menin

– Steven Closter brings more than 30 years of commercial experience in the biopharmaceutical industry to Syndax – – Company on track for two potential first- and best-in-class product launches in 2024 – WALTHAM, Mass., March 18, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced the appointment of Steven Closter as Chief Commercial Officer, effective immediately. Mr. Closter will lead the Company's commercial strategy and operations, including marketing, sales, and market access, succeeding Steve Sabus, who is departing for personal reasons. "Steven Closter is an accomplished leader with a proven track record of building commercial teams, leading successful product launches and delivering growth across a broad range of therapeutic areas," said Michael A. Metzger, Chief Executive Officer. "He has the right experience and capabilities to lead our growing and talented commercial organization as we work toward a successful transition to a fully integrated commercial business. We are thrilled to welcome him to the team and look forward to his contributions." Mr. Closter brings to Syndax over 30 years of commercial experience, which included the oversight of over a dozen product launches and indication expansions. Prior to joining Syndax, he served in various roles at Sunovion Pharmaceuticals, which was consolidated into Sumitomo Pharma America in 2023, ultimately serving as Vice President, Brand Strategy and Launch Excellence. At Sunovion, he was responsible for global pre-commercialization, launch, marketing, sales, and market access strategies for products across neurology, psychiatry, and primary care therapeutics. Before Sumitomo, Mr. Closter spent nearly 20 years in senior marketing and commercial roles at Forest Laboratories, then Allergan, most recently serving as Vice President, Marketing, where he held responsibility for marketing products covering oncology, hospital-based anti-infectives, CNS, cardiovascular and other therapeutic areas. He holds a Bachelor of Science in Business from Cornell University and a Master of Business Administration from the NYU Stern School of Business. "I have dedicated my career to strategically delivering novel medicines to patients facing a wide range of serious diseases and conditions," said Mr. Closter. "Syndax is at a pivotal moment, with the expected delivery of two first- and best-in-class therapies this year to people living with cancer. I look forward to leading the continued build-out of Syndax's commercial organization and strategies, and to helping position the Company for success in the anticipated launch of revumenib and axatilimab." Mr. Metzger added: "We thank Steve Sabus for his contributions to Syndax and for his assistance in seamlessly transitioning the role to Steven Closter. His guidance and insights helped lay a solid foundation for our commercial organization that has positioned us to be fully ready to launch. We are grateful to him for his leadership and wish him the best." About Syndax Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include revumenib, a highly selective inhibitor of the menin–KMT2A binding interaction, and axatilimab, a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. For more information, please visit or follow the Company on X (formerly Twitter) and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipate," "believe," "could," "estimate," "expects," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative or plural of those terms, and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials, the reporting of clinical data for Syndax's product candidates, and the potential use of its product candidates to treat various cancer indications and fibrotic diseases. Many factors may cause differences between current expectations and actual results, including: unexpected safety or efficacy data observed during preclinical or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; failure of Syndax's collaborators to support or advance collaborations or product candidates; and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Syndax Contact Sharon Klahre Syndax Pharmaceuticals, Inc. [email protected] Tel 781.684.9827 SNDX-G SOURCE Syndax Pharmaceuticals

ROCKVILLE, Md., March 13, 2024 /PRNewswire/ -- Expert Systems, a leader in AI-enabled drug discovery, proudly announces a significant milestone in partnership with Eilean Therapeutics LLC: the start of Phase 1 trial of balamenib (ZE63-0302), a highly selective inhibitor of the menin–KMT2A binding interaction, under the Clinical Trial Notification (CTN) scheme of the Australian Therapeutics Goods Administration (TGA). "Balamenib has a highly differentiated pre-clinical pro indicates important advantages over molecules in the same class in safety, tolerability and feasibility of outpatient treatment," commented Bill Farley, CBO at Expert Systems. "We are proud that our comprehensive hybrid AI-based platform has helped accelerate the development of a new promising & safe treatment for AML." Supported by Orbimed, Torrey Pines Investment, and Dr. John C. Byrd, Eilean Therapeutics is committed to leading the development of innovative therapies that significantly enhance treatment outcomes in both hematologic and solid malignancies. This effort is bolstered by leveraging Expert Systems' cutting-edge AI platform to speed up the discovery and development process. About Balamenib Balamenib (ZE63-0302) is an oral small molecule inhibitor of the menin-KMT2A interaction. In vitro studies with KMT2Ar specific cell lines and in vivo studies using xenograft models demonstrated that balamenib is a potent menin inhibitor when administered both as a stand-alone agent or in combination with other compounds used for the treatment of r/rAML, in particular with eiletoclax (ZE50-0134), and lomonitinib (ZE46-0134), Eilean Therapeutics' BCL-2 selective inhibitor and pan FLT3/IRAK4 inhibitor, respectively. Balamenib demonstrates improved safety compared to other molecules in the same class, with an absence of QTc prolongation and is neither a substrate nor inducer of cytochrome P450 3A4 metabolism. Furthermore, balamenib shows significantly reduced susceptibility to "hot spot" menin mutations currently being encountered in the clinic with other menin inhibitors. About Expert Systems, Inc. Expert Systems, Inc., an advanced accelerator platform, is equipped with a comprehensive, hybrid AI-based system that covers the entire spectrum of preclinical drug discovery and early development phases. This includes target identification, virtual screening, non-clinical and clinical pharmacology, chemical liability assessment, and toxicology. Utilizing a unique combination of proprietary and public databases, Expert Systems employs specialized software tools to evaluate the intellectual property landscape and construct a competitive drug intelligence strategy to de-risk candidate selection for rapid transition from in silico to first-in-human trials. Expert Systems has been pivotal in establishing seed and Series A companies, organizing and managing over 30 research and development programs across various financial investors and strategic partners in North America, Europe, and Australia. To learn more, visit About Eilean Therapeutics Eilean Therapeutics LLC is a cutting-edge biopharmaceutical company, established through a collaboration between Orbimed, Torrey Pines Investment, and Dr. John C. Byrd, dedicated to the identification of both best-in-class and first-in-class small molecule inhibitors targeting escape mutations in both hematologic and solid cancers. The company harnesses the Expert Systems Inc. hybrid AI platform alongside its key partners' exclusive data, chem-bio platforms, knowledge, and expertise. This enables Eilean Therapeutics to select molecular mechanisms of pathology with high clinical relevance, precisely designing and expediting the discovery and development processes for leading-edge therapies. Eilean Therapeutics is committed to leveraging its unique capabilities and platform to create novel, groundbreaking medicines for patients with hematologic and solid malignancies, marking a new era in targeted cancer therapy. For more information, visit Bill Farley CBO bfarley@expertsystems.inc

DOVER, Del., March 11, 2024 /PRNewswire/ -- 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 Eilean Therapeutics Australia Pty, Ltd, received clearance from the Human Research Ethics Committee in Australia to begin a Phase 1 trial of balamenib (ZE63-0302) under the Clinical Trial Notification (CTN) scheme of the Australian Therapeutics Goods Administration (TGA). The Phase 1 program includes a single ascending dose trial in healthy volunteers to evaluate the safety, pharmacokinetics and target engagement profile of balamenib, a highly selective inhibitor of the menin–KMT2A binding interaction. "The first-in-human study of balamenib in Australia represents another important milestone for Eilean Therapeutics, as we progress, with an accelerated development of our portfolio of best-in-class agents targeting hematological malignancies," stated Iain Dukes, Chief Executive Officer of Eilean Therapeutics. "The highly differentiated pre-clinical profile of balamenib emphasizes important advantages over molecules in the same class in safety, tolerability and feasibility of outpatient treatment, enabling our drug to safely treat AML patients alone and in combination with our other targeted therapies." About Balamenib Balamenib (ZE63-0302) is an oral small molecule inhibitor of the menin-KMT2A interaction. In vitro studies with KMT2Ar specific cell lines and in vivo studies using xenograft models demonstrated that balamenib is a potent menin inhibitor when administered both as a stand-alone agent or in combination with other compounds used for the treatment of r/rAML, in particular with eiletoclax (ZE50-0134), and lomonitinib (ZE46-0134), Eilean Therapeutics' BCL-2 selective inhibitor and pan FLT3/IRAK4 inhibitor, respectively. Balamenib demonstrates improved safety compared to other molecules in the same class, with an absence of QTc prolongation and is neither a substrate nor inducer of cytochrome P450 3A4 metabolism. Furthermore, balamenib shows significantly reduced susceptibility to "hot spot" menin mutations currently being encountered in the clinic with other menin inhibitors. About Eilean Therapeutics Eilean Therapeutics LLC is a pharmaceutical 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/ML 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 Eilean Therapeutics