CELL AND GENE THERAPY

Taysha Gene Therapies Announces New Additions to Leadership Team to Deepen Manufacturing and Communications Capabilities

Taysha | December 30, 2020

Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-driven gene therapy organization focused in on creating and commercializing AAV-based quality treatments for the treatment of monogenic infections of the focal sensory system in both uncommon and huge patient populaces, today reported new increases to its authority group with the arrangements of Greg Gara as Senior Vice President of Manufacturing and Kimberly Lee, D.O., as Senior Vice President of Corporate Communications and Investor Relations.

Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric gene therapy organization zeroed in on creating and commercializing AAV-based qgene therapies for the treatment of monogenic infections of the focal sensory system in both uncommon and huge patient populaces, today declared new increases to its authority group with the arrangements of Greg Gara as Senior Vice President of Manufacturing and Kimberly Lee, D.O., as Senior Vice President of Corporate Communications and Investor Relations.

Spotlight

During embryogenesis, the musculoskeletal system develops while containing within itself a force generator in the form of the musculature. This generator becomes functional relatively early in development, exerting an increased mechanical load on neighboring tissues as development proceeds.

Spotlight

During embryogenesis, the musculoskeletal system develops while containing within itself a force generator in the form of the musculature. This generator becomes functional relatively early in development, exerting an increased mechanical load on neighboring tissues as development proceeds.

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CELL AND GENE THERAPY

Hamilton and BioFluidica Pen Next Generation Liquid Biopsy Platform Co-Marketing Agreement

BioFluidica, Inc. | September 28, 2022

Biofluidica, Inc., and Hamilton Company, announced a co-marketing agreement to bring advanced Liquid Biopsy capabilities to laboratories worldwide. Biofluidica has developed the next-generation liquid biopsy platform, enabling Hamilton liquid handlers to process biological samples to isolate extremely rare circulating tumor cells, circulating Leukemic cells, fetal cells, cfDNA, and exosomes. The Biofluidica platform, LiquidScan™, integrates seamlessly into the Hamilton pipetting robots. The high precision fluid control provided by the Hamilton automated pipetting channels is designed to avoid processing loss using the Biofluidica proprietary closed-loop pipetting interface with the Biofluidica microfluidic biomarker selection chips. This announcement represents early commercialization for BioFluidica and a unique alliance for Hamilton Company. The STARlet offers a custom application-configurable liquid handling robot with sensitive programmable pneumatic features that enable walk-away automation for precision biological procedures. LiquidScan utilizes these features to isolate and enrich rare biomarker populations directly from biological samples such as a blood draw potentially replacing the need for surgical biopsies and making testing available for cancer types not previously amenable to surgical biopsy. "LiquidScan is a novel platform that enhances the ability to perform diagnostic testing applied to many diseases, including several types of cancer, prenatal diagnostics, stroke, and infectious diseases. We have worked with Hamilton to ensure seamless automation allowing for high-throughput and lower-cost testing than current surgical biopsy procedures. There is a win-win scenario here for patients, physicians, and the healthcare system. Because LiquidScan uses a standard blood draw, and non-invasive screening, patients can receive closer monitoring of treatment regimens, and physicians can attain higher quality and earlier patient results. Expensive and time-consuming surgical procedures can be removed from the health-care system." Rolf Muller, BioFluidica CEO About Hamilton Hamilton is a leading global manufacturer, providing automated liquid handling workstations and laboratory automation technology to the scientific community. With a focus on innovative design, Hamilton products incorporate patented liquid handling technologies into a portfolio that includes liquid handling platforms, standard application-based solutions, small devices, consumables, and OEM liquid handling solutions. Known for advancing life science, clinical diagnostics, forensics, and biotechnology industries, Hamilton products offer reliability, performance, and flexibility. Ensuring a continuous commitment to quality, Hamilton utilizes state-of-the-art manufacturing at production facilities in Reno, Nevada, and Bonaduz, Switzerland and has earned a global ISO 9001 certification. Privately held, Hamilton maintains headquarters in Reno, Nevada; Franklin, Massachusetts; and Bonaduz, Switzerland, along with subsidiary offices throughout the world. About BioFluidica BioFluidica Inc. is a privately held biotechnology company that has developed a revolutionary liquid biopsy platform.

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INDUSTRIAL IMPACT

MycoWorks Secures Strategic Investment from GM Ventures to Develop Fine Mycelium Materials for Sustainable Automotive Interiors

MycoWorks | October 19, 2022

Biotechnology company MycoWorks announced today its newest investor GM Ventures, the investment arm of General Motors Co. and their long-term agreement to co-develop Fine Mycelium™ materials for potential use in a range of applications within automotive design. MycoWorks' collaboration with GM marks the exploration of its entry into one of the largest end-use markets for leather and demonstrates the significant opportunity to create more sustainable materials for the automotive space. MycoWorks' breakthrough Fine Mycelium technology engineers mycelium, the infinitely renewable root structure of mushrooms, to craft a range of natural, customizable leather alternatives that match the performance of the highest quality animal leather with lower environmental impact. The company's platform has enabled a new class of premium, non-animal materials which could have the opportunity to support GM's continued progress toward its vision of a world with zero crashes, zero emissions and zero congestion. Animal-free and chrome-free, Fine Mycelium also has superior strength at low thicknesses, offering a compelling pathway to efficiency and weight reduction in car interiors while still meeting the most stringent performance, aesthetic, and environmental requirements of the automotive space. "Working with General Motors to introduce Fine Mycelium to the automotive industry is an enormous step forward in the global new materials revolution. MycoWorks's collaboration with GM is a first for us outside of the fashion industry, demonstrating the enormous potential and applications for Fine Mycelium." Matt Scullin, CEO of MycoWorks "Our strategic investment in MycoWorks aims to advance the development of sustainable automotive materials," said Wade Sheffer, managing director of GM Ventures. "This collaboration will help facilitate R&D efforts and build more sustainable alternatives for our designers." In August 2022, following an oversubscribed $125M Series C funding round, MycoWorks broke ground on its first full-scale production facility, which will enable initial mass-production volumes of several million square feet of Fine Mycelium materials per year, dramatically increase production and partnership capacity, and service Fine Mycelium to a wider range of industries and companies. About MycoWorks In 2013, co-founders Philip Ross and Sophia Wang formed MycoWorks, a San Francisco-based biomaterials company dedicated to bringing new mycelium materials to the world. MycoWorks' patented Fine Mycelium technology, an advanced manufacturing platform and breakthrough in materials science, engineers mycelium during growth to form proprietary, interlocking cellular structures for unparalleled strength and durability. About General Motors General Motors is a global company focused on advancing an all-electric future that is inclusive and accessible to all. At the heart of this strategy is the Ultium battery platform, which powers everything from mass-market to high-performance vehicles. General Motors, its subsidiaries and its joint venture entities sell vehicles under the Chevrolet, Buick, GMC, Cadillac, Baojun and Wuling brands.

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CELL AND GENE THERAPY

Eiger BioPharmaceuticals Provides Update on Plans for Emergency Use Authorization Application Following FDA Feedback

Eiger BioPharmaceuticals, Inc. | October 06, 2022

Eiger BioPharmaceuticals, Inc. a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus and other serious diseases, today announced that, following feedback from the U.S. Food and Drug Administration the company will not submit an emergency use authorization application of peginterferon lambda for the treatment of patients with mild-to-moderate COVID-19. Following Eiger's press release on September 6, 2022, the company submitted a pre-EUA meeting request to FDA, as well as additional morbidity and mortality outcomes data and analyses from the investigator-sponsored TOGETHER study. This included further statistical modeling and efficacy analyses of the study's primary and secondary endpoints and long-term follow-up data that the company believes continue to support the initial positive topline outcomes reported in March. In response, FDA denied the request for a pre-EUA meeting. Citing its concerns about the conduct of the TOGETHER study, FDA concluded that any authorization request based on these data is unlikely to meet the statutory criteria for issuance of an EUA in the current context of the pandemic. FDA suggested that, given peginterferon lambda's mechanism of action and the ongoing need for improved COVID-19 therapeutics, Eiger consider requesting an end-of-Phase 2 meeting to discuss a company-sponsored pivotal trial that could support an eventual Biologics License Application. Eiger is evaluating next steps for this program, in the U.S., as well as ex-U.S. emergency use authorization pathways and strategic options for continued development of peginterferon lambda for COVID-19 and other respiratory viral infections. "While we are disappointed that FDA will not consider an EUA application based on results generated from the TOGETHER study, we continue to have strong conviction in the potential of peginterferon lambda to confer a meaningful benefit for patients with COVID-19 and other respiratory viral infections. COVID-19 related deaths remain alarmingly high around the globe, including in the U.S. where, according to recent data from the Centers for Disease Control and Prevention, approximately 400 people die every day from this disease." David Cory, President and CEO, Eiger Eiger is advancing a late-stage pipeline of multiple FDA Breakthrough Therapy designated programs in Phase 3, including lonafarnib and peginterferon lambda for hepatitis delta virus (HDV) infection, and avexitide for congenital hyperinsulinism. The company expects to report topline data from D-LIVR, Eiger's landmark Phase 3 study of lonafarnib-based regimens for HDV, by year end. About TOGETHER Study TOGETHER is an independent multi-center, investigator-sponsored, randomized, placebo-controlled adaptive platform Phase 3 study evaluating therapeutics in newly diagnosed, high-risk, non-hospitalized patients with mild-to-moderate COVID-19. TOGETHER is the largest placebo-controlled study in COVID-19 and has evaluated 11 different therapeutic agents for non-hospitalized COVID-19 patients. The study was ongoing at the time the peginterferon lambda arm was added. The evaluation of peginterferon lambda versus placebo was the second largest study to date of a COVID-19 therapeutic of > 1,900 patients. Eligibility criteria required that all patients had laboratory-confirmed mild or moderate COVID-19 and were randomized within seven days of symptom onset. The study enrolled patients regardless of vaccination status or variant strain of SARS-CoV-2. The primary endpoint was a reduction in risk of clinical outcome comparing hospitalizations or emergency room visits greater than six hours after a single subcutaneous injection of peginterferon lambda versus placebo through Day 28. A key secondary endpoint was reduction in risk of hospitalizations or death in patients when dosed within three days of symptom onset. The TOGETHER study recruited from 12 sites in Brazil and 5 sites in Canada. About Peginterferon Lambda Peginterferon lambda is an investigational late-stage, first-in-class, type III interferon that stimulates immune responses that are critical for the development of host protection during viral infections and has been well-tolerated in clinical studies. Eiger is developing peginterferon lambda for the treatment of HDV infection. Peginterferon lambda has been administered to over 4,000 subjects in 28 clinical trials of HBV, HCV, HDV and COVID-19. Peginterferon lambda is an investigational agent and not yet approved for any indication. Eiger has received Orphan Designation by the U.S. Food and Drug Administration and European Medicines Agency, and Fast Track and Breakthrough Therapy Designation by FDA for peginterferon lambda in HDV. About Eiger Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious diseases. The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication.

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