REG - Avacta Group PLC - Second dose escalation in phase 1 trial of AVA6000

AvactaAnnouncement

29/06/2022 07:00

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RNS Number : 5475Q  Avacta Group PLC  29 June 2022

 

29 June 2022

 

 

 

Avacta Group plc

 

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

 

Avacta announces second dose escalation in the Phase I clinical study of
AVA6000 Pro-doxorubicin

 

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 first-in-human Phase I trial
(ALS-6000-101) of AVA6000 Pro-doxorubicin will advance to the third dose
cohort following a positive review of the safety data from the dosing of the
second cohort.

 

Avacta's Safety Data Monitoring Committee (SDMC), comprised of clinicians
currently recruiting patients, has completed its review of the safety data
from the second cohort dosed with AVA6000 at 120mg/m(2) in the ongoing Phase I
trial. Following this review, the SDMC has recommended that the clinical trial
continues as planned and escalates to the next dose of AVA6000 at 160mg/m(2).

 

AVA6000 is a novel form of doxorubicin that has been modified with Avacta's
pre|CISION™ FAP-activated delivery platform to improve its safety and
therapeutic index. 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.
Anthracyclines such as doxorubicin, a generic chemotherapeutic agent, with a
market size that is expected to grow to $1.38bn by 2024 1  (#_ftn1) , are
widely used as part of standard of care in several tumour types, but
doxorubicin's use is limited by cumulative toxicity associated with
cardiomyopathy.

 

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

"AVA6000, and the pre|CISION platform more broadly, have the potential to
deliver safer and affordable oncology drugs that could significantly improve
cancer patients' lives. We are very pleased with the progress being made with
ALS-6000-101 study and look forward to seeing more data as it emerges from the
trial."

 

Neil Bell, Chief Development Officer of Avacta added:

"The recommendation from the Safety Data Monitoring Committee to initiate
dosing in Cohort 3 with 160mg/m(2) of AVA6000 is an endorsement of the
emerging safety and tolerability profile in the patients enrolled in this
study to date. We look forward to providing additional updates as the dose
escalation phase of the trial progresses."

 

 

-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.

 

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  (#_ftnref1)
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)

 

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