the AffiDX(®) SARS-CoV-2 antigen test has
been shown to detect the Omicron variant of the SARS-CoV-2 virus in patient
samples in a small clinical study. Whilst the AffiDX(®) antigen test is
effective at identifying high viral loads of Omicron, further laboratory
analysis carried out by Avacta indicates that the sensitivity of the test is
reduced at lower viral loads when compared with the sensitivity of the
AffiDX(®) test with previous SARS-CoV-2 variants.

 

The AffiDX(®) SARS CoV-2 antigen lateral flow test contains both a
proprietary Affimer(®) reagent and a commercially available antibody. Our
data show that the Affimer(®) reagent in the AffiDX(®) test detects the
Omicron variant with the same sensitivity as the Delta variant, and it is the
performance of the antibody, with which the Affimer(®) is paired in the test,
that has been affected by the additional Omicron mutations. The Company has
therefore independently taken the decision to pause sales of the AffiDX(®)
antigen test whilst it replaces the antibody in the product to ensure that its
performance with the Omicron variant matches the high performance with
previous mutations.

 

Alastair Smith, Chief Executive of Avacta Group, commented:

"The continued high performance of the Affimer(®) reagent in the AffiDX(®)
antigen test, despite the large number of mutations in the Omicron variant, is
testament to the robustness of our platform technology.

 

"As a responsible business, we set very high standards for ourselves and our
products and have continually kept the performance of the AffiDX(®) antigen
test under review as new SARS-CoV-2 variants have arisen. Our determination to
only provide high quality, high performance diagnostic tests has led us to the
correct decision to pause all marketing of the AffiDX(®) lateral flow antigen
test. We have, of course, been unable to market the product in the UK since
October 2021, as the product continues to await approval under the new CTDA
regulatory process.

 

"We believe COVID-19 testing remains a long-term commercial opportunity. We
will therefore use the robustness of the Affimer(®) platform, and what we
have learned about the SARS-CoV-2 virus, to generate the next generation
antigen test that will be as resilient as possible to any future mutations.

 

"The performance of other marketed SARS-CoV-2 antigen lateral flow tests may
well be adversely affected by the Omicron variant. This mutant is already the
dominant SARS-CoV-2 variant in many countries and may soon be the dominant
variant globally. We therefore believe it is essential that similar Omicron
sensitivity studies be performed on all SARS-CoV-2 antigen tests and the
results communicated to ensure the public can have confidence in the results
these tests generate."

 

ENDS

 

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 (http://www.avacta.com)

 Tony Gardiner, Chief Financial Officer

 Michael Vinegrad, Group Communications Director

 Stifel Nicolaus Europe Limited (Nomad and Broker)             Tel: +44 (0) 207 710 7600

 Nicholas Moore / Nick Adams / Fred Walsh / Nicholas Harland   www.stifel.com (http://www.stifel.com/)

 FTI Consulting (Financial Media and IR)                       Tel: +44(0) 203 727 1000

 Simon Conway / Alex Shaw                                      Avacta.LS@fticonsulting.com (mailto:Avacta.LS@fticonsulting.com)

 Zyme Communications (Trade and Regional Media)                Tel: +44 (0)7891 477 378

 Lily Jeffery                                                  lily.jeffery@zymecommunications.com

                                                             (mailto:katie.odgaard@zymecommunications.com)

 

About Avacta Group plc - https://www.avacta.com (https://www.avacta.com/)

 

Avacta Group is developing novel cancer immunotherapies and powerful
diagnostics based on its two proprietary platforms - Affimer(®) biologics and
pre|CISION™ 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 London and 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 is developing an in-house pipeline of
Affimer-based diagnostic assays, including the AffiDX(®) SARS-CoV-2 Lateral
Flow Rapid Antigen Test, and works with partners world-wide to develop bespoke
Affimer(®) reagents for third party products.

 

Avacta's Therapeutics Division is working to deliver a more tolerable and
durable treatment response for oncology patients who do not respond to
existing immunotherapies. By combining its two proprietary platforms the Group
is building a wholly owned pipeline of clinically differentiated cancer
therapies, aiming to extend the therapeutic benefits to all cancer patients.
In 2021 Avacta transitioned to become a clinical stage biopharmaceutical
company, commencing a phase I first-in-human, open label, dose-escalation and
expansion study of AVA6000, a pro-doxorubicin, the Group's lead pre|CISION™
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 ModernaTX, Inc. (formerly 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 and a collaboration
with Point Biopharma to develop radiopharmaceuticals based on the
pre|CISION™ platform. Avacta continues to actively seek to license its
proprietary platforms in a range of therapeutic areas.

 

To register for news alerts by email go
to www.avacta.com/investor-news-email-alerts
(http://www.avacta.com/investor-news-email-alerts)

 

 

 1  https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests#omicronvariantimpact
(https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests#omicronvariantimpact)

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