Trials for Mild Cognitive Impairment, Inflammatory Bowel Disease, MS; New ePRO Offering; THREAD Acquires InVibe
February 2, 2022 | Trials for mild cognitive impairment, inflammatory bowel disease, and MS; ObvioHealth announces a new ePRO offering; positive results for Renalytix risk monitoring tool in diabetic kidney disease study; acquisitions, mergers, and more.
Cognito Therapeutics and Providence Health Plan announced a collaboration to conduct a Phase 3 study of Cognito’s breakthrough, non-invasive disease-modifying therapy for patients with Mild Cognitive Impairment (MCI). The Phase 3 real-world evidence study will evaluate the safety, efficacy, and cost-effectiveness of Cognito’s therapeutic platform in MCI patients treated within Providence Health Plan’s network of nationally renowned neurology specialists. This first of its kind registrational study is expected to begin in Q2 2022, running in parallel to Cognito’s pivotal Phase 3 study in patients with mild-to-moderate Alzheimer’s Disease (AD). This newly launched study with Providence Health Plan is part of a larger multi-study Phase 3 program evaluating Cognito’s disease-modifying optogenetics-based therapeutic in patients with MCI and mild-to-moderate AD. Press release.
Temedica GmbH, based in Munich, is collaborating with NOVENTI Health SE, the largest provider of enterprise resource planning (ERP) systems and claims management solutions for pharmacies in Germany. Temedica and NOVENTI will combine their expertise and capabilities to develop new healthcare insights through Temedica’s data analytics platform, Permea. NOVENTI will add specific health information to further enrich Permea´s insights into patient care. Permea is the data analytics platform recently launched by Temedica to gain a new understanding of healthcare for medical research, development and application of therapies, based on Temedica’s proprietary patient-generated, real-world data. Press release.
Iterative Scopes and Janssen Research & Development are working together on a collaboration to augment Janssen’s clinical trials for inflammatory bowel disease with the deployment of cutting-edge AI and computer vision tools. Patient recruitment and clinical trial workflow inefficiencies are ongoing challenges for gastrointestinal clinical researchers and drug developers. Through this agreement, Iterative Scopes and Janssen will work together to integrate computational gastroenterology solutions to enhance assessment and interpretation of endoscopic video images, facilitating recruitment of eligible patients for Janssen’s IBD clinical trials. Johnson & Johnson Innovation – JJDC, Inc., the strategic venture capital arm of Johnson & Johnson, participated with other investors in Iterative Scopes’ $30 million Series A financing, which closed in August 2021, as well as their $150 million Series B financing, which closed in December 2021. Press release.
ObvioHealth has announced the launch of Augmented ePRO, a tech-enabled clinical trial service that combines AI-assisted ePRO instruments with a centralized clinical rating platform to deliver more accurate, standardized study outcomes. Designed to address the subjectivity and variability that are characteristic of ePRO (electronic patient reported outcomes), this multi-pronged tool enables clinical trial participants to record source data—photos, audio, or video—in real time and upload it using the ObvioHealth app. Once the media is uploaded to the platform, each outcome is assessed and scored by a clinician and/or expert rater. Throughout the process, the COACH (Clinical Oversight And Coordination Hub) virtual site team provides virtual support to both participants and raters, ensuring quality control from start to finish. The platform also contains features that can contribute to the novel outcomes of tomorrow. The clinical notes feature within Augmented ePRO allows clinicians to detail why a rating was determined, and these notes can serve over time to program automatic ratings. Press release.
THREAD has acquired inVibe, a voice-powered research and insights technology solution for the life sciences and health care industry. As clinical trials and real-world research have grown more complex, experts have challenged the industry to bring the patient voice into research studies in one platform. THREAD's new offering addresses these needs by providing actionable intelligence for customers focused on real-world patient experience. This also proactively keeps THREAD customers in compliance as regulators are now requiring patient insights and feedback to be incorporated into clinical research. All inVibe employees, including co-founders, and offices will join the global THREAD team. Financial details of the acquisition are not being disclosed. Press release.
Renalytix announced the publication of positive study results for KidneyIntelX as a risk monitoring tool to assess impact and response to novel treatments for patients with diabetes and chronic kidney disease (CKD) at increased risk for cardiovascular events. KidneyIntelX combines three proprietary biomarkers (sTNFR1, sTNFR2, and KIM-1) and seven clinical variables from a patient’s electronic health record with machine learning to generate a patient-specific risk score. Study data support the value of KidneyIntelX to risk-stratify disease, monitor treatment response, and assess changes in risk over time, showing clinical utility not only as a bioprognostic risk assessment tool but also as a longitudinal monitoring tool. The study identified samples from patients with baseline diabetic kidney disease (DKD) to assess the association of baseline and changes in KidneyIntelX with subsequent DKD progression using the CANVAS (CANagliflozin cardioVascular Assessment Study) multinational clinical trial design as framework. Risk and response to the novel therapeutic were assessed in 1,325 participants from the trial with concurrent DKD and available baseline plasma samples, and KidneyIntelX accurately risk-stratified this large multinational cohort for progression of DKD. Press release.
Imeka, a neuroimaging company combining diffusion imaging and AI to map white matter integrity, announced a collaboration with Atara Biotherapeutics, Inc. to utilize Imeka's novel biomarker technology in a Phase 2 clinical study of patients with progressive forms of multiple sclerosis (MS). Imeka's non-invasive Advanced Neuro Imaging Endpoints (ANIE) biomarker platform will measure the potential effect of Atara's investigational treatment, ATA188, on neuroinflammation and remyelination in the brain and spinal cord in patients with primary progressive MS and secondary progressive MS. Atara is currently evaluating ATA188 in the Phase 2 EMBOLD clinical study in the U.S. and Australia. Press release.
Loftware, a global software company specializing in Enterprise Labeling and Artwork Management solutions, has acquired PRISYM ID, a provider of regulated content and label management solutions with a focus on clinical trials, medical device, and pharmaceutical labeling. The acquisition expands Loftware’s Enterprise Labeling solution offerings for the medical device and pharmaceutical industries while enhancing Loftware’s end-to-end cloud-based labeling platform by adding advanced clinical trial labeling and regulated content management capabilities. Building on PRISYM ID’s industry focus, Loftware will offer customers new levels of innovation to help enable compliance through accurate, validation-ready labeling solutions and regulated product content, while also growing the Loftware platform and offering more services to these strategic markets. The platform empowers companies to optimize continuity, improve agility, and enable traceability as they’re faced with new and ensuing challenges around today’s complex supply chain, which has placed extra emphasis on the importance of labeling. Press release.
Caris Life Sciences and HotSpot Therapeutics, which specializes in allosteric therapeutics, announced a partnership to advance precision medicine approaches for HotSpot’s emerging product portfolio. The partnership will focus initially on two therapeutic programs, the first of which is HotSpot’s novel allosteric inhibitor of the E3 ubiquitin ligase CBL-B, an important target in cancer immunotherapy, spanning from pre-first-in-human trials through potential companion diagnostics and launch. Caris has amassed molecular data on more than 356,000 patients and clinical outcomes on more than 275,000 patients. Insights gained from Caris’ best-in-class real-world clinico-molecular matched database will be leveraged to optimize HotSpot’s development programs, including cohort design, biomarker strategy, and future CDx needs and strategies. Under the terms of the agreement, patients enrolled in HotSpot’s Phase 1 through Phase 3 trials will undergo longitudinal testing with Caris’ comprehensive tissue and liquid molecular profiling analysis. In addition to the commitment to profiling and real-world data insights, Caris is granted negotiation rights for CDx programs of partnership therapeutic programs. While detailed partnership financial terms have not been disclosed, the financial commitment is based on program specifics and has the potential to exceed $40 million if programs progress through regulatory approval and additional milestones are met. Press release.
Sosei Heptares and Verily, an Alphabet precision health company, announced that they have entered into a strategic research collaboration. The research agreement brings together the complementary capabilities of Verily’s immune profiling and Sosei Heptares’ G-protein-coupled receptor (GPCR) structure-based drug design. The companies will collaborate to prioritize the GPCR targets using Sosei Heptares' StaR (stabilized receptor) platform and structure-based drug design expertise, with the goal of generating lead molecules for further development or out-licensing. Press release.
Cognivia announced a new name for the company formerly known as Tools4Patient, which provides clinical trials solutions based on AI/ML that account for individual patient personality traits, beliefs, and perceptions. The transition to Cognivia more closely reflects the company’s mission to “quantify the power of the mind” and integrate this information into data analyses to optimize and accelerate drug development. Cognivia also announced changes to its Board of Directors. Christian Jourquin, a longtime senior leader at Solvay and past board member of ING Bank, became a member of the Board. Graham Bunn, Ph.D., joined the team as Strategic Advisor to the Board. Dr. Bunn has held several leadership roles in CROs and clinical technology companies, including Vice President at Parexel International, Vice President at Medidata, and Global Vice President at Quintiles, now IQVIA. Press release.
Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, announced the acquisition of Institut Dr. Schauerte, a CRO headquartered in Munich, Germany. Founded in 1990, Institut Dr. Schauerte is a full-service, technology-oriented CRO that specializes in late-phase, non-interventional, and post-market clinical follow-up studies. It has conducted more than 400 studies across a range of therapeutic areas. Press release.
BioLife Solutions, a supplier of bioproduction tools and services for the cell and gene therapy and broader biopharma markets, announced an extended collaboration with Seattle Children’s Therapeutics, a venture at Seattle Children’s, bringing cutting edge, curative technologies and therapies to defeat pediatric cancer and other diseases that impact children. The increased alliance will focus on establishing best practices in biopreservation and closed-system manufacturing with the introduction and integration of Sexton’s AF-500 for closed-system processing for cell therapy manufacturing and viral vector delivery that will be used in Seattle Children’s Therapeutics new lentiviral vector manufacturing facility called VectorWorks. Press Release.
