NeuroSense and NeuraLight | July 29, 2022
NeuroSense Therapeutics Ltd. a company developing treatments for severe neurodegenerative diseases, and NeuraLight, a company developing objective and sensitive biomarkers for neurological disorders, today announced a collaboration to advance the science of digital biomarkers in the detection and monitoring of neurological diseases including amyotrophic lateral sclerosis.
NeuraLight's platform, uses proprietary computer vision and deep learning algorithms to extract over 100 occulometic markers from facial videos captured with a standard webcam. NeuroSense is conducting a Phase IIb PARADIGM trial, which is a double-blind, placebo-controlled study evaluating the efficacy of NeuroSense's lead combination drug candidate, PrimeC, in the treatment of ALS. The NeuroSense-NeuraLight collaboration entails sharing and tracking patient data to advance the identification and use of ALS digital biomarkers in a parallel study conducted by NeuraLight. This collaboration marks NeuraLight's first clinical trial and comes on the heels of NeuraLight's $25M Series A raise.
"There is compelling value in the use of precise biomarkers to diagnose and track the progression of neurodegenerative diseases. We are very pleased to work with the stellar team at NeuraLight who are pioneering the development of digital oculometric biomarkers, which complement our extensive evaluation of biological markers of ALS. We believe these tools have the potential to enable patient stratification and increase the likelihood of success in a future NeuroSense pivotal trial of PrimeC in the treatment of ALS. This is a first step in what we envision as a long-term collaboration with NeuraLight in ALS as well as future studies we plan for Alzheimer's disease and Parkinson's disease."
NeuroSense CEO Alon Ben-Noon
Dr. Rivka Kreitman, NeuraLight's Chief Innovation Officer, commented, "Along with advancing a promising therapy for ALS, we look forward to demonstrating that oculometrics serve as a robust proxy for the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) through this partnership. The validation of our technology's efficacy will improve success rates of trials moving forward – ensuring objectivity, reliability, and replicability, as well as reducing costs and friction."
Amyotrophic lateral sclerosis (ALS) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years of diagnosis. In the US alone, over 5,000 patients are diagnosed yearly with ALS, and researchers anticipate the number of ALS patients in the US to grow 24 percent by 2040. The cause of ALS is unknown, making it difficult for researchers to develop disease-modifying therapies for the neurodegenerative disease.
PrimeC, NeuroSense's lead drug candidate is a combination therapy that was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). NeuroSense completed a Phase IIa clinical study which successfully met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. Through a collaboration with Massachusetts General Hospital in Boston on novel Neuron-Derived Exosomes (NDEs), NeuroSense is working to further determine the biological changes in ALS-related pathologies and the effect of PrimeC on relevant targets. Results from this study are expected Q2 2022.
NeuraLight is on a mission to transform the lives of billions of people impacted by neurological disorders by digitizing neurological evaluation and care. Our AI-driven platform integrates multiple digital markers to accelerate and improve drug development, monitoring, and precision care for patients with neurological disorders. The technology driving the platform includes proprietary Deep Learning algorithms which automatically extract a host of digital oculometric markers from facial videos captured with a standard webcam or smartphone. Our founders are repeat entrepreneurs and industry veterans (including both the co-founder of Chorus.ai and the founding CTO of Flatiron health) leading a 25-strong team, supported by renowned neurologists and 2 Nobel laureates as well as a stellar Scientific Advisory Board, and have raised $30.5M to date.
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
Resilience | June 07, 2022
National Resilience, Inc. (Resilience) and The University of Texas MD Anderson Cancer Center today announced the launch of a joint venture, the Cell Therapy Manufacturing Center, to accelerate the development and manufacturing of innovative cell therapies for patients with cancer. Uniting the strengths of Resilience and MD Anderson, the joint venture will advance its work within a culture of academic innovation alongside industrial expertise.
The Cell Therapy Manufacturing Center will be based in a state-of-the art 60,000-square-foot manufacturing facility in the Texas Medical Center, with a team of 70 employees focused on process and analytical development as well as early-phase and clinical-stage Good Manufacturing Practices (GMP).
The joint venture combines MD Anderson’s expertise in immunotherapy and cell therapies as well as a leading clinical trials infrastructure, with Resilience’s innovative biomanufacturing technologies, advanced analytics and a national network for developing and producing cell therapies. Together, the parties aim to accelerate the path of cell therapies to the clinic, while enabling scalability and a smooth transition to late-phase clinical and commercial activities.
Cell therapies have had a dramatic impact for patients with certain cancers, but progress has been hampered by structural challenges, This novel joint venture was conceived to address those challenges by harnessing the complementary capabilities of two world-class organizations, allowing us to advance innovative programs to deliver impactful therapies to patients.”
Jason Bock, Ph.D., Chief Executive Officer of the Cell Therapy Manufacturing Center.
The joint venture will engage with MD Anderson researchers and external industry collaborators to advance new therapies through preclinical and clinical development, ensuring consistent and safe products that can be evaluated rapidly in clinical trials led by MD Anderson physicians. Resilience customers will be able to leverage this offering as part of the company’s growing network of biomanufacturing facilities that are flexible enough to scale projects from small-batch pre-clinical to large-scale commercial production. Resilience has 10 facilities across North America, with more than 1 million square feet of manufacturing space.
The promise of cell therapies to help patients in need has been limited by a lack of innovation in biomanufacturing, This collaboration aims to overcome those hurdles by extending our network with this unique partnership, creating opportunities to incubate innovative ideas and provide cutting-edge biomanufacturing technologies and processes to researchers, with a goal of bringing more cell therapies to patients.”
Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience.
The joint venture will advance the most promising cell therapy modalities to answer unmet clinical needs, including engineered tumor infiltrating lymphocytes (TILs), chimeric antigen receptor (CAR)-modified T cells, endogenous T cells (ETCs), engineered natural killer (NK) cells and other emerging technologies, for patients with hematological and solid tumors. MD Anderson researchers are leaders in the field of cancer cell therapy, responsible for advancing the translational and clinical development of many of the currently approved and experimental cell therapies.
The joint venture is built upon MD Anderson’s Biologics Development platform, formerly part of the institution’s Therapeutics Discovery division. Current strategic collaborations with MD Anderson’s Biologics Development platform will continue; collaborative relationships with MD Anderson’s Therapeutics Discovery division, as well as physicians and scientists across the institution, also will be maintained.
We believe in the tremendous potential of cell therapies to deliver solutions that offer cures, not merely prolonged survival. Resilience offers unique capabilities that make it an ideal choice for unlocking that potential and accelerating impactful cell therapies, Our mission at MD Anderson is to end cancer, and this joint venture is a strategic step toward realizing that goal.”
Ferran Prat, Ph.D., J.D., senior vice president for Research Administration and Industry Relations at MD Anderson.
Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development.
CELL AND GENE THERAPY
iTolerance | July 01, 2022
iTolerance, Inc., an early-stage privately held regenerative medicine company developing technology to enable organoid, tissue, and cell therapy, announced entering into a joint collaboration with LyGenesis, Inc., a clinical-stage biotechnology company with an organ regeneration technology platform. The joint collaboration is aimed at evaluating the potential of iTOL-201, a product candidate being developed combining LyGenesis' LYG-LIV-100 liver cell therapy and iTolerance's SA FasL microgel immune tolerance platform to permit the growth of ectopic livers without the requirement for immune suppression.
The joint research effort of iTolerance and LyGenesis has produced in vitro data using iTOL-201 and is now moving toward small animal proof of concept work to assess the potential of the combined technology for producing ectopic livers capable of saving the animals from fatal liver disorders without the requirement for immune suppression.
With our lead therapy now in the clinic in a Phase 2a trial in patients with End Stage Liver Disease, we have turned our attention toward a second-generation therapy capable of growing ectopic organs without the need for immune suppression. iTolerance's platform holds enormous promise in this respect and we look forward to the results from our joint proof of concept work."
Dr. Michael Hufford, Co-Founder and Chief Executive Officer of LyGenesis.
While long-term immunosuppression continues to be an obstacle for the use of cell and regenerative therapies, the research being conducted between both LyGenesis and iTolerance could allow for a major advancement in organ regeneration, As we advance our own pipeline of therapies focused on supporting pancreatic islet engraftments, I believe this synergistic collaborative research with LyGenesis has the potential to successfully combine technologies to drive significant value for both biotech companies and importantly, the patients we work to serve."
Dr. Anthony Japour, Chief Executive Officer of iTolerance.