REG - Avacta Group PLC - Update on AVA6000 Phase 1a Clinical Trial Progress

AvactaAnnouncement

21/03/2024 07:00

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RNS Number : 6882H  Avacta Group PLC  21 March 2024

 

 

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
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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|CISION(TM) 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|CISION(TM) 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|CISION(TM) 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/m(2)), 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/m(2)) 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                                                           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

                                                                            Tel: +44 (0) 207 710 7600

 Stifel Nicolaus Europe Limited (Nomad and Joint Broker)                    www.stifel.com (http://www.stifel.com/)

 Nicholas Moore / Nick Adams / Samira Essebiyea / Nick Harland / Ben Good

 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, 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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