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.
prnewswire | May 08, 2023
Frost & Sullivan announced that it has awarded Genomenon with the 2023 Global Technology Innovation Leadership Award. Each year, Frost & Sullivan presents this award to the company that has developed a product with innovative features and functionality that is gaining rapid acceptance in the market. The award recognizes the quality of the solution and the customer value enhancements it enables. Frost & Sullivan market analysts determined that Genomenon excels in many of the criteria and best practices identified as critical for the global pharma and clinical diagnostics genomics markets.
Genomenon is a genomic intelligence software company that combines AI-powered Genomic Language Processing (GLP) with expert review by genetic scientists to deliver the most comprehensive knowledgebase of genomic evidence available. Their fit-for-purpose combinatorial approach to identifying and indexing published genomic evidence gives them a unique advantage over other open access and commercial genomic data resources in this space.
Clinical diagnostic labs rely on Genomenon's Mastermind Genomic Search Engine to find critical information needed to diagnose rare genetic diseases and identify the most appropriate patient treatment options. Pharmaceutical companies engaged in the development of rare disease therapeutics partner with Genomenon to gain deep insights into the genetic drivers of disease. The Genomenon scientific team leverages information in the Mastermind knowledgebase to provide the genomic intelligence pharmaceutical companies need to better understand disease mechanisms, more accurately estimate disease prevalence, design clinical trials, and prepare documentation for regulatory approvals.
Pavel Zhebrouski, a best practices research analyst at Frost & Sullivan, observed, "Genomenon differentiates itself in the space by providing a unique combination of AI technology and human expertise. Genomenon empowers rare disease pharmaceutical and biotechnology companies to make informed decisions about promising candidates in their pipeline and help propel novel therapeutics to market. Its commitment to innovation and creativity, scientific rigor, and accuracy, while achieving commercial success, differentiates it from competitors," added Tejashri Khadilkar, Frost & Sullivan industry analyst.
Frost & Sullivan Best Practices awards recognize companies in various regional and global markets for demonstrating outstanding achievement and superior performance in leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analyses, and extensive secondary research to identify best practices in the industry.
Genomenon is an AI-driven genomics company focused on making genomic information actionable for patients with rare genetic diseases and cancer. Keeping pace with the ever-evolving body of knowledge within genomics, Genomenon connects current research with patient DNA to accelerate clinical decision-making and pharmaceutical drug discovery and development.
INDUSTRIAL IMPACT, MEDICAL
Businesswire | March 29, 2023
Bicycle Therapeutics plc a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that it has entered into a strategic collaboration agreement with Novartis to develop, manufacture and commercialize Bicycle® radio-conjugates (BRCs) for multiple agreed upon oncology targets.
“This collaboration builds on the groundbreaking clinical work we have been doing in the toxin conjugate field and provides new and additional validation for this unique technology,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. “We look forward to working closely with Novartis to pioneer the discovery and development of potential new cutting-edge radiopharmaceutical cancer treatments based on Bicycles. We believe the properties of Bicycles make them well suited for the development of precision guided radiopharmaceuticals and represents the next leg in the application of our proprietary discovery platform in oncology.”
Under the terms of the agreement, Bicycle will utilize its proprietary phage platform to discover Bicycles to be developed into BRCs. Novartis will be responsible for further development, manufacture and commercialization of the BRCs. Novartis will fund all pre-clinical and clinical development and commercialization activities. Bicycle will receive a $50 million upfront payment and is eligible for development and commercial-based milestone payments totaling up to $1.7 billion. Bicycle will also be eligible to receive tiered royalties on Bicycle-based medicines commercialized by Novartis.
About Bicycle Therapeutics
Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development. Bicycle is evaluating BT5528, a second-generation Bicycle Toxin Conjugate targeting EphA2; BT8009, a second-generation BTC targeting Nectin-4, a well-validated tumor antigen; and BT7480, a Bicycle TICA™ targeting Nectin-4 and agonizing CD137, in company-sponsored Phase I/II trials. In addition, BT1718, a BTC that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial sponsored by the Cancer Research UK Centre for Drug Development. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA.