TIDMAVCT
RNS Number : 4991P
Avacta Group PLC
18 February 2021
18 February 2021
Avacta Group plc
("Avacta" or "the Group" or "the Company")
Phase I Clinical Trial Authorisation for AVA6000 Approved by
MHRA
Approval for the phase I dose-escalation and expansion study of
Avacta's novel pre|CISION(TM) FAP-activated Doxorubicin
pro-drug
Avacta Group plc (AIM: AVCT), the developer of Affimer(R)
biotherapeutics and reagents, announces that it has received
approval from the Medicines and Healthcare Products Regulatory
Agency (MHRA) for its Clinical Trial Authorisation (CTA) in the UK
for a phase I study of its lead pre|CISION(TM) pro-drug, AVA6000
pro-doxorubicin.
In AVA6000, doxorubicin has been modified with Avacta's
pre|CISION(TM) chemistry, which renders the modified drug inactive
in the circulation until it enters the tumour micro-environment.
Here it is activated by an enzyme called FAP (fibroblast activation
protein), which is in high abundance in most solid tumours but not
in healthy tissue such as the heart.
In animal models AVA6000 has been shown to significantly
increase the amount of active drug in a tumour compared with the
heart and has significant potential to improve tolerability and
achieve better clinical outcomes for patients.
The MHRA CTA approval is for a phase I clinical study and is a
first-in-human, open-label, multi-centre study to be carried out in
the UK in patients with locally advanced or metastatic solid
tumours, which are known to be FAP positive including pancreatic,
colorectal, breast, ovarian, bladder and non-small cell lung
cancers, squamous cell carcinoma of the head and neck and
soft-tissue sarcoma.
The timing of dosing the first patient in the study may be
affected by the ongoing COVID-19 pandemic and its effect on
hospital resources. However, it is anticipated that the study will
start around mid-year.
Alastair Smith, Chief Executive Officer of Avacta Group,
commented:
"I am delighted to receive this approval for the AVA6000
Pro-doxorubicin phase I study from the MHRA. This is a significant
milestone for Avacta and opens the path to a potentially
transformational clinical proof-of-concept study for AVA6000 and
the pre|CISION platform.
If the AVA6000 study shows that the pre|CISION chemistry is
effective in reducing systemic toxicity of doxorubicin in humans,
then it can be applied to a range of other established
chemotherapies to improve their safety and efficacy. This would
open up a pipeline of next generation chemotherapies for the Group
with significant clinical and commercial value in a chemotherapy
market that is expected to grow to $56 billion by 2024.(1)
I look forward to updating the market on the timing of the
dosing of the first patient and on the clinical data in due
course."
Professor Chris Twelves, AVA6000 Study Chief Investigator, Leeds
Teaching Hospitals Trust and the University of Leeds,
commented:
"This is tremendous news. When I see patients with cancer I want
to offer them more effective treatments with fewer side effects. My
team are excited to be part of the AVA6000 Phase I first into human
study and we look forward to enrolling patients into the clinical
trial ."
Neil Bell, Chief Development Officer of Avacta Group,
commented:
" The AVA6000 clincial trial authorisation approval represents
another important milestone for the pre|CISION platform and AVA6000
programme. Working in partnership with the UK regulatory authority,
the Medicines and Healthcare products Regulatory Agency (MHRA),
Avacta has obtained approval to initate our first Phase I
open-label clinical study to evaluate AVA6000, a novel
FAP-activated doxorubicin prodrug.
By utilizing FAP activation as a selective drug delivery system
the pre|CISION platform provides the capability to deliver
chemotherapies to the tumour microenvironment whilst limiting
severe and life-threatening toxicities in non-target tissues.
pre|CISION has the potential to change future treatment paradigms
for many chemotherapies which have not yet optimised their clinical
utility.
The next key milestone for the AVA6000 programme is to dose our
first patient, planned for mid-year 2021 in the UK. Notwithstanding
Covid-19 restrictions, the team are energetically working towards
achieving this milestone, which will see Avacta transform into a
clinical stage company. "
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).
[1]
https://www.globenewswire.com/news-release/2019/06/19/1871180/0/en/Chemotherapy-Market-Estimated-to-Be-Valued-at-USD-56-491-59-Million-to-Register-a-Robust-CAGR-of-11-50-By-2024.html
- 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
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.
To register for news alerts by email go to
www.avacta.com/investor-news-email-alerts
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