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Kudo Biotechnology is a global CDMO, providing world-class, end-to-end mRNA manufacturing solutions, all under one roof. Kudo has state-of the-art clinical GMP manufacturing facilities and labs in Boston, China & Singapore, making pDNA, mRNA and LNP. Kudo Bio differentiates by being a one-stop stop for all your mRNA manufacturing needs, by streamlining the process, removing bottlenecks and ensuring ease in your CMC. Our performance matches and surpasses industry-leading yields & efficiencies across all stages of the process. Our speed of 6.5 months from sequence to GMP mRNA-LNP exceeds industry platinum standards, and our quality is superior to competitors while maintaining full compliance with global regulatory requirements. Kudo Bio has a track record of accomplishing end-to-end GMP manufacturing with products entering the clinic, and successfully completing multiple batches of process validation after international technology transfer. We have an industry-leading manufacturing cGMP facility with capacity to make up to 50 GMP batches annually, with deep technology partnerships enabling access to scale-up expertise & production know-how. Finally a comprehensive quality management system with QA/QC capabilities which meet major regulatory agencies compliance requirements is paramount to delivering products to customers around the world.
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.
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.
Type 1 diabetes (T1D), formerly known as juvenile diabetes, is a chronic, life-threatening disease that affects millions of people worldwide. In the United States, 30,000 new cases are estimated every year with half of those cases diagnosed in young children. Type 1 diabetes is an autoimmune disease in which the patient`s immune system goes awry and attacks and destroys the pancreatic beta cells. Beta cells are responsible for regulating blood sugar (glucose) levels by producing precise amounts of the essential hormone insulin. The discovery of injectable insulin in the 1920s changed T1D from a uniformly fatal disease with a life expectancy of months to one that could be carefully managed for decades through multiple daily blood glucose measurements and insulin injections. However, insulin injections are not a cure and patients face a lifetime of difficult disease management and serious complications including kidney failure, blindness and nerve damage. Despite nearly a century passing since the discovery of insulin, insulin injection remains the only treatment available to patients. Semma Therapeutics was founded to develop transformative therapies for patients who currently depend on insulin injections. Recent work in the laboratory of Professor Douglas Melton led to the discovery of a method to generate billions of functional, insulin-producing beta cells in the laboratory. These cells develop in islet-like clusters grown from stem cells. Initial preclinical work in animal models of diabetes has shown that transplantation of these cells are sufficient to control blood glucose levels. This breakthrough technology has been exclusively licensed to Semma Therapeutics for the development of a cell-based therapy for diabetes. Ongoing research at Semma Therapeutics is focused on combining these proprietary cells with a state-of-the-art cell delivery and immune protection strategy that can protect these cells from the patient`s immune system and allow the beta cells to function as they do in non-diabetic individuals. Implantation of the beta cell-filled device has the potential to provide a true replacement for the missing beta cells in a diabetic patient and would not require patient immunosuppression. Semma Therapeutics is working to bring this new therapeutic option to the clinic and improve the lives of patients with diabetes.
San Diego-based Biocept, Inc. (Nasdaq: BIOC) develops and performs diagnostic assays that provide clinically actionable information to improve outcomes for patients with a variety of cancers. Biocept`s unique combination of cell-based and cell-free DNA analysis allows us to rapidly detect and monitor certain cancer biomarkers in blood and cerebrospinal fluid (CSF). Our patented Target Selector™ technology quantitatively analyzes tumor cells for tumor-associated biomarkers, offering high sensitivity and specificity compared with methods currently used by other laboratories. In addition to our broad portfolio of blood-based liquid biopsy tests, we offer the CNSide™ CSF assay, which addresses an unmet clinical need for patients with cancer that has metastasized to the central nervous system. Between 10% and 30% of patients with cancer will develop brain or spinal cord metastasis. Survival is often low, and few are diagnosed early enough for effective therapeutic intervention. CNSide answers three key questions: Is there a tumor? Is there a target for treatment? Is there a trend in treatment response? We offer diagnostic laboratory services for oncologists, pathologists, hospitals, cancer centers, universities, pharmaceutical and clinical researchers, and other healthcare providers. Our CLIA-certified and CAP-accredited laboratory combines a highly trained professional staff with innovative instrumentation for optimal test results and quality control. Biocept works with strategic industry leaders, as well as major cancer centers across the U.S., to further its mission of helping to improve outcomes for cancer patients. We also are utilizing our molecular diagnostic capabilities to offer nationwide RT-PCR-based COVID-19 testing and services to support public health efforts. Revenue from COVID-19 testing has supported further investment in our core oncology business, positioning the company for long-term success.