CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Ligand Pharmaceuticals | February 21, 2023
In a recent announcement by biopharmaceutical firm, Ligand Pharmaceuticals, the U.S. Food and Drug Administration (FDA) has given accelerated approval for FILSPARITM (sparsentan). This will be helpful in treating adults with primary IgAN condition who are at risk of rapid disease progression, typically defined as a urine protein-to-creatinine ratio (UPCR) of less than 1.5 g/g.
FILSPARI, a once-daily oral medicine, is the first and only non-immunosuppressive therapy authorized for the treatment of IgAN. Two critical pathways are selectively targeted of IgAN (endothelin-1 and angiotensin II) to check disease progression. Up to 150,000 Americans may have the rare kidney illness IgAN, which is the main cause of kidney failure brought on by glomerular disease. Among these patients, it is predicted that 30,000 to 50,000 can be treated using the indication that has received accelerated approval. Travere has stated that it anticipates FILSPARI to be available from February 27, 2023, and it will offer a thorough patient support program all the way through the patient's therapeutic journey.
Eric Dube, Ph.D., President and CEO of Travere Therapeutics, said, “The accelerated approval of FILSPARI is a significant milestone on our path to advancing a transformative treatment for the IgA nephropathy community.” He further added, “As a first-of-its-kind, non-immunosuppressive therapy, we believe FILSPARI has the potential to ultimately become the new standard of care for IgA nephropathy and offer hope to those living with this condition who until now have had few treatment options. We are grateful to the patients, caregivers, clinical trial investigators, healthcare providers, and advocates who have worked alongside us to develop this innovative first-in-class therapy.”
(Source – Business Wire)
About Ligand Pharmaceuticals
Ligand Pharmaceuticals creates or acquires technologies that aid in the discovery and development of drugs by pharmaceutical firms. The company’s business model generates value for stockholders by offering a diverse portfolio of biotech and pharmaceutical product income streams, that are underpinned by an effective and low corporate cost structure.
Read More
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
GenScript | March 03, 2023
GenScript Biotech Corporation, a leading tools and services provider for life-science research, recently announced the expansion of its Singapore facility to provide a high-quality gene synthesis service. This expansion has added 976 square meters to the facility, bringing its total size to 3,500 square meters, making it the third-largest facility for GenScript globally. This development will also increase the staff at the Singapore facility to 150.
In February 2022, GenScript Asia-Pacific opened a recombinant protein production facility, which will now offer an advanced gene synthesis service. This expansion is a significant step towards GenScript's aim to provide top-notch services required for novel vaccine and therapeutic development in the life-sciences field.
The Singapore facility uses modernized, automated workstations that can synthesize more than 400 genes daily, ensuring precise measurement, eliminating human error, and providing a consistently high-quality product. The new facility's goal is to decrease project turnaround time for a more global mix of clients while maintaining customer data security. The new facility's capacity is dedicated to gene and cell therapy research and vaccine development programs.
GenScript's Life Science Group President, Dr. Ray Chen, commented, "We understand that global supply is a huge challenge, and we remain committed to expanding our reach to meet the increasing demand for our customers worldwide. At GenScript, we take great pride in our ability to provide reliable and efficient solutions to our customers, and we are fully committed to delivering on this promise. As we continue to expand our global footprint, we remain dedicated to providing the highest-quality products and services to our customers, wherever they may be located."
(Source – PR Newswire)
About GenScript
Founded in 2002, GenScript is a leading biotech firm. It has a global presence across the EU, North America, Greater China and Asia Pacific and has served more than 300,000 customers from over 160 countries and regions around the world. With more than 5,000 employees, it is dedicated to providing premier, convenient, and reliable products and services. The company strongly focuses on technology development, with over 100 patents and 270 patent applications in fields such as immunotherapy, synthetic biology, chemical synthesis, antibody design and bioinformatics. GenScript's products and services have been cited in 74,700 scientific papers worldwide as of June 2022. The company's vision is to become the most reliable biotech company in the world, working towards the betterment of human and environmental health through biotechnology.
Read More
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Center for Breakthrough Medicines | February 27, 2023
Center for Breakthrough Medicines (CBM), a leading contract development and manufacturing organization dedicated to addressing the challenges of commercializing cell and gene therapies, and Virion Therapeutics, a clinical-stage biotech firm focused on developing accessible and adaptable CD8+ T cell-based technologies for cancer and infectious diseases, have recently announced a strategic collaboration agreement.
CBM will partner and manufacture with Virion Therapeutics on their checkpoint modifier clinical development programs, including the First-in-Human VRON-0200 immunotherapy, designed to treat chronic Hepatitis B Virus (HBV) infection.
The collaboration aims to develop VRON-0200, a pan-genotypic, global therapeutic immunotherapy that targets chronic HBV infection, which affects over 295 million people worldwide. HBV impairs CD8+ T cells, which results in the loss of viral control. VRON-0200 induces a broad CD8+ T cell response, which includes responses to the core and pol regions not generally induced by the infection. Therefore, VRON-0200 is designed to stimulate a highly functional immune response to help clear the virus.
CBM's Co-Founder and Chief Business Officer Audrey Greenberg commented, "Virion is working to revolutionize the immunotherapy treatment landscape, and we are honored to partner with them on this bold mission as we share a common goal – to create a future free of cancer and chronic infectious diseases." She further emphasized, "We have assembled best-in-field technical teams, supported by industry-leading product and process development, manufacturing, and testing capabilities, all located within a single, world-class manufacturing facility. We look forward to working with Virion to bring their life-saving therapies to the patients who need them most, as quickly as possible."
(Source – PR Newswire)
About Center for Breakthrough Medicines
The Center for Breakthrough Medicines is a pioneering contract development and manufacturing organization (CDMO) situated in the center of "Cellicon Valley," with a focus on cell and gene therapies. It offers an all-in-one solution to expedite the speed of delivering advanced treatments to the market. Its customer-oriented approach, combined with a culture that prioritizes the needs of patients, guarantees dependable and high-quality process and analytical development, GMP testing, viral vector manufacturing, plasmid production, cell therapy bioprocessing and cell banking services throughout the entire life cycle of a product.
Read More