TIDMAVCT
RNS Number : 8295M
Avacta Group PLC
19 September 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.
19 September 2023
Avacta Group plc
("Avacta" or the "Company" and, together with its subsidiary
undertakings, the "Group")
Successful Completion of ALS-6000-101 Sixth Dose Escalation and
Clinical Update
- Excellent safety profile of AVA6000 continues to be observed
in the sixth dose escalation cohort.
- Significant reduction in tumour volume confirmed in a patient with soft tissue sarcoma.
- Cohort 7 to be the final dose escalation cohort in the Phase 1a three weekly dosing study.
- Revised regulatory strategy aims to achieve earlier
commencement of pivotal Phase 2 study in soft tissue sarcoma in
2024.
- Detailed Phase 1a data expected to be released in Q4 2023.
Avacta Group plc (AIM: AVCT), a life sciences company developing
innovative, targeted oncology drugs and powerful diagnostics, today
announces the successful completion of the sixth dose escalation
cohort in the ALS-6000-101 dose escalation Phase 1 clinical trial
to evaluate the safety and tolerability of AVA6000 and provides an
update on clinical progress.
The data from the sixth cohort continue to show an excellent
safety profile for AVA6000. Additionally, a tumour response
(significant tumour volume reduction) has been confirmed in a
patient with soft tissue sarcoma on the trial, and there are
further indications of clinical activity in patients across other
indications.
AVA6000 is a tumour targeted form of doxorubicin that has been
chemically modified with Avacta's pre|CISION(TM) platform, designed
to reduce systemic side effects by targeting the release of the
active chemotherapy to tumour tissue.
A total of 35 patients with a range of advanced and/or
metastatic solid tumours have now been dosed at the clinical trial
in sites in the UK and United States. AVA6000 continues to be well
tolerated by patients in cohort 6 despite receiving 2.79 times the
typical dose of doxorubicin. A clinically significant reduction in
the toxicities usually associated with standard doxorubicin
chemotherapy continues to be observed. These data continue to
demonstrate the potential to administer higher doses, more cycles
of AVA6000, or more frequent dosing compared to doxorubicin.
On the basis of the very favourable safety profile of AVA6000,
the Safety Data Monitoring Committee (SDMC) has recommended
continuation to the seventh dose cohort at 385 mg/m(2) , which is
equivalent to approximately 3.5 times the standard dose of
doxorubicin.
The Company and its advisers have decided that Cohort 7 will be
the final dose escalation cohort in the ALS-6000-101 Phase 1a
safety study for three weekly dosing.
In addition to the excellent safety profile being observed for
AVA6000, clear signs of efficacy have now been confirmed. One
patient with soft tissue sarcoma has shown a significant reduction
in tumour volume in response to the drug, with further signs of
activity observed in patients with cancers not limited to soft
tissue sarcoma.
In light of the positive data emerging from the ALS-6000-101
study the Company has adapted its clinical development strategy
with the aim of bringing forward the start of a potentially pivotal
phase 2 study in soft tissue sarcoma, subject to receiving the
necessary regulatory approvals.
The excellent safety profile of AVA6000 should allow more
frequent and/or higher dosing compared with the standard
doxorubicin regimen which could in turn improve the outcome for
patients. Therefore, in parallel with the completion of cohort 7,
the Company intends to begin a short study to explore more frequent
dosing (fortnightly) of AVA6000 as a first line treatment in
patients with soft tissue sarcoma. The study is expected to begin
in Q4 2023 subject to receipt of approval of a protocol amendment
from the US Food & Drug Administration (FDA).
The study is designed to determine whether fortnightly or three
weekly dosing should be the recommended Phase 2 dosing regimen, as
well as potentially providing additional indications of activity in
soft tissue sarcoma patients. The study will replace the much
longer planned Phase 1b efficacy study, and is expected to allow
the Company to bring forward the start of the potentially pivotal
Phase 2 efficacy study into 2024.
The Company expects to publish detailed data from the
ALS-6000-101 clinical study, including clinical and pharmacokinetic
data, in the fourth quarter of 2023.
Dr Alastair Smith, Chief Executive of Avacta Group plc
commented:
"I believe that we are on the verge of a paradigm shift in how
chemotherapy is delivered to cancer patients.
The safety and initial efficacy signals emerging from the data
in the AVA6000 Phase 1 study are very encouraging indeed. The
pre|CISION(TM) platform is doing exactly what it was designed to do
- target the release of active chemotherapy to the tumour tissue,
sparing healthy tissues and improving the safety and tolerability
of the drug whilst delivering potentially superior efficacy.
I'm particularly pleased that, even at this early stage and in
this patient group, we have a confirmed, significant response in a
patient with soft tissue sarcoma, as well as other positive signals
across a number of other patients.
We're now aiming to accelerate the clinical development of
AVA6000 and begin the Phase 2 efficacy study earlier than
originally planned. The Phase 2 trial will follow a short study to
determine the safety and efficacy of fortnightly dosing to allow us
to determine the recommended Phase 2 dosing regimen.
I look forward very much to sharing the detailed data from the
Phase 1a study in due course."
-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 Tel: +44 (0) 207 710 7600
(Nomad and Broker) www.stifel.com
Nicholas Moore / Nick Adams /
Samira Essebiyea / Nick Harland
/ Dhiren Suares / William Palmer-Brown
ICR Consilium
Mary-Jane Elliott / Jessica Hodgson avacta@consilium-comms.com
/ Sukaina Virji
About Avacta Group plc - www.avacta.com
Avacta Group plc is a life sciences company working to improve
people's health and well-being through innovative oncology drugs
and powerful diagnostics. Operating through two divisions,
Diagnostics and Therapeutics, the Group's mission is to provide
professionals and consumers with solutions that improve healthcare,
fitness and well-being.
Avacta's Therapeutics Division, a clinical stage oncology drug
innovator, is building a wholly owned pipeline of novel Affimer(R)
immunotherapies and pre|CISION(TM) tumour targeted chemotherapies.
This approach is designed to address the lack of a durable response
to current cancer immunotherapies experienced by most patients and
reduce the severe systemic toxicities caused by chemotherapies.
There are five programmes in the pipeline as well as several global
research collaborations and licensing partnerships. Avacta's lead
programme, AVA6000, is a pre|CISION(TM) tumour-targeted form of the
established chemotherapy doxorubicin. AVA6000 is in Phase I
clinical trials in patients with locally advanced or metastatic
selected solid tumours.
The Affimer(R) platform is an alternative to antibodies that has
been designed to address many of the drawbacks of antibodies which,
despite their shortcomings, currently dominate the
immuno-diagnostics and immuno-therapeutics markets.
The pre|CISION(TM) tumour targeting platform can be used to
modify a chemotherapy in order to selectively release the active
drug in tumour tissue thereby reducing the systemic exposure that
causes damage to healthy tissues. pre|CISION(TM) modified
chemotherapies are designed to reduce the side effects and improve
the overall safety and therapeutic potential of these powerful
anti-cancer treatments.
Avacta's Diagnostics Division develops and supplies a broad
range of in-vitro diagnostic (IVD) solutions. The Division is
growing rapidly through an M&A strategy to deliver a
global-scale IVD business providing market-leading solutions for
healthcare professionals and consumers to inform treatment and
monitor health and well-being. In October 2022, Avacta acquired
Launch Diagnostics which serves the hospital pathology laboratory
market in the UK and Europe. In May 2023, Avacta acquired Coris
Bioconcept a Belgium-based lateral flow test developer and
manufacturer adding a broad range of marketed professional-use
rapid tests into the Diagnostics Division. Avacta Diagnostic's
research and development centre in Wetherby, UK uses its
proprietary Affimer(R) platform to differentiate immunodiagnostic
products to provide market-leading performance.
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