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Castle Creek Biosciences, Inc. is a clinical-stage cell and gene therapy company focused on developing and commercializing disease-modifying therapies for patients suffering from rare diseases for which there is a lack of available treatment options. The company`s proprietary autologous fibroblast platform potentially allows for the development of personalized, targeted and redosable cell-based gene therapy product candidates for monogenic and chronic disorders. The company`s most advanced product candidate, dabocemagene autoficel (D-Fi), is currently being evaluated in a Phase 3 clinical trial for the localized treatment of chronic wounds due to recessive dystrophic epidermolysis bullosa (RDEB). The company is also currently evaluating FCX-013 in a Phase 1/2 clinical trial for the treatment of moderate to severe localized scleroderma. In addition, Castle Creek Biosciences is pursuing discovery and potential development of early-stage novel product candidates with the goal of expanding its robust pipeline into other rare diseases and broader indications where there are significant unmet needs. The company operates an in-house, commercial-scale manufacturing facility in Exton, Pennsylvania that benefits from the validated systems and processes previously implemented at the site for manufacture of an FDA-approved cell therapy product. Castle Creek Biosciences, Inc. is a portfolio company of Paragon Biosciences, LLC.
BioScience Business Solutions is a Carlsbad, CA-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
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).
biOasis Technologies Inc., an early stage biopharmaceutical company, engages in the research, development, and commercialization of technologies and products for the diagnosis and treatment of central nervous system diseases and disorders. The company develops Transcend program, a protein vector, which is a proprietary carrier for the transport of therapeutic agents across the blood brain barrier for treatment of a range of neurological, oncological, and infectious disease applications; and Cognitest, a proprietary in vitro diagnostic assay for Alzheimer’s disease. It has a collaborative research agreement with the University of British Columbia to assist the company in development of an enzyme linked immunosorbent assay to detect levels of p97 in blood for the purpose of evaluating the correlation between p97 and Alzheimer’s disease. The company was incorporated in 2006 and is headquartered in Vancouver, Canada.
Cortendo AB is a global biopharmaceutical company founded in 1996, incorporated in Sweden, and based in the United States. Cortendo recognizes the urgent need to make new medicines available for people with orphan diseases, and the Company is committed to delivering therapies that make a difference. An orphan disease is one for which the pharmaceutical industry has not worked to make new medicines. It may be a rare disease (in the U.S. this is defined as a disease that affects fewer than 200,000 people) or a disease such as tuberculosis, cholera, typhoid or malaria that is not often diagnosed in developed countries but remains common in countries that are still developing. Cortendo’s initial strategic goal is to be the global leader in finding, developing and making medicines for people with orphan endocrine diseases, with its most advanced program in Cushing’s syndrome. Cortendo research led to the development of COR-003 (levoketoconazole) which is currently being studied in the Phase 3 global SONICS trial for the treatment of endogenous Cushing’s syndrome. COR-003 has received orphan designation from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Cortendo is building the capabilities and resources to independently develop and commercialize its orphan assets in key global markets and to partner non-strategic product opportunities, such as BioPancreate-2001 for Type 1 and Type 2 diabetes. The company also intends to leverage its commercial expertise by working with partners to acquire, develop, and commercialize late-stage or commercial assets in a select few orphan disease focus areas.