Pixofisiran/Lixadesiran

HONG KONG, GERMANTOWN, Md., and SUZHOU, China, Sept. 19, 2024 /PRNewswire/ -- Sirnaomics Ltd. (the " Company", Stock Code: 2257, together with its subsidiaries, the " Group" or " Sirnaomics"), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, today announced that the company in collaboration with Dr. Mark Nestor's team from the Center for Clinical and Cosmetic Research in Miami Florida has jointly published a major breakthrough for its novel siRNA therapeutics revealing a novel mechanism of action of a significant reduction of adipose tissue in preclinical animal models. This groundbreaking work entitled "Novel injectable polypeptide nanoparticle encapsulated siRNA targeting TGF-β1 and COX-2 for localized fat reduction I: Preclinical in vitro and animal models", published at Journal of Cosmetic Dermatology, 2024; 00:1-11, creates a solid foundation for the Company's RNAi-based therapeutic program for focal fat reduction treatment. The study evaluates the efficacy of STP705, an injectable containing siRNA encapsulated within histidine-lysine polypeptide (HKP) nanoparticles targeting transforming growth factor β1 (TGF- β1) and cyclooxygenase-2 (COX-2), crucial mediators in adipocyte differentiation and fat retention, using in vitro experiments on mouse preadipocytes and in vivo trials using Diet Induced Obese (DIO) mice and Yucatan minipigs. The study results indicated that STP705 effectively reduced the expression of TGF-β1 and COX-2, with a notable decrease in adipocyte volume and lipid content without apparent adverse systemic effects. In DIO mice, the HKP- siRNA complex demonstrated precise localization to injected adipose tissue, maintaining significant gene silencing, and detectable levels of siRNA for up to 14 days post-administration. The data in minipigs showed a significant reduction in subcutaneous adipose tissue thickness up to 56 days post-administration. In conclusion: These studies support the use of targeted-siRNA therapy specifically targeting TGF-β1 and COX-2, for localized fat reduction, offering a potential minimally invasive alternative to current fat reduction methods. Mark S. Nestor, M.D., Ph.D., a recognized world expert in clinical research in clinical Dermatology and aesthetics, who is a Voluntary Professor at the Department of Dermatology and Cutaneous Surgery and the Department of Surgery, Division of Plastic Surgery at the University of Miami, Miller School of Medicine and serves as Director of the Center for Clinical and Cosmetic Research™ and the Center for Cosmetic Enhancement®, Aventura, Florida, is the senior author of this publication; he comments: "The results of all of the pre-clinical studies clearly indicate the significant potential of STP705 to use as a safe and effective method of reducing localized fat accumulation and sets the stage for the clinical pathway for this indication." Dr. Patrick Lu, the founder, Chairman and CEO of Sirnaomics, comments, "The latest publication indicated that Sirnaomics' leading drug candidate, STP705, has exhibited a novel mechanism of action, by specifically silencing TGF-β1 and COX-2 in the subdermal adipose tissue, resulted in localized fat reduction. The preclinical studies not only showed that It is safe and very well-tolerated, but also achieved preliminary efficacy in inducing adipocyte apoptosis and tissue remodeling, suggesting a safer alternative or adjunct to existing fat reduction therapies." About Sirnaomics Sirnaomics is an RNA therapeutics biopharmaceutical company that focuses on the discovery and development of Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates in preclinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both Asia and the United States. Based on its proprietary delivery technologies: Polypeptide Nanoparticle Formulation and the 2nd generation of GalNAc conjugation, the Group has established an enriched drug candidate pipeline. Sirnaomics is currently holding a leadership position on advancing RNAi therapeutics for oncology application with multiple successes of its clinical programs for STP705 (Phase IIa, IIb) and STP707 (Phase I). The ongoing Phase I study of STP122G represents the first drug candidate of GalAhead™ technology entering clinical development with an encouraging therapeutic efficacy and safety readouts. Learn more at: . SOURCE Sirnaomics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

HONG KONG, GERMANTOWN, Md. and SUZHOU, China, July 31, 2024 /PRNewswire/ -- Sirnaomics Ltd. (the " Company", Stock Code: 2257.HK, together with its subsidiaries, the " Group" or " Sirnaomics"), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, today announced a partnership with Gore Range Capital LLC (" Gore Range Capital") (Dallas, TX, USA) for establishment of a joint venture, Sagesse Bio, Inc., to advance its novel RNAi therapeutic products into aesthetic medicine. Sagesse Bio, Inc., a Delaware corporation (" Sagesse Bio"), combines the strength of Sirnaomics' leadership in RNAi-based technology and product development for focal fat reduction and Gore Range Capital's world leading expertise in skin health industry and financial resources, to accelerate clinical development of the company's innovative products for addressing a fast-growing aesthetic medicine market. Sagesse Bio will rapidly advance Sirnaomics lead compound that is IND-enabled and currently in Phase II clinical trials for other indications. Initial indications of interest include body contouring and fat reduction. The founders, board of directors, and newly established executive management team of Sagesse Bio are comprised of a group of well-accomplished senior executives from skin health industry, world-renowned clinicians in dermatology and aesthetic medicine, and leading experts in RNAi medicine. The strategic goal of Sagesse Bio is to become a world-leading aesthetic medicine company with innovative technologies and aesthetic products. Frederick Beddingfield, MD, PhD, serving as Chairperson of the board of directors of Sagesse Bio, is an internationally renowned dermatologist and expert in biopharma and the aesthetics industry, who has led the development of global leading brands such as BOTOX®, JUVEDERM®, LATISSE® and KYBELLA®. He served as Chief Medical Officer of Allergan Medical and Kythera, and as CEO of Sienna Bio and Kira Pharmaceuticals, and currently serves on the board of directors of Cytrellis Biosystems. Dr. Beddingfield stated: "I could not be more excited to help lead and build Sagesse Bio. We have an amazing team with the right experience and a unique opportunity based on the finding of adipocytolysis with good tolerability in human clinical studies, to rapidly advance our IND-approved lead product." Mr. Humberto Antunes, co-founder of Sagesse Bio, partner of Gore Range Capital, former Chairman and CEO of Galderma/Nestlé Skin Health, an internationally renowned executive in skin health industry, comments: "The strategic goal of Sagesse Bio is to deliver innovative and life changing therapies to patients with an initial emphasis on focal fat destruction." "We are thrilled to build this historic partnership: RNAi therapeutic candidate is moving into medical aesthetic product development for body contouring," commented Dr. Patrick Lu, founder, Chairman of the board, executive director, President and CEO of Sirnaomics. "The joint expertise and resources from both Sirnaomics and Gore Range Capital are setting up a strong foundation for a tremendous growth potential of Sagesse Bio with its accelerated product development speed." The board of directors of the Company has approved, and the board of directors and the stockholders of Sagesse Bio have approved, a series of agreements in relation to the partnership (the "Agreements"). The Company and Sagesse Bio have signed the Agreements, which shall become effective only upon being approved by the shareholders of the Company at an upcoming general meeting. Under the partnership arrangement, Sagesse Bio will initiate a clinical evaluation immediately for its leading product candidate, SGY-101, with scientific and technical support from Sirnaomics, receiving assignment and licensing of certain relevant intellectual property rights for the licensed product. In return, Sirnaomics will receive milestone payments of up to US$33 million and a majority equity position of Sagesse Bio with value of approximately US$36 million upon successful equity or debt financing in the future at a minimum pre-financing valuation of Sagesse Bio at US$60 million. Gore Range Capital is responsible for initial funding and building the executive management team and advisory board. In addition, with its well-built domain expertise and extensive networks in the skin health industry, Gore Range Capital is able to provide a hands-on approach for Sagesse Bio's fundraising and business development challenges. About Gore Range Capital Gore Range Capital is focused on investments in the skin health businesses. Gore Range's approach is simple: "We invest in what we know." Over the course of their respective careers the Gore Range team has built domain expertise and extensive networks across multiple areas of healthcare. Through Gore Range Capital, capabilities are channeled to focus on the largest organ and the most visible manifestation of personal identity: the skin. At Gore Range, the hands-on approach of operationally focused private equity is blended with the early-stage guidance needed in venture capital. Formed in 2015, Gore Range works closely with portfolio companies and industry leaders to bring skin health innovations to market. To accomplish this mission, Gore Range leverages its team of experienced healthcare investors, leaders, and practitioners to bring strategic, financial and scientific expertise to its investments. Learn more at: . About Sirnaomics Sirnaomics is an RNA therapeutics biopharmaceutical company that focuses on the discovery and development of innovative drugs for indications with unmet medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both Asia and the United States. Based on its proprietary delivery technologies, a polypeptide nanoparticle RNAi platform and GalNAc RNAi platform, GalAhead™, Sirnaomics has established an enriched drug candidate pipeline. STP122G, which represents the first drug candidate utilizing the Company's GalAhead™ mxRNA technology, is currently in Phase I development. STP237G is the first dual-targeted drug based on a GalAhead™ muRNA technology and is in the late stage of preclinical development. The Company has also had multiple successes with oncology applications through its clinical programs for STP705 and STP707. With the establishment of the it manufacturing facility in China, Sirnaomics is undergoing a transition from a biotech company to a biopharma corporation. Learn more at: . CONTACT: USA Media Contact: George Ji, MBA Head of Finance and Administration Email: [email protected] Asia Media Contact: Johnson Shen, M.A. Senior Business Manager for Investor Relations Email: [email protected] SOURCE Sirnaomics