REG - Avacta Group PLC - First patient treated in Phase 1 trial of AVA6103

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RNS Number : 8120Y  Avacta Group PLC  31 March 2026

 

 

Avacta announces first patient treated in Phase 1 FOCUS-01 trial of FAP-Exd
(AVA6103) - a sustained-release pre|CISION(®) exatecan peptide drug conjugate

 

Enrollment underway in second Avacta clinical program at first three
specialist U.S. oncology centers

 

Initial data from the trial expected later this year

 

LONDON and PHILADELPHIA - March 31, 2026 - Avacta Therapeutics (AIM: AVCT,
"the Company", "Avacta"), a clinical stage biopharmaceutical company
developing pre|CISION(®), a tumor-activated oncology delivery platform, is
pleased to announce today, that the first patient has been treated in the
FOCUS-01 trial, the multicenter, open‑label Phase 1 clinical trial of
FAP-Exd (AVA6103) in adults with selected advanced cancers.

 

Avacta has very recently announced
(https://avacta.com/results-of-oversubscribed-placing-and-subscription/) a
£10 million fundraise by way of an oversubscribed placing and subscription to
extend the Company's cash runway into early Q1 2027, expected to provide
sufficient funding beyond the initial clinical data readout on AVA6103.

 

 

Christina Coughlin, CEO of Avacta, commented:

 

"We are maintaining our momentum with both a successful fundraise and a
critical trial opening for patients, which is expected to demonstrate the
benefits of the pre|CISION(®) Gen Two sustained release mechanism of our
second pipeline asset, AVA6103.

 

Dosing the first patient in our Phase 1 FOCUS-01 trial of AVA6103 marks a
significant milestone for our targeted oncology pipeline. Our pre|CISION(®)
PDC approach is designed to selectively deliver payloads to tumor tissue,
which we believe could unlock the full potential of exatecan while minimizing
systemic toxicity.

 

Beyond exatecan, our novel chemistry in the Gen Two approach has two key
pipeline advantages: this both allows controlled release of the payload within
the tumor and enables many additional payloads to be linked with the peptide
complex, further opening the market opportunity for the pre|CISION(®)
platform.

 

We look forward to rapidly gathering data from patients in the FOCUS-01 trial,
which is designed to determine the kinetics of payload release,
pharmacodynamics, safety and preliminary efficacy of AVA6103."

 

 

The FOCUS-01 Clinical Trial

The Phase 1a dose escalation portion of the FOCUS-01 clinical trial will
evaluate the safety, tumor and plasma pharmacokinetics, pharmacodynamics and
preliminary efficacy of AVA6103 in patients with one of four solid tumors in
the advanced setting: pancreatic cancer, cervical and vulvar cancer, gastric
and gastroesophageal junction cancers, and small cell lung cancer.

 

The selection of these initial four tumor types for the dose escalation
portion of the trial was based on an AI approach investigating the
co-expression of a gene that can predict sensitivity to the topoisomerase 1
inhibition mechanism (SLFN11) and FAP as part of the Company's strategic
collaboration with Tempus AI.  The data mining team ranked solid tumor
indications based on the gene expression profiles to predict those cancer
indications with the highest probability of success.

 

The trial is expected to enroll approximately 144 patients and is designed to
identify a dose and regimen for further clinical development using a Bayesian
statistical method. The Bayesian Optimal Interval (BOIN) design accelerates
data collection through flexible cohort management while minimizing the
probability of improper dose selection in the two arms of the trial, designed
to investigate two dosing schedules (with every 3 weeks and every 2 weeks arms
dosing in parallel).

 

The first three centers open for enrollment in the FOCUS-01 study are the
Virginia Cancer Specialists (VCS) Research Institute in Fairfax, Virgina, NEXT
Oncology Specialists in Dallas, Texas, and START Midwest Center for Oncology
Research in Grand Rapids Michigan. Further information on the study can be
found on clinicaltrials.gov
(https://clinicaltrials.gov/study/NCT07454642?term=AVA6103&viewType=Card&rank=1)
, under study number NCT07454642.

 

 

Alexander Spira MD, PhD, FACP, FASCO, Co-Director, Virginia Cancer Specialists
(VCS) Research Institute and one of the lead investigators of the trial,
commented:

 

"Targeting a potent topoisomerase I inhibitor specifically to the tumor, and
thereby minimizing damage to healthy cells, potentially marks a significant
advance in cancer care. We're excited to work with Avacta and join this Phase
1 trial for AVA6103 and to bring this cutting-edge approach into reality and
improve treatment options for patients in need.

 

With the pre|CISION(®) platform reaching approximately 90% of solid tumors,
it opens up so many opportunities in the clinic and we are happy to work with
Avacta on this exciting new approach."

 

-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.

 

About FAP-Exd (AVA6103)

 

AVA6103 is the second clinical candidate and is the first asset in the
pipeline based on the Gen Two innovative pre|CISION(®) sustained release
mechanism that provides for prolonged release of payload directly in the
tumor, minimizing systemic exposure.  AVA6103 is being evaluated in the
FOCUS-01 Phase 1 trial (FAP-Exd in Oncologic Cancers with Unmet needS).
Preclinical data suggest this approach has optimized payload delivery with a
high intratumoral concentration and prolonged exposure of released payload in
the tumor, coupled with limited systemic exposure to the released payload.

 

 

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