Eilean Therapeutics LLC

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

Beat AML is transforming treatment for people with acute myeloid leukemia through a collaborative targeted treatment approach New trial arm will evaluate lomonitinib, Eilean's precision therapy designed to address AML treatment resistance DOVER, Del., June 11, 2024 /PRNewswire/ -- Eilean Therapeutics AU Pty Ltd, 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, has joined The Leukemia & Lymphoma Society (LLS) in the groundbreaking collaborative Beat AML® Master Clinical Trial. Eilean's investigational agent, lomonitinib (ZE46-0134) has been selected for a new trial arm for patients with FLT3 mutated relapsed/refractory (R/R) acute myeloid leukemia (AML). Lomonitinib is a highly potent and selective pan-FLT3/IRAK4 inhibitor that targets clinically relevant FLT3 mutations and putative escape pathways. Given the excellent safety profile (with no cytological changes) and ability to rapidly reach steady state, target engagement exposures in a healthy volunteer study, it is anticipated that lomonitinib will have a deeper response (i.e. more CR/CRh) and longer duration of response in R/R AML patients and eventually expand to be the best-in-class FLT3 inhibitor. This will be Beat AML's first phase 1 sub study, as well as its first precision medicine study in patients whose AML has relapsed or not responded to previous therapies. "The Beat AML Master Trial provides a unique opportunity to contribute to the advancement of science in AML and evaluate the potential of lomonitinib in FLT3 mutated relapsed refractory AML," commented Iain Dukes, Chief Executive Officer of Eilean Therapeutics. Beat AML® is among the first cancer clinical trials to be sponsored by a nonprofit. It brings together a broad global collaboration of the best and brightest clinicians, cancer centers, pharmaceutical companies, and operational and technology partners, all unified to fundamentally change the treatment approach to AML. The trial has generated impressive results, showing superior survival rates and better quality of life when patients receive targeted treatment matched to the genetic mutations or their blood cancer in place of standard-of-care chemotherapy treatment. "This partnership with Eilean is exactly what LLS envisioned when we began the Beat AML trial," said Ashley Yocum, Ph.D., LLS executive research lead for Beat AML. "Working with partners like Eilean to evaluate their new and potentially breakthrough approaches to AML treatment in the Beat AML framework will speed the process of bringing new treatments to both newly diagnosed patients and those previously treated with other therapies." About Lomonitinib Lomonitinib is a highly potent and selective inhibitor of FLT3 ITD, TKD and other clinically relevant FLT3 mutations, as well as IRAK4. FLT3 mutations are the most frequently identified mutations in AML. There are two main mechanisms of resistance to FLT3 inhibitors: the FLT3-ITD-F691L mutation deemed the "gatekeeper" mutation that confers resistance to all currently approved FLT3 inhibitors and the activation of the IRAK4 escape pathway. Lomonitinib inhibits both resistance mechanisms. About Eilean Therapeutics Eilean Therapeutics, AU Pty Ltd 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 (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. 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 . About The Leukemia & Lymphoma Society The Leukemia & Lymphoma Society® (LLS) is the global leader in the fight against blood cancer. The LLS mission: cure leukemia, lymphoma, Hodgkin's disease, and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care. Founded in 1949 and headquartered in Rye Brook, NY, LLS has regions throughout the United States and Canada. To learn more, visit . Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET. For additional information, visit lls.org/lls-newsnetwork. Follow us on Facebook, Twitter, and Instagram. Eilean Media Contact: Amy Burd CSO aburd@eileanther.com LLS Media Contact: Ryan McDonald mediarelations@lls.org View original content to download multimedia: SOURCE Eilean Therapeutics

DOVER, Del., June 10, 2024 /PRNewswire/ -- Eilean Therapeutics LLC, is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared the IND for lomonitinib (ZE46-0134), allowing the company to proceed with a Phase 1 clinical trial in FLT3 mutated relapsed/refractory (R/R) AML. While the Phase 1 study has already initiated in Australia, clearance from the FDA will allow the trial to be initiated in the US. Lomonitinib is a highly potent and selective pan-FLT3/IRAK4 inhibitor that targets clinically relevant FLT3 mutations and putative escape pathways. "This is a major milestone for Eilean Therapeutics and validates our rational drug discovery approach with our collaborator Expert Systems," commented Iain Dukes, Chief Executive Officer of Eilean Therapeutics. "We are looking forward to getting our clinical trial underway in the US and further expanding our global trial testing a targeted approach to treating FLT3 mutated AML." About Lomonitinib Lomonitinib is a highly potent and selective inhibitor of FLT3 ITD, TKD and other clinically relevant FLT3 mutations, as well as IRAK4. FLT3 mutations are the most frequently identified mutations in AML. There are two main mechanisms of resistance to FLT3 inhibitors: the FLT3-ITD-F691L mutation deemed the "gatekeeper" mutation that confers resistance to all currently approved FLT3 inhibitors and the activation of the IRAK4 escape pathway. Lomonitinib inhibits both resistance mechanisms. Given the excellent safety profile (with no cytological changes) and ability to rapidly reach steady state, target engagement exposures in a healthy volunteer study, it is anticipated that lomonitinib will have a deeper response (i.e. more CR/CRh) and longer duration of response in R/R AML patients, and eventually expand to be the best-in-class FLT3 inhibitor. 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 (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. 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 Eilean Therapeutics