pp-101 Injection
Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
Comments
Indication: Unresectable recurrent or metastatic PD‑L1–expressing, HPV16‑positive head and neck squamous cell carcinoma in adults
Clinical stage: Phase 2/Phase 3 clinical development (AHEAD‑MERIT trial)
Modality: mRNA‑based cancer immunotherapy
Mechanism / Target: Encoded HPV16 oncoproteins E6 and E7 stimulate antigen‑specific T‑cell immune responses against HPV16‑driven tumor cells
Route / form: Intravenous injection (lipoplex‑formulated mRNA vaccine)
Differentiation: First‑in‑class mRNA immunotherapy targeting HPV16 oncogenic neoantigens with the potential for synergy with checkpoint inhibition in HPV16‑driven cancers
Manufacturer #38937
Clinical-stage biotechnology company focused on mRNA therapeutics and immunotherapies, primarily in oncology and infectious diseases. Develops precision medicines designed to activate or direct immune responses against disease targets. Strategy emphasizes global clinical development and strategic partnerships.