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

DOVER, Del., Oct. 15, 2024 /PRNewswire/ -- Lomond Therapeutics, a subsidiary of Eilean Therapeutics LLC, a biopharmaceutical company dedicated to discovering and developing best-in-class and first-in-class small molecule inhibitors to target escape mutations in hematologic and solid malignancies, today 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.

"We are pleased with the progress we have made to date and excited with the FDA clearance of our IND to initiate patient testing of lonitoclax," said Dr. Iain Dukes, Chief Executive Officer of Eilean Therapeutics. "Given the highly differentiated pre-clinical and healthy volunteer profile of lonitoclax, we believe that lonitoclax has the potential to be the best-in-class BCL-2 inhibitor and look forward to working with the leukemia and lymphoma community in initiating our Phase 1 clinical study."

About Lonitoclax

Lonitoclax has earlier reported novel binding, best-in-class potency and selectivity against BCL-2, a key pro-survival protein that is overexpressed in many cancers. This clinical candidate demonstrated equivalent in vivo anti-tumor efficacy to venetoclax in B cell and myeloid malignancy cell lines and in vivo models. Compared to venetoclax, lonitoclax exhibits significantly less suppression of non-malignant immune cell populations, a result that suggests superior selectivity, and an improved safety profile. Lonitoclax has previously completed a series of healthy volunteer studies where no 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 Eilean Therapeutics

Eilean Therapeutics LLC 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 pre-clinical work with this molecule was done by Eilean Therapeutics in collaboration with the Leukemia Drug Development Laboratory at the University of Cincinnati led by Byrd and Dr. Erin Hertlein. The company is utilizing a proprietary hybrid AI platform (Expert Systems Inc.), leveraging its key partners' proprietary data, chem-bio platforms, knowledge, and expertise to choose highly valuable molecular mechanisms of pathology; to precisely design and accelerate the execution of discovery and development of best-in-class and first-in-class therapies. Eilean 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.eileanther.com.

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SOURCE Lomond Therapeutics