REG - Avacta Group PLC - AVA6000 receives Orphan Drug Designation from FDA

AvactaAnnouncement

05/09/2022 07:00

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RNS Number : 1883Y  Avacta Group PLC  05 September 2022

 

5 September 2022

 

 

 

Avacta Group plc

 

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

 

AVA6000 receives Orphan Drug Designation from the US Food and Drug
Administration

 

Avacta Group plc (AIM: AVCT), a clinical stage oncology drug company and
developer of powerful diagnostics based on its innovative Affimer(®) and
pre|CISION™ platforms, announces that the US Food and Drug Administration
(FDA) has granted Orphan Drug Designation (ODD) to the company's lead
pre|CISION drug candidate, AVA6000, for treatment of soft tissue sarcoma.

 

AVA6000 is a form of the generic chemotherapy doxorubicin that has been
modified using the pre|CISION technology so that it is activated predominantly
in the tumour with the aim of sparing healthy tissue from exposure and
improving the safety, tolerability and efficacy of the drug. Doxorubicin has a
market size that is expected to grow to $1.38bn by 2024, and is widely used as
part of the standard of care in several cancer types. Avacta has an ongoing
Phase 1 clinical trial to assess the safety and pharmacokinetics of AVA6000
which has potential as a treatment for patients with a range of cancer types,
including soft tissue sarcoma.

 

The FDA can grant ODD based on a review of preclinical data from
investigational treatments for rare diseases, such as soft tissue sarcoma,
which are defined as conditions affecting fewer than 200,000 people in the US.
This designation qualifies the developer of the drug for certain incentives,
including, seven years of market exclusivity upon drug approval from the FDA.

 

Soft-tissue sarcoma is a rare mesenchymal malignancy which accounts for less
than 1% of all adult tumours. Despite the successful advancement of localised
therapies, such as surgery and radiotherapy, these tumours can recur, often
with metastatic disease. The American Cancer Society estimates that, in 2022
approximately 13,190 new soft tissue sarcomas will be diagnosed, and about
5,130 people are expected to die of the disease in the US.

 

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

"We are delighted to receive Orphan Drug Designation from the FDA for AVA6000,
which is a reflection of the high quality of the preclinical data and the
potential benefit the pre|CISION platform can bring to cancer patients.

 

"This designation provides tax credits and other incentives for drug
developers addressing rare diseases. Most notably the Orphan Drug Designation
will give Avacta, if AVA6000 is approved for treatment of soft tissue sarcoma,
seven years of market exclusivity in the US, which is a significant commercial
advantage."

 

 

-Ends-

 

The information contained within this announcement is deemed by the Company to
constitute inside information as stipulated under the Market Abuse Regulations
(EU) No. 596/2014 as it forms part of UK domestic law by virtue of the
European Union (Withdrawal) Act 2018 ('MAR'). Upon the publication of this
announcement via Regulatory Information Service ('RIS'), this inside
information is now considered to be in the public domain.

 

 

 

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

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

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

 Simon Conway / Alex Shaw / George Kendrick                    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 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 and is derived from a
small human protein. Affimer technology has been designed to address many of
the negative issues of antibodies, principally: the time taken to generate new
antibodies, the reliance on an animal's immune response; poor specificity in
many cases; in addition to, the complexity and high cost of manufacture.
Despite these shortcomings, antibodies currently dominate markets, such as
diagnostics and therapeutics, which are worth in excess of $100bn.

 

Avacta's pre|CISION™ targeted chemotherapy platform is designed to
selectively release active chemotherapy in FAP rich tumour tissue to limit the
systemic exposure that causes damage to healthy tissues, and thereby aims to
improve the overall safety and therapeutic potential of these powerful
anti-cancer treatments.

 

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

 

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 generate more tolerable and
durable treatments for oncology patients who do not respond to existing
therapies. By combining its two proprietary platforms the Group is building a
wholly owned pipeline of clinically differentiated cancer therapies. In 2021
Avacta transitioned to become a clinical stage biopharmaceutical company, when
it commenced a phase I trial in patients with locally advanced or metastatic
selected solid tumours. The study was a first-in-human, open label,
dose-escalation and expansion study of the Group's lead pre|CISION™ prodrug,
AVA6000 (a pro-doxorubicin).

 

Avacta has established drug development partnerships with pharma and biotech,
including 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 recent license agreement with
Point Biopharma for them to develop radiopharmaceuticals based on the
pre|CISION™ platform.

 

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