DOVER, DE, USA I June 20, 2025 I Lomond Therapeutics Holdings, Inc. (“Lomond Therapeutics”), a clinical-stage biotechnology company dedicated to discovering and developing potentially best-in-class and first-in-class medicines for the treatment of hematological malignancies, today 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).
“The acceptance of our third U.S. IND is an important milestone for Lomond Therapeutics”, said Iain Dukes, Chief Executive Officer of Lomond Therapeutics. “This IND clearance allows us to begin the next stages of our clinical development for lonitoclax focusing on acute myeloid leukemia (AML). Through this Phase 1 study, we aim to advance our understanding of safety, tolerability, manufacturing feasibility and mechanism of action of lonitoclax.”
Lomond Therapeutics today announced that the U.S. FDA has cleared it’s IND application for a Phase 1 multicenter study
About Lomond Therapeutics
Lomond Therapeutics is a biopharmaceutical company co-founded by Orbimed, Torrey Pines Investment and Dr. John C. Byrd, focused on the discovery and development of best-in-class and first-in-class small molecule inhibitors that target escape mutations in hematologic and solid cancers. The company is utilizing a proprietary hybrid AI platform of Expert Systems Inc., leveraging its key partners proprietary data, chem/bio tools, knowledge and expertise to choose highly valuable molecular mechanism of pathology, to rationally design, accelerate discovery and optimize development of best-in-class and first-in-class therapies. Lomond Therapeutics’ goal is to utilize its capabilities and platform to become a leader in developing novel breakthrough medicines to maximize the clinical benefit when treating hematologic and solid malignancies. For more information visit www.lomondther.com.
About Lonitoclax
Lonitoclax has earlier reported novel binding, best-in-class potency and selectivity against BCL2, a key pro-survival protein that is overexpressed in many cancers. To mitigate the hematologic and immune toxicities observed with venetoclax, lonitoclax was designed with a unique binding to improve selectivity for Bcl-2 over Bcl-xL. In addition, a shorter half-life and reduced P4503A4 inhibition properties were built into the molecule to mitigate tumor lysis syndrome and drug accumulation risk, respectively. Lonitoclax has demonstrated monotherapy activity in pre-clinical models, as well as synergistic activity when combined with azacytidine, FLT3 inhibitors, and menin inhibitors in AML xenograft models. Unlike venetoclax, lonitoclax had minimal immunosuppressive activity on B cells, CD8 T cells, and NK cells in preclinical models. Lonitoclax has completed a series of healthy volunteer studies where no significant safety signals were observed at exposures where ex vivo activation of caspase in CLL primary cells was observed, a surrogate marker of BCL-2 inhibition in tumors. This emphasizes important advantages over venetoclax and venetoclax-like molecules in safety, tolerability and feasibility of outpatient treatment, enabling the molecule to safely target AML and CLL patients alone and in combination with other targeted therapies.
About the Phase 1 Clinical Trial
The Phase 1 study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of lonitoclax in combination with azacitidine in R/R AML. The study will include a dose escalation and an expansion phase with up to 60 total participants. Lomond Therapeutics is planning to initiate the study in the third quarter of 2025 across multiple investigative sites.
SOURCE: Lomond Therapeutics
Post Views: 1,464
DOVER, DE, USA I June 20, 2025 I Lomond Therapeutics Holdings, Inc. (“Lomond Therapeutics”), a clinical-stage biotechnology company dedicated to discovering and developing potentially best-in-class and first-in-class medicines for the treatment of hematological malignancies, today 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).
“The acceptance of our third U.S. IND is an important milestone for Lomond Therapeutics”, said Iain Dukes, Chief Executive Officer of Lomond Therapeutics. “This IND clearance allows us to begin the next stages of our clinical development for lonitoclax focusing on acute myeloid leukemia (AML). Through this Phase 1 study, we aim to advance our understanding of safety, tolerability, manufacturing feasibility and mechanism of action of lonitoclax.”
Lomond Therapeutics today announced that the U.S. FDA has cleared it’s IND application for a Phase 1 multicenter study
About Lomond Therapeutics
Lomond Therapeutics is a biopharmaceutical company co-founded by Orbimed, Torrey Pines Investment and Dr. John C. Byrd, focused on the discovery and development of best-in-class and first-in-class small molecule inhibitors that target escape mutations in hematologic and solid cancers. The company is utilizing a proprietary hybrid AI platform of Expert Systems Inc., leveraging its key partners proprietary data, chem/bio tools, knowledge and expertise to choose highly valuable molecular mechanism of pathology, to rationally design, accelerate discovery and optimize development of best-in-class and first-in-class therapies. Lomond Therapeutics’ goal is to utilize its capabilities and platform to become a leader in developing novel breakthrough medicines to maximize the clinical benefit when treating hematologic and solid malignancies. For more information visit www.lomondther.com.
About Lonitoclax
Lonitoclax has earlier reported novel binding, best-in-class potency and selectivity against BCL2, a key pro-survival protein that is overexpressed in many cancers. To mitigate the hematologic and immune toxicities observed with venetoclax, lonitoclax was designed with a unique binding to improve selectivity for Bcl-2 over Bcl-xL. In addition, a shorter half-life and reduced P4503A4 inhibition properties were built into the molecule to mitigate tumor lysis syndrome and drug accumulation risk, respectively. Lonitoclax has demonstrated monotherapy activity in pre-clinical models, as well as synergistic activity when combined with azacytidine, FLT3 inhibitors, and menin inhibitors in AML xenograft models. Unlike venetoclax, lonitoclax had minimal immunosuppressive activity on B cells, CD8 T cells, and NK cells in preclinical models. Lonitoclax has completed a series of healthy volunteer studies where no significant safety signals were observed at exposures where ex vivo activation of caspase in CLL primary cells was observed, a surrogate marker of BCL-2 inhibition in tumors. This emphasizes important advantages over venetoclax and venetoclax-like molecules in safety, tolerability and feasibility of outpatient treatment, enabling the molecule to safely target AML and CLL patients alone and in combination with other targeted therapies.
About the Phase 1 Clinical Trial
The Phase 1 study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of lonitoclax in combination with azacitidine in R/R AML. The study will include a dose escalation and an expansion phase with up to 60 total participants. Lomond Therapeutics is planning to initiate the study in the third quarter of 2025 across multiple investigative sites.
SOURCE: Lomond Therapeutics
Post Views: 1,464
