Alligator Bioscience | December 07, 2020
Alligator Bioscience declares an affirmed IND (Investigational new Drug) for the CD40 targeting antibody mitazalimab. IND endorsement by the US Food and Drug Administration (FDA) is an essential to begin clinical preliminaries in the USA. As of late, new benchmark information was distributed indicating that mitazalimab can possibly be top tier in the CD40 field. The comparison demonstrated the potent immune-activating properties and anti-tumor effects of mitazalimab.
"While the upcoming clinical Phase Ib/II study in pancreatic cancer, OPTIMIZE-1, will be starting in Europe, the IND opens up for later expansion in the US. This is essential for the future success of the product", said Per Norlén, CEO of Alligator Bioscience.", said Per Norlén, CEO of Alligator Bioscience. "Our key focus right now is to complete the submission of the CTA for start of OPTIMIZE-1 in the EU", he added.
The mitazalimab drug candidate has recently reported positive clinical information from a Phase I study performed by Janssen Biotech Inc., showing a manageable safety profile just as early signs of efficacy.
CELL AND GENE THERAPY
Vipergen | February 18, 2021
Vipergen ApS announced today a published study depicting a ground-breaking new medication revelation approach that empowers, interestingly, screening DNA-encoded small-molecule libraries (DELs) inside living cells. The study, published in the peer-reviewed Journal of the American Chemical Society, highlights the potential of Vipergen's Cellular Binder Trap Enrichment® (cBTE) technology to significantly grow the ability to discover novel small molecules, including against difficult-to-drug targets, and reduce attrition rates in drug discovery. Vipergen is offering its cBTE DNA-encoded library drug disclosure platform as a service to biotechnology and pharmaceutical company partners to accelerate and improve their drug discovery processes.
"This research validates the potential for Vipergen's Cellular Binder Trap Enrichment platform to become a revolutionary tool in small-molecule drug discovery based on its ability to successfully screen DELs against drug targets inside living cells, with no requirement for purified active target protein," said Nils Hansen, Ph.D., Chief Executive Officer of Vipergen. "We expect the ability to perform DEL screening under the more physiologically relevant conditions of a living cell to significantly lower attrition rates in drug discovery. Furthermore, by uniquely allowing us to eliminate the requirement for highly purified active target protein, this technology will improve timelines and bring about new options for novel drug development by allowing us to screen many more targets, prioritize those giving the most promising screening results, and screen DELs against challenging targets that are difficult to express and purify in an active form. We look forward to providing this new tool to biotechnology and pharmaceutical partners to substantially improve the efficiency and success of their small-molecule drug discovery efforts."
About Vipergen's Cellular Binder Trap Enrichment®(cBTE) Technology
Vipergen's proprietary Cellular Binder Trap Enrichment®(cBTE) is the first and only technology for screening DNA-encoded small-molecule libraries (DELs) inside a living cell. The platform is designed to accelerate and improve the success rate for discovering novel, high-quality small molecules for drug development—including against challenging drug targets that are difficult to express and purify in an active form.
About Vipergen ApS
Vipergen is a world-leading provider of small-molecule drug discovery services based on DNA-encoded library (DEL) technologies and is the first and only company capable of screening DELs inside a living cell. Vipergen provides its proprietary suite of leading-edge DEL technologies as a service to biotechnology and pharmaceutical company partners, including top pharmaceutical companies in the U.S., EU, and Japan.
Biomeme | August 20, 2020
Biomeme, Inc. announced today that the U.S. Food and Drug Administration (FDA) gave Biomeme’s SARS-CoV-2 Real-Time RT-PCR Test Emergency Use Authorization (EUA) for use in any lab CLIA-certified to perform high complexity testing. It is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is designed to detect the virus’ Orf1ab and S genes in nasopharyngeal, nasal, and oropharyngeal swab specimens, as well as nasopharyngeal wash/aspirate or nasal aspirate specimens. Unlike wet assays, which must be stored frozen and require pipetting of multiple reagents by an experienced biologist, Biomeme’s SARS-CoV-2 test is lyophilized (freeze-dried) to not only maximize shelf-life but to also enable easier transportation and storage without a cold chain.