Eilean Therapeutics LLC

DOVER, Del., Dec. 9, 2024 /PRNewswire/ -- Lomond Therapeutics, a spin-out of Eilean Therapeutics LLC, a precision oncology-focused discovery and development platform, today 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. "The positive PK, PD, and safety findings from our Phase 1 trial mark the first clinical data that underscores the differentiated profile and promising potential of lonitoclax compared to venetoclax and venetoclax-like molecules for AML, CLL, and potentially other oncology indications patients," said Dr. Iain Dukes, Chief Executive Officer of Lomond Therapeutics. "We are excited to embark on the next phase of development for lonitoclax with an ongoing CLL study." About Lonitoclax Lonitoclax is a next generation BCL-2 inhibitor that has demonstrated best-in-class molecular pharmacology with the highest 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 mode 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 azacitidine, 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. About Lomond Therapeutics Lomond Therapeutics is a biopharmaceutical company, focused on the 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 in collaboration with the Leukemia Drug Development Laboratory at the University of Cincinnati led by Dr. John Byrd and Dr. Erin Hertlein. The company is utilizing a proprietary hybrid AI platform of the Expert Systems Accelerator, 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. Lomond Therapeutics' goal is to utilize its capabilities and platform to become a leader in developing novel breakthrough medicines to treat hematologic and solid malignancies. For more information visit Media Contact: Amy Burd CSO [email protected] SOURCE Lomond Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

DOVER, Del., Nov. 11, 2024 /PRNewswire/ -- Lomond Therapeutics, a subsidiary of Eilean Therapeutics LLC, today announced an abstract related to the company's Lomonitinib, a highly potent and selective pan-FLT3/IRAK4 inhibitor that targets clinically relevant FLT3 mutations and putative escape pathways, has been accepted for a poster presentation at the upcoming American Society of Hematology (ASH) Annual Meeting, which will be held from December 7-10, 2024 in San Diego. The following abstract was published today and now available. A Randomized Placebo-Controlled Phase 1 Trial in Healthy Volunteers Investigating the Safety, Pharmacokinetics and Pharmacodynamics of a Novel FLT3/IRAK4 Inhibitor, Lomonitinib (ZE46-0134) Session Name: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms Session Date: Saturday, December 7, 2024 Presentation Time: 5:30 PM - 7:30 PM Location: San Diego Convention Center, Halls G-H 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 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 Media Contact: Amy Burd CSO [email protected] SOURCE Lomond Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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 . Media Contact: Amy Burd CSO [email protected] SOURCE Lomond Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED