Sophia Genetics Gets CE-IVD Mark for Cancer Detection Solution

Genomeweb | April 11, 2019

NEW YORK (GenomeWeb) – Sophia Genetics said today that it has received CE-IVD designation for its Solid Tumor Solution (STS) molecular diagnostic application. Sophia STS was designed to detect and characterize genomic alterations in 42 clinically relevant genes related to various solid tumors across multiple types of cancer, the Lausanne, Switzerland-based company said. The application runs on top of the Sophia AI artificial intelligence platform. According to Sophia, STS can detect single-nucleotide variants, insertions and deletions, and gene amplification events. It also can identify microsatellite instability status in six loci associated with colorectal cancer. "It is designed to maximize diagnostic yield and guide treatment and management decisions," Gioia Althoff, senior vice president for genomics at Sophia Genetics, said in a statement.

Spotlight

Commissioned for the 20th BioEquity Europe (May 20-21, Barcelona), this exclusive report discusses the latest trends shaping the biopharma industry in Europe.

Spotlight

Commissioned for the 20th BioEquity Europe (May 20-21, Barcelona), this exclusive report discusses the latest trends shaping the biopharma industry in Europe.

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Bio Detection K9 Develops Cutting-Edge Detection for Grape Virus Diseases

Bio Detection K9 | May 19, 2022

Bio Detection K9 (BDK9) is pleased to announce its upcoming detection service for Leafroll and Red Blotch Virus in grapes. Of the 86 different viruses known to infect vineyards, Leafroll 3 and Red Blotch virus are among the most prevalent. These pathogens can infect all wine, table and rootstock grapes. They occur in grape production areas around the world and are responsible for causing over 70 billion dollars of damage in the United States alone. To combat these insidious diseases, BDK9 is launching a cost-effective service that can quickly and accurately pinpoint infected vines before the pathogens have a chance to spread. Utilizing proprietary technology, BDK9 develops training aids that have the scent of the target viruses. The result is a harmless substance with a highly specific scent that dogs are systematically trained to detect. This is the same proven methodology BDK9 employs to screen humans for COVID-19 at airports, stadiums and public events worldwide. The challenge is like finding a needle in a haystack when trying to detect an infected plant among thousands of potentially threatened vines, But thanks to our completely safe training aid, we can teach canines to accurately detect a viral disease in any tissue, roots, vines, or leaves." Dr. William Schneider, Chief Research Scientist for BDK9. BDK9's unique technology is effective in many different areas, from humans to agriculture, and the company is proud to be at the forefront of disease detection. We're thrilled about the release of this new, cutting-edge technology and are pleased to offer this to the wine industry, Our company continues to set the standard in agriculture disease detection with our effective programs, and we take great pride in the fact that we're able to take action and truly address these important issues as they arise. " Wade Morrell, CEO of BDK9. About Bio Detection K9 Bio Detection K9 (BDK9) is the world leader in precision agriculture and human host pathogen bio detection. Led by a veteran USDA virologist, BDK9 works with canines and cutting-edge technology to identify disease in both humans and agriculture. Their dogs are trained to isolate individual pathogens with unparalleled accuracy and specificity. All training is performed safely and Bio Detection Canines™ are unharmed during the process. BDK9 is not only at the forefront of precision pathogen detection through this unique combination of technology and training, but their services are efficient, cost effective and non-invasive.

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CELL AND GENE THERAPY

Biogen and Ginkgo Bioworks Collaborate and License Agreement to Develop Novel Gene Therapy Manufacturing Platform

Biogen, Ginkgo Bioworks | May 22, 2021

Biogen and Ginkgo Bioworks announced a partnership in gene therapy today. The companies aim to redefine the industry standard for manufacturing recombinant adeno-associated virus (AAV)-based vectors by working together. Recombinant AAV-based vectors are extensively used in the development of novel gene therapies with the ability to cure neurological and neuromuscular diseases, as well as other conditions in a variety of therapeutic areas. Manufacturing is now time-consuming and expensive, making it difficult to develop therapies for diseases with high dosage requirements and large patient populations. Ginkgo intends to address these issues by using its mammalian cell programming platform to increase the performance of AAV-producing plasmid vectors and cell lines, potentially accelerating Biogen's development of novel gene therapies. “We believe that Ginkgo's unique combination of cell programming expertise, proprietary tools, and biological system awareness makes them a perfect collaborative partner to explore a broad range of design ideas to optimize constructs,” said Alphonse Galdes, Ph.D., Biogen's Head of Pharmaceutical Operations and Technology.“They share our goal of ensuring that approved therapies are not delayed due to manufacturing constraints and are available to patients all over the world.” “We are delighted to partner with Biogen as they seek to develop treatments that can potentially delay, stop, or cure neurological and neurodegenerative diseases, as well as to improve the industry standard for AAV manufacturing,” said Jason Kelly, CEO of Ginkgo Bioworks. “Synthetic biology is utilizing the power of living cells to develop the next generation of therapeutics, including CAR-T, CRISPR, and gene therapies, which we hope would have a significant effect on the lives of many people.” Biogen will have access to Ginkgo's proprietary cell programming platform and capabilities under the terms of the agreement. Ginkgo will use its bioengineering facilities and resources to improve Biogen's gene therapy manufacturing processes' AAV output titers. Ginkgo will receive a $5 million initial payment and will be eligible for milestone payments of up to $115 million if the partnership programs achieve certain research, development, and commercial milestones. About Biogen Our mission at Biogen is clear: we are neuroscience pioneers. Biogen discovers, develops, and delivers innovative therapies for people suffering from severe neurological and neurodegenerative diseases, as well as related therapeutic adjacencies, around the world. Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray, and Nobel prize winners Walter Gilbert and Phillip Sharp as one of the world's first major biotechnology firms. Biogen currently has the leading portfolio of medicines for the treatment of multiple sclerosis, is the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics, and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer's disease, and dementia, neuromuscular disorders, movement disorders, ophthalmology, and neuropsychiatry. About Ginkgo Bioworks Ginkgo is building a platform for program cells in the same way as we program machines. The platform is enabling the growth of biotechnology across a wide range of markets, from food and agriculture to industrial chemicals and pharmaceuticals. Ginkgo is also closely involved in a variety of COVID-19 response efforts, such as community testing, epidemiological tracing, vaccine development, and therapeutics discovery.

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MEDICAL

Yescarta® Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL)

LBCL | April 04, 2022

Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved Yescarta® (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Yescarta demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS; hazard ratio 0.398; P< 0.0001) over the current standard of care (SOC) that has been in place for decades. EFS was determined by blinded central review and defined as the time from randomization to the earliest date of disease progression, commencement of new lymphoma therapy, or death from any cause. Additionally, 2.5 times more patients receiving Yescarta (40.5%) were alive at two years without disease progression or need for additional cancer treatment, after their one-time infusion of Yescarta vs. SOC (16.3%), and the median EFS was four-fold greater (8.3 months vs. 2.0 months) with Yescarta vs. SOC. Yescarta is also being reviewed by global regulatory authorities for additional indications inclusive of the ZUMA-7 patient population. ZUMA-7 is considered a landmark trial for being the first and largest trial of its kind, with the longest follow-up. Earlier this month, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines in Oncology for B-cell Lymphomas to include Yescarta for “Relapsed disease <12 mo or Primary Refractory disease” under Diffuse Large B-cell Lymphoma (DLBCL) as a Category 1 recommendation. Yescarta is the first CAR T-cell therapy to receive a NCCN Category 1 recommendation. NCCN defines Category 1 as recommendations based upon high-level evidence with uniform NCCN consensus that the intervention is appropriate. Kite started with a very bold goal: creating the hope of survival through cell therapy. Today’s FDA approval brings that hope to more patients by enabling the power of CAR T-cell therapy to be used earlier in the treatment journey. This milestone has been years in the making. On behalf of the entire Kite community, we would like to thank the patients and physicians who have been on this journey with us. You are what drives us every day to explore the full potential of cell therapy.” Christi Shaw, Chief Executive Officer of Kite. CAR T-cell therapies are individually made starting from a patient’s own white blood cells, called T-cells. The cells are removed through a process similar to donating blood and sent to Kite’s specialized manufacturing facilities where they are engineered to target the patient’s cancer, expanded, and then returned to the hospital for infusion back into the patient. Referring physicians and patients can immediately begin accessing Yescarta CAR T-cell therapy for this new FDA-approved indication through Kite’s 112 authorized treatment centers across the U.S. Definitive clinical trial results such as these do not come along often and should drive a paradigm shift in how patients with relapsed or refractory LBCL are treated moving forward. Patients who do not respond to or relapse after initial treatment should quickly be referred to a CAR T-cell therapy authorized treatment center for evaluation.” Jason Westin, MD, MS, FACP, ZUMA-7 Principal Investigator, Director, Lymphoma Clinical Research, and Associate Professor, Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center. Kite CAR T-cell therapy products are widely covered by commercial and government insurance programs in the U.S. Kite has also invested in expansion of manufacturing capacity ahead of today’s FDA decision to support patient access. LLS was an early supporter of CAR T-cell therapy research, and to be able to see this innovative advance become available as an earlier line of treatment is truly remarkable. Current standard of care is a difficult process for patients, and no one knows at the start who will make it to stem cell transplant. With today’s FDA decision, patients will have earlier access to this potentially curative treatment.” ​ Lee Greenberger, PhD, Chief Scientific Officer of The Leukemia & Lymphoma Society (LLS). Yescarta was initially approved by the FDA in 2017 based on the ZUMA-1 trial for a smaller population of LBCL patients who failed two or more lines of therapy. The ZUMA-1 trial has recently reported durable 5-year survival results, with Yescarta showing 42.6% of study patients alive at 5 years and that 92% of those patients alive at 5 years have needed no additional cancer treatment at this important milestone. As the only company dedicated exclusively to the research, development, commercialization, and manufacturing of cell therapy on a global scale, Kite has all functions critical to cell therapy vertically integrated. This structure enables the continual refinement and support of the highly specialized and complex end-to-end processes needed to support and improve upon patient outcomes with CAR T-cell therapy. About ZUMA-7 Study The FDA approval of Yescarta CAR T-cell therapy for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy is based on results from the ZUMA-7 study. Patients had not yet received treatment for relapsed or refractory lymphoma and were potential candidates for autologous stem cell transplant (ASCT). Results were presented in a Plenary session at the American Society of Hematology’s (ASH) Annual Meeting & Exposition in December 2021 and simultaneously published in the New England Journal of Medicine (NEJM). About LBCL Globally, LBCL is the most common type of non-Hodgkin lymphoma (NHL). 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