REG - Avacta Group PLC - Q1 2026 Business Update

AvactaAnnouncement

Yesterday 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20260409:nRSI7128Za&default-theme=true

RNS Number : 7128Z  Avacta Group PLC  09 April 2026

 

 

Q1 2026 Business Update

 

 

LONDON and PHILADELPHIA - April 9, 2026 - Avacta Therapeutics (AIM: AVCT, "the
Company", "Avacta"), a clinical stage biopharmaceutical company developing
pre|CISION(®), a tumor-activated oncology delivery platform, today provides
a business update through the first quarter of 2026.

 

Q1 2026 Highlights

 

Gen Two (AVA6103)

·    The Investigational New Drug (IND) application for Avacta's first Gen
Two program, AVA6103 (FAP-Exd, pre|CISION(®)-enabled exatecan), was cleared
in January. Three specialist oncology centers are now open for enrollment in
the U.S. On 31 March 2026 Avacta announced the first patient was treated as
planned in the FOCUS-01 Phase 1 clinical trial.

 

·    In February 2026 highly favorable data from a preclinical study were
presented, comparing the pre|CISION(®) sustained release payload delivery of
AVA6103 with a highly successful antibody drug conjugate, Enhertu(®). The
study used a synthetic comparator arm and demonstrated the optimized
pre|CISION(®) payload delivery with rapid tumor penetration, one log higher
maximal tumor concentration, and 3x tumor selectivity index (TSI) of the
exposure (AUC) in tumor versus plasma.

 

Gen One (AVA6000)

·    Positive health authority interactions were reported in the Gen One
program, AVA6000 (Faridoxorubicin, pre|CISION®-enabled doxorubicin),
resulting in the lifting of the lifetime maximum dose due to highly favorable
cardiac safety and an agreement on the dose selection for subsequent trials.

 

Financial

·    Completed a successful financing with an oversubscribed placing and
subscription raising £10 million, as announced on 27 March 2026, extending
the cash runway into early Q1 2027 and allowing the Company to retain 100%
ownership of all assets in the pipeline.

 

·    Christina Coughlin, CEO and Brian Hahn, CFO participated in the
46(th) Annual TD Cowen Health Care Conference in Boston on March 4, 2026

 

 

Company Outlook for 2026

 

·    Updated preclinical and translational data on the Gen Two AVA6103
program will be presented at the American Association of Cancer Research
(AACR) Annual Congress in San Diego on 21 April 2026.  Initial clinical data
in the AVA6103 program are anticipated in late H2 2026.

 

·    A clinical data update on Gen One AVA6000 clinical data from the
Phase 1a and 1b cohorts is expected at a medical conference in H1 2026. This
would include updated efficacy data in expansion cohorts, including the lead
indication of salivary gland cancer, as well as the cardiac safety data which
resulted in the removal of the lifetime maximum dose limit, as announced on 03
February 2026.

 

·    Payload selection and clinical candidate selection in the Gen Three
pre|CISION(®) Dual Payload program (AVA6207) are expected in H2 2026.
Updated in vitro and in vivo preclinical data will also be presented at the
AACR Annual Congress on 21 April 2026.

 

Christina Coughlin MD, PhD, CEO of Avacta, commented:

 

"Avacta continued to build momentum, having reached a number of important
milestones in the first quarter of 2026, with treatment of the first patient
in the FOCUS-01 trial of AVA6103 being a critical step forward in the
development of our pre|CISION(®) platform.  The sustained release mechanism
allows the modulation of the kinetics of payload release, and also opens up
the platform to many therapeutic modalities over the Gen One approach.

 

Furthermore, our AVA6000 (faridoxorubicin) program is especially well
positioned following the updates from health authorities which allow the
lifting of the lifetime maximum dosing and dose selection.

Our first, second and third generation assets are all attracting substantial
interest from multiple parties for potential partnering. With our recent
financing completed, we now have funding in place beyond multiple value
inflection points through the rest of 2026 and we are excited about this
potentially transformative period for the Company, delivering benefit for our
patients and our shareholders alike."

 

 

-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.

 

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  UPDIPMRTMTAMBBF



            Copyright 2019 Regulatory News Service, all rights reserved