ABO2011 / Suzhou Abogen Biosci - LARVOL DELTA

Nonclinical efficacy and safety evaluation of IL-12 mRNA delivered by a novel lipid nanoparticle (AACR 2025) - "Here, we report on ABO2011 (LNP-IL12 mRNA), developed by Abogen Bioscience, an innovative mRNA therapeutic cancer vaccine with novel lipid nanoparticles encoding IL-12.The LNP-IL12 mRNA significantly activates a robust T-cell-mediated adaptive immune response and exhibits strong anti-tumor potential...It was shown that LNP-IL12 mRNA mediated immunotherapy can safely and effectively induce a strong immune response. In conclusion, we conducted relevant evaluation studies with LNP-mIL12 mRNA as an example, trying to establish non-clinical efficacy evaluation criteria for mRNA therapeutics."

Clinical • Oncology • CD8 • IFNG • IL10 • IL12A • IL1B • IL6 • TNFA

An umbrella trial (RECHALLENGE) to evaluate the safety and preliminary efficacy of combination or sequential immunotherapy in advanced solid tumor patients after disease progression in clinical trials. (ESMO-IO 2024) - P1/2 | "Those who progressed on drug A (SG1827, CD80 fusion protein) or B (ABO2011, mRNA vaccine encoding IL-12) will receive their respective drug with Triplimab at 3 mg/kg IV every two weeks, continuing their prior treatment regimen (cohort A, B). Secondary endpoints include efficacy assessments like objective response rate, disease control rate, duration of response, progression-free survival, and overall survival. This trial began in May 2024 and has enrolled 3 patients at the time of submission."

Clinical • Metastases • Oncology • Solid Tumor • CD80 • IL12A

Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=218 | Recruiting | Sponsor: Suzhou Abogen Biosciences Co., Ltd. | N=160 ➔ 218 | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Preliminary safety, antitumor activity, and pharmacodynamics of intratumoral ABO2011 (IL-12 mRNA) in patients with advanced solid tumors. (ASCO 2024) - P1 | "Intratumoral ABO2011 was safe and well-tolerated in pts with advanced solid tumors. The pharmacodynamic changes were as expected. Promising preliminary antitumor activities of the single agent and the pharmacodynamic profiles support further investigation of ABO2011 in combination with immune checkpoint inhibitor."

Clinical • IO biomarker • Metastases • PK/PD data • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Pancreatic Cancer • Solid Tumor • CD8 • CXCL10 • CXCL11 • CXCL9 • IFNG • IL12A • PD-L1

Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 Monotherapy in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: Suzhou Abogen Biosciences Co., Ltd. | Enrolling by invitation ➔ Recruiting | Phase classification: P1 ➔ P1/2 | N=40 ➔ 160 | Trial completion date: Nov 2025 ➔ Dec 2026 | Trial primary completion date: May 2025 ➔ Dec 2025

Enrollment change • Enrollment status • Metastases • Monotherapy • Phase classification • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study to Evaluate ABO2011 Monotherapy in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=40 | Enrolling by invitation | Sponsor: Suzhou Abogen Biosciences Co., Ltd. | Recruiting ➔ Enrolling by invitation

Enrollment status • Metastases • Monotherapy • Oncology • Solid Tumor

A Study to Evaluate ABO2011 Monotherapy in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Suzhou Abogen Biosciences Co., Ltd.

Metastases • Monotherapy • New P1 trial • Oncology • Solid Tumor

ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • IFNG • IL12A

ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

New P1 trial • Oncology • Solid Tumor • IFNG • IL12A