CELL AND GENE THERAPY, MEDICAL
QIAGEN | January 11, 2023
QIAGEN recently announced its acquisition of Verogen, a leader in utilizing next-generation sequencing (NGS) technologies to advance the future of human identification (HID) and forensic investigation.
QIAGEN, which introduced the first commercial kits to purify DNA from forensic casework samples in the late 1990s, is one of the leaders in the HID/forensics sector.
Verogen, a privately-owned company launched in 2017, provides NGS tools and professional services to the worldwide human identification community to assist in resolving criminal and missing-person situations.
Thierry Bernard, CEO of QIAGEN, said, “Bringing together Verogen and QIAGEN creates a unique opportunity to better help investigators and researchers to advance forensic science and to find missing persons, accurately identify suspects and exonerate the innocent.”
(Source: Business Wire)
Brett Williams, CEO of Verogen, stated, “We are proud to take our successful partnership with QIAGEN to the next level in a combination that we believe creates significant advantages for all stakeholders.”
(Source: Business Wire)
Verogen's sequencing and analysis solutions are optimized for Illumina's MiSeq FGx® Sequencing System. Due to this acquisition, QIAGEN receives exclusive distribution rights for this version of the MiSeq sequencer designed exclusively for forensics applications.
So far, more than 300 MiSeq FGx Sequencing Systems have been placed, making a strong debut in this market segment. The Verogen portfolio of kits for use on this sequencer includes the ForenSeq suite of kits, consisting of the DNA Signature Prep, Kintelligence, Imagen, and MainstAY product lines, which provide forensics professionals with better answers to aid in the resolution of the most difficult unsolved cases.
Additionally, QIAGEN gains complete access to Verogen's leading GEDmatch database and GEDmatch PRO™ interface. GEDmatch, which presently has more than 1.8 million genealogical profiles, is continuously expanding and enabling users to upload genetic profiles created by other genealogy websites to broaden the search for familial connections. In addition, GEDmatch PRO™ is designed to assist law enforcement and forensic teams with investigative comparisons of data submitted by GEDmatch users with their consent.
QIAGEN is a leading worldwide provider of Sample to Insight solutions, which allow clients to get valuable molecular insights from samples containing biomolecules. Its sample technologies isolate and process RNA, DNA, and proteins from blood, tissue, and other materials. In addition, the assay technologies make these biomolecules visible and accessible for analysis.
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Biocytogen | January 05, 2023
RenNano™, a fully human heavy-chain antibody platform developed by Biocytogen Pharmaceuticals Co., Ltd., has been launched officially. RenNano™ joins RenMab™ and RenLite® as the newest member of the RenMice™ family. All three RenMice™ technologies from Biocytogen work together to speed up the search and development of entirely human monoclonal, bispecific/multispecific, and single-domain antibodies (sdAbs, or nanobodies).
Camels and sharks produce heavy-chain-only antibodies (HCAb), indicating their variable domains (VHH or sdAb) are functional without pairing with the light chain. Still, humans and mice produce antibodies that require heavy and light chain coupling to be effective. Because of their molecular weight and size, sdAbs can enter solid tumor tissues and breach the blood-brain barrier. Additionally, the sdAb's larger CDR3 region allows for detecting the otherwise concealed epitopes of GPCRs and other challenging targets.
Nanobodies offer their benefits, but it's challenging to use animals that naturally make HCAbs, like camels, in large numbers to create monoclonal antibodies due to their size, slow reproduction rate, and limited offspring supply. However, humanizing camelid antibody sequences for pharmaceutical use adds another layer of complexity and time to the drug development process.
Accordingly, Biocytogen modified the constant area of the entirely human RenMab™ model to create the RenNano™ Mouse, which is genetically modified to manufacture HCAbs. RenNano™ Mouse is one of the world's most comprehensive human antibody platforms due to the substitution of the mouse genes with the complete human heavy chain variable genes.
Biocytogen, a global biotechnology company, is at the forefront of developing cutting-edge methods for studying and creating new antibody-based pharmaceuticals. Biocytogen has streamlined the entire drug development process by integrating its drug efficacy screening platforms and clinical solid development expertise with its proprietary RenMab™, RenLite®, and RenNano™ platforms for the fully human monoclonal antibody, bispecific/multispecific antibody, and nanobody develo
INDUSTRIAL IMPACT, DIAGNOSTICS
Vaxxinity, Inc. | March 21, 2023
Vaxxinity, Inc. a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, announced that the first subjects have been dosed in a randomized, double-blind, placebo-controlled Phase 1 clinical trial of VXX-401, an investigational vaccine designed to lower low-density lipoprotein (LDL) cholesterol, a known factor contributing to heart disease, by targeting proprotein convertase subtilisin/kexin type 9 serine protease (PCSK9). Heart disease remains the leading cause of death globally, claiming over 18 million lives per year, despite the existence of approved treatments that lower LDL.
“This is an exciting milestone for VXX-401 and Vaxxinity in our pursuit to vaccinate the world against heart disease with a preventative option that is convenient and accessible, addressing an unmet need to combat the leading global cause of death,” said Mei Mei Hu, Chief Executive Officer of Vaxxinity. “PCSK9 antibody therapies are well-tolerated and effective, but huge unmet patient need remains. In order to solve the problem of heart disease, the world needs a scalable, accessible technology that can reach the hundreds of millions, if not billions of people at risk. With an LDL-lowering vaccine we can potentially offer an option that’s cost-effective, safe, convenient, long-acting, and deployable.”
The multicenter Phase 1 dose-escalation trial aims to enroll 48 subjects aged 18 to 75 years, with LDL cholesterol between 2.59 and 4.89 mmol/L. The objectives of the trial are to evaluate safety, tolerability and immunogenicity (as measured by serum anti-PCSK9 antibody titers). Pharmacodynamics of the immune response will be measured by LDL cholesterol levels, an established model of PCSK9 inhibition in hypercholesterolemia.
“We’re excited to get this first-in-human trial of VXX-401 started. The concept of a vaccine for cholesterol could be a game-changer in cardiovascular health due to its potentially very broad reach and impact on human health,” said Professor Stephen Nicholls of Monash University and Victorian Heart Hospital in Australia. “Targeting PCSK9 with a monoclonal antibody is a proven and effective approach for lowering cholesterol and reducing the risk of heart attack and stroke. Despite the availability of statins and the approval of PCSK9-targeting medicines, there is still a need for new therapies. VXX-401 has the potential to extend the use of PCSK9 inhibition to the full population who could benefit.”
Earlier this month, Vaxxinity presented pre-clinical data at the American College of Cardiology/World Congress of Cardiology Annual Scientific Session demonstrating that VXX-401 induced robust anti-PCSK9 antibodies and durable LDL cholesterol lowering without affecting high-density lipoprotein (HDL) cholesterol levels, indicating that VXX-401 has the potential to be a safe and effective LDL lowering therapy. Data in non-human primate studies show that VXX-401 was well tolerated and provided durable and significant LDL reduction of 30% to 50% change from baseline. The data also demonstrate VXX-401’s immunogenicity: purified antibodies from immunized animals bound to human PCSK9 with high affinity, and exhibited a dose-dependent functional inhibition of PCSK9 in vitro. Additionally, Peripheral Blood Mononuclear Cells (PBMCs) collected prior to immunization did not release cytokines upon stimulation with various components of the vaccine, suggesting that VXX-401 may safely overcome immune tolerance.
VXX-401 was designed using Vaxxinity’s proprietary synthetic peptide vaccine platform and is being developed for the treatment of hypercholesterolemia. The platform is designed to harness the immune system to convert the body into its own natural “drug factory,” stimulating the production of antibodies. VXX-401 is designed to induce robust, long-acting antibodies against PCSK9 in order to lower LDL cholesterol.
Vaxxinity, Inc. is a purpose-driven biotechnology company committed to democratizing healthcare across the globe. The company is pioneering a new class of synthetic, peptide-based immunotherapeutic vaccines aimed at disrupting the existing treatment paradigm for chronic disease, increasingly dominated by monoclonal antibodies, which suffer from prohibitive costs and cumbersome administration. The company’s proprietary technology platform has enabled the innovation of novel pipeline candidates designed to bring the efficiency of vaccines to the treatment of chronic diseases, including Alzheimer’s, Parkinson’s, migraine, and hypercholesterolemia. The technology is also implemented as part of a COVID-19 vaccine program. Vaxxinity has optimized its pipeline to achieve a potentially historic, global impact on human health.