INDUSTRIAL IMPACT, DIAGNOSTICS
Kite Pharma and Arcellx | January 31, 2023
On January 30, 2023, Kite and Arcellx, Inc. informed that they have completed their previously-announced global strategic collaboration to co-develop and co-market CART-ddBCMA.
CART-ddBCMA is Arcellx's lead late-stage candidate for treating patients with relapsed or refractory multiple myeloma.
For the majority of patients, multiple myeloma is an incurable disease; hence, there is a continuing demand for treatments that are not only effective but also secure and easily available.
Arcellx's T-cell treatment, CART-ddBCMA, uses the company's unique synthetic binder, the D-Domain, and is now being studied in Phase 2 pivotal trials. Kite and Arcellx will work together to develop and market the CART-ddBCMA asset in the United States, while Kite will handle sales and marketing for the product in all other regions.
About Kite Pharma
Kite, a Gilead company, is a global biopharmaceutical company with its headquarters in Santa Monica (California). Cell therapy, which aims to treat and maybe even cure cancer, is the company's main area of research and development. Kite, the industry leader in cell therapy, has successfully administered CAR T-cell treatment to more patients than any other company. Process development, vector production, clinical trial supply, and commercial product manufacturing are all part of Kite's expansive in-house cell therapy manufacturing network, the most extensive in the world.
About Arcellx
Clinical biotechnology firm Arcellx, Inc. is rethinking cell treatment by developing novel immunotherapies for patients with cancer and other fatal diseases. The company considers cell therapies one of the most promising areas of modern medicine. Its goal is to improve the quality of life for people everywhere by creating safer, more effective, and widely available cell therapies. CART-ddBCMA is the principal product candidate being developed by Arcellx and is now in Phase 2 pivotal trials for treating relapsed or refractory multiple myeloma (r/r MM). The FDA has recognized CART-potential ddBCMAs by designating them as a regenerative medicine advanced therapy, an orphan drug, and a fast-track product.
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CELL AND GENE THERAPY, INDUSTRIAL IMPACT
GenScript | March 03, 2023
GenScript Biotech Corporation, a leading tools and services provider for life-science research, recently announced the expansion of its Singapore facility to provide a high-quality gene synthesis service. This expansion has added 976 square meters to the facility, bringing its total size to 3,500 square meters, making it the third-largest facility for GenScript globally. This development will also increase the staff at the Singapore facility to 150.
In February 2022, GenScript Asia-Pacific opened a recombinant protein production facility, which will now offer an advanced gene synthesis service. This expansion is a significant step towards GenScript's aim to provide top-notch services required for novel vaccine and therapeutic development in the life-sciences field.
The Singapore facility uses modernized, automated workstations that can synthesize more than 400 genes daily, ensuring precise measurement, eliminating human error, and providing a consistently high-quality product. The new facility's goal is to decrease project turnaround time for a more global mix of clients while maintaining customer data security. The new facility's capacity is dedicated to gene and cell therapy research and vaccine development programs.
GenScript's Life Science Group President, Dr. Ray Chen, commented, "We understand that global supply is a huge challenge, and we remain committed to expanding our reach to meet the increasing demand for our customers worldwide. At GenScript, we take great pride in our ability to provide reliable and efficient solutions to our customers, and we are fully committed to delivering on this promise. As we continue to expand our global footprint, we remain dedicated to providing the highest-quality products and services to our customers, wherever they may be located."
(Source – PR Newswire)
About GenScript
Founded in 2002, GenScript is a leading biotech firm. It has a global presence across the EU, North America, Greater China and Asia Pacific and has served more than 300,000 customers from over 160 countries and regions around the world. With more than 5,000 employees, it is dedicated to providing premier, convenient, and reliable products and services. The company strongly focuses on technology development, with over 100 patents and 270 patent applications in fields such as immunotherapy, synthetic biology, chemical synthesis, antibody design and bioinformatics. GenScript's products and services have been cited in 74,700 scientific papers worldwide as of June 2022. The company's vision is to become the most reliable biotech company in the world, working towards the betterment of human and environmental health through biotechnology.
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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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