TIDMAVCT
RNS Number : 8030T
Avacta Group PLC
29 November 2021
29 November 2021
Avacta Group plc
("Avacta" or "the Group" or "the Company")
Avacta Announces FDA Approval of its Investigational New Drug
(IND) Application for AVA6000
Enables expansion of recruitment into ongoing phase I study to
include eligible US patients upon opening of clinical sites in
early 2022
Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical
company developing innovative cancer therapies and powerful
diagnostics based on its proprietary Affimer(R) and pre|CISION(TM)
platforms, is pleased to announce that the US Food and Drug
Administration (FDA) has approved its Investigational New Drug
(IND) application for AVA6000. This will allow the Group to expand
its Phase I clinical trial, ALS-6000-101, into clinical trial sites
in the United States.
AVA6000 is a novel form of doxorubicin that has been modified
with Avacta's pre|CISION(TM) platform to improve its safety and
therapeutic index. Anthracyclines such as doxorubicin, a generic
chemotherapy for which the market is expected to grow to $1.38bn by
2024[1], are widely used as part of standard of care in several
tumour types, but their use is limited by cumulative toxicity.
AVA6000 has been designed to limit cell penetration of the drug,
and therefore its cell killing effect, until it is specifically
activated by fibroblast activation protein <ALPHA> (FAP)
which is in high concentration in many solid tumours compared with
healthy tissues. The resulting reduced exposure of healthy tissues
to active doxorubicin has the potential to significantly increase
its therapeutic index by reducing the incidence of adverse effects,
including cardiotoxicity and myelosuppression.
The FDA has completed its 30-day review of Avacta's IND
application, which was submitted ahead of schedule in October 2021,
and has concluded that the Group may proceed with its proposed
clinical investigation. This allows Avacta to enroll eligible
patients into US clinical trial sites for the company's Phase I
multi-centre study, ALS-6000-101. As previously announced in August
2021, the Company has begun recruiting and dosing patients for this
study at several clinical trial sites in the UK, and continues to
expect the dose escalation phase for this trial to complete by Q2
2022 followed by completion of the dose expansion phase around
mid-2023. Enrollment in US clinical trial sites is expected to
begin in early 2022.
Dr Alastair Smith, Chief Executive Officer of Avacta Group,
commented:
"We are delighted to have received approval from the FDA to add
clinical trial sites in the United States as part of the Phase I
study for AVA6000. This is a major milestone in our development of
pre|CISION(TM) chemotherapies and is testament to the performance
of our clinical development team and the quality of the
pre-clinical data for AVA6000.
"Provided that the study shows that the pre|CISION(TM)
technology is effective in reducing systemic toxicity of
Doxorubicin, then that would open up an extensive and proprietary
pipeline for Avacta of next-generation pre|CISION(TM)
chemotherapies with significant clinical and commercial advantages
in a chemotherapy market that is expected to exceed $74 billion by
2027[2].
"We now look forward to opening up clinical trial sites in the
United States and additional clinical trial sites in the UK."
Neil Bell, Chief Development Officer of Avacta Life Sciences
commented:
"We are excited to bring the first FAP-activated
chemotherapeutic to the clinic in the US, which has the potential
to meaningfully impact patients with difficult-to-treat tumours.
The clearance of the AVA6000 IND by the FDA enables the opening of
key US sites to support the ALS-6000-101 clinical trial which is
currently recruiting patients across clinical sites in the UK."
- 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
Michael Vinegrad, Group Communications
Director
Stifel Nicolaus Europe Limited (Nomad Tel: +44 (0) 207 710 7600
and Broker) www.stifel.com
Nicholas Moore / Nick Adams / Fred
Walsh / Ben Maddison
FTI Consulting (Financial Media Tel: +44(0) 203 727 1000
and IR) Avacta.LS@fticonsulting.com
Simon Conway / Alex Shaw / Stephanie
Cuthbert
Zyme Communications (Trade and Tel: +44 (0)7891 477 378
Regional Media) lily.jeffery@zymecommunications.com
Lily Jeffery
About ALS-6000-101 Clinical Study
ALS-6000-101 is a Phase I study in patients with locally
advanced or metastatic selected solid tumours, known to be
FAP-positive, in which cohorts of patients receive ascending doses
of AVA6000 to determine the maximum tolerated dose and establish a
recommended Phase II dose. The second part of the study is an
expansion phase where patients receive AVA6000 to further evaluate
the safety, tolerability and clinical activity at this recommended
Phase II dose across selected tumour types. The dose escalation
phase for this study is anticipated to complete by Q2 2022 followed
by completion of the dose expansion phase by Q2 2023. For more
information visit www.clinicaltrials.gov (NCT04969835).
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(R) 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(TM) 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(R)
SARS-CoV-2 Lateral Flow Rapid Antigen Test, and works with partners
world-wide to develop bespoke Affimer(R) 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(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 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(TM) 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
[1]
https://www.prnewswire.com/news-releases/doxorubicin-market-size-is-expected-to-reach-138-billion-by-2024-grand-view-research-inc-602613665.html
[2]
https://www.globenewswire.com/en/news-release/2021/02/08/2171622/0/en/Cancer-Chemotherapy-Market-Value-Anticipated-To-Reach-US-74-3-Billion-By-2027-Acumen-Research-and-Consulting.html
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