This announcement contains inside information for the purposes
of Article 7 of the UK version of Regulation (EU) No 596/2014 which
is part of UK law by virtue of the European Union (Withdrawal) Act
2018, as amended ("MAR"). Upon the publication of this announcement
via a Regulatory Information Service, this inside information is
now considered to be in the public domain.
21 March
2024
Avacta Group
plc
("Avacta"
or the "Group" or the "Company")
Update on AVA6000 Phase 1a
Clinical Trial Progress
Three patients now dosed in
the US in two-weekly dose escalation study
Avacta receives approval to
enrol patients in the UK in the ongoing two-weekly dose escalation
study
Avacta Group plc (AIM: AVCT), a life
sciences company developing innovative, targeted oncology drugs and
powerful diagnostics, is pleased to announce that
yesterday the third patient was dosed in the first
cohort of the two-weekly Phase 1a dose escalation study of its lead
pre|CISIONTM drug AVA6000, a peptide
drug conjugate designed to target the release of the chemotherapy
doxorubicin to tumor tissue.
Many solid tumors have higher levels
of an enzyme called fibroblast activation protein ("FAP") compared
with healthy tissues. The pre|CISIONTM technology is
designed to render a chemotherapy inert until it encounters FAP.
FAP targeted release of a chemotherapy aims to reduce damage to
healthy tissues and systemic side effects, improve the tolerability
for patients and thereby allow optimisation of the dosing schedule
to improve efficacy.
The safety and tolerability of
AVA6000 are continuing to be assessed in a Phase 1a dose escalation
study. As announced on 13 December 2023, data to date from the
three-weekly dosing arm of the trial demonstrated that
the pre|CISIONTM platform
targets the release of the chemotherapy to the tumor as intended,
that AVA6000 significantly improved the safety and tolerability of
doxorubicin and that AVA6000 is already showing encouraging
preliminary clinical signs of anti-tumor activity.
Cohort 7 was the final cohort in the
three-weekly study and even at this dose level (385
mg/m2), which is approximately 3.5x the equivalent
standard dose of doxorubicin, dose-limiting toxicities were not
observed and the Safety Data Monitoring Committee ("SMDC") has
concluded that this dose level is safe. A number of patients remain
on the three-weekly study at this time in several different
cohorts.
Based on this very favourable
three-weekly dosing safety profile, Avacta commenced a two-weekly
dosing safety study in the US on the basis that this is likely to
lead to better efficacy. Three patients have now
been dosed in cohort 1 (160 mg/m2) of the two-weekly
dose escalation study in the US and Avacta has received regulatory
and ethics approval to open sites in the UK in the two-weekly arm.
Avacta anticipates that the SMDC will review the two-weekly cohort
1 data by the end of April.
The combined data from the
three-weekly and two-weekly studies will provide information to
allow the Company to define the dose and schedule to be used in
future efficacy studies. Patients can be dosed in
parallel in the two-weekly dose escalation study and Avacta remains
on track to begin the dose expansion efficacy study in the second
half of 2024. The data from the expansion study will be used
to inform the optimal choice of a single orphan indication for the
Phase 2 efficacy study which will follow on immediately.
Dr
Alastair Smith, Chief Executive Officer of Avacta Group,
commented:
"We are extremely pleased with
the continued excellent progress of AVA6000 in the Phase 1a dose
escalation study. These emerging data clearly demonstrate that the
pre|CISION™ peptide drug conjugate platform is functioning in the
way it was designed and is capable of targeting the release of a
cancer therapy to the tumor. Targeted therapy that spares healthy
tissues is a holy grail of oncology drug development and we believe
we have a unique platform to target FAP-rich tumor tissues to
deliver significantly better outcomes for patients and substantial
value to our shareholders.
"The continuing validation of the
pre|CISION™ platform we are seeing in the clinic underlines our
confidence in the significant opportunity to apply pre|CISION™ to a
range of warheads, including those much more potent than
doxorubicin.
We are now in a very strong position
to deliver significant clinical and commercial milestones relating
to AVA6000 and the wider pre|CISION™ platform, and we are looking
forward to providing a further detailed update on the clinical
trial at the American Association for Cancer Research meeting in
April."
Lee Cranmer MD, PhD, FACP, Curtis
and Elizabeth Anderson Endowed Professor in Sarcoma Research,
University of Washington and Professor and Director of Sarcoma
Oncology, Fred Hutchinson Cancer Center,
commented:
"I am encouraged by the initial data
with AVA6000 in the Phase 1 trial and look forward to working with
my fellow investigators and our collaborators at Avacta to
understand better the optimal dosing for this novel approach to
targeted cancer therapy."
-Ends-
For
further information from Avacta Group plc, please
contact:
Avacta Group plc
Alastair Smith, Chief Executive
Officer
Tony Gardiner, Chief Financial
Officer
Michael Vinegrad, Group
Communications Director
|
Tel: +44
(0) 1904 21 7070
www.avacta.com
|
Stifel Nicolaus Europe
Limited (Nomad and Joint Broker)
Nicholas Moore / Nick Adams / Samira
Essebiyea / Nick Harland / Ben Good
|
Tel: +44
(0) 207 710 7600
www.stifel.com
|
Peel Hunt (Joint Broker)
James Steel / Chris Golden / Patrick
Birkholm
|
Tel: +44
(0) 207 418 8900
www.peelhunt.com
|
ICR Consilium (Media and
IR)
Mary-Jane Elliott / Jessica Hodgson
/ Sukaina Virji
|
avacta@consilium-comms.com
|
About Avacta Group plc - https://www.avacta.com
Avacta Group is a UK-based company
focused on improving healthcare outcomes through targeted cancer
treatments and diagnostics.
Avacta has two divisions: an
oncology biotech division harnessing proprietary therapeutic
platforms to develop novel, highly targeted cancer drugs, and a
diagnostics division, focused on supporting healthcare
professionals and broadening access to testing. Avacta's two
proprietary platforms, Affimer® and pre|CISION™ underpin its cancer
therapeutics whilst the diagnostics division leverages the Affimer®
platform to drive competitive advantage in its markets.
The pre|CISION™ platform modifies
chemotherapy to be activated only in the tumor tissue, reducing
systemic exposure and toxicity. This is achieved by harnessing an
enzyme called FAP which is highly upregulated in most solid tumors
compared with healthy tissues, turning chemotherapy into a
"precision medicine". The lead pre|CISION™ programme, AVA6000 a
tumour activated form of doxorubicin, is in Phase 1 studies and has
shown dramatic improvement in safety compared with standard
doxorubicin, and early signs of clinical activity.
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