INDUSTRIAL IMPACT, MEDICAL
prnewswire | April 17, 2023
Caris Life Sciences® the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, and Flare Therapeutics, a biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, today announced a multi-year strategic collaboration to accelerate precision medicine approaches across five of Flare's therapeutic programs into clinical trials through advanced molecular profiling approaches that guide patient selection and participation.
The partnership reinforces Flare's commitment to longitudinal testing, leveraging Caris' comprehensive molecular tissue and liquid profiling services including whole exome sequencing and whole transcriptome sequencing for patients enrolled in Flare's clinical trials, while also applying Caris' data and analytics tools to bolster future clinical trial enrollment programs and companion diagnostics capabilities.
"We understand the importance of shaping translational insights early on as a major area of focus to help ensure efficient drug development at scale and clinical trial preparedness," said Michaela Bowden, Ph.D., Chief Development Officer at Flare. "With access to Caris' robust clinico-genomic real-world data, comprehensive molecular profiling and extensive precision oncology alliance network, we are well positioned to unlock the full potential of drugging transcription factors by further unraveling the molecular complexities of cancer at the patient level and successfully enter the next phase of our growth as a clinical stage company."
Through comprehensive molecular profiling and the application of advanced artificial intelligence and machine learning, Caris has created the largest clinico-genomic database coupled with cognitive computing to unravel the molecular complexity of disease. Under the terms of the agreement, Flare will leverage Caris' industry-leading next generation sequencing technology for the molecular testing of patients treated with Flare's assets. In addition, Flare will receive access to Caris' data insights and analytics capabilities to accelerate oncology drug discovery, identify novel biomarkers and optimize clinical positioning strategies for their pipeline. Flare will also leverage Caris' biomarker-driven patient selection for clinical trials, allowing Caris the first option to develop a companion diagnostic for any drug candidate developed as part of the collaboration.
"This broad partnership with Flare will leverage Caris' leading molecular science and technology solutions to support Flare's novel approach to decipher the biology of transcription factors to develop small molecule medicines," said Milan Radovich, Ph.D., Senior Vice President and Chief Scientific Officer of Caris Life Sciences. "The data accessibility and continuum across real world and clinical trial populations will provide Flare the necessary insights for successful molecule discovery and development."
About Caris Life Sciences
Caris Life Sciences® is the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare and improve patient outcomes. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced artificial intelligence (AI) and machine learning algorithms, Caris has created the large-scale clinico-genomic database and cognitive computing needed to analyze and unravel the molecular complexity of disease. This information provides an unmatched resource and the ideal path forward to conduct the basic, fundamental research to accelerate discovery for detection, diagnosis, monitoring, therapy selection and drug development to improve the human condition.
With a primary focus on cancer, Caris' suite of market-leading molecular profiling offerings assesses DNA, RNA and proteins to reveal a molecular blueprint that helps patients, physicians and researchers better detect, diagnose and treat patients. The company's latest advancement, Caris Assure™, is a blood-based, circulating nucleic acids sequencing (cNAS) assay that combines comprehensive molecular analysis (Whole Exome and Whole Transcriptome Sequencing from blood) and serial monitoring
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MEDICAL
Businesswire | June 07, 2023
Matica Biotechnology, Inc. a contract development and manufacturing organization specializing in the GMP production of cell and gene therapies, today unveiled the company’s new MatiMax™ cell lines at the BIO International Convention, taking place in Boston, MA..
Proprietary to Matica Bio, MatiMaxTM HEK293 and HEK293T cell lines have been rigorously optimized to enable.
Faster doubling times – Reaching as low as 17 hours, which can significantly shorten processing timelines; 30% faster than industry standards
Improved transfection efficiencies – Reducing the amount of DNA and transfection reagents required for production
Increased titers – Supporting higher virus production at a lower cost
“The current industry standard for media-based cell line development — typically focused on a limited set of factors, such as glucose, glutamine, nitrogen and ammonia — can potentially limit scalability, which is mission critical when selecting cell lines during the early stages of cell and gene therapy development to stay competitive,” said Michael Stewart, Matica Bio’s chief technology officer. “As a specialized CDMO, we are changing the rules of the game by incorporating a more holistic, multi-dimensional philosophy into our cell line platforms for cell and gene therapies, which incorporates some of the most advanced processes, analytical technologies and media analysis available. This fine tuning is absolutely necessary to reduce bottlenecks for any viral vector expression system, which, in turn, can improve yields and enable doubling times that are faster than other cell line service offerings on the market.”.
MatiMaxTM is available for customers to use today, and comes in four different cell line options.
HEK293: Adherent
HEK293: Suspension
HEK293T: Adherent
HEK293T: Suspension
“As advances in gene modified therapies continue to grow, Matica Bio is well-positioned to support the exploding number of cell and gene therapy candidates under development, which helps our clients reach the clinic faster with high-quality products,” said Andrew Arrage, Matica Bio’s Chief Commercial Officer. “We already have several clients currently using MatiMaxTM lines, which have immediate availability and attractive licensing terms. Our objective is to empower biopharmaceutical developers to achieve their clinical and commercial goals, and, ultimately, treat more patients.”.
About Matica Biotechnology, Inc.
Matica Biotechnology, Inc. is a contract development and manufacturing organization (CDMO) specializing in fully integrated cell and gene therapy manufacturing. The industry-leading experts at our state-of-the-art facility in College Station, Texas, deliver breakthrough therapies rapidly and safely through innovative manufacturing solutions.
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INDUSTRIAL IMPACT, DIAGNOSTICS
Vaxxinity, Inc. | March 21, 2023
Vaxxinity, Inc. a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, announced that the first subjects have been dosed in a randomized, double-blind, placebo-controlled Phase 1 clinical trial of VXX-401, an investigational vaccine designed to lower low-density lipoprotein (LDL) cholesterol, a known factor contributing to heart disease, by targeting proprotein convertase subtilisin/kexin type 9 serine protease (PCSK9). Heart disease remains the leading cause of death globally, claiming over 18 million lives per year, despite the existence of approved treatments that lower LDL.
“This is an exciting milestone for VXX-401 and Vaxxinity in our pursuit to vaccinate the world against heart disease with a preventative option that is convenient and accessible, addressing an unmet need to combat the leading global cause of death,” said Mei Mei Hu, Chief Executive Officer of Vaxxinity. “PCSK9 antibody therapies are well-tolerated and effective, but huge unmet patient need remains. In order to solve the problem of heart disease, the world needs a scalable, accessible technology that can reach the hundreds of millions, if not billions of people at risk. With an LDL-lowering vaccine we can potentially offer an option that’s cost-effective, safe, convenient, long-acting, and deployable.”
The multicenter Phase 1 dose-escalation trial aims to enroll 48 subjects aged 18 to 75 years, with LDL cholesterol between 2.59 and 4.89 mmol/L. The objectives of the trial are to evaluate safety, tolerability and immunogenicity (as measured by serum anti-PCSK9 antibody titers). Pharmacodynamics of the immune response will be measured by LDL cholesterol levels, an established model of PCSK9 inhibition in hypercholesterolemia.
“We’re excited to get this first-in-human trial of VXX-401 started. The concept of a vaccine for cholesterol could be a game-changer in cardiovascular health due to its potentially very broad reach and impact on human health,” said Professor Stephen Nicholls of Monash University and Victorian Heart Hospital in Australia. “Targeting PCSK9 with a monoclonal antibody is a proven and effective approach for lowering cholesterol and reducing the risk of heart attack and stroke. Despite the availability of statins and the approval of PCSK9-targeting medicines, there is still a need for new therapies. VXX-401 has the potential to extend the use of PCSK9 inhibition to the full population who could benefit.”
Earlier this month, Vaxxinity presented pre-clinical data at the American College of Cardiology/World Congress of Cardiology Annual Scientific Session demonstrating that VXX-401 induced robust anti-PCSK9 antibodies and durable LDL cholesterol lowering without affecting high-density lipoprotein (HDL) cholesterol levels, indicating that VXX-401 has the potential to be a safe and effective LDL lowering therapy. Data in non-human primate studies show that VXX-401 was well tolerated and provided durable and significant LDL reduction of 30% to 50% change from baseline. The data also demonstrate VXX-401’s immunogenicity: purified antibodies from immunized animals bound to human PCSK9 with high affinity, and exhibited a dose-dependent functional inhibition of PCSK9 in vitro. Additionally, Peripheral Blood Mononuclear Cells (PBMCs) collected prior to immunization did not release cytokines upon stimulation with various components of the vaccine, suggesting that VXX-401 may safely overcome immune tolerance.
About VXX-401
VXX-401 was designed using Vaxxinity’s proprietary synthetic peptide vaccine platform and is being developed for the treatment of hypercholesterolemia. The platform is designed to harness the immune system to convert the body into its own natural “drug factory,” stimulating the production of antibodies. VXX-401 is designed to induce robust, long-acting antibodies against PCSK9 in order to lower LDL cholesterol.
About Vaxxinity
Vaxxinity, Inc. is a purpose-driven biotechnology company committed to democratizing healthcare across the globe. The company is pioneering a new class of synthetic, peptide-based immunotherapeutic vaccines aimed at disrupting the existing treatment paradigm for chronic disease, increasingly dominated by monoclonal antibodies, which suffer from prohibitive costs and cumbersome administration. The company’s proprietary technology platform has enabled the innovation of novel pipeline candidates designed to bring the efficiency of vaccines to the treatment of chronic diseases, including Alzheimer’s, Parkinson’s, migraine, and hypercholesterolemia. The technology is also implemented as part of a COVID-19 vaccine program. Vaxxinity has optimized its pipeline to achieve a potentially historic, global impact on human health.
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