August 31, 2022 | An ultra-sensitive assay accurately measures antibodies against SARS-CoV-2; a single-vendor gene-to-mRNA service delivers custom mRNA within six to eight weeks; Mayo Clinic manufactures biotherapeutics for rare and complex conditions; and more. 

The Institute for Basic Science (IBS) leaders recently met at the National Institutes of Health (NIH) and announced their collaboration with St. Jude Children's Research Hospital to increase virus research capacity and ability to respond to infectious disease outbreaks. Meeting participants discussed their respective institutes' latest research status and possible cooperation opportunities between institutions. These initial meetings could potentially lead to additional communication and information exchanges between the IBS and NIH in the field of life sciences in the future. Press release. 

PathAI announced a multi-year expanded collaboration agreement with Bristol Myers Squibb. The initial work will focus on key translational research in oncology, fibrosis, and immunology, with an overall goal of transitioning into clinical trials. Bristol Myers Squibb and PathAI will utilize AI pathology models with the potential to de-risk therapeutic development across Bristol Myers Squibb’s pipeline. In addition, the companies plan to leverage these models to help enhance patient segmentation in clinical trials across multiple disease indications and develop AI-powered diagnostics, including measuring CD8 T-cell infiltration across oncology areas. Press release. 

The Wyss Institute for Biologically Inspired Engineering at Harvard University announced that Spear Bio licensed its DNA nanotechnology-driven ultrasensitive Successive Proximity Extension Amplification Reaction protein-detection technology, granting the Boston-based startup rights to commercialize the technology. Spear Bio will develop a reagent-based platform for ultrasensitive protein detection in small-volume samples with an initial focus on research-use-only applications. Their first focus will be to commercialize an ultra-sensitive assay that can accurately measure the levels of neutralizing antibodies against SARS-CoV-2. Press release. 

The University of Texas MD Anderson Cancer Center and Erasca announced a strategic research and development collaboration to evaluate multiple agents from Erasca’s pipeline targeting the RAS/mitogen-activated protein kinase pathway as either single-agent or combination therapies. The new strategic partnership will enhance Erasca’s and MD Anderson’s evaluation of Erasca’s ERK1/2 inhibitor ERAS-007 and its SHP2 inhibitor ERAS-601 in combination with investigational and standard-of-care agents, including Erasca’s proprietary pipeline programs, such as the KRAS G12D inhibitor ERAS-4. Under the terms of the five-year agreement, collaborative preclinical and clinical studies will be conducted on non-small cell lung cancer, gastrointestinal malignancies, and additional mutually agreed-upon indications. Press release. 

SpIntellx announced a new partnership with iCura Diagnostics to transform precision oncology. SpIntellx’s software-based solutions will combine with iCura Diagnostics’ expertise as a technical CRO, propelling the pace of immunotherapy and targeted therapy development. Through this strategic alliance, the two companies will deliver advanced spatial analytics and explainable AI-powered decisions at scale across the drug development continuum, driving multimodal data integration, optimizing clinical workflow, accelerating biomarker discovery, and empowering personalized care. They also plan to launch a suite of solutions combining genomic, proteomic, transcriptomic, and clinical data to explore the complex spatial heterogeneity in the tumor microenvironment. Press release. 

GenScript USA announced a new research use only and pre-clinical messenger RNA (mRNA) synthesis service for biopharma research and development teams. Messenger RNA provides new therapeutic opportunities to synthesize the proteins used to engineer personalized medicines, but until now, mRNA development involves contracting with several specialist suppliers. In contrast, GenScript's IVT mRNA offers a single-vendor gene-to-mRNA service that delivers custom mRNA within six to eight weeks, expanding the possibilities for personalized medicines such as patient-specific cancer vaccines or protein replacement for rare diseases. Press release. 

EVONETIX announced the opening of its early access program for semiconductor synthesized DNA. Evonetix’s proprietary process utilizes a novel silicon chip to control the synthesis of DNA at many thousands of independent thermally controlled reaction sites, or “pixels,” on the chip surface. This approach enables the accurate synthesis of thousands of sequences on a single chip to meet the demand for complex libraries and assembly of long DNA, addressing the DNA supply bottleneck in synthetic biology. Researchers can apply for the company’s early access program to receive some of the first DNA prepared using its technology and demonstrate the efficacy of Evonetix DNA in routine molecular biology workflows. Press release. 

SEQSTER PDM announced the release of SeqsterOS—an Operating System for patient registries and clinical studies—in Amazon Web Services Marketplace, a curated digital catalog of third-party software, data, and services that help businesses build solutions. SEQSTER OS automates and integrates real-world data in real time, leading to better study participant engagement and retention. Its HIPAA and FDA 21 CFR Part 11-compliant OS provides an end-to-end solution for pharmaceutical companies and contract research organizations. Its multi-region high availability/disaster recovery redundancy powers all the tools needed for study and data management. Press release. 

Mayo Clinic announced a strategic collaboration with National Resilience to manufacture biotherapeutics for rare and complex conditions and establish Rochester as a center for biomanufacturing regenerative technologies. The partnership combines science, engineering, and manufacturing to develop biologic-derived medicines to facilitate tissue-specific repair. Mayo's goal is to accelerate clinical care options for patients. Press release. 

Boston University’s Chronic Traumatic Encephalopathy (CTE) Center researchers will team up with the Laboratory for Science and Health in Artistic Performance at Ohio University to study the brains of stunt performers in a program called Stunt Performance Research Investigating Neurological Trauma (SPRINT). BU CTE Center researchers suspect stunt performers are at high risk for CTE because they are exposed to repeated trauma throughout their stunt-performing careers. With this combined effort, researchers hope to gather essential information to improve safety in stunt performance, preserve the long-term brain health of stunt performers, and advocate for specialized healthcare provisions. Press release. 

Saama Technologies announced a multi-year agreement with Merck to build and operationalize a new clinical data layer leveraging Saama’s Life Science Analytics Cloud (LSAC), strengthen Merck’s clinical development capabilities, and expedite pipeline progress. Under the agreement, Merck will integrate LSAC into its clinical development systems to improve speed and efficiency related to the ingestion, curation, and transformation of data and facilitate processing from multiple internal and external data sources to various business platforms and analytics needs. Saama's LSAC is an end-to-end, machine learning-enabled clinical data management and cognitive insight platform designed to accelerate clinical research outcomes. Press release. 

A team of researchers at the Patient-Focused Research at LUNGevity Foundation conducted a multi-step project involving patients, caregivers, trialists, regulators, and clinical trial sponsors to streamline the informed consent process. Informed consent forms are long, usually written in scientific jargon, and include extraneous information. Patients supported the creation of a tri-fold template summarizing key points of the ICF, which could serve as an addendum. The appendix would provide a summary of pertinent details with page numbers for more information. Press release. 

Researchers at the University of California San Diego School of Medicine and Rady Children’s Hospital-San Diego joined a nationwide study to understand the long-term impact of COVID-19 across all US demographic patient groups. The $1.15 billion, four-year study, sponsored by the National Institutes of Health, is called the Researching COVID to Enhance Recovery (RECOVER). The teams will evaluate how often long-COVID occurs within the community following acute infection and follow the natural history of and risk factors for the disease over several years in newborns, children, and young adults. The RECOVER consortium represents and supports more than 100 researchers at more than 200 sites. The teams will study and share data in real time, providing the scale necessary to develop information and answers as quickly as possible. Press release. 

Arabian International Healthcare Holding Company (“Tibbiyah”), an integrated healthcare solutions provider in Saudi Arabia, announced a definitive Joint Venture Agreement with BGI Almanahil Health for Medical Services, a subsidiary company of BGI Health, in the formation and operation of a limited liability company to be called Saudi Advanced Medical Lab LIMITED in Saudi Arabia. The new company, owned 50% by BGI Almanahil and 50% by Tibbiyah, will provide clinical laboratory testing and bio-information services to hospitals, research institutes, and medical centers and clinics for the public and private sectors. Press release. 

The National Institutes of Health (NIH) launched the Initiative to Improve Education in the Principles of Rigorous Research. This program—led by the Office of Research Quality at the National Institute of Neurological Disorders and Stroke, part of NIH—will contain various training modules covering the strict application of the scientific method to experimental rigor, good study design, and transparency in reporting. The initiative also includes the Creating an Educational Nexus for Training in Experimental Rigor (CENTER) award. The University of Pennsylvania in Philadelphia received a grant for building a platform to bring high-quality teaching materials to the broader scientific community. The other four awards are projects that will develop the educational materials in collaboration with, and ultimately hosted by, CENTER. Press release. 

Children’s Hospital of Philadelphia (CHOP) helped launch a new computational platform that will harmonize pediatric cancer data, allowing stakeholders to accelerate drug development for pediatric cancer. CHOP researchers created the Molecular Targets Platform to facilitate pediatric research in response to the Research to Accelerate Cures and Equity for Children Act, which requires companies to test cancer drugs in children when the adult drug shares a molecular target. CHOP researchers used their expertise to harmonize data from six major data sources on pediatric cancer targets, genes, and pathways. The platform allows users to query multiple aspects of pediatric cancer, from cancer targets to a gene’s relationship to disease. Press release. 

Akadeum Life Sciences launched their Dead Cell Removal Microbubble Kit to enable researchers to separate viable cells from dead cells. When mixed in the sample, microbubbles bind to the dead cells and then float them to the surface for removal, leaving behind healthy cells. This revolutionary cell separation method effectively maintains a larger number of viable and only requires about half the starting amount of cells as other methods due to its low cell loss rate. The benefits of microbubble technology are vital for researchers, giving them more flexibility in the types and numbers of experiments that can be performed. Press release. 

Thermo Fisher Scientific launched a new automated sample prep and ultra-high-performance liquid chromatography system to improve efficiency, robustness, sensitivity, and sample traceability. The new Thermo Scientific Transcend DSX-1 eliminates disc punching typically associated with dried matrix (spot) cards and optimizes sample extraction and recovery of multiple matrices (e.g., blood, urine, serum, and saliva). Proprietary flow-through desorption with heated capillary eliminates the need for manual, time-consuming extraction protocols, and the automatic addition of an internal standard before the extraction minimizes matrix interference. Furthermore, the Intelligent Vision Camera ensures data integrity and enables retrospective monitoring by capturing sample traceability, the chain of custody, and accurate spot recognition. Press release. 

A new agreement between Upstate Medical University and Binghamton University’s Thomas J. Watson College of Engineering and Applied Science will strengthen ties between the two schools and encourage closer research collaborations. A memorandum of understanding (MOU) signed last week will allow the institutions to jointly pursue sponsored funding opportunities and develop solutions to today’s pressing medical problems. The agreement also provides Watson faculty greater access to Upstate’s core facilities, biosamples, clinical data, and access to human subject research. Likewise, Binghamton University’s Health Sciences Core facility will be available to Upstate’s researchers. The MOU is slated to last five years, with renewals possible beyond 2027. Press release. 

The University of Texas MD Anderson Cancer Center and TransCode Therapeutics announced a strategic alliance to advance TransCode’s RNA-targeted oncology therapeutic and diagnostic candidates pipeline. TransCode and MD Anderson scientists will collaborate on preclinical studies to further validate TransCode’s therapeutic and diagnostic candidates and expand the reach of TransCode’s discovery engine. The collaboration has the potential to inform multiple clinical programs in TransCode’s pipeline, starting with its lead therapeutic candidate designed to treat numerous metastatic cancers. Press release. 

The Alliance for Clinical Trials in Oncology, in partnership with the National Cancer Institute, part of the National Institutes of Health, announced the opening of a new study that aims to assess the utility of early cancer detection blood tests. The Alliance Multicancer Early Detection (MCED) Biobank Study will enroll approximately 2,000 men and women aged 40 to 75 who are either healthy individuals without cancer, individuals with untreated cancer, or individuals who may have cancer. These blood tests identify the presence of multiple cancers before symptoms occur. The Alliance MCED Biobank Study will also incorporate a new web-based tool called the Alliance Participant Engagement Portal. This optional resource will allow participants to receive direct updates about the study's progress via text or e-mail. Press release. 

The National Institutes of Health updated its Strategic Plan for NIH Research to Cure Hepatitis B, which focuses on developing a cure and improved strategies for vaccination, screening, and follow-up care. The virus transmits through contact with infected bodily fluids. People infected early in life may develop chronic infections, suffer liver-related complications, and succumb to the illness. The updated plan details three priorities: improve understanding of Hepatitis B biology, build tools and resources, and create strategies to cure and prevent the disease. Press release. 

NeuroSense Therapeutics and NeuraLight announced a collaboration to advance the science of digital biomarkers in detecting and monitoring neurological diseases, including amyotrophic lateral sclerosis (ALS). The NeuroSense-NeuraLight partnership entails sharing and tracking patient data using proprietary computer vision and deep learning algorithms to advance the identification and use of ALS digital biomarkers in a parallel, double-blind, placebo-controlled study conducted by NeuraLight. This collaboration marks NeuraLight's first clinical trial and comes on the heels of NeuraLight's $25M Series A raise. Press release.