Hydra Biosciences, Inc.

Board will help advance the mission and support development of our game-changing IUD for contraception (3D-001)MANSFIELD, Mass., March 13, 2024 (GLOBE NEWSWIRE) -- 3Daughters, a clinical development company fueling evolutionary healthcare for women, announced the appointment of Michele LaRussa, Vincent J. Miles, Ph.D., and Sarah J. Stevens, Ph.D., to serve on the Company’s Board of Directors. These strategic appointments mark a significant milestone in the company's plan to revolutionize birth control with a newly designed Intrauterine Device (IUD), 3D-001, to address a major barrier to adoption, insertion pain. An IND for 3D-001 will be filed this year followed by a Phase 1 clinical trial. Ms. LaRussa, Dr. Miles, and Dr. Stevens provide a collective wealth of experience and skillful expertise from the life sciences industry, perfectly aligning with 3Daughters' mission to drive therapeutic innovation within the women's health arena. Their appointments are set to enhance the company's strategic direction and drive the development of groundbreaking healthcare solutions for women, starting with the revolutionary frameless, magnetic nonhormonal IUD. Mary Beth Cicero, CEO of 3Daughters, expressed her enthusiasm about the new additions to the board: "We are incredibly excited to have the collective strengths of Michele, Sarah, and Vin on our Board of Directors. Their invaluable experience with the crucial aspects of an emerging life sciences company - regulatory affairs, drug development, manufacturing, and fundraising, are exactly what 3Daughters needs as we move into the clinic with our novel IUD and Slider™ system (inserter/retriever) to address insertion pain, a major barrier to adoption. Their guidance and enthusiasm will be instrumental in shaping a future where women will have improved healthcare options." Ms. LaRussa has a distinguished career in regulatory affairs and clinical development, built over 32 years of experience in various therapeutic areas. Currently, she is the Chief Regulatory Officer at SFJ Pharmaceuticals, following a significant 13-year tenure at Novartis, where she held leadership roles, including Chief of Staff to the Global Head of R&D. Her extensive background includes key positions at Allergan, GlaxoSmithKline, Kala Pharmaceuticals, and Liquidia Technologies, and she was the Chief Regulatory Officer at Atox Bio. Michele has a B.Sc. in Chemistry degree from the University of South Florida. Dr. Miles is a well-known and respected member of the biotech and venture capital community with a career spanning more than 45 years that encapsulates a spectrum of pivotal roles that have influenced the industry's growth. For the last 16 years, Vin has been a partner and executive director at Abingworth, a key life sciences investment firm, and has served on the boards of multiple biotech companies, including IFM Therapeutics, Dicerna Pharmaceuticals, Chiasma, Hydra Biosciences, and Personalis. His previous roles include Senior Vice President at Alnylam Pharmaceuticals and VP positions at Millennium Pharmaceuticals, RiboGene, and Pharmacia. He also directed the technology transfer office at Dana-Farber Cancer Institute and started his career in R&D at Amersham International. Dr. Miles holds a B.Sc. in Biochemistry and a Ph.D. in Biochemical Embryology from University College London. Dr. Stevens, with over 20 years in the biopharmaceutical industry, currently leads the Labs & Cleanroom on Demand Business Unit at Azzur Group, delivering bespoke solutions to early-phase manufacturers for faster market entry. Her career spans pivotal roles in CDMO and CRO leadership, including Senior Vice President at Quotient Sciences and Global Head of Drug Product Development at Albany Molecular Research. Sarah has a rich background in drug development and manufacturing and contributed to novel drug formulations at Encap Drug Delivery with patented oral dosage forms during her post-doctoral fellowship at the University of Strathclyde. Her academic credentials include an M.Pharm and an MBA from the University of Strathclyde, a Ph.D. in Pharmaceutical Sciences from the University of Manchester, and a Lean Six Sigma Green Belt. Michele, Vin and Sarah’s expertise and experience will significantly contribute to the company's aggressive plans for clinical development of a game-changing IUD for contraception. With this first product, 3Daughters expects to disrupt the IUD market and establish a position as a major innovator in women's healthcare. About 3Daughters™ 3Daughters is a clinical development company focused on evolutionary healthcare for women where cutting-edge research and innovation is desperately needed. The Company’s technology platform is based on physics and geometry to deliver targeted therapy to the uterus. The first product, (3D-001), is a frameless, magnetic, nonhormonal intrauterine device (IUD) for long-acting contraception that conforms to a woman’s body and is combined with our unique, patented Slider™ system (insertion/ retrieval) designed to eliminate steps and pain points as well as the nuisance factor of strings (needed for removal). 3Daughters’ vision is to solve health issues for women, particularly significant (neglected) problems. 3Daughters plans to radically disrupt the IUD market by addressing the major adoption barrier — insertion pain. This pain is associated with all current rigid, plastic T-shape framed IUDs on the market and prevents women from selecting one of the most effective forms of birth control. Visit 3daughtershealth.com for more information. Contact: Louis Scottiinfo@3Daughtershealth.com

关注并星标CPHI制药在线 边缘性人格障碍（BPD）是一种复杂又严重的精神科疾病，主要以情绪、人际关系、自我形象、行为的不稳定，并且伴随多种冲动行为为特征。据悉，BPD大约影响全球2%-6%的人口，且75%的BPD患者为女性，高达10%的BPD患者因发生自杀行为而死亡。       与抑郁症、精神分裂症等精神疾病不同，心理治疗是BPD的一线治疗方案。证据显示，结构化的心理治疗尤其是辩证行为治疗（DBT）对BPD有效，但由于客观条件所限，很多患者无法接受到这一治疗手段，而且即便参与进来，脱落率也很高。       目前，全球尚无针对性药物获批用于治疗BPD，不过临床使用抗抑郁药、抗精神病药和抗焦虑药物来控制BPD患者的某些症状，如抑郁，冲动和焦虑。       不过，BPD的治疗现状有望得到改善，目前已有几款药物被开发用于治疗BPD，如大冢的brexpiprazole、Oryzon Genomics的vafidemstat、勃林格殷格翰/Hydra Biosciences的BI 1358894、Intra-Cellular Therapies的Lumateperone、COMPASS Pathways的Psilocybin 。       brexpiprazole是一种每日一次的第二代（非典型）口服抗精神病药物，由大冢发现，灵北和大冢联合开发，目前已被批准用于治疗抑郁症和精神分裂症。brexpiprazole治疗抑郁症和精神分裂症的确切作用机制尚不明确，可能是通过5-HT1A受体和多巴胺D2受体的部分激动剂活性、血清素5-HT2A受体的拮抗剂活性联合介导。此外，brexpiprazole对去甲肾上腺素α1B/2C受体也表现出高亲和力。       2021年8月，大冢制药宣布brexpiprazole治疗BPD的2期临床试验（NCT04100096）的结果。该试验没有达到主要终点——在预定义时间点上，brexpiprazole与安慰剂在BPD Zanarini评分量表从基线的变化方面没有发生统计学上的显著分离。不过，在研究的其他时间点，观察到统计学上比安慰剂更大的数值改善。       vafidemstat（ORY-2001）是Oryzon Genomics开发的一种口服赖氨酸特异性去甲基化酶1（LSD1）抑制剂，可减轻认知障碍，包括记忆丧失和神经炎症，同时具有神经保护作用。       2020年7月，Oryzon Genomics公布的vafidemstat治疗自闭症、多动症和BPD三种精神疾病的2a期临床研究REIMAGINE结果显示：所有患者的（临床总体印象量表-严重性量表）CGI-S评分、临床总体印象量表-改善性量表（CGI-I）评分、神经精神问卷-激越或攻击行为量表（NPI-A/A，共4个条目）评分和总NPI评分（共12个条目）均显著下降。此外，vafidemstat可以显著改善BPD患者的BPD检查表（BPDCL）评分和自杀严重程度评定量表（C-SSRS，评估自杀倾向）评分。       今年4月，Oryzon Genomics宣布vafidemstat治疗BPD的2b期临床研究PORTICO在预定的中期分析中取得了积极的结果。       BI 1358894是一款典型瞬时受体电位离子通道（TRPC5）拮抗剂，被开发用于治疗边缘性人格障碍、抑郁和创伤后应激障碍，目前其针对BPD的临床试验已进入2期临床。2014年4月，勃林格殷格翰与瞬时受体电位（TRP）通道调制领域的的领导者Hydra BioSciences达成首次研发合作，开发TRPC4/5抑制剂，用于治疗中枢神经系统（CNS）疾病和失调。       lumateperone是一种首创小分子药物，可选择性且同时调节5-羟色胺、多巴胺及谷氨酸这3种涉及严重疾病的神经递质通路，2019年12月被FDA 批准用于治疗成人精神分裂症。目前，lumateperone针对BPD的临床试验进入2期阶段。       总结       与抑郁症、精神分裂症等精神疾病相比，边缘性人格障碍(BPD)药物治疗进展相对较慢，缺乏针对性治疗药物。不过，目前已有企业开始关注BPD，多款药物进入临床试验阶段。Oryzon Genomics的vafidemstat进展相对较快，治疗BPD的2b期临床试验已取得积极结果。期待未来BPD治疗可以早日迎来新突破。智药研习社近期直播报名来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- ​Imago BioSciences, Inc. (Imago) (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), today announced the appointment of Laurie Keating to its Board of Directors on November 17, 2021. Keating is a seasoned executive, with nearly two decades of her 40-year career in diverse roles within the biopharmaceutical industry. “I am pleased to welcome to Laurie to Imago’s Board of Directors as the company continues to grow, following our successful IPO in July,” said Hugh Young Rienhoff, Jr., M.D., Chief Executive Officer of Imago BioSciences. “Laurie brings extensive experience to our Board and we look forward to leveraging her judgment, skills and know-how as we progress bomedemstat, our novel LSD1 inhibitor, through the regulatory process.” Laurie Keating most recently served as Executive Vice President and Chief Legal Officer at Alnylam Pharmaceuticals, where she led the company’s global public policy and government relations, legal, and intellectual property groups. Prior to joining Alnylam, Keating served as Senior Vice President, General Counsel and Secretary at Millennium Pharmaceuticals, where she led the legal, intellectual property, corporate quality and compliance groups. Prior to Millennium, Keating was the founding chief executive officer of Hydra Biosciences, a privately held, venture-backed company, and served on Hydra’s Board for six years. “Imago’s advances in the potential treatment of myeloproliferative neoplasms with bomedemstat are highly promising, and I am thrilled to join the company’s Board of Directors at such an exciting time,” said Laurie Keating. “I look forward to contributing to Imago’s continued growth, and collaborating with the leadership team as we navigate the regulatory and clinical development processes, in an effort to bring a much-needed new treatment option to underserved patients.” Keating currently sits on the Board of Directors for Immuneering Corporation and MassBIO, a non-profit organization dedicated to growing the biopharmaceutical industry, adding value to the healthcare system, and improving patient lives in Massachusetts. She has a bachelor’s degree in economics from the University of California, Berkeley and received her J.D. from the University of California, Hastings College of Law. About Imago BioSciences Imago BioSciences is a clinical-stage biopharmaceutical company discovering and developing novel small molecule product candidates that target lysine-specific demethylase 1 (LSD1), an enzyme that plays a central role in the production of blood cells in the bone marrow. Imago is focused on improving the quality and length of life for patients with cancer and bone marrow diseases. Bomedemstat, an orally available, small molecule inhibitor of LSD1, is the lead product candidate discovered by Imago for the treatment of certain myeloproliferative neoplasms (MPNs), a family of related, chronic cancers of the bone marrow. Imago is evaluating Bomedemstat as a potentially disease-modifying therapy in two Phase 2 clinical trials for the treatment of essential thrombocythemia (NCT04254978) and myelofibrosis (NCT03136185). Bomedemstat has U.S. FDA Orphan Drug and Fast Track Designation for the treatment of ET and MF, European Medicines Agency (EMA) Orphan Designation for the treatment of ET and MF, and PRIority MEdicines (PRIME) Designation by the EMA for the treatment of MF. The company is based in South San Francisco, California. 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 “anticipates,” “may,” “will,” “should,” “expect,” “believe” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements may relate to, but are not limited to, Keating’s contributions to Imago’s Board of Directors, the results, conduct, progress and timing of Imago’s clinical trials, the regulatory approval path for bomedemstat, expectations of future operating results or financial performance, market size and growth opportunities, plans for future operations, competitive position, technological capabilities and strategic relationships, as well as assumptions relating to the foregoing. Forward looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. You should not put undue reliance on any forward looking statements. Forward looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved, if at all. Except as required by law, Imago does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.