REG - Avacta Group PLC - Clinical data on AVA6000 in salivary gland cancers

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RNS Number : 4140G  Avacta Group PLC  01 June 2026

 

Avacta presents updated clinical data showing encouraging early efficacy
signals for AVA6000 in salivary gland cancers at ASCO 2026

 

Multiple confirmed partial and minor responses observed in patients with SGC

 

Continuing very good safety profile, with removal of the lifetime maximum
doxorubicin limit based on highly favorable cardiac safety

 

 

LONDON and PHILADELPHIA - June 1, 2026 - Avacta Therapeutics (AIM: AVCT, "the
Company", "Avacta"), a clinical stage biopharmaceutical company developing
pre|CISION(®), a tumor-activated oncology delivery platform, today released
updated Phase 1a/1b and  pharmacokinetics (PK), safety, toxicity and
preliminary efficacy data with faridoxorubicin (AVA6000,
pre|CISION(®)-enabled doxorubicin) at the 2026 American Society of Clinical
Oncology (ASCO) Annual Meeting in Chicago.

 

Christina Coughlin, CEO of Avacta, commented:

 

"Today's data further underscores our confidence in both our Gen One product
faridoxorubicin (AVA6000) and our pre|CISION(®) technology to significantly
improve treatment options for cancer patients.

 

"We are particularly encouraged by signs of efficacy in patients with salivary
gland cancers (SGC and the consistency of these data from Phase 1a and 1b
support the potential for this agent to move to later stage trials. The
excellent safety profile was further demonstrated by the absence of severe
cardiac toxicity and lifting of the lifetime maximum, following careful
analysis of drug concentration versus effect on the heart.

 

"We look forward to presenting further data updates from this trial later in
June, at the BIO International Convention."

 

Faridoxorubicin demonstrates favorable safety and consistent efficacy in Phase
1a and the Phase 1b SGC expansion cohort: At the recommended dose for
expansion (RDE) of 310 mg/m(2), faridoxorubicin (AVA6000) demonstrated a
safety profile consistent with that seen earlier during Phase 1a dose
escalation, when comparing grade 3/4 adverse events. The rates of toxicities
remain lower than those historically observed with conventional doxorubicin,
despite the RDE representing a dose level that is nearly three times the
maximum tolerated dose of conventional doxorubicin level (75 mg/m(2)).

Efficacy among patients in the SGC expansion cohort also remained consistent,
with multiple confirmed responses (four partial responses and nine minor
responses observed among 38 evaluable patients). The disease control rate
remains consistent at 92% (35/38 with best response of stable disease or
response).  Nine patients are continuing treatment, and a further 11 patients
remain in follow up for disease progression.

 

PK and exposure-response data lead to lifting of lifetime maximum exposure:
Active doxorubicin is released following dosing with faridoxorubicin, as is
cleaved from the inert drug by the FAP enzyme in the tumor microenvironment
(TME). Only a small fraction of the active payload subsequently enters the
circulation and reaches other organs, including the heart, with a delay and at
lower concentrations. This contrasts with the profile seen with conventional
doxorubicin dosed intravenously, which delivers high systemic concentrations
from the outset. Here, released doxorubicin is rapidly distributed, and
eliminated more slowly, consistent with the known PK of conventional
doxorubicin.

 

Preliminary Population PK (PopPK) modeling demonstrates that the sharp
systemic C(max) peaks, which are typical with conventional doxorubicin dosing,
are eliminated with AVA6000. AVA6000 dosing results in higher clearance and
larger central volume of distribution for released doxorubicin, compared with
conventional doxorubicin. This shows that released doxorubicin enters plasma
gradually following FAP-mediated cleavage in the TME.

 

There were no severe cardiac toxicity events reported and only minimal changes
in left ventricular function (as measured by left ventricular ejection
fraction, LVEF) observed in the 111 patients dosed to date, even with a subset
of patients having reached the (protocol-defined) lifetime maximum exposure of
550 mg/m(2). Only four patients (<4%) reported significant reductions in
LVEF and no cardiomyopathy events of any grade were observed.

 

Due to limited evidence of cardiac toxicity, an exposure-response analysis was
conducted to assess the relationship between exposure to released doxorubicin
and changes in LVEF on a per-patient basis. This analysis found no meaningful
relationship between the LVEF changes and released doxorubicin exposure,
suggesting that the cardiac toxicity observed with conventional dosing of
doxorubicin is not observed with released doxorubicin from faridoxorubicin.
This supported removal of the lifetime maximum limit of dosing. The Company
received Health Authority agreement with this conclusion and hence the limit
was removed from the study protocol earlier this year.

 

The study continues to enroll patients and Avacta plans to present further
data on the AVA6000 program at BIO International Convention, taking place June
22-25, 2026 in San Diego, CA, USA.

 

-Ends-

 

For further information from Avacta, please contact:

 

 Avacta Group plc                                   https://avacta.com/ (https://avacta.com/)

 Christina Coughlin, Chief Executive Officer        via Cohesion Bureau

 Strand Hanson Limited (Nominated Adviser)          www.strandhanson.co.uk (http://www.strandhanson.co.uk)

 James Harris / Chris Raggett / James Dance

 Zeus (Broker)                                      www.zeuscapital.co.uk (http://www.zeuscapital.co.uk)

 James Hornigold / George Duxberry / Dominic King

 Cohesion Bureau                                    avacta@cohesionbureau.com (mailto:avacta@cohesionbureau.com)

 Communications / Media / Investors

 Richard Jarvis

 

About Avacta - https://avacta.com/ (https://avacta.com/)

Avacta Therapeutics is a clinical-stage life sciences company expanding the
reach of highly potent cancer therapies through its proprietary pre|CISION®
platform. pre|CISION® is a 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. Avacta's innovative pre|CISION® peptide drug conjugates (PDC)
are a novel entry to the XDC drug class, leveraging the success of antibody
drug conjugates with alternative methods of delivery beyond antibodies.

 

Our pre|CISION® PDCs leverage this tumor-specific release mechanism to
provide unique benefits over traditional antibody drug conjugates, releasing
active payload in the tumor and reducing systemic exposure and toxicity which
enables dosing to be optimized to deliver the best outcomes for patients. The
lead clinical program is faridoxorubicin (AVA6000), a Gen One FAP-enabled
pre|CISION® version of doxorubicin that delivers the payload directly in the
tumor with limited peripheral blood exposure and has demonstrated preliminary
activity in tumor types sensitive to doxorubicin including salivary gland
cancer and soft tissue sarcoma.

 

 

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