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We are pioneering a new therapeutic approach to treat debilitating ear, nose and throat (ENT) diseases that impact the lives of millions of people.
Momenta is a biotechnology company with a product pipeline of both complex mixture generic and novel drugs. Our complex mixture generics and follow-on biologics effort is focused on building a thorough understanding of the structure-process-activity of complex mixture drugs to develop generic versions of marketed products. While we use a similar analytical and development approach across all of our product candidates, we tailor that approach for each specific product candidate. Our first objective is to apply our core analytical technology to thoroughly characterize the structure of the marketed product. By defining the chemical composition of multiple batches of a marketed product, we are able to develop an equivalence window which captures the inherent variability of the innovator`s manufacturing process. Using this information, we then build an extensive understanding of the structure-process relationship to design and control our manufacturing process to manufacture reproducibly an equivalent version of the marketed product. Where necessary, and as required by the U.S. Food and Drug Administration, or FDA, we will supplement an application with additional supportive structure-activity data (e.g., immunogenicity, pharmacodynamics). Our goal is to obtain FDA approval for and commercialize generic or follow-on versions of complex mixture products, thereby providing high quality, safe and affordable medicines to patients in need.
Unum is a Cambridge, MA-based cellular therapeutics company ushering in a new wave of innovation in cancer immunotherapy. Unum has built an antibody-coupled T-cell receptor (ACTR) platform that, when combined with tumor-specific antibodies, directs an individual’s cytotoxic T-lymphocytes (CTLs) to kill tumor cells. In contrast to other approaches that hit a single target and treat a narrow set of tumors, Unum’s approach is not restricted by antigens and may have applications for treating many types of cancers. Our lead program based on ACTR technology is expected to enter Phase I clinical testing soon to assess safety and efficacy in certain forms of leukemia and lymphoma. In parallel, we are actively seeking partners interested in using the ACTR technology to arm novel proprietary antibodies with a T-cell to improve their therapeutic potential. Working initially to pre-clinically validate antibody-ACTR combinations with partners, we expect to rapidly advance multiple proprietary combinations into clinical testing within the next few years.
SantenUSA.com - a specialty pharmaceutical offering ophthalmic products & research for retinal disorders, glaucoma, and other eye diseases.