MBS8 / MonTa Biosciences - LARVOL DELTA

Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=69 | Recruiting | Sponsor: MonTa Biosciences ApS | Trial completion date: Apr 2024 ➔ Jun 2026 | Trial primary completion date: Apr 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Micellar formulation provides potent and tolerable TLR7 agonist treatment for anti-cancer immunotherapy. (PubMed, J Immunol) - "1V270-micelles were well tolerated by non-human primates at doses equivalent to those displaying therapeutic activity in murine cancer models. Overall, the study provides novel insights into the mode of action of TLR7 agonists and demonstrates good and sustained tolerability of 1V270-micelles across animal models and excellent efficacy in murine cancer models by bridging innate and adaptive immunity."

Journal • Hematological Disorders • Hepatology • Oncology

Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=69 | Recruiting | Sponsor: MonTa Biosciences ApS | Trial completion date: Apr 2023 ➔ Apr 2024 | Trial primary completion date: Apr 2023 ➔ Apr 2024

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • IL6 • TNFA

Efficacy and safety of the TLR7 agonist micelles MBS8(1V270) tested in pre-clinical models (AACR 2023) - P1 | "Together, these data provide a rationale for clinical studies of MBS8(1V270) as monotherapy and in combination with immune checkpoint inhibitors. MBS8(1V270) is currently under clinical investigation in the clinical trial MBS8-101 (ClinicalTrials.gov identifier NCT04855435)."

Preclinical • Oncology • IL6

Systemic administration of TLR7/8 agonist micelles triggers a potent anti-tumor response mediated by neutrophils as primary effector cells followed by establishment of an immune memory response (SITC 2022) - P1 | "Background Clinical use of TLR7/8 agonists is currently restricted to topical application of Imiquimod for treatment of superficial basal cell carcinoma since systemic administration is a challenge due to dose-limiting toxicity. Further, an adaptive immune response was initiated including generation of tumor antigen-specific CD8 + cells and establishment of immune memory response. MBS8 was well tolerated in rodents and cynomolgus monkeys at dose levels above therapeutic effective doses identified in mice, thus providing a good therapeutic window."

Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Solid Tumor • CD8

Systemic TLR7/8 micelles trigger a novel and potent anti-tumor response by strong recruitment of neutrophils leading to massive tumor cell killing. (ASCO 2022) - P1 | "Background: Clinical use of TLR7/8 agonists is currently restricted to topical application of Imiquimod for treatment of superficial basal cell carcinoma since systemic administration is prevented due to dose-limiting toxicity. MBS8 showed significant anti-cancer activity in multiple in vivo solid tumor models when administered either as monotherapy or in combination with ICIs. MBS8 demonstrated a novel mode of action with neutrophils playing a central role as primary effector cells causing a rapid killing of tumors. Further, adaptive immune response was initiated including generation of tumor specific CD8+ cells and establishment of the immune memory."

IO biomarker • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Solid Tumor • CD8 • TLR7

Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=69 | Recruiting | Sponsor: MonTa Biosciences ApS | Trial completion date: Nov 2022 ➔ Apr 2023 | Trial primary completion date: Oct 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date • Oncology • Solid Tumor • IL6 • TNFA

Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1; N=69; Recruiting; Sponsor: MonTa Biosciences ApS

Clinical • New P1 trial • Oncology • Solid Tumor • IL6 • TNFA