CELL AND GENE THERAPY
BioInvent | October 27, 2020
BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech company focused on novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces it has received regulatory authority approval of its clinical trial application (CTA) in Denmark for a Phase I/IIa, first-in-human study of BI-1808, as monotherapy and in combination with the anti-PD-1 therapy Keytruda® (pembrolizumab) for the treatment of solid tumors and cutaneous T-cell lymphoma (CTCL). Martin Welschof, CEO of BioInvent, says, "CTA approval for our Phase I/IIa trial of BI-1808 marks the first anti-TNFR2 antibody to enter clinical development. BI-1808 is a first-in-class anti-TNFR2 antibody, which we believe is a very promising approach for cancer therapy, and testament to the power of our proprietary n-CoDeR® and F.I.R.S.TTM platforms to generate antibodies to novel targets with potent anti-tumoral activity. We expect to enroll the first patient before the end of the year and to submit an investigational new drug (IND) application in the U.S. in the coming weeks." The study will explore the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent and in combination with Keytruda® in patients with ovarian cancer, non-small cell lung cancer and CTCL. It will also investigate the expression of potential immunological markers that might be associated with clinical responses. The trial will be conducted at several sites across Europe and the U.S. and is expected to enroll approximately 120 patients.
TransPerfect Life Sciences | February 16, 2022
TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, today announced that Innovaderm will scale their implementation of Trial Interactive to further enable and optimize remote clinical operations.
Innovaderm, a North America-based contract research organization (CRO) that specializes in clinical studies for dermatology, leveraged Trial Interactive remote monitoring rooms to drive research forward and continue helping partners discover new therapies during the COVID-19 pandemic. By incorporating customized Trial Interactive remote monitoring rooms into its service offering, Innovaderm allowed customers to access Trial Interactive’s Study Document Collaboration solution, enabling successful remote trial execution.
Innovaderm’s partnership with TransPerfect began several years ago with language translation services. To eliminate its paper-based approach for clinical trial document management, Innovaderm then implemented Trial Interactive’s eTMF. As Innovaderm further optimized its clinical research strategy, TI Study Start-Up replaced the CRO’s manual process for distribution and collection of essential documents from sites, resulting in a more transparent, efficient path for site activation and reduced timelines for starting new studies.
Trial Interactive delivers user-friendly document and trial management solutions to help pharmaceutical, biotechnology, and CRO companies effectively streamline product development life cycles. A connected eClinical experience, Trial Interactive improves speed, quality, and compliance across site identification, selection, and activation, as well as study teams and site personnel training, content management, eISF, eTMF management, CTMS, and closeout. The platform offers industry-leading, fast-to-implement, cost-effective solutions in a secure 21 CFR Part 11-compliant environment.
“Trial Interactive worked with us to ensure our remote monitoring room configuration met our key requirements so we could conduct our studies without interruptions, delays, or significant changes. As we’ve faced unexpected shifts in the way we run and monitor studies, Trial Interactive has been key to enabling us to perform remote monitoring visits.”
Isabel Dorion, Director of Clinical Operations at Innovaderm
Michael Smyth, TransPerfect Life Sciences Solutions Division President, stated, “We’re moving into an era where decentralized clinical trials are becoming more common, and conducting clinical research processes remotely is key to keeping trials moving forward and getting life-saving products to market faster. With our solution of remote monitoring rooms, Trial Interactive has been able to help clients like Innovaderm shift to remote processes without losing momentum for their studies.”
About Trial Interactive
TransPerfect’s Trial Interactive is an industry leader in practical eClinical innovation that simplifies and automates clinical processes for sponsors, CROs, and sites around the world. The 21 CFR part 11 compliant unified platform delivers an author-to-archive collaboration experience with solutions for clinical document management, site selection, site activation, eLearning, compliance training, quality, and CTMS with seamless solution interoperability and indexing to the eTMF. Trial Interactive is consistently selected by clinical professionals for providing the most comprehensive yet intuitive experience with the most complete offering of technology and expert TMF services. Trial Interactive helps study teams streamline their operations by cutting unnecessary expenses, expediting timelines, reducing compliance risks, and improving operational excellence.
About TransPerfect Life Sciences
TransPerfect Life Sciences specializes in supporting global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include eTMF and eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact.
About Innovaderm Research, Inc.
Innovaderm is a prominent contract research organization (CRO) collaborating with the biotech companies in the management of Phase 1 to 3 dermatology trials across many regions. Founded in 2000, the company provides a broad range of services including study design, protocol development, site selection, patient recruitment, regulatory and ethics submissions, clinical trial management, clinical monitoring, data management, biostatistics, medical monitoring, pharmacovigilance and medical writing. Committed to quality, Innovaderm is managing its activities in accordance to current Good Clinical Practice (GCP) from the International Conference of Harmonization (ICH), and being fully compliant with major international regulations such as the FDA (USA), Health Canada and EMA (Europe).
Omega Therapeutics, Inc | October 14, 2021
Omega Therapeutics, Inc. ("Omega"), a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programing™ platform, today announced a strategic research collaboration with researchers at the Stanford University School of Medicine to explore the therapeutic potential of Omega Epigenomic Controllers (OECs) to control ocular disease genes associated with inflammation or regeneration of ocular tissues.
Under the terms of the collaboration, Omega and members of the Ophthalmology Department of Stanford University School of Medicine will use the OMEGA Epigenomic Programming platform to discover and research novel ocular targets for potential future OEC development candidates. Albert Wu, M.D., Ph.D., FACS, Associate Professor of Ophthalmology, will serve as principal investigator. Other contributors will include Jeffrey Goldberg, M.D., Ph.D., Professor and Chair of Ophthalmology, and Michael Kapiloff, M.D., Ph.D., Associate Professor (Research) of Ophthalmology.
"Through this research collaboration, we aim to expand the reach of our OMEGA platform within regenerative medicine, immunology, and inflammation with ocular disease targets. We will continue exploration of the broad potential of our disruptive platform and OECs, our new class of mRNA therapeutics as programmable epigenetic medicines."
Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics
About Omega Therapeutics
Omega Therapeutics is a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming™ platform. The OMEGA platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth and differentiation to cell death. The OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's engineered, modular, and programmable mRNA-encoded epigenetic medicines, Omega Epigenomic Controllers™, target specific intervention points amongst the thousands of mapped and validated novel DNA-sequence-based epigenomic loci to durably tune single or multiple genes to treat and cure disease through Precision Genomic Control™. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases.