About FAP-Exd (AVA6103)21 Apr 2026 09:50
FYI : RNS Footnote 21st April 2026
"About AVA6103 (FAP-Exd)
AVA6103 is the second clinical candidate and is based on the 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.
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 six solid tumors in the advanced setting: pancreatic cancer, cervical and vulvar cancer, gastric and gastroesophageal junction cancers, small cell lung cancer, colorectal cancer and hormone receptor-positive breast cancer.
The selection of the six 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."
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RNS footnote 14th April 2026
"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. "
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