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.
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MEDTECH, INDUSTRIAL IMPACT
INOVIO Pharmaceuticals, Inc. | February 01, 2023
On January 31, 2023, INOVIO, a leading biotechnology firm focused on the development and commercialization of DNA medicines to protect and treat people from cancer, HPV-associated diseases, and infectious diseases, announced a strategic reorganization to meet operational efficiency commitments and better position the company to deliver DNA medicines to patients.
Following the previously announced end of clinical development projects in late 2022, the restructuring is estimated to result in yearly savings of roughly $4.3 million and an 11% reduction in full-time personnel. These and other strategic initiatives divert resources needed to progress critical programs, such as INOVIO's product candidate INO-3107 for the treatment of Recurrent Respiratory Papillomatosis (RRP).
INOVIO anticipates a $1.1 million one-time restructuring charge in the first quarter of 2023. Its 2022 fourth-quarter and year-end financial results announcement, scheduled for March 2023, will provide more precise financial guidance.
INOVIO's lead initiatives include therapies for HPV-related disorders, such as INO-3107 for RRP and VGX-3100 for cervical high-grade squamous intraepithelial lesions (HSIL). In the first quarter of 2023, INOVIO is anticipated to release the results of its Phase 3 REVEAL2 study for VGX-3100 and the second cohort of its Phase 1/2 trial for INO-3107.
About INOVIO Pharmaceuticals, Inc.
Headquartered in Plymouth Meeting, PA, INOVIO Pharmaceuticals, Inc. is a biotechnology firm dedicated to bringing precisely designed DNA therapeutics to market in order to treat, cure, and protect individuals from infectious diseases, cancer, and HPV-related diseases. INOVIO's in-development DNA medications are delivered utilizing its investigational proprietary smart device, CELLECTRA®, to elicit immune responses against targeted pathogens and malignancies. Its DNA medicines platform and the proprietary smart device can target almost any DNA sequence. With 15 clinical studies in development, the company has the potential to save and protect lives throughout the world and fuel a new decade of DNA medicines.
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INDUSTRIAL IMPACT, MEDICAL
Inscripta, Inc. | January 24, 2023
Inscripta®, a leading global life science technology firm, recently announced the acquisition of two synthetic biology pioneers, Infinome Biosciences and Sestina Bio, which will advance Inscripta's strategy of developing and commercializing biomanufactured products for a wide expanse of industrial and consumer markets.
The acquisitions show Inscripta's belief in the bioeconomy's commercial potential and the power of genome engineering to expedite biomanufacturing innovation. Inscripta's CEO, Sri Kosaraju, commented, "Tackling the unprecedented opportunity to improve global health and sustainability through biomanufacturing requires a strong combination of talent, experience, technology, and commercial assets." He added, "Infinome and Sestina Bio allow us to advance our strategy and complement our technological innovation and capabilities needed for creating the next generation of biobased manufacturing products and processes."
(Source- PR Newswire)
Before the acquisition, Infinome was closely associated with Inscripta. By utilizing Inscripta's genome engineering technology, it created the GenoScaler™, a proprietary strain engineering platform designed to optimize microorganisms for biomanufacturing rapidly.
Sestina Bio brings an innovative, data-driven approach to developing and identifying strains that survive the rigors of commercial scale-up.
Inscripta is building on its tradition of technological innovation with the inclusion of Infinome and Sestina Bio and has already begun applying its cutting-edge technology to develop products for a diverse set of industrial and consumer markets. In addition, Inscripta has a number of collaborative and proprietary products in various phases of development. One such example of an announced partnership to develop and commercialize multiple bio-manufactured goods is Kalsec® Inc., a food and beverage ingredient solutions firm. Separately, Inscripta is engaging in commercial discussions about its previously announced development of a ready-to-scale microbial strain that produces Bakuchiol, a natural retinol alternative.
About Inscripta, Inc.
Founded in 2015, Inscripta is a life science technology firm dedicated to using biomanufacturing to create a cleaner, healthier, and more sustainable world. It enables scientists to strengthen and expand domestic biomanufacturing and encourages the development of novel, safe, and secure biotechnology technologies. Its automated OnyxTM platform, which includes an instrument, consumables, tests, and software, makes CRISPR-based genome engineering accessible to any research lab. Inscripta supports customers globally through its facilities in Boulder (Colorado), San Diego and Pleasanton (California) and Copenhagen (Denmark)
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