REG - Avacta Group PLC - Avacta Quarterly Update

AvactaAnnouncement

31/03/2025 07:15

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RNS Number : 8729C  Avacta Group PLC  31 March 2025

Avacta Provides Business Update for the First Quarter of 2025 Outlining
Progress Against Strategic Objectives

 

AVA6000 Phase 1b expansion cohorts enrolling with data targeted for later in
2025

 

AVA6103 IND-enabling studies underway with a Phase 1 trial anticipated to
begin in the first quarter of 2026

 

Multiple presentations at the AACR Annual Meeting highlight the promise of the
pre|CISION(®) platform

 

Transformation into a pure-play therapeutics company prioritizes proprietary
pre|CISION(®) platform and extends cash runway into Q1 2026

 

 

 

LONDON AND PHILADELPHIA - March 31, 2025 Avacta Therapeutics (AIM: AVCT, 'the
Company'), a life sciences company developing next generation peptide drug
conjugates (PDC) targeting powerful anti-tumor payloads directly to the tumor,
today provides a business update on progress for the first three months of
2025 and a review of upcoming milestones.

 

Christina Coughlin, M.D., Ph.D., Chief Executive Officer of Avacta, said: "We
made a strong start to 2025, continuing to make excellent progress against all
of our strategic objectives. We are very encouraged by the Phase 1 data from
FAP-Dox (AVA60000) so far, which continue to show an excellent tolerability
profile and increasingly durable responses in salivary gland cancers. We are
now enrolling in multiple dose expansion cohorts, including triple negative
breast cancer with preliminary data targeted for later in 2025.

 

"Our pre|CISION(®)-enabled exatecan program (FAP-EXd, AVA6103) also continues
to progress toward a Phase 1 trial initiation early next year, underscoring
our deep commitment to pioneering a novel, differentiated class of medicines
to revolutionize drug delivery mechanisms. We are enthusiastic about the
promise of a potent topoisomerase I inhibitor delivered in this mechanism."

 

pre|CISION(®) Medicine Pipeline

 

FAP-Dox (AVA6000), a pre|CISION(®)-enabled form of doxorubicin chemotherapy,
advances to Phase 1b dose expansion.  During the first quarter, Avacta
completed the Phase 1a dose escalation portion of the trial, demonstrating
promising early efficacy and a favorable safety profile. As of the most recent
data cut-off, AVA6000 continues to show improved tolerability compared to
conventional dose doxorubicin, with no observed events of severe cardiac
toxicity. Encouraging progression-free survival (PFS) data has also been
observed in patients with salivary gland cancers. The Company has begun
enrolling patients in the Phase 1b expansion cohorts, including salivary gland
cancer, triple negative breast cancer and high-grade soft tissue sarcoma and
plans to report updates from these trials later in 2025. For more details see
announcement from 07 March 2025 here.
(https://avacta.com/avacta-announces-promising-early-efficacy-and-safety-data-for-ava6000-in-the-phase-1a-dose-escalation-and-ongoing-enrollment-in-the-phase-1b-expansion-cohorts/)
 

 

·    AVA6103, a pre|CISION(®)-enabled PDC comprised of the pre|CISION
peptide linked to the potent topo I inhibitor exatecan, continues preclinical
development. AVA6103 is currently in investigational new drug (IND)-enabling
studies with a Phase 1 trial anticipated to begin in the first quarter of
2026.

 

·    Upcoming Data Presentations at AACR. Avacta is presenting three
posters at the American Association for Cancer Research (AACR) Annual Meeting
from April 25-30, 2025 in Chicago, IL. The presentations will feature data
from the Company's proprietary pre|CISION(®) platform and pipeline of next
generation peptide drug conjugates (PDCs), including clinical data on AVA6000
and preclinical pharmacology highlights for AVA6103. For more details see
announcement from 26 March 2025 here
(https://avacta.com/avacta-therapeutics-announces-presentations-at-2025-aacr-annual-meeting/)
.

 

·    Novel data from our strategic collaboration with Tempus AI continues
to be reported, including at the AACR Annual Meeting in Chicago.

 

Executive Leadership Team Addition

.

·    Strengthened management team. In January Avacta strengthened the
management team with the appointment of Brian Hahn as Chief Financial Officer
("CFO"). Brian is a seasoned CFO with over 25 years' biopharma financial and
operational experience. He spent 15 years as CFO and Senior Vice President of
GlycoMimetics, Inc., where he led the company's 2014 initial public offering
("IPO") on Nasdaq.

Notice of 2024 Preliminary Results

Avacta expects to report its Preliminary Results for the 12 months ended 31
December 2024 during May 2025.

 

-Ends-

 

For further information from Avacta, please contact:

 

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

 Michael Vinegrad, Group Communications

 Director

 Peel Hunt (Nomad and Joint Broker)

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

 Panmure Liberum (Joint Broker)                             www.panmureliberum.com (http://www.panmureliberum.com)

 Emma Earl / Will Goode / Mark Rogers

 ICR Healthcare

 Mary-Jane Elliott / Jessica Hodgson / Stephanie Cuthbert   avacta@icrhealthcare.com (mailto:avacta@icrhealthcare.com)

 Investor Contact

 Renee Leck                                                 renee@thrustsc.com (mailto:renee@thrustsc.com)

 THRUST Strategic Communications

 Media Contact

 Carly Scaduto                                              Carly@carlyscadutoconsulting.com

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 Carly Scaduto Consulting

 

 

About Avacta - www.avacta.com
(https://eur01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.avacta.com%2F&data=05%7C02%7CChris.Coughlin%40avacta.com%7Ce5faa8dfbe3d49fc56f808dd35799958%7C64d2165ff9e04869bc73bfe4fc4fa9ab%7C0%7C0%7C638725518576703790%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=qWTC74zmTzjVQqwaFiKeiHUwMY5RUlsvb7C%2BkLRahGU%3D&reserved=0)

Avacta Therapeutics is a clinical-stage life sciences company expanding the
reach of highly potent cancer therapies with the pre|CISION(®) platform.
pre|CISION(®) is a proprietary payload delivery system based on a
tumor-specific protease (fibroblast activation protein or FAP) that is
designed to concentrate highly potent payloads in the tumor microenvironment
while sparing normal tissues. Our innovative pipeline consists of
pre|CISION(®) peptide drug conjugates (PDC) or Affimer(®) drug conjugates
(AffDC) that leverage the tumor-specific release mechanism, providing unique
benefits over traditional antibody drug conjugates.

 

About the pre|CISION(®) Platform

The pre|CISION(®) platform comprises an anticancer payload conjugated to a
proprietary peptide that is a highly specific substrate for fibroblast
activation protein (FAP) which is upregulated in most solid tumors compared
with healthy tissues. The pre|CISION(®) platform harnesses this tumor
specific protease to cleave pre|CISION(®) peptide drug conjugates and
pre|CISION(®) antibody/Affimer(®) drug conjugates in the tumor
microenvironment, thus releasing active payload in the tumor and reducing
systemic exposure and toxicity, allowing dosing to be optimized to deliver the
best outcomes for patients.

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