About Stemline Therapeutics
Stemline Therapeutics is a clinical stage biopharmaceutical company developing oncology therapeutics that target cancer stem cells (CSCs) as well as the tumor bulk. Among Stemline's drug candidates are SL-401 and SL-701, both of which have demonstrated clinical activity including durable complete responses (CRs) and an overall survival (OS) benefit versus historical controls in Phase I/II studies.On June 10th, 2020, Stemline Therapeutics was acquired by Menarini Group.
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Expert Collections containing Stemline Therapeutics
Expert Collections are analyst-curated lists that highlight the companies you need to know in the most important technology spaces.
Stemline Therapeutics is included in 3 Expert Collections, including Cancer.
Pharmaceutical and biotechnology companies with cancer therapy drug candidates.
Regenerative medicine refers to the process of activating, replacing, engineering or regenerating human genetic material, cells, tissues or organs to restore normal function. It also includes bioengineered tissues used for in vitro testing (e.g. organ-on-a-chip, organoids).
Companies involved in the research, development, and commercialization of chemically- or biologically-derived therapeutic & theranostic drugs. Excludes vitamins/supplements, CROs/clinical trial services.
Stemline Therapeutics Patents
Stemline Therapeutics has filed 1 patent.
Transcription factors, Clusters of differentiation, Oncology, Cancer treatments, Experimental cancer drugs
Transcription factors, Clusters of differentiation, Oncology, Cancer treatments, Experimental cancer drugs
Latest Stemline Therapeutics News
Aug 19, 2022
Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union Submission supported by results from the pivotal Phase 3 EMERALD study showing a statistically significant difference in the efficacy in favor of elacestrant over current standard-of-care (SOC) medications for both the overall study population and patients whose tumors harbor an ESR1 mutation. August 19, 2022 05:00 AM Eastern Daylight Time FLORENCE, Italy & NEW YORK--( BUSINESS WIRE )--The Menarini Group (“Menarini”), a privately held Italian pharmaceutical and diagnostics company, and Stemline Therapeutics (“Stemline”), a wholly-owned subsidiary of the Menarini Group, today announced that EMA has validated the Marketing Authorization Application (MAA) for elacestrant, a selective estrogen receptor degrader (SERD), for patients with ER+/HER2- advanced or metastatic breast cancer. Validation of the application confirms the submission is complete and begins EMA’s centralized review procedure. “There is a major unmet need in the treatment of advanced or metastatic ER+/HER2- breast cancer after resistance builds in the earlier lines of treatment,” commented Elcin Barker Ergun, Chief Executive Officer of the Menarini Group. “The acceptance of our application for review by the EMA represents a significant step for our company and we look forward to working with the agency to potentially bring elacestrant to patients suffering from second- and third-line ER+/HER2- advanced or metastatic breast cancer in Europe.” The Phase 3 EMERALD study (NCT03778931) evaluated elacestrant compared to SOC endocrine monotherapy (investigators’ choice of either fulvestrant or an aromatase inhibitor) in ER+/HER2- advanced or metastatic breast cancer patients. The study results were recently published online in the Journal of Clinical Oncology (JCO) on May 18, 2022. Further post-hoc analysis from the study will be presented at the European Society for Medical Oncology (ESMO) Congress 2022 taking place September 9-13, 2022, in Paris, France. The Menarini Group obtained global licensing rights for elacestrant in July 2020 from Radius Health, Inc, who conducted and successfully completed the EMERALD study. Based on the positive phase 3 data, Stemline submitted a MAA to EMA on July 27, 2022. The regulatory review for elacestrant is also underway in the U.S. as the Food and Drug Administration (FDA) has recently accepted a New Drug Application for elacestrant designating a Priority Review. The Menarini Group is now fully responsible for global registration, commercialization and further development activities for elacestrant. About Elacestrant (RAD1901) and the EMERALD Phase 3 Study Elacestrant is an investigational selective estrogen receptor degrader (SERD). In 2018, elacestrant received Fast Track designation from the FDA. Preclinical studies completed prior to EMERALD indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer. The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+/HER2- advanced/metastatic breast cancer patients. The study enrolled 477 patients who had received prior treatment with one or two lines of endocrine therapy, including a CDK 4/6 inhibitor. Patients in the study were randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoint of the study was progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. Secondary endpoints included evaluation of overall survival (OS), objective response rate (ORR), and duration of response (DOR) and safety. About The Menarini Group The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini’s products are available in 140 countries worldwide. For further information, please visit www.menarini.com . About Stemline Stemline Therapeutics, a wholly-owned subsidiary of The Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics. Stemline commercializes a novel targeted treatment directed to CD123 for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the United States and Europe which is also being evaluated as monotherapy and in combination with other agents, in additional clinical trials for a variety of other indications. Stemline has an extensive clinical pipeline of small molecules and biologics in various stages of development for a host of solid and hematologic cancers. About Radius Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, neuro-orphan diseases, and oncology. Radius’ lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Contacts
Stemline Therapeutics Frequently Asked Questions (FAQ)
When was Stemline Therapeutics founded?
Stemline Therapeutics was founded in 2003.
Where is Stemline Therapeutics's headquarters?
Stemline Therapeutics's headquarters is located at 750 Lexington Ave, New York.
What is Stemline Therapeutics's latest funding round?
Stemline Therapeutics's latest funding round is Acq - P2P.
How much did Stemline Therapeutics raise?
Stemline Therapeutics raised a total of $13.24M.
Who are the investors of Stemline Therapeutics?
Investors of Stemline Therapeutics include Menarini Group and Pequot Capital Mangement.
Who are Stemline Therapeutics's competitors?
Competitors of Stemline Therapeutics include Minerva Biotechnologies, Dare Bioscience, Oxford BioMedica, Animal Cell Therapies, NGM Biopharmaceuticals and 13 more.
Compare Stemline Therapeutics to Competitors
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Animal Cell Therapies is a biotech firm that aims to improve the lives of animals through thoughtful research and development. The ACT team is focused on developing and delivering cellular treatment and services to customers.
Scientists at Epeius Biotechnologies have developed a targeted delivery system (TDS) that can transport genes or other therapeutic agents directly to diseased areas in the body. This pathotropic, or disease-seeking, technology has enabled the company to develop Rexin-G, a tumor-targeted, injectable gene delivery system that has demonstrated remarkable safety and single-agent efficacy in clinical trials internationally. Rexin-G is currently in clinical trials for pancreatic cancer in the U.S. ƒƒ‚ƒš‚" where it has achieved FDA orphan drug status ƒƒ‚ƒš‚" and has accelerated approval in the Philippines for the treatment of all solid tumors that are resistant to standard chemotherapy. The company's international clinical outreach with Rexin-G has enabled us to expedite further demonstrations that Rexin-G is highly active in a broad spectrum of chemo-resistant tumor types with efficacy and excellent safety profiles. The company are a biopharmaceutical company focused on expanding the therapeutic utility and commercialization of the company's pathotropic approach to disease treatment through internal development and commercialization of the company's oncology products and cancer vaccines, and through strategic partnerships in additional areas of oncology, immunology, cardiovascular, ocular, and wound healing applications, precision targeted diagnostics, and stem cell technologies.
ASC is a privately held biotechnology company dedicated to the development and commercialization of enabling technologies to enhance and expand the therapeutic potential of stem cell therapies. The key technology platforms (ASC-101 and ASC-201) are designed to improve the homing and engraftment of stem cells to target organs and increase their therapeutic potential for cancer patients. Additionally, these platforms have the potential to enhance stem cell treatment of inflammation from chemotherapy/radiation, solid tumors, autoimmune diseases, and ischemic diseases including myocardial infarction and stroke. ASC has strategic partnerships with medical research institutions including the University of Texas M.D. Anderson Cancer Center, the Oklahoma Medical Research Foundation, University of California, the Burnham Institute, Indiana University, Rush Presbyterian and VidaCord Technologia Biomedica.
Cell Line Genetics aims to provide services and products to support research institutions, as well as biotechnology and pharmaceutical companies focused on embryonic stem cell and cancer research.
OxThera is a biopharmaceutical company with products in late stage clinical development focusing on Primary and Secondary Hyperoxaluria. OxThera's intellectual property includes worldwide patents for compositions and treatment of hyperoxaluria with bacteria, and enzymes. Oxabact holds Orphan Drug designations in Europe and in the US for the treatment of primary hyperoxaluria.
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