TIDMAVCT
RNS Number : 5591W
Avacta Group PLC
13 December 2023
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.
13 December 2023
Avacta Group plc
("Avacta" or "the Group" or "the Company")
ALS-6000-101 Phase 1a Three-Weekly Dose Escalation Safety Study
Data
The data confirm the pre|CISION (TM) platform's ability to
transform the safety profile of doxorubicin through tumour
targeting
Cohort 7, the final cohort in the three-weekly dose escalation
safety study of AVA6000, has completed enrolment and is ongoing
A fortnightly dosing study to optimise the selection of the
Phase 2 dose is now screening patients in the United States
Avacta Group plc (AIM: AVCT), a life sciences company developing
innovative, targeted oncology drugs and powerful diagnostics, is
pleased to provide detailed pre-clinical, clinical and
pharmacokinetic data from the Phase 1a dose escalation study of its
lead pre|CISION(TM) programme, AVA6000, a tumour activated form of
doxorubicin.
The key conclusions drawn from the data for AVA6000 to date
are:
1. The pre|CISION(TM) platform targets the release of a
chemotherapy to the tumour as intended. The data show that the
pre|CISION(TM) modification is cleaved specifically by Fibroblast
Activation Protein (FAP), an enzyme present in high concentrations
in many solid tumours compared with healthy tissue. In the case of
AVA6000, this targets the release of doxorubicin to the tumour
microenvironment, concentrating the active cytotoxic drug within
the tumor microenvironment and limiting systemic exposure to the
chemotherapy.
2. AVA6000 has significantly improved the safety and
tolerability of doxorubicin. A significant reduction in the
frequency and severity of the known doxorubicin toxicities has been
observed across the dosing range. A maximum tolerated dose has not
been reached in the three-weekly dose escalation study despite
dosing approximately 3.5x the normal level of doxorubicin in the
highest and final dose cohort in this part of the Phase 1a
study.
3. AVA6000 has shown encouraging preliminary clinical signs of
anti-tumour activity. Preliminary results in the Phase 1a trial
demonstrate activity of AVA6000 in patients with tumours with high
FAP activity, validating the mechanism of action of AVA6000. For
example, a 59-year-old male patient with Undifferentiated
Pleomorphic Sarcoma (UPS) has shown a reduction in tumour volume of
65% with a duration of response >6 months and ongoing. A number
of other patients with different cancer types have shown smaller
ongoing reductions in tumour volume or stable disease.
4. The next steps with AVA6000 involve optimising the patient
population, dose and schedule in order to increase efficacy and
tolerability of doxorubicin treatment via pre|CISION(TM) targeting.
Given the favourable safety data from the three-weekly dosing
study, a fortnightly dosing study, which is now screening patients
with high FAP levels in the United States, will assist in
optimising the schedule and dose for a potentially pivotal Phase 2
study in 2024.
Dr Alastair Smith, Chief Executive Officer of Avacta Group,
commented:
"Targeting potent therapies to the tumour, while limiting the
systemic toxicity that often characterises these therapies, is one
of the holy grails of cancer drug development. The data we released
today show that the pre|CISION(TM) modification is cleaved
specifically by FAP, and not by other human enzymes, and this
mechanism can be used to target the activation of a chemotherapy to
the tumour microenvironment, significantly reducing the systemic
exposure and improving the safety of the drug.
"The encouraging safety and tolerability observed with the
pre|CISION(TM) platform facilitates optimisation of dosing used
with existing chemotherapies by exploring higher and more frequent
doses and/or more treatment cycles. The ability to target the
activation of a toxic drug to the tumour tissue also makes it
possible to consider using even more potent cytotoxics that could
not previously have been administered as systemic chemotherapies
for safety reasons.
"The potential of the pre|CISION (TM) platform to change the way
in which potent cytotoxic drugs are delivered, improving cancer
patients' quality of life and treatment outcomes, is truly
remarkable."
Dr William Tap, Chief, Sarcoma Medical Oncology at Memorial
Sloan Kettering Cancer Center, NY also commented:
"These initial clinical data are encouraging and demonstrate
that the novel drug delivery mechanism of AVA6000 has the potential
to demonstrate single agent activity in patients with solid tumours
that express high levels of FAP. The safety data when compared with
standard doxorubicin are highly encouraging and demonstrate the
power of the pre|CISION (TM) platform to avoid normal tissue
effects while concentrating the toxin in the tumor
microenvironment."
Avacta's Chief Executive Officer Alastair Smith, Chief
Scientific Officer Fiona McLaughlin and Consultant Christina
Coughlin will present a detailed review of the AVA6000 preclinical
and clinical data, followed by investor Q&A, on the Investor
Meet Company ("IMC") platform at 11:00am GMT. This presentation
will be made available via the Company's website after the
meeting.
Investors who already follow Avacta on IMC will automatically be
invited to join the live stream. Investors who do not have an IMC
account can sign up for free at
https://www.investormeetcompany.com/avacta-group-plc/register-investor
and then click "Add to meet" on the Avacta page in order to receive
an invitation.
-Ends-
For further information from Avacta Group plc, please
contact:
Avacta Group plc Tel: +44 (0) 1904 21 7070
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 Joint Broker) www.stifel.com
Nicholas Moore / Nick Adams / Samira
Essebiyea / Nick Harland / William
Palmer-Brown
Peel Hunt (Joint Broker) Tel: +44 (0) 207 418 8900
James Steel / Chris Golden / Patrick www.peelhunt.com
Birkholm
ICR Consilium (Media and IR) avacta@consilium-comms.com
Mary-Jane Elliott / Jessica Hodgson
/ Sukaina Virji
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, which is
executing on an M&A led growth strategy to create a
full-spectrum diagnostics business focused on supporting healthcare
professionals and broadening access to testing. Avacta's two
proprietary platforms, Affimer(R) and pre|CISION(TM) underpin its
cancer therapeutics whilst the diagnostics division leverages the
Affimer(R) platform to drive competitive advantage in its
markets.
The pre|CISION(TM) platform modifies chemotherapy to be
activated only in the tumour tissue, reducing systemic exposure and
toxicity. This is achieved by harnessing an enzyme called FAP which
is highly upregulated in most solid tumours compared with healthy
tissues, turning chemotherapy into a "precision medicine". The lead
pre|CISION(TM) 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.
Affimer(R) is a novel biologic platform which has significant
technical and commercial advantages compared with antibodies and is
used both to develop advanced immunotherapies and to improve the
performance of immunodiagnostics.
With a balanced business and capital allocation model: a
high-value oncology pipeline supported by a revenue generating,
fast-growing diagnostics business, Avacta seeks to create long-term
shareholder value alongside patient benefit.
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