ALS-6000-101 Phase 1a Three-Weekly Dose Escalation Safety Study Data
13 December 2023 - 11:00PM
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|CISIONTM 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|CISIONTM programme, AVA6000, a tumour activated form
of doxorubicin.
The key conclusions drawn from the data for
AVA6000 to date are:
- The
pre|CISIONTM platform targets the release of
a chemotherapy to the tumour as intended. The data show
that the pre|CISIONTM 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.
- 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.
- 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.
- 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|CISIONTM
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™ 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™ 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|CISIONTM 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™ 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
plcAlastair Smith, Chief Executive OfficerTony Gardiner,
Chief Financial OfficerMichael Vinegrad, Group Communications
Director |
Tel: +44 (0) 1904 21 7070www.avacta.com |
Stifel Nicolaus Europe
Limited (Nomad and Joint Broker)Nicholas Moore / Nick
Adams / Samira Essebiyea / Nick Harland / William Palmer-Brown |
Tel: +44 (0) 207 710 7600www.stifel.com |
Peel Hunt (Joint
Broker)James Steel / Chris Golden / Patrick Birkholm |
Tel: +44 (0) 207 418 8900www.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,
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® 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 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™ 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® 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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