RE: Rudyard Kipling15 Feb 2025 18:18
RK wrote fiction -Avacta print facts :
https://avacta.com/about/
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.
Our lead pre|CISION® program AVA6000, a Gen One peptide drug conjugate form of doxorubicin, recently completed Phase 1a studies and is currently moving into indication-specific expansion cohorts in three diseases. AVA6000 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 FAPhigh and doxorubicin sensitive diseases. A significant concentration of released doxorubicin is observed in all patients with post-treatment biopsies, even in patients whose tumors have lower levels of FAP activity. In addition, multiple responses have occurred in patients with expression of FAP only noted in stromal cells (cancer-associated fibroblasts, or CAFs). This indicates that tumor cell expression of FAP is not required for the release of doxorubicin, with even lower levels of stroma-only expression being sufficient.
In the AVA6000 Phase 1 trial, we have observed multiple favorable changes in the pharmacokinetic profile of released doxorubicin, including a dramatic reduction in the maximal concentrations of released doxorubicin, reduction in exposure (AUC) and reduction in volume of distribution, essentially recapitulating the preclinical findings. The changes in the kinetics in patients underscore the mechanism of action of the pre|CISION® platform provide a framework for platform improvements in the PK of additional warheads.
The pre|CISION® chemistry has been optimized in our Gen Two PDC in the pipeline, whereby the conjugations are optimized to (1) significantly extend half-life of the conjugated drug and thus the released warhead and (2) modulate the rate of cleavage (kcat/Km).
The pre|CISION® chemistry has been optimized in our Gen Two PDC in the pipeline, whereby the conjugations are optimized to (1) significantly extend half-life of the conjugated drug and thus the released warhead and (2) modulate the rate of cleavage (kcat/Km). Both of these developments are anticipated to significantly alter the pharmacokinetic profile of a released warhead and enables our scientists to tune the delivery of warheads directly to the tumor with minimal peripheral exposure in normal tissues. Our first Gen Two pre|CISION® medicine is AVA6103, a PDC containing the most potent topoisomerase 1 inhibitor in clinical testing, exatecan.
Our Gen 3 pre|CISION® pipeline leverages the highly specific binder proteins, the Affimer® proteins to create an entirely novel class of drug, the Affimer-DC (AffDC) which have 3 key advantages over tr
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