{"entity":{"id":"apg-157","kind":"drug","name":"APG-157","aka":[],"tldr":"APG-157 is an experimental oral immunomodulator from Aveta Biomics, in phase 3 trials for locally advanced head and neck squamous cell carcinoma, recurrent high-grade glioma / glioblastoma and oral dysplasia.","summary":"APG-157 is an oral immunomodulator (soft hydrogel pastille dissolved in the mouth) from Aveta Biomics. An oral therapy the company says acts upstream of immune checkpoints in the tumour immune microenvironment: it modulates NF-kB and STAT3 signalling and is designed to shift tumour-associated macrophages away from an immunosuppressive M2-like state. Its furthest stage is phase 3, for locally advanced head and neck squamous cell carcinoma (oral cavity, oropharynx), recurrent high-grade glioma / glioblastoma and oral dysplasia (precancer). ClinicalTrials.gov registers it in 4 studies linked below. Phase 3 in newly diagnosed locally advanced HNSCC registered, not yet recruiting (NCT07667296); FDA Fast Track and Orphan Drug designations in that setting per company. Phase 2 neoadjuvant HNSCC (NCT05312710) and phase 1b/2a with bevacizumab in recurrent high-grade glioma (NCT06011109) active, not recruiting. Phase 2 in oral dysplasia recruiting (NCT05865028, investigator-sponsored). Whether it works in people has not been established unless a trial below reports it.","status":"phase-3","asOf":"2026-11-03","links":[{"label":"Aveta Biomics: avetabiomics.com","url":"https://avetabiomics.com/pipeline"},{"label":"Aveta Biomics: avetabiomics.com","url":"https://avetabiomics.com/science"},{"label":"Aveta Biomics: clinicaltrials.gov","url":"https://clinicaltrials.gov/study/NCT07667296"},{"label":"ClinicalTrials.gov: trials of APG-157","url":"https://clinicaltrials.gov/search?intr=APG-157"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["oropharyngeal-cancer","glioblastoma","oral-cavity-cancer"],"sections":[],"technologies":[],"targets":["stat3"],"drugs":[],"companies":["aveta-biomics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07667296","nct05312710","nct06011109","nct05865028"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo gap audit, class 5 (company pipeline pages and ClinicalTrials.gov v2)","editedOn":"2026-11-03"},"code":"APG-157","modality":"Oral immunomodulator (soft hydrogel pastille dissolved in the mouth)","mechanism":"An oral therapy the company says acts upstream of immune checkpoints in the tumour immune microenvironment: it modulates NF-kB and STAT3 signalling and is designed to shift tumour-associated macrophages away from an immunosuppressive M2-like state.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/apg-157/","neighbours":{"cancer":[{"id":"glioblastoma","kind":"cancer","name":"Glioma & glioblastoma","route":"/cancers/glioblastoma/"},{"id":"oral-cavity-cancer","kind":"cancer","name":"Oral cavity cancer (mouth and tongue)","route":"/cancers/oral-cavity-cancer/"},{"id":"oropharyngeal-cancer","kind":"cancer","name":"Oropharyngeal cancer (tonsil and base of tongue)","route":"/cancers/oropharyngeal-cancer/"}],"target":[{"id":"stat3","kind":"target","name":"STAT3","route":"/targets/stat3/"}],"company":[{"id":"aveta-biomics","kind":"company","name":"Aveta Biomics","route":"/companies/aveta-biomics/"}],"trial":[{"id":"nct05865028","kind":"trial","name":"A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia","route":"/trials/nct05865028/"},{"id":"nct07667296","kind":"trial","name":"APG-157 in Locally Advanced Head and Neck Squamous Cell Carcinoma","route":"/trials/nct07667296/"},{"id":"nct05312710","kind":"trial","name":"Safety and Efficacy of APG-157 in Head and Neck Cancer","route":"/trials/nct05312710/"},{"id":"nct06011109","kind":"trial","name":"Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab","route":"/trials/nct06011109/"}]}}