LBS-007 / Lin BioSci - LARVOL DELTA

Unraveling Novel Mechanisms for Targeting the Intra-S-Phase Checkpoint in p53-Mutated Acute Myeloid Leukemia (ASH 2023) - "When used sequentially with LBS-007, hydroxyurea provided a robust response yielding GI50's between 1 and 3 nM for LBS-007, effectively blocking DNA replication origins (LBS-007) and inducing fork stalls (HU)...Most impressively, the combination of LBS-007 and venetoclax was exponentially enhanced when used in conjunction with ceralasertib (4.8 pM)...Our results identify a unique and potentially efficacious strategy to treat one of the most difficult to treat subtypes of AML. These findings will provide the rationale for potential clinical trials using CDC7 inhibition in p53 mutated or R/R AML."

IO biomarker • P53mut • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CDC7 • MCM2 • TP53

The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: Lin BioScience, Inc | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

TARGETING DNA REPLICATION AND THE INTRA-S-PHASE CHECKPOINT FOR TREATMENT OF TP53-MUTATED AML (EHA 2025) - "These results intimately link replication origin firing and fork collapse, suggesting this approach could serve as a potential therapy for Tp53 mutated AML.Subsequently, we tested LBS-007 in combination with standard AML therapies, such as azacitidine (a methyltransferase inhibitor) and venetoclax (a BCL2 inhibitor). Our findings suggest that targeting DNA replication and activating the intra-S-phase checkpoint is a promising therapeutic strategy for AML patients with Tp53 mutations or 17p deletions. We are continuing to investigate the efficacy of LBS-007 in the context of other common mutations in AML co-occurring with Tp53 alterations and aim to identify rational biomarkers for current and upcoming clinical trials involving LBS-007."

IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CDC7 • MCM2 • TP53

Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007 (GlobeNewswire) - "Lin BioScience...announced that its lead pipeline, LBS-007, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia. Lin BioScience is currently conducting a phase 1/2 trial in patients with relapsed or resistant acute leukemias in the US, Australia, and Taiwan..."

Fast track • Trial status • Acute Myelogenous Leukemia

The Safety and Tolerability of LBS-007 in Patients with Relapsed or Resistant Acute Leukaemias (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: Lin BioScience, Inc | N=60 ➔ 90

Enrollment change • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: Lin BioScience, Inc | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2023 ➔ Jul 2023

Enrollment open • Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias (clinicaltrials.gov) - P1/2 | N=60 | Not yet recruiting | Sponsor: Lin BioScience, Inc

New P1/2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology