Avacta Group Regulatory News (AVCT)

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 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, 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:

About Avacta - 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.