March 2, 2022 | A first-in-class myeloid checkpoint inhibitor was granted fast track designation, clinical trial results are in for vagus nerve stimulation to treat heart failure, a clinical trial launches to assess glycosaminoglycan profiling as all-cancer detection method, and new agreements have been entered or extended to promote decentralized trials and the use of digital twins.

Lunaphore, a Swiss life sciences company developing technology to enable spatial biology in every laboratory, announced it has entered a collaboration with the Pathology Department at Massachusetts General Hospital to develop an in vitro diagnostic (IVD) that evaluates sensitivity of solid tumors to poly-ADP ribose polymerase (PARP) inhibitors, with an initial focus on ovarian, breast and prostate cancers. The project will be led by Markus D. Herrmann, M.D., Ph.D., Director of Computational Pathology at Massachusetts General Hospital, who is also Assistant Professor of Pathology at Harvard Medical School. Lunaphore and Dr. Herrmann will collaborate to develop a multiplexed immunofluorescence assay that can measure the expression of multiple proteins using the COMET platform currently installed at Massachusetts General Hospital. Press release.

Immune-Onc Therapeutics, Inc., a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IO-202, a first-in-class myeloid checkpoint inhibitor targeting leukocyte immunoglobulin-like receptor B4 (LILRB4, also known as ILT3) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML). Immune-Onc received Orphan Drug Designation for IO-202 for the treatment of AML in 2020. LILRB4, also known as ILT3, is an immune inhibitory transmembrane protein found on monocytic myeloid cells, including dendritic cells. LILRB4 inhibits antigen-presenting cell activation, resulting in immune tolerance. LILRB4 is also expressed on certain hematologic cancer cells and monocytic myeloid cells in the solid tumor microenvironment. Immune-Onc and The University of Texas published pioneering research in Nature illuminating the role of LILRB4 in immune suppression and tumor infiltration in AML and presented the rationale for targeting LILRB4 in solid tumors at the AACR Annual Meeting 2021. Press release.

Parasym in partnership with the University of Oklahoma announced groundbreaking research into neuromodulation treatment for heart failure. The randomized-controlled trial, led by principal investigator Stavros Stavrakis at the University of Oklahoma’s Health Sciences Center, used the Parasym neuromodulation device to significantly improve cardiac mechanics and quality of life and to enable reductions in inflammatory markers in a patient population that historically has very few treatment options available. The positive results pave the way for a new era of heart failure treatment. The results from the clinical trial using Parasym’s neuromodulation device demonstrate that Parasym—the only non-invasive, low risk and minimal side effect option—has significantly improved the quality of life for patients suffering from heart failure. The device works by stimulating the vagus nerve and sending signals to the brain, which favorably alters the nervous system and reduces inflammation of the heart. Report.

Researchers from the Antimicrobial Resistance (AMR) Interdisciplinary Research Group (IRG) at Singapore-MIT Alliance for Research and Technology (SMART), MIT’s research enterprise in Singapore, alongside collaborators at Nanyang Technological University, have identified a novel phage lysin—Abp013—that could be used as an alternative antimicrobial agent against two of the most deadly bacteria: Acinetobacter baumannii and Klebsiella pneumoniae. The study is supported by the National Research Foundation (NRF) Singapore under its Intra-CREATE Collaborative Seed Grant. In a paper titled “Novel Phage Lysin Abp013 against Acinetobacter baumannii” published in the medical journal Antibiotics, the SMART AMR team reveals Abp013’s ability to effectively access and kill various bacterial strains. The study showed that Abp013 displayed good permeability and killing activity against multiple Acinetobacter baumannii and Klebsiella pneumoniae strains, even when they are in a more complex environment in which typical lysins are ineffective. Press release. 

Cleveland Clinic announced their Top 10 Medical Innovations for 2022. The list of breakthrough technologies was selected by a committee of Cleveland Clinic subject matter experts, led by D. Geoffrey Vince, Ph.D., executive director of Innovations and chair of Biomedical Engineering at Cleveland Clinic. In order of anticipated importance, the Top 10 Medical Innovations for 2022 are as follows: next generation mRNA vaccinology, PSMA-targeted therapy in prostate cancer, new treatment for the reduction of LDL (Inclisiran), novel drug for treatment of type 2 diabetes (combo glucose-dependent insulinotropic polypeptide and glucagon-like peptide receptor agonist), breakthrough treatment for postpartum depression (intravenous neurosteroid), new targeted medication for hypertrophic cardiomyopathy (cardiac myosin inhibitor), non-hormonal alternatives for menopause (NK3R antagonists), implantables for severe paralysis, AI for early detection of sepsis, and predictive analytics for hypertension.

Swedish molecular diagnostic company Elypta announced the launch of clinical study LEVANTIS-0087A (LEV87A), intended to validate the diagnostic performance of GAGomes—the complete profile of human glycosaminoglycans—as metabolic biomarkers for Multi-Cancer Early Detection (MCED). The study aims to detect any-type cancer in adults who show no symptoms and have no recent history of cancer. The study builds upon proof-of-concept data shared at the American Society of Clinical Oncology (ASCO) conference in June 2021, which indicated that GAGomes could detect one third of all stage I cancers across 14 types. Elypta’s liquid biopsy exceeds the performance of other proposed approaches that use biomarkers based on circulating tumor DNA, which have been shown to capture less than one in five stage I cancers in asymptomatic adults. LEV87A is a retrospective population cohort-based case-control study enabled in part by the low sample volumes required by Elypta’s liquid biopsy. Press release.

Clinixir Company Limited, a startup Clinical Research Organization (CRO) in Thailand, has selected Oracle’s innovative clinical research and pharmacovigilance solutions as its eClinical platform. Clinixir chose the Oracle Health Sciences Clinical One Cloud Service for its comprehensive, end-to-end technology capabilities and breadth of applications. It has also selected Oracle Argus for its safety management, amongst other Oracle applications. Clinixir is the largest provider of clinical trial services to Thailand’s Ministry of Health, as well as several universities, hospitals, and pharmaceutical companies. After careful evaluation, Clinixir selected Oracle to help it run and optimize its clinical trial budgeting, planning and management, monitoring, and analytics. With Oracle, Clinixir will be able to establish a unified data platform for its clinical trial and safety operations and integrate its recently selected Oracle NetSuite Enterprise Resource Planning (ERP) system. Press release.

Unlearn, developer of the Twintelligent RCT, announced that the company has entered into a multi-year collaboration with Merck KGaA, Darmstadt, Germany to accelerate late-stage clinical trials with novel trial designs that include Digital Twins. Initially, the collaboration will focus on advancing the regulatory approval of candidates in Merck KGaA, Darmstadt, Germany’s immunology pipeline, with the potential to expand into other therapeutic areas. Unlearn works with pharma, biotech companies, and academic researchers to optimize human clinical trials by applying cutting-edge artificial intelligence methods to historical patient data. The company generates Digital Twins, which are comprehensive, longitudinal predictions of a patient’s prognosis on a control treatment. Integrating Digital Twins into clinical trials is expected to reduce the required number of patients needed to be enrolled while enabling unbiased estimates of treatment effects. Unlike existing methods such as external control arms, the method Unlearn has developed to incorporate Digital Twins into Twintelligent RCTs does not introduce bias and maintains randomization, two aspects critical to regulators. Using Twintelligent RCTs, Merck KGaA, Darmstadt, Germany plans to incorporate prognostic information from Digital Twins into its randomized controlled trials to enable smaller control groups and generate evidence suitable for supporting regulatory decisions. Press release.
RealTime Software Solutions has released the inSITES Report Builder, a powerful custom reporting tool built into RealTime’s leading Clinical Trial Management System (CTMS) that now allows all customers, at no additional charge, to build and save their own customized reports to monitor site-wide performance and maximize efficiencies and outcomes. The inSITES tool includes a myriad of data points for customers to choose from when building reports on key areas of the business including patient visits, finances, and recruitment. The new tool also allows customers to use “drag-and-drop” technology to reorder their report data to best meet their needs. Press release.

Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, announced that it has entered into a data sharing agreement with Pfizer, a leader in innovative IBD research. The agreement aims to accelerate successful, efficient development of potential new treatments for patients suffering from IBD worldwide by standardizing endoscopic interpretation. As part of the agreement, Pfizer will grant access to one of its IBD clinical trial databases, allowing Iterative Scopes to enrich its disease severity scoring algorithms. Currently, disease severity scoring systems, such as the Mayo Endoscopic Score (MES), are used to meet inclusion criteria in IBD clinical trials and to measure primary and secondary endpoints. These metrics are highly subjective and dependent on physician experience and intuition. Moreover, they present patient recruitment and workflow challenges. Iterative Scopes’ computational algorithms resolve these challenges when integrated with existing colonoscopy imagery to determine clinical trial eligibility. The company’s computational software automates interpretation of colonoscopy videos, enabling clinical trial investigators to arrive at standardized MES scores for individual patients. Press release.

Seqirus, a global leader in influenza prevention and a business of CSL Limited, announced an investment in a new Research and Development (R&D) facility located in Waltham, Mass. The new facility will support the company's growing R&D portfolio, with a focus on a self-amplifying messenger RNA (sa-mRNA) technology platform, the next generation of mRNA technology. The facility will serve as the company's central R&D hub for current and future vaccine design, and collaborations with stakeholders from across the industry and academia. sa-mRNA technology is an important element in Seqirus' R&D pipeline, in addition to the company's adjuvanted, cell-based influenza vaccine (aQIVc) candidate, which combines Seqirus' proprietary MF59 adjuvant with cell-based influenza technology and is progressing into Phase 3 clinical development this year. Press release.

Complion and WCG IRB, the first eISF/eReg and cIRB respectively, have announced the first and only eISF connected to WCG to accelerate the management of IRB documentation throughout the entire clinical trial process. Any site globally is a single click away from connecting Complion to all of their WCG IRB protocols on Connexus for efficiently managing their cIRB documentation electronically into their own eISF seamlessly. Studies are accelerated by ensuring sites are inspection-ready with and notified of approvals, correspondences, and key protocol documents from WCG IRB. Additional benefits include more effective remote monitoring, easier site adoption, and sponsor oversight by eliminating manual processes to move documents from IRB to eISF. Motivated by site-centricity, the Complion and WCG partnership goes a step further to provide a seamless end-to-end user experience and eliminate redundancies for leading academic medical centers, hospitals, research networks, and independent sites using WCG Velos eResearch CTMS. Further, sites realize improved access to information related to patient safety and study conduct with easy clinical staff access to key study documents in WCG Velos powered by Complion and its WCG IRB connection. This adds to the growing list of live and readily available Complion connected solutions. Press release.

Medidata, a Dassault Systèmes company, announced that Parexel, a leading global clinical research organization (CRO) focused on development and delivery of innovative new therapies to advance patient health, is extending their 15-year global strategic partnership. This builds upon the trusted relationship between the two companies and sets the goal of jointly pioneering a new era of decentralized clinical trial technology (DCT) for the life sciences industry. Parexel also participates in Medidata’s Early Adopter DCT program leveraging its unified platform, the myMedidata patient portal, Sensor Cloud, and Medidata’s proprietary Patient Centricity by Design program. Parexel provides feedback and insights to help ensure the portal meets the needs of patients, sites, and sponsors. With myMedidata, patients can virtually access all of their clinical trial needs through one web-based portal, removing the need for provisioned devices and improving clinical trial experiences. Press release.

SomaLogic, a leader in data-driven proteomics technology, announced that the company will begin assaying samples from the Multi-Ethnic Study of Atherosclerosis (MESA) study beginning in the first quarter of 2022. SomaLogic will use its industry-leading assay to analyze 105 million protein measurements from 15,000 samples spanning 15 years of clinical interactions. The MESA study is focused on subclinical cardiovascular disease and the risk factors that predict progression to clinical signs and symptoms. Because the data is shared with outside investigators, this study has also been used by hundreds of investigators to understand other diseases, including COVID-19, eye disease and non-alcoholic steatohepatitis (NASH). SomaLogic will use the SomaScan assay data from the MESA study, as well as information from clinical visits and health histories, to further validate its SomaSignal tests, specifically for cardiovascular disease, diabetes risk and NASH. Press release.

Science 37 and physIQ announced a collaboration to help research sponsors use remote biosensors and machine learning to build more robust data sets. This will help increase the number of digital biomarkers and generate insights from continuous data streams to more quickly and objectively demonstrate the safety and efficacy of treatments. physIQ’s robust platform scalability, near real-time capabilities, established FDA clearance, and proven ability to support large global clinical trials strengthen Science 37’s ability to support additional novel digital biomarkers, advance clinical events detection and provide more proactive safety monitoring. physIQ enables Sponsors to efficiently identify valuable digital measures from large amount of noise inherent in biosensors. Press release.