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RxGen is a Hamden, CT-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Palleon is targeting glycan-sensing checkpoints to unleash both the innate and adaptive immune responses to cancer.
Cognate BioServices is a leading contract development and manufacturing organization specialized in cell and cell-mediated gene therapies. We pride ourselves in the level of quality and experience we bring to the table. Cognate is a dynamic, results-driven, organization focused on providing the broadest range of commercialization services to regenerative medicine, cellular immunotherapy and advance cell therapy companies, organizations and institutions. Cognate provides a unique combination of custom services to companies across all points of clinical and commercial development ranging from early preclinical studies, to mid phase trials and product scale-up though later stage clinical trials and bridging into commercial manufacturing. Cognate applies the know-how and expertise of its business, scientific and technical teams to successfully develop autologous and allogeneic products across multiple cell-based technology platforms from start to finish.
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.
Vital Therapies, Inc. is a biotherapeutic company focused on developing a cell-based system for the treatment of acute liver failure. Our product candidate, the ELAD® System, is a human cell-based, bio-artificial liver support system that operates outside the body, or extracorporeally, and is designed with the proposed intent to allow the patient’s own liver to regenerate to a healthy state, or to stabilize the patient until liver transplant. The ELAD System incorporates our human liver-derived cells, or VTL C3A cells, contained in four hollow fiber cartridges, that are combined with single use customized disposable sets and an ancillary delivery system. Data from ELAD clinical studies has shown trends that may indicate a potential to increase survival rates in patients with acute liver failure. ELAD has received orphan designation in the United States and Europe for the treatment of acute liver failure. Prior to the initiation of our ongoing Phase III clinical trial program, over 145 subjects have received therapy with the ELAD System in seven clinical trials and through a compassionate use program, which we believe collectively suggests a promising therapeutic profile. In March 2013, we initiated VTI-208, a Phase III randomized, controlled clinical trial in 200 subjects with alcohol-induced liver decompensation. We reached the midpoint in enrollment of this trial in April 2014, and anticipate the release of preliminary data in the first half of 2015. In addition, we are conducting a second Phase III randomized, controlled clinical trial, VTI-210, in 150 subjects with severe acute alcoholic hepatitis, or AAH, which is a subset of AILD, and expect to initiate enrollment of subjects later in 2014. In the second quarter of 2014, we began enrollment of a Phase II clinical trial of the ELAD System in subjects with either fulminant hepatic failure, or FHF, or surgery-induced acute liver failure, or SILF. We anticipate the release of data from VTI-210 in 2016 and the Phase II component of VTI-212 in 2015 or 2016.