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.
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MEDTECH, INDUSTRIAL IMPACT
BioNTech and InstaDeep | January 12, 2023
BioNTech and InstaDeep Ltd. recently signed an agreement wherein the former is set to acquire InstaDeep, a worldwide leader in AI and ML technologies.
The acquisition involves a total upfront payment of about £362 million in cash, while BioNTech shares will be used to buy the remaining 100% of InstaDeep shares, excluding those currently held by BioNTech.
The acquisition strengthens BioNTech's aim to establish world-leading abilities in AI-driven drug discovery and develop vaccines as well as next-generation immunotherapies to treat diseases with significant unmet medical needs. In addition, the company will enhance its network of worldwide research collaborators and expand its presence in many talent hubs throughout the United States, the Middle East, Africa, and Europe due to the acquisition.
With the acquisition of InstaDeep, BioNTech's proven and new AI- and ML-based models will be added to all of its discovery platforms and linked to an automated lab infrastructure through InstaDeep's DeepChainTM platform.
MD, CEO and Co-Founder of BioNTech, Prof. Ugur Sahin, said, "Since the inception of BioNTech, we have focused on leveraging computational solutions to create personalized immunotherapies that can reach a wide patient population."
(Source: Globe Newswire)
Adding to this, CEO and Co-Founder of InstaDeep, Karim Beguir, stated, "AI is progressing exponentially and our mission at InstaDeep has always been to make sure it benefits everyone. We are very excited to join forces and become one team with BioNTech, with whom we share the same culture of deep tech innovation and focus on positive human impact."
(Source: Globe Newswire)
About BioNTech
BioNTech is a fully-integrated and worldwide leader in immunotherapy. It has been focusing on automating and digitizing processes and developing capacities for the specialized production of individual vaccinations and large-scale goods, such as the COVID-19 vaccine. As immunotherapy pioneers, the company believes that science and innovation can make a difference for humankind. Therefore, since the beginning, it has focused on harnessing the immune system's total capacity to combat cancer and infectious diseases.
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CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Aldevron | January 20, 2023
Aldevron®, a worldwide leader in the custom development and production of plasmid DNA, RNA, and proteins for the biotech sector, recently announced the launch of Eureca-V™ nuclease.
Eureca-V™, licensed from Inscripta®, is the wild-type MAD7® CRISPR Type-V nuclease at research grade, with GMP to follow.
The launch of Aldevron's Eureca-V nuclease at advanced therapies week expands the toolkit of accessible CRISPR nucleases for therapeutic, diagnostic, and agricultural workflows. In addition, a pass-through license for research use is conveyed with the purchase of Eureca-V nuclease, allowing customers to thoroughly examine the product without committing to a long-term licensing agreement.
Vice President and General Manager of Aldevron's Protein Business Unit, Tom Foti, said, "The availability of Eureca-V drives forward the entire genomics medicine industry and enhances Aldevron's position as a supplier of choice for CRISPR drug substances and drug products." He added, "We are proud to work alongside our partners at Inscripta to bring the innovative, off-the-shelf catalog product to market now as well as provide a clear path to GMP in 2023."
(Source – Cision PR Newswire)
Eureca-V at the research grade level ensures the acceleration of CRISPR translational research. In addition, the product will assist academic and commercial scientists seeking a wild-type Type-V CRISPR nuclease that targets T-rich regions of the genome.
Venkata Indurthi, Chief Scientific Officer at Aldevron, expressed, "We are thrilled to offer Eureca-V product at research grade starting today, and later this year, our clients can expect a smooth transition to our GMP product." He further added, "Aldevron's extensive history in CRISPR nucleases allows researchers to develop therapies that will eventually address global health issues."
(Source – Cision PR Newswire)
It will be the third GMP CRISPR nuclease by Aldevron and the first Type-V nuclease available as a GMP catalog product. It is a leader in supplying vital raw materials and reagents used for cell and gene therapy manufacturing. The company's portfolio of CRISPR nucleases is applied globally in preclinical and clinical research applications.
About Aldevron
Aldevron is a pioneer in advancing biological science. Its custom development and manufacturing services have provided scientists all across the world with the components they need to accelerate research and create labs for revolutionary science and breakthrough discoveries. The company aims to deliver products and services that contribute significantly to global biological research. It seeks to be the partner of choice forproducing high-quality plasmid DNA, proteins, enzymes, and other biologicals to support its clients' goals.
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