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MEI Pharma (Nasdaq: MEIP) is a San Diego-based pharmaceutical company focused on leveraging its extensive development and oncology expertise to identify and advance new therapies for cancer. Our approach to building our pipeline is to license promising cancer agents and create value in programs through development and commercialization, or strategic partnerships, as appropriate. Our portfolio contains four clinical-stage drug candidates, including one candidate in an ongoing global registration trial and another candidate that is anticipated to advance into a registration trial this year. Our drug candidate pipeline includes: Pracinostat, an oral HDAC inhibitor that is in a Phase 3 pivotal study in combination with azacitidine for the treatment of acute myeloid leukemia. Pracinostat is also being evaluated in a clinical study in patients with myelodysplastic syndrome. Pracinostat is licensed to Helsinn Healthcare SA, a Swiss pharmaceutical corporation. ME-401, a selective oral inhibitor of phosphatidylinositol 3-kinase (“PI3K”) delta. ME-401 is anticipated to progress into a single-agent registration study in 2018 for the treatment of adults with relapsed or refractory follicular lymphoma. Voruciclib, an orally administered and selective cyclin-dependent kinase (“CDK”) inhibitor differentiated by its potent in vitro inhibition of CDK9 in addition to CDK6, 4 and 1. Initiation of a Phase I dose-escalation study in patients with relapsed and/or refractory B-cell malignancies after failure of prior standard therapies is scheduled to being in the second calendar quarter of 2018. ME-344, a novel and tumor selective, isoflavone-derived mitochondrial inhibitor drug candidate, has demonstrated evidence of single-agent activity against refractory solid tumors in a Phase I study. In preclinical studies, tumor cells treated with ME-344 resulted in a rapid loss of ATP and cancer cell death. It is currently being evaluated in an investigator-initiated study in combination with the VEGF inhibitor bevacizumab (marketed as Avastin®) in patients with HER2 negative breast cancer.
HilleVax is a biopharmaceutical company focused on the development and commercialization of novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate in development for the prevention of moderate-to-severe acute gastroenteritis caused by norovirus infection.
Sera Prognostics is a leading proteomic and bioinformatics company dedicated to improving the lives of women and babies through precision biomarker-based tests designed to enhance pregnancy care. Sera’s vision is to deliver pivotal information in early pregnancy to physicians, to help them to improve the health of their patients and reduce costs of healthcare delivery. Sera’s PreTRM® Test reports to a physician the individualized risk of a pregnant woman to deliver prematurely, enabling earlier proactive interventions in patients with higher risk. Rigorous clinical validation of PreTRM® Test performance (accuracy of predicting premature delivery) was reported in the American Journal of Obstetrics & Gynecology in 2016 in a U.S. cohort of 5,501 patients across 11 centers. Preterm birth is defined as any birth before 37 weeks gestation and is a leading cause of illness and death in newborns. The 2020 March of Dimes Report Card shows that of nearly 4 million babies born annually in the U.S., more than one in ten is born prematurely. Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, vision and hearing loss, and can generate significant cost throughout the lives of affected children. The annual U.S. health care costs to manage complications of prematurity were estimated at $31.5B for 2015. Sera is also developing a robust pipeline of innovative tests focused on other complications of pregnancy. Using its advanced proprietary mass spectrometry and bioinformatics platform technologies, Sera detects biologically important protein expression differences to build high performing predictions of risk for adverse pregnancy outcomes (including preterm birth, preeclampsia, gestational diabetes, growth restriction, and others).
Millendo Therapeutics is focused on developing novel treatments for endocrine diseases. Our mission is to build a leading endocrine company that creates distinct and transformative treatments for a wide range of diseases where there is a significant unmet medical need. We are currently advancing two product candidates: livoletide (AZP-531) and nevanimibe (ATR-101). Livoletide is being developed for Prader-Willi syndrome while nevanimibe is in development for the treatment of two different orphan adrenal diseases: Classic Congenital Adrenal Hyperplasia (CAH) and Endogenous Cushing`s Syndrome (CS).
Girindus America is a Cincinnati, OH-based company in the Healthcare, Pharmaceuticals, and Biotech sector.