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Omega Therapeutics, Inc. (Nasdaq: OMGA) is a clinical-stage biotechnology company revolutionizing medicine through its innovative approach to genomic control. Founded in 2017 by Flagship Pioneering, Omega leverages its proprietary OMEGA platform to develop programmable epigenomic mRNA medicines, aimed at treating and curing a broad range of diseases without altering native nucleic acid sequences.
Omega's core business revolves around the discovery and development of precision therapeutics that selectively direct and control genomic expression pre-transcriptionally. This novel approach allows the company to target nearly all human genes, including those that have been historically undruggable and difficult-to-treat.
The company’s pipeline includes therapeutic candidates for a variety of disease areas such as oncology, rare genetic diseases, immunology, inflammation, metabolic diseases, and regenerative medicine. One of the highlights of Omega’s innovative work includes the development of Omega Epigenomic Controllers, which have shown promising preclinical results, such as the modulation of immune activity to produce significant anti-inflammatory responses.
Recent achievements include the presentation of new preclinical data at the 11th International mRNA Health Conference in Berlin and the American Association for the Study of Liver Diseases' (AASLD) The Liver Meeting® 2023. These data demonstrated Omega’s ability to control the expression of multiple genes simultaneously, showcasing the platform's potential beyond individual diseases.
Financially, Omega Therapeutics reported a cash reserve of $60.0 million as of March 31, 2024, anticipating this will fund operations into Q1 2025. Their recent strategic prioritization aims to extend their cash runway while focusing resources on near-term milestones to support long-term shareholder value.
For more information, visit omegatherapeutics.com, or follow Omega Therapeutics on X (formerly Twitter) and LinkedIn.
Cellarity has announced the release of a groundbreaking single-cell dataset aimed at advancing genetic information mapping, available for a Kaggle competition at NeurIPS 2022. This dataset, generated through collaboration with Yale University and others, includes a time course of 300,000 CD34+ stem cells from human donors, evaluated across five time points. The initiative seeks to develop machine learning algorithms to understand cell differentiation and gene regulation implications for medicine. Entries for the competition close on November 15, 2022.
Omega Therapeutics, Inc. (Nasdaq: OMGA) announced FDA clearance of its IND application for OTX-2002, the first programmable epigenomic controller targeting MYC-driven hepatocellular carcinoma. A Phase 1/2 clinical trial is expected to launch in the second half of 2022, evaluating the drug's safety and efficacy. The company reported $173.7 million in cash as of June 30, 2022, but also noted a net loss of $25.9 million, up from $15.4 million a year prior, primarily due to increased research and administrative expenses.
Omega Therapeutics (Nasdaq: OMGA) will be featured in a fireside chat at the 2022 Wedbush PacGrow Healthcare Conference on August 10, 2022, at 8 a.m. ET. Chief Scientific Officer Thomas McCauley will represent the company, which leads in mRNA therapeutics as programmable epigenetic medicines through its OMEGA Epigenomic Programming™ platform. A live webcast will be accessible via their website, with an archived replay available for 90 days.
Omega Therapeutics has received FDA clearance for its Investigational New Drug (IND) application to initiate a Phase 1/2 clinical trial of OTX-2002, a first-in-class Omega Epigenomic Controller targeting hepatocellular carcinoma (HCC). This trial, expected to launch in the second half of 2022, will assess the safety and preliminary antitumor activity of OTX-2002, which aims to downregulate MYC expression through epigenetic modulation. This milestone represents a significant step for Omega as it marks the first clinical evaluation of an epigenomic controller.
Omega Therapeutics (Nasdaq: OMGA) has presented promising preclinical data on OTX-2002, an epigenomic controller targeting the MYC oncogene, at the ESMO 2022 World Congress. The data showed significant in vivo efficacy in xenograft tumor models and successful downregulation of MYC expression in non-human primates. OTX-2002 demonstrated potential as a monotherapy and in combination with immune checkpoint inhibitors. An Investigational New Drug (IND) application has been filed with the FDA to advance OTX-2002 into clinical trials for hepatocellular carcinoma (HCC).
On June 23, 2022, Omega Therapeutics (Nasdaq: OMGA) announced it will present preclinical data for its lead candidate OTX-2002, targeting hepatocellular carcinoma (HCC), at the ESMO 2022 World Congress in Barcelona from June 29 to July 2, 2022. This first-in-class mRNA therapeutic aims to downregulate the MYC oncogene, which is linked to aggressive HCC in ~70% of cases. An IND application for OTX-2002 has been submitted to the FDA, marking a significant step in the company's development pipeline of programmable epigenetic medicines.
On June 15, 2022, Omega Therapeutics (Nasdaq: OMGA) announced the submission of an Investigational New Drug (IND) application for OTX-2002, a novel mRNA therapeutic targeting hepatocellular carcinoma (HCC). This marks a significant milestone as OTX-2002 is the first of its kind in a new class of programmable mRNA therapeutics designed to downregulate c-Myc expression. The company plans to begin a Phase 1 clinical trial post-FDA clearance, highlighting the potential impact of this therapy on the high mortality rate associated with HCC.
CAMBRIDGE, Mass. -- Flagship Pioneering and Tessera Therapeutics announced Dr. Michael Severino has been appointed as the new CEO of Tessera. With over 20 years of experience in biopharmaceuticals, Severino previously served as Vice Chairman and President of AbbVie, overseeing the development of numerous FDA-approved therapies. Tessera, known for its innovative GENE WRITING technology, aims to transform genetic medicine. Severino's appointment follows Geoff von Maltzahn’s transition to Board Chair, marking a strategic leadership shift as the company prepares for the next phase of growth with its GENE WRITING platforms.
Omega Therapeutics (Nasdaq: OMGA), a biotech company focused on mRNA therapeutics as programmable epigenetic medicines, announced participation in two investor conferences. Mahesh Karande, President and CEO, will speak at the Jefferies Healthcare Conference on June 10, 2022, at 9:30 a.m. ET, and at the Goldman Sachs 43rd Annual Global Healthcare Conference on June 15, 2022, at 5:40 p.m. ET. Live webcasts will be available on their website, with archived replays for 90 days. The company is pioneering innovative approaches in disease treatment through its OMEGA Epigenomic Programming™ platform.
Flagship Pioneering has introduced ProFound Therapeutics, leveraging its ProFoundry™ Platform to discover tens of thousands of novel human proteins, significantly broadening therapeutic targets. The company, founded in 2020, aims to transform human health through unprecedented insights into protein interactions. A commitment of
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