REG - Avacta Group PLC - FDA Approval of IND Application for AVA6000

AvactaAnnouncement

29/11/2021 07:00

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RNS Number : 8030T  Avacta Group PLC  29 November 2021

 

29 November 2021

 

Avacta Group plc

 

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

 

Avacta Announces FDA Approval of its Investigational New Drug (IND)
Application for AVA6000

 

Enables expansion of recruitment into ongoing phase I study to include
eligible US patients upon opening of clinical sites in early 2022

 

Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company
developing innovative cancer therapies and powerful diagnostics based on its
proprietary Affimer(®) and pre|CISION™ platforms, is pleased to announce
that the US Food and Drug Administration (FDA) has approved its
Investigational New Drug (IND) application for AVA6000. This will allow the
Group to expand its Phase I clinical trial, ALS-6000-101, into clinical trial
sites in the United States.

 

AVA6000 is a novel form of doxorubicin that has been modified with Avacta's
pre|CISION™ platform to improve its safety and therapeutic index.
Anthracyclines such as doxorubicin, a generic chemotherapy for which the
market is expected to grow to $1.38bn by 2024 1 , are widely used as part of
standard of care in several tumour types, but their use is limited by
cumulative toxicity. AVA6000 has been designed to limit cell penetration of
the drug, and therefore its cell killing effect, until it is specifically
activated by fibroblast activation protein α (FAP) which is in high
concentration in many solid tumours compared with healthy tissues. The
resulting reduced exposure of healthy tissues to active doxorubicin has the
potential to significantly increase its therapeutic index by reducing the
incidence of adverse effects, including cardiotoxicity and myelosuppression.

 

The FDA has completed its 30-day review of Avacta's IND application, which was
submitted ahead of schedule in October 2021, and has concluded that the Group
may proceed with its proposed clinical investigation. This allows Avacta to
enroll eligible patients into US clinical trial sites for the company's Phase
I multi-centre study, ALS-6000-101. As previously announced in August 2021,
the Company has begun recruiting and dosing patients for this study at several
clinical trial sites in the UK, and continues to expect the dose escalation
phase for this trial to complete by Q2 2022 followed by completion of the dose
expansion phase around mid-2023. Enrollment in US clinical trial sites is
expected to begin in early 2022.

 

Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented:

"We are delighted to have received approval from the FDA to add clinical trial
sites in the United States as part of the Phase I study for AVA6000. This is a
major milestone in our development of pre|CISION™ chemotherapies and is
testament to the performance of our clinical development team and the quality
of the pre-clinical data for AVA6000.

 

"Provided that the study shows that the pre|CISION(TM) technology is effective
in reducing systemic toxicity of Doxorubicin, then that would open up an
extensive and proprietary pipeline for Avacta of next-generation
pre|CISION(TM) chemotherapies with significant clinical and commercial
advantages in a chemotherapy market that is expected to exceed $74 billion by
2027 2 .

 

"We now look forward to opening up clinical trial sites in the United States
and additional clinical trial sites in the UK."

 

Neil Bell, Chief Development Officer of Avacta Life Sciences commented:

"We are excited to bring the first FAP-activated chemotherapeutic to the
clinic in the US, which has the potential to meaningfully impact patients with
difficult-to-treat tumours. The clearance of the AVA6000 IND by the FDA
enables the opening of key US sites to support the ALS-6000-101 clinical trial
which is currently recruiting patients across clinical sites in the UK."

- Ends -

 

For further information from Avacta Group plc, please contact:

 

 Avacta Group plc                                          Tel: +44 (0) 844 414 0452

 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 Broker)         Tel: +44 (0) 207 710 7600

 Nicholas Moore / Nick Adams / Fred Walsh / Ben Maddison   www.stifel.com (http://www.stifel.com/)

 FTI Consulting (Financial Media and IR)                   Tel: +44(0) 203 727 1000

 Simon Conway / Alex Shaw / Stephanie Cuthbert             Avacta.LS@fticonsulting.com (mailto:Avacta.LS@fticonsulting.com)

 Zyme Communications (Trade and Regional Media)            Tel: +44 (0)7891 477 378

 Lily Jeffery                                              lily.jeffery@zymecommunications.com

                                                         (mailto:katie.odgaard@zymecommunications.com)

 

About ALS-6000-101 Clinical Study

 

ALS-6000-101 is a Phase I study in patients with locally advanced or
metastatic selected solid tumours, known to be FAP-positive, in which cohorts
of patients receive ascending doses of AVA6000 to determine the maximum
tolerated dose and establish a recommended Phase II dose. The second part of
the study is an expansion phase where patients receive AVA6000 to further
evaluate the safety, tolerability and clinical activity at this recommended
Phase II dose across selected tumour types. The dose escalation phase for this
study is anticipated to complete by Q2 2022 followed by completion of the dose
expansion phase by Q2 2023. For more information visit www.clinicaltrials.gov
(http://www.clinicaltrials.gov) (NCT04969835).

 

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

 

Avacta Group is developing novel cancer immunotherapies and powerful
diagnostics based on its two proprietary platforms - Affimer(®) biologics and
pre|CISION™ tumour targeted chemotherapies.

 

The Affimer(®) platform is an alternative to antibodies derived from a small
human protein. Despite their shortcomings, antibodies currently dominate
markets, such as diagnostics and therapeutics, worth in excess of $100bn.
Affimer technology has been designed to address many of these negative
performance issues, principally: the time taken to generate new antibodies and
the reliance on an animal's immune response; poor specificity in many cases;
their large size, complexity and high cost of manufacture.

 

Avacta's pre|CISION™ targeted chemotherapy platform releases active
chemotherapy in the tumour, which limits the systemic exposure that causes
damage to healthy tissues, and thereby improves the overall safety and
therapeutic potential of these powerful anti-cancer treatments.

 

The Group comprises two divisions: The therapeutics development activities are
based in London and Cambridge, UK and the Group is generating near-term
revenues from Affimer reagents for diagnostics, bioprocessing and research,
through a separate diagnostics business unit based in Wetherby, UK.

 

Avacta's Diagnostics Division is developing an in-house pipeline of
Affimer-based diagnostic assays, including the AffiDX(®) SARS-CoV-2 Lateral
Flow Rapid Antigen Test, and works with partners world-wide to develop bespoke
Affimer(®) reagents for third party products.

 

Avacta's Therapeutics Division is working to deliver a more tolerable and
durable treatment response for oncology patients who do not respond to
existing immunotherapies. By combining its two proprietary platforms the Group
is building a wholly owned pipeline of clinically differentiated cancer
therapies, aiming to extend the therapeutic benefits to all cancer patients.
In 2021 Avacta transitioned to become a clinical stage biopharmaceutical
company, commencing a phase I first-in-human, open label, dose-escalation and
expansion study of AVA6000, a pro-doxorubicin, the Group's lead pre|CISION™
prodrug, in patients with locally advanced or metastatic selected solid
tumours.

 

Avacta has established drug development partnerships with pharma and biotech,
including a research collaboration with ModernaTX, Inc. (formerly Moderna
Therapeutics Inc.), a multi-target deal with LG Chem worth up to $400m, a
joint venture in South Korea with Daewoong Pharmaceutical focused on cell and
gene therapies incorporating Affimer immune-modulators and a collaboration
with Point Biopharma to develop radiopharmaceuticals based on the
pre|CISION™ platform. Avacta continues to actively seek to license its
proprietary platforms in a range of therapeutic areas.

 

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

 

 

 

 

 

 

 

 

 1 
https://www.prnewswire.com/news-releases/doxorubicin-market-size-is-expected-to-reach-138-billion-by-2024-grand-view-research-inc-602613665.html
(https://www.prnewswire.com/news-releases/doxorubicin-market-size-is-expected-to-reach-138-billion-by-2024-grand-view-research-inc-602613665.html)

 

 2 
https://www.globenewswire.com/en/news-release/2021/02/08/2171622/0/en/Cancer-Chemotherapy-Market-Value-Anticipated-To-Reach-US-74-3-Billion-By-2027-Acumen-Research-and-Consulting.html
(https://www.globenewswire.com/en/news-release/2021/02/08/2171622/0/en/Cancer-Chemotherapy-Market-Value-Anticipated-To-Reach-US-74-3-Billion-By-2027-Acumen-Research-and-Consulting.html)

 

 

 

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