March 8, 2021 | Wearables for blood cancer clinical trials, new members of DTRA, new light and health research center, digital twin consortium, and more.

BioIntelliSense has entered into a strategic partnership with The Leukemia & Lymphoma Society (LLS) to incorporate use of the BioSticker medical wearable device and data services in clinical trials of hematological cancer patients. The BioSticker is the first FDA-cleared single-use medical device that enables 30 days of continuous vital signs monitoring. The BioIntelliSense medical grade Data-as-a-Service (DaaS) platform and FDA 510(k) Class II medical wearable device provides a new standard for Remote Patient Monitoring (RPM), by combining an effortless patient experience with medical grade clinical accuracy, for cost-effective virtual trials. The LLS clinical trials will include use of the BioSticker medical device for the continuous collection of vital sign and physiological data which includes temperature, heart rate, respiratory rate at rest, activity level and body position. The BioSticker data services and advanced analytics will be used by LLS to correlate symptoms to treatment. Press release.

Cerba Research has announced a new partnership with Biokortex, a provider of digital solutions to the healthcare sector. This partnership will leverage patient biological and medical data to support drug developers and CROs with patient identification and recruitment activity. The benefits of this new partnership include leveraging patients’ biological and medical data as well as biomarker and genetic data from the global Cerba Healthcare network; a global footprint with data on global testing, frequency, and accuracy; and a platform for screening and companion diagnostic testing across Europe and Africa. By connecting real-world laboratory data from clinical sites and digitizing patient data, this partnership will optimize patient recruitment for precision medicine by identifying patients expected to respond to your product—moving efficiently into clinical trials and allowing patients to receive information on new therapies at the right time. Press release.

Digital Twin Consortium and FIWARE Foundation have entered into a collaborative agreement to accelerate the development, deployment, and wide-scale adoption of open digital twin technologies. Digital twins are growing their capabilities and sophistication. However, grasping their full potential may require integrating systems and data across entire organizational ecosystems. That's exactly where both organizations are set to create value and synergies. As part of the collaboration, both have agreed to collaborate on digital twin standardization requirements, and the open-source implementation of jointly identified standards requirements; realize interoperability, based on information exchange by harmonizing technology components and other elements; and align work in horizontal sectors toward the adoption of results in various vertical domains through reference use cases and pilot projects; and foster adoption among academia, researchers, and companies (among others) of open standards for digital twins and open-source technology, used as reference implementation of such standards. Press release.

Vocalis Health has announced results of a clinical study conducted in collaboration with the Municipal Corporation of Greater Mumbai (MCGM) at their NESCO COVID-19 Center to validate Vocalis Health’s COVID-19 screening tool, VocalisCheck. VocalisCheck is a software-only product that can be accessed via smartphones or other devices. Users simply count from 50 to 70, their voice recording is transformed to a picture (spectrogram) containing 512 features. That picture is then compared using AI machine learning/deep learning techniques to a composite picture based upon the voice recordings of COVID-19 positive participants in clinical trials to determine whether there is a high or low correlation between them. The MCGM study included over 2,000 participants who spoke numerous languages including English, Hindi, Marathi and Gujarati. Results from an unblinded validation set of 288 participants demonstrated an AUC of 0.88, which translated to accuracy of 81.2 percent, sensitivity of 80.3 percent and specificity of 81.4 percent. VocalisCheck has also obtained a CE mark. VocalisCheck is the first device with CE mark approval for its medical intended use of screening for COVID-19. Press release.

Jasper Therapeutics has launched a Phase 1/2 clinical trial to evaluate JSP191, Jasper’s first-in-class anti-CD117 monoclonal antibody, as a targeted, non-toxic conditioning regimen prior to allogeneic transplant for sickle cell disease (SCD). Jasper Therapeutics and the National Heart, Lung, and Blood Institute (NHLBI) have entered into a clinical trial agreement in which NHLBI will serve as the Investigational New Drug (IND) sponsor for this study. Press release.

The Icahn School of Medicine at Mount Sinai has launched a new center for research into light’s impact on health. The Mount Sinai Center for Light and Health Research in the Department of Population Health Science and Policy will expand on Mount Sinai’s research into light’s influence on mental and physical health, including burgeoning areas such as ultraviolet technology disinfection. The clinical research conducted through the Center will investigate how to use light to improve people’s lives by stabilizing their circadian rhythms, the natural internal clock that regulates the body’s sleep-wake cycle. Researchers will study how light, either from daylight or electric indoor light, affects circadian rhythms in various populations, from the very young to the very old, including patients with COVID-19, cancer, Alzheimer’s disease, depression, and other illnesses. The goal is to help abate symptoms and improve their sleep, mental health, and cognition. Press release.

Medidata has launched Sensor Cloud, a transformative platform for managing a broad range of sensor and digital health technology data during the clinical trial process. Sensor Cloud seamlessly integrates with Medidata Rave Clinical Cloud and supports continuous patient data collection from both Medidata and third-party medical-grade sensors. Following Medidata’s recent acquisition of digital biomarker business MC10, the launch of Sensor Cloud further strengthens the company’s unique data ingestion, analytics, and insights capabilities that currently provide differentiated value to patients, trial sites, trial sponsors and contract research organizations. Using Sensor Cloud, researchers can access sensor data through a single API and integrate new sensor technologies in weeks rather than months. Sensor Cloud provides the ability to enable greater insights through proprietary analytics including novel digital biomarker discovery; lower costs and enable greater operational efficiency by making it easier for patients to share data and stay enrolled in trials; standardize data from ingestion through delivery via a common data model; and reduce site and patient burden by cutting down on-site visits, time, and travel through a more flexible engagement model. Press release.

Parexel and NeoGenomics have announced a strategic partnership to advance the application of precision medicine in oncology clinical trials by applying real-world genomics data to accelerate patient matching and optimize trial design, site selection, clinical development and translational research. The collaboration with NeoGenomics will enhance Parexel’s use of real-world data across various applications, including identifying and estimating prevalence of genomic mutations within respective populations, genomic patterning to stratify patients according to novel biomarkers, and use of de-identified patient data to precisely target patient populations. Collectively these data are designed to better inform clinical trial feasibility, enhance patient matching and create a holistic view of the patient journey by linking genomic data with clinical and consumer datasets. The collaboration will ultimately enable researchers to quickly enroll patients with common to rare cancer mutations and connect them to clinical trials providing the best likelihood of potential treatment success. Press release.

Thermo Fisher Scientific has signed an agreement with JW Therapeutics, a leading cell therapy company, to ensure non-exclusive commercial access to Thermo Fisher’s Gibco CTS Dynabeads CD3/CD28. The agreement will support the clinical development and commercial manufacturing of leading CAR-T (Chimeric Antigen Receptor T-Cells) therapies in China, including JW Therapeutics’ lead product relmacabtagene autoleucel (“relma-cel”). Relma-cel is an anti-CD19 CAR-T therapy for third-line treatment for relapsed or refractory (“r/r”) B-cell lymphoma. The therapy’s new drug application (NDA) has been accepted by China's National Medical Products Administration (NMPA). Relma-cel is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China. The CTS Dynabeads platform is part of Thermo Fisher’s proven Cell Therapy Systems (CTS) product portfolio designed to ease the transition from clinical development to commercial manufacturing of T-cell therapies. Press release.

MMS Holdings is the latest to join the Decentralized Trials & Research Alliance (DTRA), which launched on December 10th, 2020, plans to unite industry stakeholders, including healthcare companies, regulators, patient groups and research organizations with a singular mission to make clinical trial participation widely accessible by advancing policies, research practices, and new technologies in decentralized clinical research. Press release.

Several bits of news from Charles River Laboratories this month. The company has entered into a strategic partnership with Cypre, a biotechnology company that is using 3D hydrogel technology to advance the understanding of the tumor microenvironment and predict therapeutic efficacy. The partnership will provide Charles River clients with access to Cypre’s proprietary 3D tumor model platform, Falcon-X, which will expand Charles River’s 3D in vitro testing services to further optimize immuno-oncological approaches for its clients. Press release. Charles River also announced a definitive agreement to acquire Cognate BioServices, Inc., a premier, cell and gene therapy contract development and manufacturing organization for approximately $875 million in cash, subject to customary closing adjustments. The transaction is expected to close by the end of the first quarter of 2021, subject to regulatory requirements and customary closing conditions. Press release. Finally, Charles River has announced a strategic partnership with Kibur Medical to offer exclusive access to its implantable microdevice (IMD) for in vivo preclinical oncology studies. Kibur’s IMD provides an opportunity to transform how researchers may assess efficacy of oncology compounds in vivo as both individual and combination therapies. Kibur’s microdevice technology can hold up to 20 different compounds for local administration, which allow it to measure interactions between disease tissue and microdoses of therapies to predict the optimal drug regimen; rapidly test multiple combinations at once in vivo in most solid tumors​; and dose therapies directly into disease tissue, allowing for investigative studies of early-stage compounds where pharmacokinetic properties are poorly understood. Press release.