January 26, 2023 | A major new initiative in cancer research to study the role and function of the non-coding genome and epigenome in multiple cancer types; the first one-stop-shop decentralized clinical trial platform bundled with site and trial execution services for the digital therapeutics market; a unique and unparalleled suite of early to late-phase CRO services across Europe, the US, and Asia Pacific; and more.

Curebase announced the release of its integrated software and services package for digital therapeutics (DTx) trials that accelerates enrollment and allows sponsors to launch their studies faster. The new Curebase offering now includes the first one-stop-shop decentralized clinical trial (DCT) platform bundled with site and trial execution services for the DTx market. It also includes virtual site models, CRO services, and recruitment tactics tried and tested in digital therapeutic studies, allowing DTx sponsors to launch a study with the confidence of proven execution quickly. Not only does the Curebase DCT model accelerate the enrollment process, but it also allows DTx trial sponsors to scale studies to include more geographically and ethnically diverse participants. Press release.

Cure Mito Foundation, in collaboration with five rare disease companies—PTC Therapeutics, Astellas, Saol Therapeutics, Standigm, and Abliva—announced the launch of a unique Corporate Advisory Council (CAC). The CAC’s goal is to unite mitochondrial disease stakeholders across different organizations with a common goal to accelerate the development and delivery of treatments, and ultimately a cure, for Leigh syndrome and mitochondrial disease. CAC members will have a seat around the table within the patient advocacy community while raising awareness and visibility of its companies and their programs. Press release.

Strata Oncology announced that Gilead Sciences agreed to collaborate on the Strata Precision Indications for Approved THerapies (Strata PATH) trial by providing TRODELVY (Sacituzumab govitecan-hziy) for eligible patients with cancer. Strata PATH is a prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of multiple FDA-approved cancer therapies in new, biomarker-guided patient populations. Several biomarkers are being considered, including quantitative RNA and multivariate algorithms that may optimize the use of different anti-cancer therapies. These biomarkers can be analyzed in parallel with the genomic mutations assessed by comprehensive genomic profiling, thus maximizing the information available from often limited tumor tissue samples. Press release.

The New York Genome Center (NYGC) announced the launch of the MacMillan Center for the Study of the Non-Coding Cancer Genome (MCSNCG), a major new initiative in cancer research to study the role and function of the non-coding genome and epigenome in multiple cancer types, including breast, ovary, pancreas, gastrointestinal, lung, and hematologic cancers. The MCSNCG will coordinate efforts to understand how behavior is encoded in cells and unravel the intricacy of intercellular interactions involved in developing cancerous cells, metastasis, and drug resistance. The MCSNCG will also leverage existing regional cancer and genomic technology research initiatives anchored by the NYGC collaborative network to study cancer genomes of under-represented minority populations to understand the role of genetic diversity in cancer, improve the application and outcome of precision medicine, and address the stark ethnic disparities in cancer research and diagnosis. Press release.

CellMax Life announced positive results from a multisite U.S. study that showed that its FirstSight blood test is highly accurate in detecting colorectal cancer and advanced adenomas. CellMax’s FirstSight is the first blood test superior to stool tests in detecting advanced adenomas and colorectal cancer. It can detect advanced adenomas by combining signatures from ctDNA and methylation along with rare epithelial cells shed from adenomas using the company’s proprietary circulating epithelial cells technology. Based on clinical data showing FirstSight’s ability to detect both colorectal cancer and advanced adenomas with high sensitivity, CellMax received Breakthrough Device Designation from the U.S. Food and Drug Administration in Q3 2021. Press release.

TC Biopharm announced a strategic collaboration with the University of Texas MD Anderson Cancer Center to expand the knowledge base of how gamma-delta T cells work in oncology settings. The partnership combines MD Anderson's clinical trial infrastructure and the translational research expertise of its immunotherapy platform with the clinical data of TC BioPharm's targeted gamma-delta T cell oncology pipeline. Under the terms of the three-year agreement, the research teams will work together on preclinical and clinical studies to evaluate the potential for gamma-delta T-cell therapies and to better understand the behaviors of these cells in patients. The collaborators will form a six-person steering committee to drive the development of both the data set and subsequent assays for each study. Press release.

Greenphire, a financial lifecycle management company for clinical trials, announced the appointment of Owen Newman as the Chief Financial Officer (CFO). Joining the company's leadership team, Newman brings over 25 years of financial experience, most recently as CFO of Simeio. Newman will report directly to Greenphire's CEO, Jim Murphy. Newman brings an extensive background in financial operations management, risk management, strategic planning, mergers and acquisitions, process improvement, and regulatory compliance. Before Simeio, Newman cultivated his fintech depths by serving as the Senior Vice President of Finance and Divisional Chief Financial Officer at ACI Worldwide. Press release.

Novotech has announced the acquisition of EastHORN as a part of Novotech’s global expansion program. The acquisition means biotech clients can access Novotech’s unique and unparalleled suite of early to late-phase CRO services across Europe and the US, with a specialist focus on the Asia Pacific, where the company has built a reputation for delivering high-quality expedited clinical trials. Novotech has decades of biotech drug development experience, exceptional site and investigator relationships, access to vast patient populations, and a project management approach focused on problem-solving, ownership, and flexibility. Consistent investment in advanced training and technology combines to deliver an exceptional full-service biotech CRO solution. Press release.

Baylor Scott & White Research Institute, the Translational Genomics Research Institute, part of City of Hope, a nonprofit biomedical research center, and OncoHost announced a new research study. This new, multi-year study will use Baylor Scott & White’s Texas Immuno-Oncology Biorepository—which collects, catalogs, and stores samples of biological material for cancer research—to analyze resistance mechanisms in cancer using multi-omics tools, including proteomics, single cell analysis, Ct-DNA, microbiome analysis, bioinformatics, and machine learning tools. A comprehensive analysis will be conducted on lung cancer patients at various stages of the disease, analyzing elements such as the host response, the patient’s microbiome, tumor DNA, and immune system activity. The study will use OncoHost’s PROphet platform, a plasma-based, proprietary proteomic analysis tool that guides decision-making in choosing first-line treatment in cancer patients. The platform also identifies and highlights personalized drug combinations to mitigate active resistance mechanisms to overcome treatment resistance. Press release.

Symeres announced the acquisition of Oncolines as their third acquisition in the past ten months. Oncolines is a contract research organization that offers precision medicine services in oncology and immunotherapy. Their mission is to help clients bring improved and novel therapies to the right patient population faster. The company offers cancer cell line profiling assays through a panel of over 200 cell lines, combination studies to identify novel synergies, and mechanistic cell biology. This acquisition complements Symeres’ drug discovery capabilities with high-quality biology and biophysics capabilities in oncology. TSymeres will extend Oncolines’ services across the broader Symeres platform, resulting in a more integrated offering to service new and existing customers better. Press release.

BC Platforms has been chosen to analyze and manage data collected from the Health for Life in Singapore (HELIOS) study, which forms part of the SG100K data set for Singapore's National Precision Medicine program. The HELIOS study is a state-of-the-art population cohort study established and led by the Lee Kong Chian School of Medicine (LKCMedicine) at Nanyang Technological University, Singapore. The population study aims to identify environmental, lifestyle, and genetic factors that cause heart disease, diabetes, cancer, and other chronic diseases in Singapore. BCP will provide BC|INSIGHT and BC|RQUEST for safely and securely managing LKCMedicine’s genotype and phenotype patient data from a large Asian cohort safely and securely. The platform has a high focus on user experience, and it is fully equipped with cohort-building tools and capabilities to automate data release approval processes and highly dynamic open workspaces. Press release.

Agilent Technologies announced a partnership with Akoya Biosciences to develop multiplex-immunohistochemistry diagnostic solutions for tissue analysis and to commercialize workflow solutions for multiplex assays in the clinical research market. Integrating Agilent’s Dako Omnis (autostaining instrument) and Akoya’s PhenoImager HT (imaging platform) for multiplex chromogenic immunohistochemistry and immunofluorescent assays will create a singular end-to-end commercial workflow, including reagents, staining, imaging, and analysis. These assay solutions will enable researchers and medical professionals to address patient selection needs of novel therapeutics and rapidly translate their discoveries into clinical testing. This agreement will deliver an end-to-end multiplex solution for biomarker clinical research enabled by digital pathology, providing capabilities across the pharma value chain. Press release.

Biognosys AG and Bruker Corporation announced a strategic partnership in which Bruker has made a majority-ownership investment in Biognosys. Financial details were not disclosed. Biognosys will access Bruker’s leading 4D proteomics timsTOF technology for deeper, unbiased high-precision proteomics unimpaired by epitope cross-reactivity—all with higher throughput and excellent reproducibility. The Bruker-Biognosys collaboration is expected to create unique synergies between Biognosys’ versatile portfolio of proprietary proteomics services, software, and kits and Bruker’s pioneering timsTOF platform. As a result of the strategic partnership, Biognosys plans to open its first advanced proteomics CRO services laboratory in the United States. Press release.

Medable announced a partnership with the non-profit, Every Cure, which officially launched in September in collaboration with the Clinton Global Initiative to scale up an innovative “drug repurposing” research approach to identify treatments for rare diseases. Every Cure is on a mission to save more lives by identifying new uses for existing drugs and conducting clinical trials of the most promising treatments to evaluate their effectiveness for FDA-approval or off-label clinical use. Every Cure has developed a MATRIX tool that uses machine learning and AI to identify and rank treatments. A pilot study uncovered 106 promising drug repurposing opportunities in the first 147 diseases. Medable will provide specialized software and services while Every Cure conducts clinical trials of the most promising and high-impact opportunities for FDA approval of an existing drug with a new indication. Press release.