Lucid Diagnostics | March 25, 2022
Lucid Diagnostics Inc., a commercial-stage cancer prevention diagnostics company and a majority-owned subsidiary of PAVmed Inc, announced that investigators at the Louis Stokes Cleveland Department of Veterans Affairs Medical Center had enrolled their first patient in a Department of Defense ("DoD")- Katarina B. Greer, M.D., an associate professor of medicine at Case Western Reserve University School of Medicine in Cleveland, is the lead investigator of the research. Lucid supplies the study with EsoCheck® Esophageal Cell Collection Devices and will conduct EsoGuard testing on the obtained samples.
We are proud to be partnering with Dr. Greer and the Cleveland VA on this important investigator-initiated clinical study, The study will add important clinical evidence on the impact of EsoGuard in enhancing early detection of esophageal precancer to prevent esophageal cancer deaths by reserving endoscopy for those with a positive EsoGuard test.”
Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer.
Despite strong clinical practice guideline recommendations, endoscopy has had limited success as a widespread screening tool for Barrett’s Esophagus (BE), a precursor for esophageal adenocarcinoma, a highly lethal form of esophageal cancer, We hope to demonstrate that a strategy that incorporates initial office-based non-endoscopic testing of at-risk patients with EsoGuard improves endoscopy yield and overall cost-effectiveness.”
Only around 10% of at-risk GERD patients advised for esophageal precancer (BE) screening undergo traditional, invasive upper gastrointestinal endoscopy (EGD). Over 80% of people who undergo EGD screening have a negative result, subjecting the overwhelming majority of these patients to a complicated, invasive, expensive, and inconvenient surgery requiring anesthesia in a specialist procedure center or hospital. EsoGuard has been demonstrated to be 90% sensitive and specific for identifying esophageal precancer and cancer when done on EsoCheck samples, potentially removing the bulk of these negative EGDs, benefiting patients, providers, and the healthcare system.
The trial will include up to 100 Cleveland VA patients who meet the American College of Gastroenterology's criteria for esophageal pre-cancer screening. The research compares two screening strategies: (1) regular EGD screening; and (2) EsoGuard testing followed by EGD exclusively in individuals with a positive EsoGuard result. The trial will determine if utilizing EsoGuard to triage patients to EGD improves overall BE screening rates and decreases the number of EGDs with negative screening results. Additionally, the research will analyze the economic implications for the VA system of these two options.
GenScript | May 18, 2022
GenScript USA Inc., the world's leading life-science research tools and services provider, announced the availability of new GMP-grade GenExact™ single-stranded DNA (ssDNA) and GenWand™ closed-end linear double-stranded DNA (dsDNA) services. These services will enable next-generation gene and cell therapy R&D programs to advance to IND filing and clinical trials faster and more efficiently.
Today's announcement, made at the American Society of Gene & Cell Therapy (ASGCT) 25th annual meeting (booth #280), further establishes GenScript as the leading provider of non-viral homology-directed repair (HDR) template solutions for immune-cell engineering. GenScript now offers varying grades of non-viral HDR payload materials that support use cases across early discovery research, process development, and clinical studies.
CRISPR-based non-viral gene insertion methods have gained popularity among research teams with concerns about the FDA's recent draft guidance concerning the use of viruses for gene and cell therapy. Non-viral HDR templates, in combination with CRISPR technology, can accelerate cell engineering compared to traditional GMP virus-based engineering, delivering results faster than alternate techniques.
This new investment by GenScript demonstrates our commitment to non-viral delivery technology. We look forward to continuing to work with our partners and stakeholders in academia and industry to support their cell therapy R&D programs and further development of non-viral delivery platforms and workflows, We know this technology will be a more efficient and safer solution for cell engineering."
Ray Chen, PhD, president of GenScript USA Life Science Group.
GenScript's GMP ssDNA And dsDNA services enable faster CAR-T drug development:
GenExact™ ssDNA up to 5000nt in length, 100mg/batch production scale
GenWand™ closed-end, linear dsDNA up to 10,000nt in length, gram level/batch production scale
GenScript has been collaborating with several academic and industry partners in the development of CRISPR non-viral gene insertion. Recently, Dr. Alex Marson's lab at UCSF published a paper demonstrating how CRISPR RNP technology can both knock out endogenous T-cell receptors and integrate replacement anti-cancer receptors.
The UCSF team has been using GenScript's latest single-strand DNA to improve non-viral gene knock-in efficiency. Working in collaboration with GenScript, the team engineered modifications to the DNA payload to promote co-localization and delivery (or 'shuttle') to the nucleus.
About GenScript Biotech Corporation
GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Based on its leading gene synthesis technology, GenScript has developed four major platforms including the global cell therapy platform, the biologics contract development and manufacturing organization (CDMO) platform, the contract research organization (CRO) platform, and the industrial synthesis product platform.
GenScript was founded in New Jersey, USA in 2002 and listed on the Hong Kong Stock Exchange in 2015. GenScript's business operation spans over 100 countries and regions worldwide, with legal entities located in the USA, mainland China, Hong Kong, Japan, Singapore, the Netherlands, and Ireland. GenScript has provided premium, convenient, and reliable products and services for over 100,000 customers.
CELL AND GENE THERAPY
Kaneka Eurogentec | February 23, 2022
Kaneka Eurogentec, an FDA inspected contract development and manufacturing organization announced today that its mRNA manufacturing facility has successfully produced a 25 g batch of mRNA for a US customer.
Eurogentec’s GMP mRNA manufacturing service offers in vitro transcription (IVT), purification, quality control and batch release of GMP material up to 25 g scale in its current facility in Belgium. In this project Eurogentec successfully produced and purified 25 g of material in one batch that will be tested by the customer. This quantity is equivalent to 100,000’s to millions of doses of mRNA, potentially sufficient for late clinical and commercial uses.
Ingrid Dheur, Vice President Biopharma Development at Kaneka Eurogentec stated, “This successful production confirms our ability to produce mRNA at large scale and with a quantity and purity level that exceeds the targets requested by the customer.”
“The rapid growth in cell and gene therapy products is driving the need for plasmid DNA and mRNA production. Our existing pharma and biotech customers have already expressed the need for such large-scale manufacturing capabilities, and we have developed methods to respond to these needs. Additionally, we are currently in the planning stages for a 2nd manufacturing facility to further expand our GMP mRNA manufacturing offering”.
Lieven Janssens, President and CEO at Kaneka Eurogentec
Messenger RNA (mRNA) is a molecule that encodes for a protein which will have a beneficial effect in patients. Rather than producing complex proteins, producing mRNA is a convenient way to deliver the protein as a precursor. The production of mRNA is much simpler than producing a recombinant protein and thus mRNA molecules have the advantage of enabling a shorter production time to clinic. For example, current mainstream therapies for the protection against COV-SARS-2 infections are based on mRNA and have been developed in record time. The success of these COVID-19 mRNA vaccines has opened the evaluation of mRNA for other infectious diseases, for example influenza or HIV, and the need for custom large-scale production of GMP mRNA.
About Kaneka Eurogentec
Eurogentec was founded in 1985 as one of the first biotech companies in Belgium. Kaneka Eurogentec contributes to improving health and fighting diseases by supplying products and services to scientists involved in life science research, molecular diagnostics, and therapeutic developments. The Liège-based company is recognized as one of the major suppliers in the field of genomics and proteomics as well as a trusted Contract Development and Manufacturing Organization (CDMO) for the bio-production of pharmaceuticals.
Eurogentec is one of a few CDMOs capable of manufacturing GMP oligonucleotides, mRNA, plasmid DNA and recombinant proteins for human injectable use, with commercial products sold in USA, Europe and Japan.
In 2010, Eurogentec, renamed Kaneka Eurogentec in April 2017, became part of Kaneka Corporation, a large Japanese chemical company focusing on technology and innovation.
About Kaneka Corporation
Kaneka is an innovation-oriented chemical company. Traditionally the company has been active in polymers, fermentation, biotechnology, and electronics, as well as other fields. Business activities now span a broad spectrum of markets ranging from plastics, EPS resins, chemicals and foodstuffs to pharmaceuticals, medical devices, electrical and electronic materials, and synthetic fibers. The life science related activities are currently one of the strategically important domains for Kaneka. The company has been a pioneer among Japanese chemical companies in establishing overseas operations, beginning in 1970 with a subsidiary in Belgium.