REG - Avacta Group PLC - AGM Business Update

AvactaAnnouncement

26/06/2024 07:00

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RNS Number : 9307T  Avacta Group PLC  26 June 2024

 

 

 

26 June 2024

 

 

Avacta Group plc

 

("Avacta" or the "Group" or the "Company")

 

AGM Business Update

 

Second Cohort in the AVA6000 Phase 1 Arm 2 Completed, Patient Dosing is
Ongoing in Cohort Three

 

Avacta Announces the Assembly of a Scientific Advisory Board to Guide AVA6000
Development and Pipeline Progress

 

Further evolution of the Board, including appointment of Darlene Deptula-Hicks
as Non-Executive Director of the Board of Directors

 

 

Avacta Group plc (AIM: AVCT), a clinical stage life sciences company
developing innovative, targeted cancer treatments and powerful diagnostics,
provides a business update ahead of the Annual General Meeting (AGM) which
will be held today, Wednesday, 26 June 2024. At the meeting, Christina
Coughlin MD, PhD, CEO, and Shaun Chilton, Non-Executive Chairman, will make
the following announcements on clinical and operational progress and the
appointment of a new Non-Executive Board director.

 

Avacta confirms that Arm 2 of the Phase 1 trial for AVA6000, a peptide drug
conjugate form of doxorubicin chemotherapy, has successfully completed its
second cohort without dose limiting toxicities observed. Patients are now
being dosed in the third cohort. This puts Avacta on track to achieve its
stated clinical objectives for 2H 2024. To support the progress of this trial,
Avacta has appointed a Scientific Advisory Board of senior cancer experts and
researchers.

 

In line with the previously announced evolution of the Board, Avacta also
announces the following:

 

·      The appointment of Darlene Deptula-Hicks to the position of
Non-Executive Director, effective following the AGM. Darlene is an
entrepreneurial financial leader with proven expertise in building strategic
external partnerships to achieve business results and increase shareholder
value, with expertise in capital markets as well as operational and commercial
experience including product commercialization, supply chain, manufacturing
and quality assurance.

·      Tony Gardiner has stepped down from the Board of Directors with
immediate effect. The search for a new permanent CFO is underway and Tony will
remain in the post to ensure an orderly transition.

 

Christina Coughlin MD, PhD, CEO of Avacta, commented:

 

"The ongoing trial of AVA6000 is progressing well and remains on track to
achieve our stated goals of initiating the expansion cohorts, updating the
clinical data for AVA6000 and detailing our pipeline of innovative new
medicines. We are pleased to be able to announce today the formation of an
expert Scientific Advisory Board to support and guide the progress of this
trial and we look forward to our Research and Development Spotlight Science
Day in London in the fourth quarter of 2024 where we'll be providing more
detail on the future of the pre|CISION™ platform. We are also continuing to
strengthen the Avacta Board with a new Chair and the appointment of a
Non-Executive Director and these combined changes support our growing
confidence that we have the right team and plan in place for this
extraordinary science."

 

Shaun Chilton, Chairman of the Board of Avacta, added,

 

"Avacta is at a pivotal time in its evolution, intensifying its focus on
advancing the pre|CISION™ technology through clinical development. As we do
so, it's critical that the Avacta Board has the right commercial, financial
and operational experience to support this. We are pleased to confirm the
addition of Darlene Deptula-Hicks to the Avacta Board. Darlene brings both
commercial acumen and deep capital markets experience, both invaluable to
growing biotechnology companies. We look forward to the benefit of her
expertise and experience."

 

"I'd also like to thank Tony Gardiner for his commitment and service as Chief
Financial Officer of Avacta and on the Avacta Board. We're grateful that Tony
will remain as CFO on an interim basis."

 

Clinical, operational and strategic updates

 

Clinical update - Successful Completion of Second Cohort in Arm 2 of the
AVA6000 Phase 1 trial

 

·      The Company's Phase 1 trial for AVA6000, a peptide drug conjugate
form of doxorubicin chemotherapy, successfully completed its second cohort
without dose limiting toxicities observed. Two patients have been dosed in the
third cohort.

 

·      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").

 

·      Avacta is on track to achieve its stated objectives for 2H 2024
including the initiation of the expansion cohorts and providing an update of
the clinical data in the AVA6000 trial.

 

Formation of Scientific Advisory Board (SAB)

 

Avacta also announces the creation of a Scientific Advisory Board to provide
expert insight and guidance on the ongoing clinical development of AVA6000 and
the pipeline, including the pre|CISION™ platform. The Board will be chaired
by William D. Tap MD, Chief of the Sarcoma Oncology Service at the Memorial
Sloan Kettering Cancer Center in New York City. Dr. Tap will be joined by
several colleagues in both the UK and US including:

 

·      Robin Jones, MBBS, MRCPD, MD, Professor and Group Leader in
Sarcoma Clinical Trials at The Institute of Cancer Research and the Royal
Marsden Hospital in London.

·      Lee Cranmer, MD, PhD, Head of Sarcoma Oncology at the University
of Washington and Fred Hutchinson Cancer Center, Seattle, Washington.

·      Robert Metcalf, MBChB MRCP PhD, Clinician Scientist in
Experimental Cancer Medicine and Honorary Consultant in Head and Neck Cancer
Oncology and Salivary Gland Cancer Expert at the Christie NHS Foundation
Trust, Manchester.

·      Alan Ho, MD, PhD, Clinician-Scientist and translational clinical
researcher on the head/neck medical oncology service at Memorial Sloan
Kettering Cancer Center, New York City.

·      Andrea Napolitano, M.D., PhD. Consultant Oncologist and
Experimental Therapeutics Expert at the Institute for Cancer Research and
Royal Marsden Hospital, London.

·      Anthony Yu, MD, MS, Clinical Onco-Cardiologist specializing in
the management of cardio-toxicities of approved and experimental therapeutics,
Memorial Sloan Kettering Cancer Center, New York City.

 

Portfolio update

 

·      As previously stated, Avacta is focusing resources on the
development of its therapeutic business and in particular on the acceleration
of the clinical programme for its pre|CISION™ platform.

 

·      Avacta confirmed within the preliminary results statement issued
on 30 April 2024 that it is reviewing strategic options in relation to its
diagnostics business to ensure it maximises value for shareholders. Whilst
this process is ongoing, the Group continues to grow revenues, with the sale
of Coris products through the Launch Diagnostics ("Launch") distribution
channels and the expansion of Launch into the German market. The transfer of
the Affimer(® )screening technology to the Coris operations in Belgium has
enabled the Group to close the Wetherby laboratory facilities, resulting in
operational cost savings. The division, as previously stated, is on track to
be EBITDA positive in H2 2024.

 

Financial update

 

·      The financial performance for the year to date is in-line with
market forecasts and the Group's unaudited cash position as at 31 May 2024 was
circa £35 million, which provides sufficient funds to progress AVA6000 into
Phase 2 clinical trials and develop the Group's wider pipeline of innovative
new medicines.

 

Appendix:  Further disclosures regarding Darlene Deptula-Hicks

 

Avacta also discloses the following information in accordance with Schedule
2(g) of the AIM Rules for Companies.

 

Full name: Darlene Marie Deptula-Hicks

 

Age: 67 years

 

Current directorships/partnerships:

·      Normunity, Inc.

·      Aerami Therapeutics, Inc.

·      Aerami Therapeutics Holdings, Inc.

·      Abcuro, Inc.

·      Crimson Consulting, LLC

 

 

Previous directorships/partnerships held in the past 5 years:

·      Giner Lifesciences, Inc.

·      Xenetic Biosciences, Inc.

 

 Darlene M. Deptula-Hicks does not hold any ordinary shares in Avacta.

 

There are no other disclosures required in connection with the appointment
Darlene M. Deptula-Hicks under Schedule Two(g) of the Aim Rules for Companies.

 

For further information from Avacta Group plc, please contact:

 

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

 Christina Coughlin, CEO                               www.avacta.com (http://www.avacta.com/)

 Tony Gardiner, Chief Financial Officer

 Michael Vinegrad, Group Communications Director

 Peel Hunt (Nomad and Broker)

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

 ICR Consilium

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

 

 

 

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

 

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

 

Avacta Therapeutics: 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 tumours compared
with healthy tissues. The pre|CISION™ platform harnesses this tumour
specific protease to activate pre|CISION™ peptide drug conjugates and
pre|CISION™ antibody/Affimer® drug conjugates in the tumour
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 an 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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