REG - Avacta Group PLC - ALS-6000-101 Phase 1a Study Data

AvactaAnnouncement

13/12/2023 07:15

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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™ 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|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™ 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
(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 Officer                                   www.avacta.com (http://www.avacta.com)

 Tony Gardiner, Chief Financial Officer

 Michael Vinegrad, Group Communications Director

 Stifel Nicolaus Europe Limited (Nomad and Joint Broker)                   Tel: +44 (0) 207 710 7600

 Nicholas Moore / Nick Adams / Samira Essebiyea / Nick Harland / William   www.stifel.com (http://www.stifel.com/)
 Palmer-Brown

 Peel Hunt (Joint Broker)                                                  Tel: +44 (0) 207 418 8900

 James Steel / Chris Golden / Patrick Birkholm                             www.peelhunt.com (http://www.peelhunt.com)

 ICR Consilium (Media and IR)                                              avacta@consilium-comms.com (mailto:avacta@consilium-comms.com)

 Mary-Jane Elliott / Jessica Hodgson / Sukaina Virji

 

About Avacta Group plc - https://www.avacta.com (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.

 

To register for news alerts by email go to
https://avacta.com/investors/investor-news-email-alerts/
(https://avacta.com/investors/investor-news-email-alerts/)

 

 

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