lonitoclax / Eilean Therap - LARVOL DELTA

A novel: Plasma apoptosis assay to demonstrate CLL cell target engagement in first-in-human study of a highly selective oral bcl-2 inhibitor lonitoclax (ZE50-0134) (ASH 2025) - "To date, clinical trials with the first generation Bcl-2 inhibitor, venetoclax, have shown single agent or combination activity in a variety of B-cell malignancies (chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), select Non-Hodgkin's lymphoma subtypes, multiple myeloma) and myeloid diseases (acute myeloid leukemia)...Lonitoclax has demonstrated monotherapy activity in pre-clinical models, as well as synergistic activity when combined with azacytidine, FLT3 and menin inhibitors in AML xenograft models...Pharmacokinetic AUC 0-inf was increased (3.5-fold) with food but minimally influenced by itraconazole (+3%) or PPI administration (-27%)...Lonitoclax demonstrates favorable PK and safety profiles when administered orally as a single dose of up to 800 mg, with dose-proportional increases in systemic exposure, food but not DDI or PPI effect, target engagement using the novel PAA, and no treatment-related adverse events. By using the PAA to..."

First-in-human • P1 data • Acute Myelogenous Leukemia • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Leukemia • Lymphoma • Multiple Myeloma • Small Lymphocytic Lymphoma • ANXA5 • CASP3 • CD8 • CYP3A4 • FLT3

LOMOND THERAPEUTICS ANNOUNCES U.S. FDA CLEARANCE OF IND APPLICATION FOR LONITOCLAX, A SELECTIVE BCL2 INHIBITOR WITH LIMITED IMMUNE SUPPRESSION AND IMPROVED SAFETY COMPARED TO VENETOCLAX AND VENETOCLAX- LIKE MOLECULES (PRNewswire) - "Lomond Therapeutics Holdings...announced that the U.S. Food and Drug Administration (FDA) has cleared it's Investigational New Drug (IND) application for a Phase 1 multicenter study evaluating the feasibility, safety, and efficacy of lonitoclax in patients with relapsed/refractory acute myeloid leukemia (AML)."

IND • Acute Myelogenous Leukemia

Lomond Therapeutics Completes Second and Third Closings and adds Two New Investors (PRNewswire) - "Lomond Therapeutics Holdings, Inc...announced the addition of two new investors, Yosemite Capital and QIA Investments, coincident with a second and third closing, respectively, and the raising of an additional $20 million private placement financing....This transaction provides the additional resources necessary to advance our potentially best-in-class or first-in-class programs, lomonitinib, lonitoclax and our menin inhibitor, through clinical development."

Financing • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Lymphoma

LOMOND THERAPEUTICS REPORTS RESULTS FROM ONGOING CLINICAL STUDIES OF LONITOCLAX, A SELECTIVE BCL-2 INHIBITOR WITH BEST-IN-CLASS SELECTIVITY VERSUS BCL-XL AND NO CYP 3A4 LIABILITY (PRNewswire) - P1 | N=NA | "Lomond Therapeutics...announced results from single ascending dose Phase 1 clinical studies of oral once-daily lonitoclax. In this series of healthy volunteer studies, no significant safety signals were observed at exposures where robust inhibition of BCL-2 was achieved, as measured via ex vivo activation of caspase in CLL primary cells. Furthermore, administration of itraconazole, a strong inhibitor of cytochrome P450 3A4 metabolism, did not significantly alter lonitoclax exposures. These results emphasize important advantages over venetoclax and venetoclax-like molecules in safety, tolerability, and feasibility of outpatient treatment, enabling lonitoclax to be used to safely treat CLL and AML patients."

P1 data • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia

LOMOND THERAPEUTICS ANNOUNCES FDA CLEARANCE OF IND APPLICATION FOR PHASE 1 STUDY OF LONITOCLAX, A SELECTIVE BCL2 INHIBITOR, FOR CHRONIC LYMPHOCYTIC LEUKEMIA, SMALL LYMPHOCYTIC LYMPHOMA, AND SELECT LOW-GRADE LYMPHOMAS (PRNewswire) - "Lomond Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has cleared Lomond's Investigational New Drug (IND) application for a Phase 1 multicenter study evaluating the feasibility, safety, and efficacy of lonitoclax in patients with relapsed/refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, and select low-grade lymphomas."

IND • New P1 trial • Chronic Lymphocytic Leukemia • Small Lymphocytic Lymphoma