CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Lineage Cell Therapeutics, Inc. | February 23, 2023
On February 22, 2023, Lineage Cell Therapeutics, Inc., a clinical-stage biotechnology firm focused on the development of allogeneic cell therapies to restore and replace specific cell types of the human body, announced that it has entered into an exclusive option and license agreement with Eterna Therapeutics Inc. (Eterna) for the development of innovative beta 2 microglobulin (B2M)-deficient induced pluripotent stem cell (iPSC) lines that Lineage will assess for the creation of unique, differentiated cell transplant therapies.
These new cell lines to be developed by Eterna are expected to help Lineage generate more product candidates for the treatment of central nervous system (CNS) conditions and other neurology indications. Eterna holds the exclusive license for the crucial intellectual property associated with this partnership, which it obtained from its discovery partner Factor Bioscience.
Following the agreement, Eterna intends to perform specific gene-editing activities and furnish materials to Lineage for assessment. In addition, the agreement grants Lineage the option to obtain an exclusive license to use and sublicense the new gene-edited cell lines for clinical, preclinical, and commercial purposes in the field of CNS diseases. A distinctive feature of the starting cell line is the targeted elimination of the B2M gene, which is aimed at minimizing the immunogenicity of product candidates generated from the cell lines by inhibiting rejection by CD8+ T cells.
Lineage anticipates that this attribute will enhance the overall usefulness of the edited cell lines, including non-immune privileged or non-human leukocyte antigen (HLA) matched indications. Other proposed gene modifications may additionally differentiate the cell line from those currently utilized by competitors. No details of the financial agreement were disclosed.
About Lineage Cell Therapeutics, Inc.
Founded in 1990, Lineage Cell Therapeutics is a clinical-stage biotechnology company focused on developing novel cell therapies to address unmet medical needs. The company's programs are based on its proprietary cell-based therapy platform and related development and manufacturing capabilities. By using this platform, it specializes in the development and manufacture of specialized, terminally-differentiated human cells from its progenitor and pluripotent cell starting materials. These differentiated cells are intended to either support or replace cells that are dysfunctional or absent due to degenerative disease or traumatic injury and can also be administered to help the body mount an effective immune response to cancer.
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MEDTECH, INDUSTRIAL IMPACT
Atreca, Inc. | February 07, 2023
On February 6, 2023, Atreca, Inc. (Atreca), a biotechnology company that develops novel therapeutics through a deep understanding of the human immune response, with a focus on innovative novel cancer immunotherapeutics, and Xencor, Inc., a clinical-stage biopharmaceutical company that develops cytokines and engineered antibodies for the treatment of autoimmune diseases and cancer, announced, as part of their existing strategic collaboration, that they have mutually selected the first program combining an Atreca-discovered antibody with Xencor's XmAb® bispecific Fc domain and a cytotoxic T-cell binding domain (CD3).
The initiative announced is the first of up to two collaborative programs that can be selected by mutual agreement for future development and commercialization, with each partner sharing 50% of expenses and earnings. This program's clinical development, regulatory, and commercialization operations will be led by Atreca, while Xencor will lead the second prospective joint program. Furthermore, the agreement permits each partner to pursue up to two collaborative programs separately.
The unveiled joint program is based on APN-346958, an antibody discovered by Atreca. APN-346958 targets a new RNA-binding protein and is tumor-reactive in at least 50% of samples for six tumor types tested: thyroid, colorectal, head and neck, melanoma, urothelial, and brain cancer. In preclinical tests, the XmAb bispecific antibodies engineered against the target of APN-346958 displayed substantial anti-tumor activity. Atreca and Xencor hope to name a candidate from the program later this year, with Atreca aiming for an investigational new drug (IND) application in early 2025.
About Atreca
Founded in 2011, Atreca is a biopharmaceutical firm that employs its distinct discovery platform to create innovative antibody-based immunotherapeutics. Its Immune Repertoire CaptureTM (IRCTM) technology provides unmatched insight into how cancer patients' immune responses can lead to improved clinical outcomes offering access to an undiscovered terrain in oncology. Atreca was created by industry leaders, scientists, and investors who believe that unlocking today's patients' immune responses is the key to developing a new generation of therapies.
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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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