CELL AND GENE THERAPY
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.
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.
CELL AND GENE THERAPY
iXCells Biotechnologies | September 30, 2022
iXCells Biotechnologies a high growth provider of cell-based products and discovery services to the academic, biotech and pharmaceutical communities worldwide, with special focus on primary and induced pluripotent stem cell derived cellular models, today announced receiving a growth investment from Connecticut-based Great Point Partners a private investment firm focusing on the healthcare industry.
“iXCells is delighted to join GPP’s portfolio of companies operating within the rapidly growing biotech manufacturing and DD&D services space. We’re grateful for GPP’s support of our vision to translate human cell technology into innovative solutions that advance cell biology research and drug discovery. Our partnership with GPP is a critical step forward for our Company’s growth journey.”
Dr. Lynn Zhang, CEO and co-founder
iXCells President and co-founder, Dr. Nianwei Lin added, “Our customers will clearly benefit from the deployment of additional capital towards key growth initiatives that will increase iXCells’ operational capacity, expand our product/service offering and bioanalytical capabilities. In particular, we’ll be strengthening our ability to service unmet market needs in areas of personalized medicine including rare diseases. We’re very much looking forward to collaborating with GPP’s management team and broad network to advance iXCells’ mission for the benefit of all stakeholders.”
Noah Rhodes, Managing Director at GPP, commented, “Lynn and Nianwei have done an exceptional job building a rapidly growing company serving academic, biotech and pharma clients with best-in-class drug discovery solutions and disease-relevant cellular models. We were extremely impressed by the scientific expertise the management team has built within the organization, and we look forward to helping them expand their product and service offering into adjacent high-growth end markets.”
About iXCells Biotechnologies
Founded in 2014 and based in San Diego, CA, iXCells Biotechnologies is an innovative cell biology and cell technology company that provides preclinical drug discovery solutions with the focus on disease relevant cellular models enabling technologies and services to the academic, biotech and pharma communities to accelerate the pace of drug discovery. iXCells offers customers access to high quality primary and iPSC derived cells, custom iPSC services, functional bioassay development and drug screening.
About Great Point Partners
Great Point Partners, founded in 2003 and based in Greenwich, CT, is a leading health care investment firm with 30 professionals, investing in the United States, Canada, and Western Europe. GPP is currently making new minority and majority private equity investments from GPP IV. Great Point manages $1.5B of capital in its private funds and public life sciences equity strategy (BioMedical Value Fund). Great Point Partners has provided growth equity, growth recapitalization, and management buyout financing to more than 200 growing health care companies. The private equity funds invest across all sectors of the health care industry with a particular emphasis on biopharmaceutical services and supplies, alternate site care, medical device and information technology enabled businesses. The firm pursues a proactive and proprietary approach to sourcing investments and tuck-in acquisitions for its portfolio companies.
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.
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.