FORMA Therapeutics, Inc.

BOULDER, Colo., Sept. 20, 2023 (GLOBE NEWSWIRE) -- OnKure, Inc., a clinical-stage biopharmaceutical company discovering and developing the next generation of oncology precision medicines, today announced the appointment of Ann Howell as Vice President of Regulatory Affairs. Dr. Howell brings an abundance of experience managing regulatory affairs activities for both small and large biopharmaceutical companies, with global regulatory responsibilities across a variety of therapeutic areas, including oncology. “We are delighted to welcome Ann to the OnKure team,” said Tony Piscopio, Ph.D., Co-Founder, President and Chief Executive Officer of OnKure. “Ann has an impressive background in leading the regulatory strategies for numerous product developments and subsequent NDA submissions, in addition to expertise overseeing global regulatory interactions for oncology development projects. As we progress our growing pipeline in the clinic, we are confident that Ann will provide important contributions, helping us develop the next generation of precision medicines to benefit cancer patients worldwide.” Prior to OnKure, Dr. Howell served as Vice President of Regulatory Affairs at Forma Therapeutics, Inc. At Forma, she built a regulatory department and oversaw critical regulatory strategies for the development programs in rare disease and oncology, including Forma’s first NDA submission and approval for Rezlidhia for the treatment of relapsed or refractory AML. After the acquisition of Forma by Novo Nordisk A/S in 2022, Dr. Howell also served as the Integration Lead to integrate regulatory, clinical, biometrics, pharmacovigilance and other development functions. Previously, she was the Senior Director of Regulatory Affairs at Shionogi Inc., where she led U.S., European and Japanese regulatory strategies and was key in the development and execution of innovative expedited strategies and pathways. She also held regulatory affairs positions of increasing responsibility at Forest Laboratories, Inc. and Schering-Plough Corporation. Throughout her career, Dr. Howell has successfully led five NDA submissions with first round approvals, managed a successful FDA advisory committee meeting, and guided teams through complex regulatory challenges, including novel endpoint development, new approval pathways and labeling challenges. She holds M.S. and Pharm.D. degrees from the University of Oklahoma and completed a post-doctoral fellowship at Rutgers University. “OnKure’s portfolio, people, and dedication to advancing transformative oncology treatments quickly captured my attention and drew me in,” said Dr. Howell. “I am eager to begin collaborating with the OnKure team and leveraging my unique strategic, operational, and development expertise to support its growing portfolio.” About OnKure Therapeutics OnKure, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of best-in-class precision medicines that target biologically validated drivers of cancer. Using a proven structure-based drug design platform, the Company is building a robust pipeline of tumor-agnostic candidates that are designed to achieve optimal efficacy and tolerability. OnKure is currently developing bocodepsin (OKI-179), an oral, selective Class I HDAC inhibitor for the treatment of Ras pathway mutated cancers, in addition to OKI-219, a selective PI3K alpha H1047R inhibitor. To learn more, please visit and follow us on Twitter and LinkedIn. Media Contact: Amelia Tanttila OnKure, Inc. atanttila@onkure.com

For a drug to work, the molecule must bind to its target. That’s tricky for elusive targets lacking typical binding sites, but that hurdle can be overcome with molecular glue, a molecule that brings together two proteins that don’t normally interact. Molecular glues are a hot area of research in the context of targeted protein degradation, an emerging therapeutic approach that gets a disease-causing protein to go to the cell’s built-in protein disposal system. A molecular glue ensures that the enzyme tag marking a protein for disposal sticks to the target protein. Biotech companies have reached the clinic with this type of drug, but they’re all degraders. Brian Safina, president and chief scientific officer of Magnet Biomedicines, says molecular glues can do more, and the startup is now out of stealth to show how. “It’s really all focused on degradation,” Safina said of current molecular glue research. “While that’s a great way to go, there are other biological mechanisms that one can take advantage of.” Boston-based Magnet formally launched on Tuesday, backed by $50 million. The Series A financing was co-led by Newpath partners, which was the startup’s founding and initial investor, and Arch Venture Partners. Molecular glues are already available via some old and widely prescribed medicines, such as cyclosporine A and rapamycin, Safina said. But as is the case with many older drugs, the mechanism of both immunosuppressants was not known at first. In the early 1990s, Stuart Schreiber, a Harvard University professor of chemistry and biology, revealed cyclosporin works as a molecular glue that induces protein-protein interactions. Schreiber has founded or co-founded biotech startups such as Jnana Therapeutics, Forma Therapeutics, and Belharra Therapeutics. Magnet, which Schreiber also co-founded, builds on the scientist’s decades of molecular glue research while also taking the therapeutic modality beyond degradation, Safina said. “Now with degraders making inroads into disease and showing impact, Stuart found the time is right to expand beyond that in molecular discovery,” he said. Rather than finding molecular glues by chance, Magnet takes a rational approach to discovering them. The company screens chemical libraries and analyzes human genetics and protein data to identify its molecular glues. Safina says his company’s molecules, called TrueGlues, prompt “cooperative interaction” between proteins. Safina declined to disclose any of Magnet’s targets, though he said the company is initially focusing on targets that already have clinical and genetic validation. Therapeutic areas falling within that scope include immunology, oncology, and cardiovascular disease. The TrueGlue platform is indication agnostic, and that broad potential positions Magnet for partnering opportunities, Safina said. He added that the company is researching areas where “there is an opportunity to have a molecular glue to solve some of the problems that exist.” What are those problems? A targeted protein degrader molecule resembles a barbell, with each end having a different function. But Safina says these bifunctional molecules are challenging to develop as oral formulations. A molecular glue can also imbue a Magnet drug with high specificity to its target, similar to the targeting ability of antibodies. Higher specificity reduces the risk of adverse effects that happen when a drug goes off target. Magnet joins a growing group of companies researching molecular glues. Monte Rosa Therapeutics, which trades under the descriptive stock symbol “GLUE,” develops molecular glues for applications in targeted protein degradation. The Boston-based company’s most advanced program is in early clinical development for various cancers. Ambagon Therapeutics launched last year to develop glues that address the 14-3-3 family of proteins. Those glues can work in a variety of ways, such as stabilizing protein interactions, inhibiting function, restoring function, or protein degradation. The San Francisco-based startup’s preclinical pipeline currently spans six programs in cancer and one in neurodegeneration. Meanwhile, A-Alpha Bio discovers molecular glues that other companies use in their drug research. Disclosed partners of Seattle-based A-Alpha include Bristol Myers Squibb, Kymera Therapeutics, and Gilead Sciences. Magnet drugs could work in a variety of ways. While targeted protein degradation is one potential mechanism, Safina reemphasized that Magnet aims to expand beyond degradation. The startup’s drugs could inhibit function like traditional small molecules. A Magnet drug could also stabilize a target protein. Safina said Magnet’s technology should produce drugs capable of binding to targets that are tough for small molecules. Magnet will use its new capital to continue building the TrueGlue platform while applying it to a variety of targets. Safina said the Series A round will enable the startup to reach lead optimization with understanding of which types of targets are most amenable to the TrueGlue approach. The financing will also support the company through candidate nomination and preparation for an investigational new drug application, he said.

8月30日，诺和诺德以15万欧元（约16万美元）收购了Embark Laboratories。根据交易条款，其中预付款为1500万欧元（约1638万美元）。此外，Embark股东可以根据潜在开发、监管和商业里程碑的实现情况获得高达4.56亿欧元（约4.98亿美元）的额外付款。 通过此次收购，诺和诺德获得开发和商业化Embark的先导代谢项目的全部权利，并同Embark进行为期三年的研发合作。该项目目前处于临床前阶段，建立在发现“抑制食欲增加能量消耗和增强胰岛素敏感性的新靶点”的基础上。在之前的披露中，Embark表示，已经确定了一种用于心血管和代谢疾病的肽药物，以及一种正在研究肥胖症的小分子“能量消耗激活剂”，可通过加速葡糖糖摄取和增加能量消耗来促进减肥。Embark是一家由生物技术团队组建的新公司，旨在开发肥胖和相关疾病的治疗方法，诺和诺德于2017年参与了Embark的种子轮融资，当时该生物技术团队从哥本哈根大学诺和诺德基金会基础代谢研究中心分离出来。值得注意的是，此次交易是诺和诺德在8月内第二次以肥胖为布局重点的收购。此前8月10日，诺和诺德宣布以10.75亿美元的价格收购加拿大生物技术公司Inversago Pharma。当时，诺和诺德并未披露预付与里程碑付款的明细，但预计购买将在年底前完成。Inversago在研的项目是一款口服CB1反向激动剂INV-202，它在食欲调节和心脏代谢途径中能够起到重要作用，有望为肥胖症患者提供替代或补充解决方案，并有潜力为患有严重慢性疾病的人提供新的治疗选择。得益于减肥药Wegovy和糖尿病疗法Ozempic销售快速增长，诺和诺德在糖尿病和肥胖领域已经处于世界前列。今年上半年的业绩报告显示，诺和诺德的司美格鲁肽三种剂型的总销售额为92亿美元。事实上，这家巨头并不像辉瑞、吉利德等MNC一样以收购而闻名。不过，随着降糖减重市场迎来新春，诺和诺德近来还接连收购了Dicerna Pharmaceuticals和Forma Therapeutics，并与Dewpoint Therapeutics和Aspect Biosystems等初创公司合作。另一家同样在这一赛道跑马圈地的药企是礼来，后者当前市值已经突破5000亿美元。诺和诺德正在寻求通过收购合作等转变战略，加强其在糖尿病、肥胖药物市场的领先地位，目前有大约9个新项目处于临床试验阶段。通过Inversago和Embark的交易，诺和诺德将增加多达5种用于糖尿病、肥胖和代谢疾病的在研药物。“诺和诺德从事肥胖研究已有25年，我们不断寻找解决这种严重慢性疾病的新方法。”诺和肥胖研究副总裁Brian Finan表示。参考文章：1.Novo, continuing deal streak, buys another obesity drug startup；biopharmadive2.Novo Bolsters Obesity Pipeline with Potential $500M Embark Biotech Buy；biospace识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。