CELL AND GENE THERAPY
Q&#178; Solutions and IQVIA, Tasso | October 07, 2022
Q² Solutions, a wholly owned subsidiary of IQVIA and a leading global clinical trial laboratory services organization, today announced the launch of the first self-collection safety lab panel for U.S. clinical trial participants by a leading global clinical trial laboratory.
Developed in collaboration with Tasso Inc, a leader in clinical-grade blood collection solutions, this unique offering combines industry leading laboratory services, patient focused logistics and cutting-edge, self-collection technology.
Participants in clinical trials can now provide a blood specimen for lab testing in the comfort of their own home, without the need to visit an investigator site or have a healthcare professional visit them. The first test panel available through this collaboration is designed to help monitor liver function by measuring the levels of select enzymes and proteins in the blood. The panel includes tests for ALT AST ALP total bilirubin, direct bilirubin, total protein, and albumin.
“The global pandemic has accelerated the use of decentralized approaches in clinical trials. We at Q² Solutions are highly motivated to find ways to reduce patient burden related to laboratory testing, and I’m delighted that, through our collaboration with Tasso, we could make the self-collection liver panel a reality. Soon we will launch more than a dozen safety tests, and we are determined to continue to expand our catalog of tests available via the self-collection of blood.”
Brian O’Dwyer, CEO of Q² Solutions
“We are thrilled to be working with a leader like Q² Solutions on this important initiative to make laboratory testing truly patient-centric,” said Erwin Berthier, PhD, CTO and Co-Founder of Tasso. “Our clinical-grade remote sampling technology enables decentralized laboratory testing without sacrificing sample quality, a key hurdle that home testing has faced in the past. Together, Q² Solutions and Tasso are developing important solutions that make clinical trials better for both patients and sponsors.”
This self-collection liver panel was developed with trial participants at the heart of the design. The offering includes easy to use at-home self-collection kits with instructions and videos, a methodology for direct-to-patient delivery, as well as simplified specimen processing and shipping requirements.
About Q² Solutions
Q² Solutions is a leading global clinical trial laboratory services organization that provides comprehensive testing, project management, supply chain, biorepository, biospecimen, and consent tracking solutions. Leveraging our next generation technologies, we deliver agile and precise services designed to meet the diverse needs of our clients. We provide scientific expertise and innovative solutions for ADME, bioanalytical, genomics, vaccines, and central laboratory services, including flow cytometry, anatomic pathology, immunoassay, molecular, companion diagnostics and translational science, with meticulous regional and global clinical trial implementation support and high-quality data delivery. At Q² Solutions, our work is rooted in research, grounded in collaboration, and guided by our passion to turn the hope of patients and caregivers around the world into the help they need.
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 82,000 employees, IQVIA conducts operations in more than 100 countries.
IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures.
Trusted diagnostics made easy. Tasso is an emerging healthcare technology company that is transforming the traditional blood collection paradigm with a patient-centric approach. The company’s devices enable simple, convenient, and virtually painless blood collection for users. Tasso technology has the power to bring healthcare anywhere, any time. Headquartered in Seattle, Washington, Tasso is privately held and funded by grants, investments, and co-development deals with various industry leaders.
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.
CELL AND GENE THERAPY
Kriya Therapeutics | November 17, 2022
Kriya Therapeutics, Inc., a fully integrated gene therapy company advancing a broad portfolio of innovative therapeutics announced the acquisition of Redpin Therapeutics, Inc., a privately held biotechnology company developing regulatable gene therapies for intractable diseases of the nervous system. The acquisition serves as the foundation for Kriya’s neurology therapeutic area portfolio, with two lead gene therapy programs focused on epilepsy and trigeminal neuralgia.
Redpin’s proprietary chemogenetics platform can selectively activate or silence disease-causing neurons, while leaving normal functioning cells unaffected. Currently available treatments for neurological disorders typically rely on systemically administered drugs or surgical interventions to address local neuron dysfunction. However, these approaches can have limited efficacy and off-target side effects. In contrast, chemogenetics leverages gene products that are selectively responsive to a chosen small molecule. Redpin’s technology utilizes gene therapy to express engineered ion channels that are responsive to modulation by the FDA-approved anti-smoking drug varenicline to either inhibit specific overactive neurons or stimulate underactive ones.
“Redpin’s innovative chemogenetics platform has the potential to transform the lives of patients suffering from intractable neurological conditions. We are looking forward to integrating Redpin’s platform and pipeline into Kriya’s gene therapy engine as we advance our mission to develop life-changing gene therapies that can address diseases affecting millions of patients around the world.”
Shankar Ramaswamy, M.D., Co-Founder and Chief Executive Officer of Kriya
“Redpin has a built a breakthrough, validated chemogenetics approach that could have significant potential in the targeted treatment of neurological disorders,” said Dr. Elma Hawkins, Redpin Therapeutics’ President, Chief Executive Officer and Co-founder. “Kriya Therapeutics is the perfect company to take this leading ion channel-based platform forward and deliver an effective treatment option for patients. We look forward to working with the Kriya team to progress these unique targeted therapies to patients in need as rapidly as possible.”
Redpin’s investors include 4BIO Capital, Arkin Bio Ventures, Takeda Ventures Inc, New York Ventures and Alexandria Venture Investments.
Epilepsy is a brain disorder that causes recurrent spontaneous seizures. Approximately 3.4 million people in the U.S. suffer from active epilepsy, according to the U.S. Centers for Disease Control and Prevention. Current treatments for epilepsy include medication, neurostimulation and surgery to remove sections of the affected part of the brain. However between 20% to 40% of patients with newly diagnosed epilepsy will become refractory to treatment, and will continue to suffer seizures. Uncontrolled epilepsy can lead to sudden unexpected death in epilepsy (SUDEP).
About Trigeminal Neuralgia
Trigeminal neuralgia also known as Tic Douloureux, is a severe and chronic disorder that affects the trigeminal, or fifth cranial, nerve. TN patients experience progressive intense stabbing facial pain attacks that can become more severe and last longer over time. Approximately 10,000 to 15,000 new cases of TN occur each year in the U.S., according to the National Organization for Rare Disorders. While currently available treatments include anti-seizure medications and surgical procedures, a significant proportion of patients are refractory to these approaches.
About Kriya Therapeutics
Kriya is a fully integrated company pioneering novel technologies and therapeutics in gene therapy. The company aims to revolutionize how gene therapies are designed, developed, and manufactured, improving speed to market and delivering significant reductions in cost. The company is advancing a deep and diversified pipeline of innovative gene therapies in multiple therapeutic area divisions, with current pipeline programs in metabolic disorders, neurology and ophthalmology. Kriya is backed by leading life sciences and technology investors, and has core operations in Silicon Valley, California and Research Triangle Park, North Carolina.
Based in New York City, Redpin Therapeutics is a privately held, preclinical stage gene therapy company developing a proprietary chemogenetics platform for targeted cell therapies to address currently intractable diseases of the central nervous system. Using a powerful and innovative technology that inverts traditional drug development by using gene therapy to target an engineered receptor to any cell type responsible for disease and modulating its function with an already-approved drug. This has the potential to deliver effective treatments for a wide range of currently intractable neurological and psychiatric diseases and disorders. Redpin has a worldwide exclusive license from the Howard Hughes Medical Institute for the therapeutic use of this technology, and the company is working with urgency to apply it to advance important medicines for patients in desperate need of effective therapies.