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.
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.
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Axcella | February 16, 2023
On February 15, 2023, Axcella Therapeutics, a clinical-stage biotechnology firm that develops innovative approaches to complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a phase 2b/3 trial in the United States for AXA1125 for the treatment of Long COVID Fatigue.
The company stated that it has obtained FDA regulatory guidance in favor of a trial that would serve as the registration trial for patients with Long COVID Fatigue. The trial now has acceptance from both the U.K. and U.S. regulatory authorities.
Last month, the company also announced a regulatory path to registration for the treatment of Long COVID Fatigue with AXA1125, having received regulatory guidance from the U.K.'s regulatory agency, The Medicines and Healthcare products Regulatory Agency (MHRA), supporting a single trial that can serve as the registration trial for patients suffering from Long COVID Fatigue.
The guidance follows the company's submission of data to both regulatory agencies, including results from the Phase 2a randomized, double-blind, placebo-controlled study, which showed that patients who received AXA1125 experienced statistically and clinically significant improvements in both physical (p=0.0097) and mental fatigue (p=0.0097) scores compared to those on the placebo.
Consistent with the Ph2a trial, the trial for phase 2b/3 will register patients with fatigue lasting at least 12 weeks post-COVID-19 infection. The primary endpoint will use the same patient reported outcome tool, the Chalder Fatigue Questionnaire (CFQ-11), to measure fatigue improvements alongside physical function, quality of life, and ability to return to work as additional endpoints. The trial participants will receive AXA1125 or a placebo for three months.
Long COVID is a persistent long-term effect of the pandemic, which affects a large number of patients worldwide, estimated to be around one hundred million. Fatigue is the most frequently reported symptom, with recent estimates indicating that 15-20% of Americans with COVID suffer from ongoing health problems, and up to four million Americans are unable to work because of Long COVID symptoms. In addition, Long COVID has caused approximately $1 trillion in lost earnings and $544 billion in increased medical expenses.
Founded in 2010, Axcella is a clinical-stage biotechnology firm dedicated to introducing a novel approach to treating complex diseases using endogenous metabolic modulator (EMM) compositions. Its product candidates contain EMMs and derivatives that are engineered in distinct ratios and combinations to reset multiple biological pathways, improve cellular energetics, and restore homeostasis. The company's pipeline includes lead therapeutic candidates undergoing Phase 2 development for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence, the treatment of Long COVID, and the treatment of non-alcoholic steatohepatitis (NASH).
INDUSTRIAL IMPACT, MEDICAL
Twist Bioscience | March 10, 2023
On March 9, 2023, Twist Bioscience Corporation, a leading firm providing high-quality synthetic DNA through its silicon platform, announced the launch of integrated antibody discovery services. This premium offering combines the company's synthetic libraries and AI machine learning with an in vivo immunization approach acquired through its acquisition of Abveris, also known as Twist Boston. This service provides customers with optimized, development-ready antibody candidates.
The combined team, now called Twist Biopharma Solutions, is led by Tracey Mullen, MBA, the senior vice president of biopharma for Twist Bioscience. This newly formed entity leverages years of industry expertise, scientific excellence, and proprietary technology to discover the best antibody candidate for therapeutic targets of interest.
Twist Biopharma Solutions offers an end-to-end workflow for centralized antibody discovery and optimization, including target validation, hit generation, lead selection, lead optimization, and lead characterization. Twist, supported by high-throughput DNA synthesis and IgG antibody production, constructs extensive and particular synthetic antibody libraries with discovery starting with either in vivo or in vitro diversity.
The newly integrated in vivo discovery approach from Abveris of single B cell screening and hybridoma discovery enables parallel paths where multiple technology methods can be leveraged to build a panel of highly diverse antibody leads with broad epitope coverage. In addition, this multi-pronged approach can increase the likelihood of discovering highly specific, high-affinity functional antibodies by sampling synthetic and natural diversity.
The South San Francisco and Boston biopharma teams were combined to create Twist Biopharma Solutions, led by Tracey Mullen. Aaron Sato, Ph.D., remains integrally involved in Twist Biopharma Solutions and, as a chief scientific officer of Twist Bioscience, extends his expertise across the organization. Tracey Mullen joined Twist Bioscience in November 2021 through the acquisition of Abveris. In April 2022, she took on the position of senior vice president of operations, driving the completion of the Factory of the Future in Wilsonville, Oregon, which began shipping products in January 2023. Before joining Twist, she served as CEO of Abveris and worked on the antibody discovery team at Biogen.
About Twist Bioscience
Twist Bioscience is a leading biotechnology company specializing in synthetic biology and genomics. It has developed a proprietary DNA synthesis platform that enables the production of custom-designed DNA strands faster, more accurately, and at a lower cost than traditional methods. In addition, Twist collaborates with partners across industries to develop customized DNA sequences for specific applications and offers a range of other products and services, such as oligonucleotides, synthetic genes, and custom panels for next-generation sequencing. The company has also developed a library of over 100 billion synthetic antibodies, which can be used for diagnostic and therapeutic applications.