February 23, 2023 | A University of California, Davis research team predicts the female response based on input from readily available male clinical trial participants; a new solution enables researchers to measure whole transcriptomes and paired T-cell receptor sequences—alpha and beta chains—in up to 1 million cells; Insilico Medicine receives Orphan Drug Designation from the FDA for a first-in-class small molecule inhibitor designed to treat idiopathic pulmonary fibrosis; and more. 

Vysioneer announced a data-sharing agreement with Pfizer. The deal aims to lay the foundation for the application of AI in oncology clinical trials. Vysioneer's AI technology provides objective tumor response assessments and unlocks novel biomarkers to predict patient outcomes at the earliest time points. As part of the agreement, Vysioneer gains access to one of Pfizer's oncology clinical trial datasets to apply Vysioneer's advanced machine learning techniques to facilitate the drug efficacy assessment process, thereby allowing Pfizer to assess drug efficacy with greater granularity and explore advanced biomarkers and novel endpoints. AI can markedly improve clinical trial image reading processes and enhance the ability to provide more granular insights down to every single tumor. Press release. 

The University of Texas MD Anderson Cancer Center and Xilis announced a strategic collaboration to deploy Xilis’ proprietary MicroOrganoSphere (MOS) technology in support of preclinical research to accelerate the development of novel cancer therapies. Under the agreement, the two organizations aim to advance drug development and discovery projects using the MOS platform, which enables translational research on patient-derived micro tumors with new capabilities and at a scale not possible with current in vivo models. The MOS technology provides the first reliable platform to rapidly assess how a patient’s tumor responds to various cancer drug modalities within 14 days of obtaining harvested tumor cell samples while sustaining the native tumor microenvironment. The platform can also accelerate the development of disease models, such as those of rare cancers and treatment-resistant diseases. Press release. 

A University of California, Davis, research team is programming a tool to help predict the female response based on input from male clinical trial participants. Using mathematical models of excitation and contraction patterns in male and female human heart muscle cells, the team developed a regression-based “translator” to use male data to predict female heart response. Using male data, the translator successfully predicted female data that matched the computer’s simulated female data for each drug they tried. The program will make it easy to enter readily available clinical data from male EKGs and get feedback on whether the drug would be safe or unsafe for women. Press release. 

Singapore robotics firm AiTreat will embark on a new product evaluation in the United States for their massage robot powered by artificial intelligence at Mayo Clinic. A randomized controlled trial comparing the efficacy of the massage robot with existing therapies such as manual Tuina—a massage used in Traditional Chinese Medicine—in managing chronic low back pain is also being planned in Singapore. The research project will use Expert Manipulative Massage Automation (EMMA), the flagship product of AiTreat. EMMA aims to alleviate the workforce shortage of skilled massage therapists and possibly augment the work of physiotherapists in managing fewer complex cases in Singapore and other countries, thus helping bring down treatment costs while providing consistent, high-quality treatment to every patient. If the trial results are positive, it will pave the way for a robotic solution of an integrative East-West approach in managing low back pain. Press release. 

Parse Biosciences announced the availability of Evercode T-cell Receptor (TCR) and Gene Capture—new solutions to address larger-scale and immune profiling applications. Evercode TCR allows researchers to profile TCRs with whole transcriptomes in single cells at scale. Evercode TCR will enable researchers to measure whole transcriptomes and paired TCR sequences—alpha and beta chains—in up to 1 million cells. Combining TCR sequences with gene expression at this scale makes it possible to track TCR clonotypes across different T-cell subtypes and activation states to understand the immune repertoire at exceptional resolution. Parse also announced the launch of Gene Capture, a solution to reduce sequencing needs for larger studies. Gene Capture focuses sequencing on the most relevant genes, making it possible to efficiently scale projects to millions of cells and hundreds of samples. The solution allows researchers to enrich for 100s-1000s of genes, requiring 10 times less sequencing. Press release. 

Stand Up To Cancer (SU2C) announced four teams focused on increasing diversity in early-phase cancer clinical trials. Supported by a sponsorship from the Janssen Pharmaceutical Companies of Johnson & Johnson, the teams will address an imperative need in the cancer research arena by creating unique and replicable approaches that engage medically underserved communities in Phase 1 and Phase 2 cancer clinical trials. A community engagement grant program now accepts applications to support and complement the teams’ work. SU2C will provide two-year grants ranging from $50,000-$100,000 to organizations within the teams’ regions to develop new or implement existing community programs that focus on diverse cancer clinical trial recruitment. The four Diversity in Early Development Clinical Trials Research Teams will work independently on the following studies: accelerating and diversifying access to clinical trials, eliminating enrollment barriers to early phase trials in a diverse population in Los Angeles County, enhancing diversity in early phase clinical trials in an underserved urban community, and transferring care to improve access to early-phase cancer clinical trials. Press release. 

Insilico Medicine announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to INS018_055 for treating idiopathic pulmonary fibrosis, a chronic lung disease that causes a progressive and irreversible decline in lung function. INS018_055 is a potentially first-in-class small molecule inhibitor discovered by Insilico's generative AI platform, Pharma.AI. This is the first wholly owned program of the Company in which AI was used to identify a novel target and generate novel small molecules. Receiving orphan drug designation from the FDA facilitates eligibility for federal grants, tax credits for qualified clinical trials, prescription drug user fee exemptions, and a seven-year marketing exclusivity period upon FDA approval. Press release. 

CardieX Limited announced a partnership between its ATCOR subsidiary and Power. The new partnership will allow ATCOR and Power to conduct collaborative research and advance underrepresented patient access to clinical trials and clinical research within Alzheimer's, women's health, diabetes, and cardiovascular disease. A primary goal of the partnership is the premiere of new approaches for screening patients with novel inclusion/exclusion criteria across all clinical trial models (conventional, hybrid, and decentralized) to increase patient access and diversity. Digital vascular biomarkers using ATCOR's SphygmoCor technology combined with the searchable patient searchable platform of Power will enable an innovative approach to benchmark the future of patient recruitment to enhance patient-reported outcomes. The "Pulse," a new medical device from CardieX subsidiary CONNEQT, will provide advanced arterial health metrics to users from the comfort of their homes. Pulse was developed as a primary decentralized clinical trial device enhancing patient-centric screening and monitoring. The Pulse enables any patient anywhere to be part of clinical trials. Press release. 

Applied Microbiology International (AMI) responded to a consultation by the UK Government as part of an inquiry to explore the regulatory barriers and opportunities for bacteriophage therapy in the UK and their potential as an alternative or addition to conventional antimicrobial drugs. The Commons Science and Technology Committee selected AMI’s pitch as the winner of the My Science inquiry. In its consultation response, AMI outlined the benefits of bacteriophages as a treatment, including their effectiveness at targeting bacteria resistant to antibiotics, specificity, minimal impact on the gut microbiome, cost-effectiveness, and abundance. There are currently no explicit regulatory guidelines that cover phage therapy and phage-based therapeutic formulations in the European Union or the United States. Press release. 

Personalis and Moderna announced the companies have signed a new agreement to continue using the Personalis NeXT Platform as part of upcoming clinical studies evaluating mRNA-4157/V940, an investigational personalized cancer vaccine, jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada. The platform, also used in the vaccine candidate’s Phase 2b clinical study, will be used to sequence genomic information from a patient’s tumor sample to identify the unique genetic mutations most likely to generate a tailored antitumor response. Press release. 

Adherence specialists AARDEX Group and remote research platform experts in the Clinpal team at Cambridge Cognition have teamed up to provide next-level adherence monitoring during hybrid and decentralized clinical trials (DCTs). Integrating AARDEX Group’s MEMS dosing capture and analytics system with Cambridge Cognition’s Clinpal DCT platform, allows sites to access all study data, including adherence information, in one place. Clinpal manages patient creation and linking, and participants can access adherence data through the Clinpal app. The result is an integrated, easy-to-use system that provides an optimal understanding of patient medicine-taking behaviors during the study while placing no additional burden on sites or participants. Press release. 

Medable announced that its decentralized clinical trial (DCT) platform was selected by the Nova Scotia Health Innovation Hub to increase the accessibility of oncology care for remote patients in rural Nova Scotia, with the long-term aim to improve patient access and trial diversity across Canada. Using Medable’s Total Consent Management and Televisit solutions plus other services, differentiated thyroid cancer patients in the study can speak with a physician when they need it the most—from the comfort of their home. Nova Scotia Health also hopes this strategy will empower primary care providers to be more involved with their patients' post-trial through a shared care model supported by DCT technologies. Medable’s customers have achieved impressive results with decentralized and hybrid trials, including 200 percent faster enrollment and 50 percent cost reductions. Press release. 

COTA announced its membership in the Clinical Research Data Sharing Alliance (CRDSA), a non-profit, cross-industry alliance of biopharma companies, data-sharing platforms, academic institutions, and service and technology partners. As the newest member of CRDSA, COTA will participate in the Alliance’s steering committee and the Innovative Trial Design Working Group. The Working Group’s first project will be focused on non-small cell lung cancer to explore the complementary use of real-world and clinical trial data in research and drug development. The project also aims to address gaps and develop consensus standards to inform regulatory guidance using diverse data types. Press release. 

BenchSci announced the launch of its latest technology, ASCEND by BenchSci, to help remove barriers resulting in 98% of pharmaceutical research investments failing to reach patients. The intuitive software platform empowers scientists to discover biological connections, dramatically reduce trial-and-error experimentation and uncover risks early to move the most promising projects forward faster. Using curated ontology datasets, the platform makes connections across experiment outcomes to create the first commercially available, unbiased, and evidenced-based map of the underlying biology of disease. Press release. 

Verisense Health launched as a digital health software and data management company to provide sponsors with cost-efficient access to a digital biobank of longitudinal raw patient data. The new company is a spin-off of Dublin-based wearable technology services and sensor manufacturer Shimmer Research. Verisense Health will also assume the Verisense Digital Health Panel (DHP) ownership to provide clinical researchers access to raw, real-world, digital health ground-truth sensor data. Going forward, the Verisense platform will be open to non-Shimmer Research hardware. In addition, the Verisense DHP is recruiting clinical study participants and healthy volunteers to its institutional review board-approved longitudinal study. Press release. 

The Swedish medtech company Capitainer AB announced a research collaboration with AstraZeneca. The partnership will develop protocols for relevant biomarkers to AstraZeneca R&D Gothenburg’s clinical drug programs based on Capitainer’s novel self-sampling product delivering cell-free blood, allowing for new patient-centric sampling solutions implemented. Implementing remote quantitative microsampling methods provides an opportunity to transform the way clinical research is conducted in the pharmaceutical industry and has many benefits. Capitainer is the first company to present a quantitative self-sampling product that automatically separates cells from whole blood from a finger stick. Press release. 

Critical Path Institute (C-Path) announced that the European Medicines Agency (EMA) issued a letter of support for the Duchenne Regulatory Science Consortium’s (D-RSC) Model-based Clinical Trial Simulation Platform for Duchenne Muscular Dystrophy (DMD). This model-based clinical trial simulation platform—which is a first-of-its-kind for DMD—will help inform the exploration of key design constructs, including sample size, sampling scheme, patient enrollment criteria, dose and study design, and accelerate medical product development. D-RSC continues to pursue its mission with its collaborative membership spanning academic and clinical researchers, nonprofit research and patient advocacy groups, and the drug development industry. The Letter of Support can be found on the EMA website here or on C-Path’s website here. Press release. 

The Myasthenia Gravis Foundation of America (MGFA) re-launched its MGFA Global MG Patient Registry in partnership with Alira Health. The MGFA registry enables MG patients to safely, securely, and confidentially contribute their health and symptom data to help researchers design and drive clinical trials for making MG discoveries and finding better treatments to improve MG patient outcomes. Patients will add their data to the structured registry questionnaire twice a year, while also having the opportunity to contribute their day-to-day health experience data using the app, so that researchers can benefit from a deeper understanding of the lived experience of patients with MG. Press release.