FDA Grants Fast Track Designation to LBS-007 in AML

• The FDA granted LBS-007 fast track designation for the treatment of patients with acute myeloid leukemia (AML).
• LBS-007 is a non-ATP cell cycle inhibitor targeting a broad array of cancers.
• A phase 1/2 trial (NCT05756322) of the agent is currently being conducted in the US, Australia, and Taiwan for patients with relapsed or resistant acute leukemias.

The FDA has granted LBS-007 fast track designation for the treatment of patients with AML.¹

“We are thrilled to see LBS-007 showing signs of early treatment response and potential efficacy in addressing this critical unmet medical need,” said Tom Lin, MMED, PhD, MBA, chairman of Lin BioScience, in a press release. “Receiving FDA fast track designation is a significant milestone, offering an expedited pathway to advance the development of this promising therapy. We remain deeply committed to delivering transformative solutions for patients in need.”

LBS-007 is a novel targeted therapy designed to combat a wide range of cancers. By inhibiting CDC7, a crucial regulator of the cell cycle, LBS-007 effectively halts tumor cell proliferation and induces cell death. This natural, non-ATP cell cycle inhibitor has shown potent activity against both leukemia and solid tumors, particularly in chemotherapy-resistant cell lines.¹

The FDA previously granted the agent orphan drug designation in acute myeloid leukemia and acute lymphocytic leukemia in March 2018.

A close-up of red blood cells flowing through a vein: © catalin - stock.adobe.com

An ongoing phase 1/2 trial is evaluating LBS-007 in the US, Australia, and Taiwan for the potential treatment of patients with relapsed or resistant acute leukemias.² Patients aged 18 years and older with pathologically confirmed diagnoses of relapsed or resistant AML or acute lymphoblastic leukemia are eligible for enrollment. Further, patients ineligible for standard therapies that are anticipated to result in durable remission or cure, or who have no known therapy options of documented benefit and those with an ECOG performance status 0 to 2 may be included.

Phase 1 of the study is the dose finding phase which will evaluate LBS-007 as a monotherapy and in combination with venetoclax (Venclexta) and azacitidine. In phase 2, the dose-expansion phase, investigators will assess LBS-007 alone and as a combination therapy at the optimal dose identified by phase 1 of the study.²

The primary end points are to determine the number, severity and duration of adverse events (AEs) and treatment-related AEs, and to establish the recommended phase 2 dose. Secondary end points include assessing objective response rate and pharmacokinetics.

REFERENCES:

1. Lin BioScience receives U.S. FDA fast track designation For LBS-007. News release. Lin BioScience. November 27, 2024. Accessed November 27, 2024. https://tinyurl.com/2a4uw3jr

2. A phase 1/2, open-label, dose escalation and expansion study to evaluate the safety and tolerability of LBS-007 in patients with relapsed or resistant acute leukaemias. ClinicalTrials.gov. Updated October 15, 2024. Accessed November 27, 2024. https://clinicaltrials.gov/study/NCT05756322?tab=history&a=2