Orally Administered TLR7 Agonist Candidate Found Effective

Apros Therapeutics, Inc. today announced that they would present interim pharmacokinetic and pharmacodynamic Phase 1 clinical data for APR003, a first-in-class orally-administered gastrointestinal (GI)- and liver-targeted TLR7 agonist.
It is currently being evaluated in an ongoing Phase 1 dose-escalation clinical trial in relapsed/refractory colorectal cancer (CRC) patients with hepatic metastasis.
Pharmacodynamic analysis revealed that upon weekly dosing, APR003 elicited robust Interferon-alpha, Interferon-gamma inducible protein 10 (IP-10), and Interferon Stimulated Gene 15 (ISG15) responses, suggesting strong immune priming.
In addition, APR003 achieved a similar or greater IP-10 response compared to other (non-targeted) agents of the same class, indicating that the tissue-targeted approach may have an increased safety window.
These data support further clinical investigation of APR003 in other GI and Liver malignancies and metastatic disease as a single agent and in combination with checkpoint inhibitors or complementary therapies.