REG - Avacta Group PLC - Successful Completion of First Cohort

AvactaAnnouncement

23/05/2024 07:00

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RNS Number : 5554P  Avacta Group PLC  23 May 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
the publication of this announcement via a Regulatory Information Service,
this inside information is now considered to be in the public domain.

 

23 May 2024

 

Avacta Group plc

 

("Avacta" or the "Company")

 

Successful Completion of First Cohort and Dosing of Three Patients of the
Second Cohort in Arm 2 of Avacta's AVA6000 Phase 1 trial

 

Initiation of FAPI-PET Sub-study in the AVA6000 Phase 1 trial

 

-      First cohort successfully completed in Arm 2 with no adverse
safety signals and initiation of FAPI-PET sub-study to better characterize the
FAP-positive disease burden at the time of study entry in selected patients

-      Two-weekly dosing study for AVA6000, Avacta's peptide drug
conjugate, is designed to potentially optimise efficacy and maintain the
robust safety profile of AVA6000

-      The Company remains on track for stated goals in 2H 2024

 

Avacta Group plc (AIM: AVCT), a life sciences company developing innovative,
targeted oncology drugs and powerful diagnostics, is pleased to announce the
successful completion of the first cohort and dosing of 3 patients in the
second cohort in the dose escalation study of Arm 2 of its Phase 1 trial for
AVA6000, a peptide drug conjugate form of doxorubicin chemotherapy. In
addition, a sub-study utilizing FAPI-PET scanning at baseline has also
commenced to further characterize the full burden of FAP-positive disease in
patients.

 

The Phase 1 trial is evaluating the safety and tolerability of AVA6000,
Avacta's lead programme, leveraging its proprietary pre|CISION™ technology.
Arm 2 of the trial, which follows positive data from Arm 1, is designed to
optimise the schedule and dose for efficacy studies following the successful
completion of Arm 1 and will follow a two-weekly dosing schedule ("Q2W").

 

Dosing of the second cohort in Arm 2 has now commenced, with three patients
successfully dosed. The sub-study through partnership with SOFIE utilising
baseline  (18)F FAPI-74 PET scanning in the AVA6000 Phase 1 trial has
commenced and is designed to better characterise in a subset of patients the
whole-body tumor expression of the target of the pre|CISION™ molecule and
levels of fibroblast activation protein ("FAP") expression, an enzyme present
in high concentrations in many solid tumors. These data will inform on various
indications for further efficacy studies. This sub-study represents an ongoing
collaboration between Avacta and SOFIE, in the use of  (18)F FAPI-74 PET as a
complementary diagnostic.  (18)F FAPI-74 PET is currently in clinical
development and for investigational use only.

 

Avacta is on track for stated goals in the second half of 2024, including the
commencement of the dose expansion Phase 1b efficacy study and presenting
further data from the AVA6000 trial. The data from this expansion study will
be used to inform the optimal choice of a single indication for a Phase 2
efficacy study which will follow the expansions.

 

Christina Coughlin MD, PhD, Chief Executive Officer of Avacta, commented:
"We're delighted to be progressing the two weekly dosing schedule arm of the
Phase 1 trial of AVA6000. This is an important milestone which supports our
continued confidence in AVA6000 and in the wider pre|CISION™ platform. The
introduction of a new diagnostic approach of  (18)F FAPI-74 -PET scanning into
the programme will help to better characterize the FAP expression among
patients, potentially assisting in indication selection.

"We're excited to be working with our investigators to integrate these tools
to accelerate our efforts to optimise indications, dosing and schedule, as we
bring this promising program through clinical studies."

Phase 1a Arm 1

 

Seven dose cohorts (n=42) were completed in the Phase 1a Arm 1 of the trial
with a dosing schedule of every three weeks ("Q3W").

 

Data from Arm 1 of the trial, presented at the American Association for Cancer
Research (AACR) meeting in April, demonstrated that AVA6000 delivers high
concentrations of doxorubicin to the tumor microenvironment ("TME") relative
to plasma, resulting in significant antitumor activity in patients whose
tumors have over-expression of FAP.

 

A significant reduction in the frequency and severity of the known doxorubicin
toxicities was observed across the dosing range in Arm 1. 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 Arm 1 of the Phase 1a study.

 

 

-Ends-

 

For further information from Avacta Group plc, please contact:

 

 Avacta Group plc                                              Tel: +44 (0) 1904 21 7070

 Christina Coughlin, Chief Executive Officer                   www.avacta.com (http://www.avacta.com/)

 Tony Gardiner, Chief Financial Officer

 Michael Vinegrad, Group Communications Director
 Stifel                                                        Tel: +44 (0) 207 710 7600

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

 Nicholas Moore / Samira Essebiyea / Nick Harland / Ben Good
 Peel Hunt (Joint Broker)

 James Steel / Chris Golden / Patrick Birkholm                 www.peelhunt.com (http://www.peelhunt.com/)
 ICR Consilium (Media and IR)

 Mary-Jane Elliott / Jessica Hodgson / Sukaina Virji           avacta@consilium-comms.com (mailto:avacta@consilium-comms.com)

About AVA6000

AVA6000, Avacta Therapeutics' lead oncology programme, is a peptide drug
conjugate consisting of doxorubicin conjugated with a peptide moiety that is
specifically cleaved by fibroblast activation protein (FAP) in the tumor
microenvironment (TME). FAP is selectively overexpressed in many solid
tumors. The peptide moiety (pre|CISIONTM) prevents cellular entry of
doxorubicin unless cleaved by FAP, thus enabling targeted delivery of
doxorubicin directly to the TME.

About SOFIE Biosciences (SOFIE)

SOFIE's vision is to improve patient outcomes by developing and delivering
molecular diagnostics and therapeutics (theranostics). With its robust
radiopharmaceutical production and distribution network, mature contract
manufacturing services and high value theranostic intellectual property, SOFIE
is poised to deliver on the promise of radiopharmaceuticals. For more
information visit our website, https://sofie.com/ or contact us by email at
info@sofie.com (mailto:info@sofie.com)

 

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

Avacta is a UK-based life sciences company focused on improving healthcare
outcomes through targeted cancer treatments and diagnostics.

Avacta Therapeutics is a clinical stage oncology biotech division harnessing
proprietary therapeutic platforms to develop novel, highly targeted cancer
drugs.

Avacta Diagnostics focuses on supporting healthcare professionals and
broadening access to diagnostics.

Avacta has two proprietary platforms, pre|CISION™ and Affimer(®).

The pre|CISION™ platform is a highly specific substrate for fibroblast
activation protein (FAP) which is upregulated in most solid tumor compared
with healthy tissues. The pre|CISION™ platform harnesses this tumor specific
protease to activate pre|CISION™ peptide drug conjugates and pre|CISION™
antibody/Affimer® drug conjugates in the tumor microenvironment, reducing
systemic exposure and toxicity, allowing dosing to be optimised to deliver the
best outcomes for patients.

The lead pre|CISION™ programme AVA6000, a peptide drug conjugate form of
doxorubicin, is in Phase 1 studies. It has shown a dramatic improvement in
safety and tolerability in clinical trials to date compared with standard
doxorubicin and preliminary signs of clinical activity in multiple patients.

 

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