INDUSTRIAL IMPACT, MEDICAL
Globenewswire | March 31, 2023
Omega Therapeutics, Inc. a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenetic mRNA medicines, today announced a clinical supply agreement with Roche to evaluate OTX-2002, its lead candidate in development for the treatment of MYC-driven hepatocellular carcinoma (HCC), in combination with Roche’s anti-PD-L1 therapy, atezolizumab, as part of Omega’s Phase 1/2 MYCHELANGELO™ I clinical trial.
“This agreement with Roche represents continued execution of our clinical trial strategy and the next step toward realizing the transformative potential of OTX-2002, a first-in-class epigenomic controller designed to pre-transcriptionally downregulate the MYC oncogene, a historically undruggable target,” said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. “In preclinical studies, OTX-2002 demonstrated synergistic antitumor activity with existing standard of care therapies for HCC, including anti-PD-1 and anti-PD-L1 immune checkpoint inhibitors, with minimal impact on safety and tolerability. Through the combination of two orthogonal treatments, OTX-2002 and atezolizumab, a leading anti-PD-L1 therapy, we aim to simultaneously disrupt multiple drivers of cancer progression with the goal of improving treatment outcomes. With Roche’s support and partnership, we look forward to assessing the ability of this novel combination approach to enhance antitumor immune response in patients with advanced HCC.”
The ongoing Phase 1/2 MYCHELANGELO I trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of OTX-2002 as a monotherapy (Part 1) and in combination with standard of care therapies in patients with relapsed or refractory HCC and other solid tumor types known for association with the MYC oncogene. Preliminary data from the Phase 1 monotherapy dose escalation portion of the study are anticipated in 2023.
Under the terms of this agreement, Roche will supply atezolizumab and Omega will evaluate the combination as part of the overall conduct of the trial.
About Omega Therapeutics
Omega Therapeutics, founded by Flagship Pioneering, is a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenetic mRNA medicines. The Company's 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. Using a suite of technologies, paired with Omega's process of systematic, rational, and integrative drug design, 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 modular and programmable mRNA medicines, Omega Epigenomic Controllers™(OECs), target specific epigenomic loci within insulated genomic domains, EpiZips, from amongst thousands of unique, mapped, and validated genome-wide DNA sequences, with high specificity to durably tune single or multiple genes to treat and cure diseases through unprecedented precision epigenomic control. Omega’s approach enables pre-transcriptional control of most human genes including historically undruggable, intractable, and difficult to treat targets. Omega’s pipeline of OEC candidates spans a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases.are Diseases and Orphan Drugs from the Accreditation Commission for Health Care. PANTHERx is now a five-time winner of the prestigious MMIT Patient Choice Award, including the 2022 honor. PANTHERx is headquartered in Pittsburgh, licensed in all 50 states, and holds accreditations from URAC, NABP, and ACHC.
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Caris Life Sciences | March 09, 2023
Caris Life Sciences®, a leading molecular science and technology firm and Incyte Corporation have recently announced a strategic research partnership to advance precision medicine approaches for Incyte's oncology pipeline.
Caris' innovative technology integrates data from whole exome sequencing, protein analysis, whole transcriptome sequencing and proprietary AI models and signatures to enhance patient outcomes through personalized medicine development. The partnership will initially apply Caris' data and analytics tools, comprehensive molecular liquid and tissue profiling services, and clinical trial enrollment program capabilities spans two therapeutic programs, with the option to expand to four total programs.
Incyte will use Caris' data insights and analytics capabilities to uncover novel biomarkers and enhance clinical positioning strategies for its oncology initiatives. Patients enrolling in Incyte-led clinical trials will be subjected to longitudinal testing with Caris' comprehensive tissue and liquid molecular profiling tests for drug candidates developed as part of the agreement. Incyte will also use Caris' biomarker-driven patient selection for clinical trials, with the possibility of collaborating on creating companion diagnostics for the partnership's programs.
Caris Life Sciences President and Chief Scientific Officer David Spetzler, MS, Ph.D., MBA, commented, "This partnership with Incyte will leverage Caris' leading molecular science and technology solutions to support Incyte's oncology research and development efforts." He further emphasized, "The aggregate strength of our platform, which provides patient level DNA and RNA data both in tissue and blood, may help to better identify and predict patient response to therapy, which in turn may accelerate clinical trial enrollment, optimize clinical positioning and potentially enhance technical and regulatory success."
(Source – PR Newswire)
About Caris Life Sciences
Caris Life Sciences® is a leading molecular science firm that utilizes advanced technologies to revolutionize healthcare. Its suite of molecular profiling offerings, which assess RNA, DNA and proteins, enables patients, researchers and physicians to improve outcomes and save lives by revealing a molecular blueprint. Additionally, it is advancing precision medicine through the use of advanced AI and machine learning algorithms by utilizing its proprietary analytics engine, DEAN™, to develop a better understanding of the molecular mechanisms of cancer. This information helps physicians to better identify and predict patient response to therapy and supports researchers and biopharmaceutical companies in research development, clinical trials, and target identification. With headquarters in Irving, Texas, the company has offices in several locations worldwide, providing services throughout the US, Europe, Asia, and other international markets.
MEDTECH, INDUSTRIAL IMPACT
Globenewswire | April 13, 2023
Centogene N.V. the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced the launch of NEW CentoGenome®, an enhanced Next Generation Sequencing (NGS)-based assay. Healthcare professionals can leverage NEW CentoGenome to provide more comprehensive diagnostic information, which could accelerate access to potential treatment options.
Serving as a first-line test, NEW CentoGenome is the most comprehensive commercially available Whole Genome Sequencing (WGS) test on the market for both rare and neurodegenerative disorders – covering almost all disease-causing variants, including the most relevant repeat expansions associated with neurological diseases, in a single assay. NEW CentoGenome also detects Copy Number Variations (CNVs) associated with Spinal Muscular Atrophy (SMA), as well as complex disease-causing variants associated with Gaucher Disease (GD) and susceptibility to GBA1-related Parkinson's Disease (PD), with the highest levels of sensitivity.
The newly designed WGS assay leverages a Polymerase Chain Reaction (PCR)-free approach. This significantly diminishes the typical bias induced by PCR and provides higher quality sequencing data across the typically challenging regions of the genome by enabling more uniform coverage and superior performance in variant detection.
“As a pioneer of genetic diagnostics, we are committed to enabling access to high-quality diagnostics and ensuring that cutting-edge data analyses are available to support better patient health outcomes,” said Prof. Peter Bauer, Chief Medical and Genomic Officer at CENTOGENE. “Building on this expertise, CENTOGENE’s enhanced whole genome sequencing is the leading solution on the market, reflecting the latest advanced technologies and unique insights that can’t be found anywhere else to provide maximized disease coverage. Ultimately, this will provide physicians with an unparalleled level of certainty when diagnosing, prognosing, and treating patients.”
CENTOGENE’s NEW CentoGenome - Superior Technology With Market-Leading Clinical Coverage in a Single Test
CENTOGENE’s enhanced WGS solution consists of three seamlessly integrated key features
Advanced Technology for Greater Insights
Implementing PCR-free technology to significantly reduce bias and provide high-quality sequencing information for difficult-to-sequence genetic regions – enabling greater insights into coding, regulatory, and intronic regions
Superior Performance for Enhanced Disease Coverage
Delivering superior performance in variant detection thanks to CENTOGENE’s automated CE-IVD bioinformatics pipeline and medical expert-based analysis of the CENTOGENE Biodatabank, which consists of approximately 700,000 patients representing over 120 highly diverse countries
Integrated Variant Reclassification and Confirmatory Testing for a Life-Long Commitment to Patients
Demonstrating CENTOGENE’s unique commitment to improving the lives of patients with rare and neurodegenerative diseases, NEW CentoGenome is paired with life-long diagnostic support and a free-of-charge and proactive diagnosis confirmation and reclassification program
CENTOGENE’s mission is to provide data-driven, life-changing answers to patients, physicians, and pharma companies for rare and neurodegenerative diseases. We integrate multiomic technologies with the CENTOGENE Biodatabank – providing dimensional analysis to guide the next generation of precision medicine. Our unique approach enables rapid and reliable diagnosis for patients, supports a more precise physician understanding of disease states, and accelerates and de-risks targeted pharma drug discovery, development, and commercialization.