Pipeline
Avacta Therapeutics is a clinical stage biopharmaceutical company challenging current drug delivery methods to expand the utility of highly potent cancer therapeutics.
Our proprietary pre|CISION® platform masks toxic warheads by binding them to a short, engineered peptide that is cleavable only by the tumor-specific protease, fibroblast activation protein (FAP). The peptide is designed to disable the warhead before the cleavage step releases it directly in the tumor microenvironment. Our innovative pipeline consists of pre|CISION® peptide drug conjugates (PDC) or Affimer® drug conjugates (AffDC) that leverage the tumor-specific release mechanism. The tumor-specificity of the warhead release and bystander effect optimization of our medicines provide unique benefits over traditional antibody drug conjugates.
Phase 1
First Gen pre|CISION® doxorubicin
Breast cancer, head and neck cancers, dedifferentiated liposarcoma
The Phase 1 dose escalation trial of AVA6000 has completed with two independent arms enrolled, with dosing Q2W and Q3W. The recommended dose for expansion (RDE) was selected and Phase 1b expansion cohorts to enroll in patients with triple negative breast cancer (TNBC), high grade soft tissue sarcoma and salivary gland cancer.
AVA6000 is a Gen One pre|CISION® peptide drug conjugate, with our proprietary FAP-cleavable peptide attached directly to the warhead, doxorubicin, an anthracycline.
AVA6000 is administered intravenously on an every 3 week (Q3W) or every 2 week (Q2W) dosing schedule.
The clinical development of AVA6000 is ongoing in patients with FAP-positive disease and cancers with predicted sensitivity to the anthracycline mechanism of action. These cancer types include breast cancer, head and neck cancers (salivary gland subset) and soft tissue sarcomas.
IND-Enabling
Second Gen pre|CISION® exatecan
Gastric cancer, triple negative breast cancer, small cell lung cancer, pancreatic ductal adenocarcinoma
AVA6103 is in IND-enabling studies and the US IND is planned for Q4 2025/Q1 2026 and first-in-human Phase 1 development to initiate in Q1 2026.
AVA6103 is a Gen Two pre|CISION® peptide drug conjugate, with our proprietary FAP-cleavable peptide attached to the warhead exatecan via a novel linker that modulates and extends the release of the warhead from the conjugated molecule. The capping group in Gen Two PDC also contains a moiety to enhance plasma protein binding, thus extending the exposure of the conjugated molecule, delivering a sustained release version of the PDC.
The clinical development of AVA6103 is planned in patients with FAP-positive diseases with predicted sensitivity to the topoisomerase I inhibitor mechanism of action of exatecan. Such diseases include gastric cancer, triple negative breast cancer, pancreatic cancer and small cell lung cancer.
Preclinical
Third Gen pre|CISION® FAP Affimer® (AffDC). Warhead not disclosed
Head and neck squamous cell cancers, non-small cell lung cancer, colorectal cancer
The AVA7100 program is in the preclinical setting and is anticipated to have candidate selection in 2H 2025 with a potential IND in 2H 2026.
AVA7103 is a Gen Three pre|CISION® Affimer® drug conjugate (AffDC), that is based on a non-internalizing FAP-binding Affimer monomer engineered with an albumin binding Affimer to create an Affimer dimer. This dimer with 5 cysteines is conjugated using standard ADC conjugation methods to a pre|CISIONTM peptide drug conjugate of a warhead with a drug-to-Affimer® ratio (DAR) of 5. The AffDC will release the warhead specifically in the TME, avoiding normal tissue exposure and enabling treatment of patients with FAP-low diseases.
The clinical development of AVA7100 is planned in indications with a highly heterogenous expression pattern of FAP, enabled by the conjugation to the FAP Affimer® which targets the warhead into the TME. The FAP cleavable linker used in the AffDC has the same high tumor specificity of release, thus minimizing normal tissue exposure of the warhead while the Albumin binding moiety extends the plasma half-life of the conjugated drug.
To explore how we can work together, please contact our Chief Business Officer.