MEDTECH, INDUSTRIAL IMPACT
Twist Bioscience Corporation | February 13, 2023
Twist Bioscience Corporation, a company that helps customers succeed by providing high-quality synthetic DNA on its silicon platform, recently announced technology early access to the Twist enhanced Whole Genome Sequencing (eWGS) solution for applications related to non-human gnomics at the Advances in Genome Biology and Technology 2023 General Meeting conducted in Hollywood, Florida. eWGS is a unique solution that allows researchers to collect simultaneous low-pass whole genome data as well as in-depth coverage of specific areas in a high-throughput and cost-effective workflow.
The eWGS workflow begins with a modified Twist 96-plex library preparation kit, which prepares 96 samples in a single tube for sequencing. Following that, a single-tube 96-plex enrichment on an aliquot of the library is performed using a customized panel to enrich further targets that require additional coverage. The original and enhanced libraries are then merged into a single sequencer-ready pool with low whole genome coverage (0.5x to 4x) and high target-specific coverage. Researchers can tailor the coverage differential between low-pass and high-pass sites to their own needs. Preparing and enriching 96 samples for sequencing at once in a single pool enables a high-throughput workflow and may save costs by utilizing fewer materials and resources.
Twist Bioscience’s co-founder and CEO Emily M. Leproust commented, “In agricultural genomics, researchers constantly have to make a tradeoff between cost and insight. Deep sequencing across entire genomes is cost prohibitive, forcing researchers to turn to less costly approaches like genotyping by sequencing, microarrays, or low-pass WGS. These methods impose limits on the resolution, accuracy, or flexibility of experiments.” She added, “With our eWGS solution, researchers can now get all the information they need without compromising on cost or data, enabling our customers to push new boundaries in trait selection, breeding and other applications.”
(Source – Business Wire)
About Twist Bioscience Corporation
Founded in 2013, Twist Bioscience is a leading synthetic biology and genomics firm that has created a proprietary DNA synthesis platform to industrialize biological engineering. It assists researchers in the Life Sciences who are transforming the world for the better. Scientists from several sectors, including health, agriculture, data storage and industrial chemicals, employ its oligo pools, synthetic genes, and NGS target enrichment to improve human lives and the planet's sustainability. Its technology eliminates inefficiencies and enables cost-effective, high-throughput, quick, accurate DNA synthesis and sequencing. The company provides both the quantity and quality that researchers need to quickly capitalize on future prospects.
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Evaxion Biotech A/S | January 23, 2023
Evaxion Biotech A/S, a leading clinical-stage biotechnology firm focused on the development of AI-driven immunotherapies, recently announced that FDA has granted fast-track designation for the Company's customized cancer therapy, EVX-01, in conjunction with KEYTRUDA®.
In December 2022, Evaxion gained FDA clearance to proceed with its phase 2b clinical test, where patients with metastatic melanoma are given EVX-01 in combination with KEYTRUDA®. In addition, Evaxion obtained fast-track designation for the vaccine candidate on January 17, 2023. The fast track is developed to expedite FDA's assessment of innovative, novel medications with the potential to meet an unfulfilled medical need.
EVX-01, a peptide-based immunotherapy for cancer, is Evaxion's most advanced clinical asset. The program generates a unique medicine for each patient based on gene analysis of their malignancies and matching with their immune system. The Company's proprietary AI platform, PIONEER, helps facilitate this process.
Per Norlén, CEO at Evaxion, commented," We are extremely pleased that our cancer vaccine candidate EVX-01 has received the FDA fast track designation, as it enables a potentially faster approval of the vaccine. This is first and foremost to the benefit of the patients. And it is a great validation of our AI platform, PIONEER, and our drug development candidate."
(Source – Globe Newswire)
The ongoing Phase 2b clinical trial is being done at sites in Europe, the United States, and Australia. It is conducted in partnership with Merck, which supplies its PD-1 inhibitor KEYTRUDA®. The trial was launched in Australia when the first patient was enrolled in September 2022.
About Evaxion Biotech A/S
Evaxion is a clinical-stage AI-immunology™ platform company using AI, engineering expertise and drug development knowledge to identify and develop novel immunotherapies for the treatment of various cancers, bacterial diseases and viral infections. It has utilized artificial intelligence to build a diverse pipeline of candidate immunotherapies that target two of the most critical unmet medical needs in the world, cancer and infectious diseases. Its three proprietary AI platforms include PIONEER, EDEN and RAVEN.
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.