Recombinant Human Interferon Gamma Adenovirus Injection (E10B)

E10B is the second adenovirus-based anti-tumor therapy independently developed by Doublle Biotech (Guangzhou). It received NMPA approval to initiate Phase I clinical trials in May 2021, and is indicated for patients with advanced castration-resistant prostate cancer (CRPC) who have failed standard therapy.

E10B®

Recombinant Human Interferon Gamma Adenovirus Injection
Doublle Biotech (Guangzhou) · Innovative adenovirus‑based gene therapy
NMPA Phase I Approval Adenovirus Gene Therapy Castration‑Resistant Prostate Cancer Favorable Safety Profile
🎯 Direct tumor cell killing + inhibition of angiogenesis
🔬 Carries human interferon‑γ gene for long‑term stable expression of bioactive protein
Phase Ia trial: No DLT events; MTD not reached at highest dose cohort
📊 Superior anti‑tumor efficacy in multiple solid tumors vs. recombinant IFN‑γ protein
📅 NMPA Phase I clearance (May 2021) – IND No. 2021LP00726
🔬 Indication: Advanced castration‑resistant prostate cancer (after standard therapy failure)
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📖 Product Overview
Mechanism & Clinical Data

E10B delivers the human interferon‑γ gene via an adenoviral vector into somatic cells, enabling long‑term, stable expression of bioactive interferon‑γ. This protein exerts multiple anti‑tumor effects including direct tumor cell killing, inhibition of proliferation, suppression of angiogenesis, and induction of cytokines such as tumor necrosis factor.

E10B mechanism of action

Phase Ia single‑dose study results: No dose‑limiting toxicity (DLT) events were observed, and the maximum tolerated dose (MTD) was not reached even at the highest dose cohort, confirming a favorable safety profile with good patient tolerability.

✨ IND No. 2021LP00726 | Phase Ia completed, Phase Ib ongoing

📈 Efficacy & Recognition
Anti‑tumor advantage & Official Approvals

E10B has demonstrated potent anti‑tumor activity in multiple solid tumor models, showing clear superiority over recombinant IFN‑γ protein in terms of efficacy and durability.

E10B anti-tumor efficacy comparison
NMPA Phase I clinical trial approval E10B Phase Ib kick-off meeting
🏅 NMPA Clinical Trial Approval | Supported by National Innovative Drug Programs