REG - Avacta Group PLC - Avacta presents data from lead candidate at AACR

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RNS Number : 3960G  Avacta Group PLC  28 April 2025

 

 

Avacta Therapeutics Presents Data from Lead pre|CISION(®) Candidate FAP-Dox
(AVA6000) at the 2025 AACR Annual Meeting

 

Compelling Phase 1 safety and efficacy data for FAP-Dox (AVA6000) with
preliminary evidence of efficacy in salivary gland cancers and no severe
cardiac toxicity

 

Progression free survival (PFS) data to date represents a near doubling of the
benchmarking data in this patient population without reaching median PFS

 

 

LONDON and PHILADELPHIA - April 28, 2025 - Avacta Therapeutics (AIM: AVCT), a
life sciences company developing next generation peptide drug conjugates (PDC)
targeting powerful anti-tumor payloads directly to the tumor, today announced
Phase 1 data from its lead program FAP-Dox (AVA6000), that were presented
alongside preclinical pharmacokinetic results from its second pre|CISION(®)
candidate AVA6103 (FAP-EXd) at the American Association for Cancer Research
(AACR) Annual Meeting in Chicago, IL.

 

Both programs are designed to target fibroblast activation protein-alpha
(FAPα), the protease that forms the basis of the pre|CISION(®) platform. FAP
is consistently overexpressed across a broad range of solid tumors and
enriched at the tumor-stroma interface, making it an ideal target for
tumor-localized drug activation. Avacta's proprietary pre|CISION(®) chemistry
leverages this tumor-specific biology to activate potent drugs selectively at
the tumor site, enhancing efficacy while minimizing systemic toxicity.

 

"Today's clinical results mark the achievement of a proof-of-concept milestone
with our proprietary pre|CISION(®) platform demonstrating meaningful
activity," said Christina Coughlin, CEO of Avacta Therapeutics. "With AVA6000
demonstrating strong early signs of efficacy in a specific patient population
of salivary gland cancers and a differentiated safety profile, we are not only
validating a tumor-targeted approach to cytotoxics delivery - we are
establishing a foundation for this new class of precision oncology
therapeutics. These data underscore the tremendous potential of our pipeline
to deliver meaningful benefits for patients and drive sustained value creation
for our key stakeholders."

 

AVA6000 (FAP-Dox) Clinical Highlights (Abstract #CT15, Apil 29, 2025)

AVA6000 is a FAP-activated form of doxorubicin designed to reduce the systemic
side effects of conventional chemotherapy. In the Phase 1a dose-escalation
study, AVA6000 was well-tolerated across both every-three-week (Q3W) and
every-two-week (Q2W) dosing regimens. No maximum tolerated dose (MTD) was
reached despite dosing up to 385 mg/m² every three weeks.

In patients with salivary gland cancers (SGC, n=11) treated at or above the
dose level of 250 mg/m2, AVA6000 demonstrated multiple confirmed responses and
a disease control rate of 91%. Median progression-free survival (PFS) has not
yet been reached, with median follow-up exceeding 25 weeks (25.3 weeks, 5.9
months). These FAP-Dox PFS results compare favorably to recent benchmarking
data in this patient population presented at ESMO 2024, with a reported PFS of
3.5 months (15 weeks) in a large cohort (n=54) in a similar setting of
pretreated patients with SGC (Licitra et al. ESMO 2024).

Despite dosing up to 4x the dose of conventional doxorubicin, the exposure of
released doxorubicin in plasma and normal tissues is lower than that observed
with conventional dose doxorubicin (75 mg/m2 Q3W) and the median tumor to
plasma ratio is 100:1. In addition, no severe cardiac toxicity was observed,
further supporting a markedly improved safety profile over conventional
doxorubicin. The lack of toxicity is explained by the limited tissue
distribution as well as limited first pass effect exposure of released
doxorubicin.

The full Phase 1a data across all patients (n=63), including a full assessment
of the cardiac safety data with long-term follow-up are expected in the second
half of 2025.

Avacta continues to enroll patients in three Phase 1b expansion cohorts in
salivary gland cancer, triple negative breast cancer and high-grade soft
tissue sarcoma with data anticipated by the end of 2025.

Abstract Number and Title: #CT15: Comparative pharmacokinetics and tumor
activation of fibroblast activation protein (FAP)-enabled
pre|CISION(®) peptide drug conjugates

·    Session Title: First-in-Human Phase I Clinical Trials 2

·    Session Date and Time: Tuesday, April 29, 2025, 9:00 a.m. - 12:00
p.m. CT

 

 

-Ends-

For further information from Avacta, please contact:

 

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

 Michael Vinegrad, Group Communications

 Director

 Peel Hunt (Nomad and 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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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 warhead delivery system based on a
tumor-specific protease (fibroblast activation protein or FAP) that is
designed to concentrate highly potent warheads 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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