About Avacta
Avacta is not just fighting cancer—we’re challenging current drug delivery methods to expand the reach of highly potent therapeutics with an unwavering commitment to eliminate cancer. In a world where effective cancer therapy often means a difficult trade-off between efficacy and safety, we offer something different: Hope without compromise.
Avacta is a clinical stage biopharmaceutical company developing pre|CISION®, a tumor-activated oncology delivery platform. We have two assets in clinical development and are led by a management team with extensive experience in the oncology biotech space and a passionate group of scientists, clinicians and translational scientists with one goal: to eliminate cancer.
Our proprietary pre|CISION® platform uses the modality of a peptide drug conjugate (or PDC) where the peptide is designed to mask a toxic payload and the peptide is selectively released from the payload by a tumor-specific protease, fibroblast activation protein (FAP). The peptide is designed to disable the payload by preventing cellular entry prior to the cleavage step releases it directly in the tumor microenvironment.
The exquisite tumor-specificity of the release mechanism of pre|CISION® underscores its success in the clinic: namely, the released payload is concentrated in the tumor microenviroment at a ratio of 100:1 when the tumor and plasma levels are compared following the first dose of the pre|CISION® medicine. This specificity is in contrast to the release mechanism of most antibody drug conjugates, where general protease cleavable release is employed.
Our lead program faridoxorubicin (AVA6000) is a Gen One pre|CISION® peptide drug conjugate form of doxorubicin that has completed Phase 1a (dose escalation) testing and is currently enrolling in Phase 1b indication-specific expansion cohorts in three diseases (salivary gland cancer, SGC, triple negative breast cancer, TNBC and soft tissue sarcoma, STS).
Faridoxorubicin has shown a dramatic improvement in safety and tolerability compared with conventional doxorubicin and multiple ongoing and durable RECIST responses have been observed in patients with salivary gland cancers and soft tissue sarcomas. Concentration of the doxorubicin payload in the tumor v. plasma is demonstrated through biopsy studies in the ongoing trial, where effective cleavage of peptide and release of payload is observed even at the lowest level of FAP expression (1+ by immunohistochemistry).
The observed pharmacokinetics of both the PDC (faridoxorubicin) and the released payload (doxorubicin) in the Phase 1 clinical trial have been published (AACR 2025, ESMO 2025 – please see the publications section). These data formed the framework for the invention of the Gen Two pre|CISION® sustained release mechanism in the FAP-Exd (AVA6103) program, a pre|CISION enabled version of the potent topoisomerase I inhibitor, exatecan. The proprietary sustained release mechanism results in prolonged residence of the PDC in the tumor with sustained release over days with limited plasma exposure to both the PDC and released payload. This second program is in Phase 1 testing in four disease settings: pancreatic cancer, gastric and gastroesophageal junction cancers, cervical and vulvar cancers and small cell lung cancer. Data updates from this trial are anticipated in late 2026.
Our Gen 3 pre|CISION® pipeline leverages the chemistry developments in the Gen Two programs to attach two independent payloads. From a single FAP cleavage event in the Gen Three platform, two payloads are released following cleavage. Initial studies of the dual payload technology have focused on treating the resistance mechsnisms known to develop during therapy with the topoisomerase 1 inhibitor known as the DNA Damage Repair Pathway. This first dual payload technology program is anticipated to select the clinical candidate in late 2026 and proceed to IND enabling studies in 1Q 2027.