MEDTECH, INDUSTRIAL IMPACT
Cybin | January 19, 2023
On January 18, 2023, Cybin Inc., a leading biopharmaceutical firm focused on advancing Psychedelics to Therapeutics®, announced the key findings from a feasibility study undertaken by its partner Kernel, which evaluated Kernel's Flow® wearable technology to assess ketamine's psychedelic effect on cerebral cortex hemodynamics. The findings of this Cybin-sponsored study are meant to guide the program's future direction.
The key highlights of the feasibility study are
It offered important proof-of-concept for Kernel Flow as a portable functional system that delivers real-time measurements of blood oxygenation changes in the brain linked with neural activity utilizing Time Domain Near Infrared Spectroscopy (TD-fNIRS).
Exhibited changes in functional brain biomarkers caused by ketamine that are related to potential therapeutic effects, including changes in cortical function associated with psychedelic experiences.
Compared to saline, ketamine reduces the global brain connectivity of the prefrontal region and decreases the brain-wide fractional amplitude of low-frequency fluctuations (fALFF). It has been proposed that fALFF is of particular functional significance within the default mode network, which has been demonstrated to be modulated by psychedelics and is associated with several neuropsychiatric conditions.
A model incorporating neurological and physiological metrics successfully predicted mystical experience scores on the Revised Mystical Experience Questionnaire, which has been shown to mediate reductions in depressive symptomatology in prior studies.
Displayed reliable pulse rate variability (PRV) and physiological measurements of pulse rate (PR) from TD-fNIRS recordings that correspond to those obtained from commercial external photoplethysmography sensors, thereby eliminating the need for external sensors to measure cardiac activity in future experiments.
Ketamine increased PR, decreased PRV, increased absolute oxy-hemoglobin concentrations and decreased deoxy-hemoglobin concentrations while increasing electrodermal activity (measured by an external sensor), providing additional physiological measures of the impact of the ketamine doses administered in the study.
The main goal of the feasibility study was to find out how people who had been given ketamine felt about wearing Kernel Flow while in an altered state of consciousness.
The feasibility study was granted FDA Investigational New Drug approval in October 2021 and US Institutional Review Board approval in January 2022.
About Cybin
Founded in 2019 and headquartered in Canada, Cybin is a biotechnology company that develops psychedelic pharmaceutical treatments for a variety of psychiatric and neurological disorders. It collaborates with a network of world-class partners and internationally recognized scientists to develop safe and effective treatments for patients dealing with a wide range of mental health conditions. The company is currently operating in the United States, Canada, the United Kingdom, Ireland, and the Netherlands.
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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.
About VXX-401
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.
About Vaxxinity
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.
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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.
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