Biotechnology Companies see Rising Demand for new Therapies

Monday, March 4, 2019 General News
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NEW YORK, March 4, 2019 /PRNewswire/ -- The biotechnology market is one of

the biggest industries in the world. However, despite being the largest sector globally, there are still various segments that haven't been tapped into, presenting opportunities for many companies. Biotechnology is defined as technology to upgrade or
modify the whole part of a biological system for human welfare. Processes within the industry include microbiology, genetic engineering, biochemistry, and many others which can help humans recover or potentially eliminate a medical condition with proper treatment. While there are many various types of medical conditions, the market is seeing a large demand for therapeutic and diagnostic solutions such as red biotechnology, recombinant technology, and DNA sequencing. According to data compiled by Variant Market Research, the global biotechnology market is projected to reach USD 726.8 Billion by 2025, as well as grow at a CAGR of 8.1% from 2017 to 2025. Pressure BioSciences, Inc. (OTC: PBIO), Seattle Genetics, Inc. (NASDAQ: SGEN), General Electric Company (NYSE: GE), QIAGEN N.V. (NYSE: QGEN), Nektar Therapeutics (NASDAQ: NKTR)

One sector in particular within the biotechnology industry has emerged within the top segments. The monoclonal antibody market has quickly become a strong and popular industry due to demand for personalized medicine. According to Grand View Research, the global monoclonal antibodies (mAbs) market was valued at approximately USD 85.4 Billion in 2015 and is expected to reach USD 138.6 Billion by 2024. The sector is mainly being driven by increasing R&D to develop mAbs, coupled with supportive government initiatives. mAbs provide patients with targeted therapies, which is important because patients vary in how their bodies accept the treatment or therapy. Additionally, using mAbs for therapeutic purposes, including fewer adverse effects, homogeneity, specificity, and large-scale production are also bolstering the market. "Antibody-derived biologics have become a major class of modern medicine, particularly in the fight against cancer and autoimmune diseases. Crucial to the successful translation of antibodies into therapies are highly efficient antibody discovery and cell line development pipelines," said Frank F. Craig, Ph.D., Chief Executive Officer of Sphere Fluidics, "Biopharmaceutical organizations are under increasing pressure to streamline their antibody discovery and cell line development processes, with unmet needs for increased throughput, shortened timelines, reduced costs, and improved proof of monoclonality."

Pressure BioSciences, Inc. (OTCQB: PBIO) just announced breaking news this morning that, "a collaboration with The Steinbeis Centre for Biopolymer Analysis & Biomedical Mass Spectrometry ("The Steinbeis Centre"), a world-renown German research organization.  The collaboration is combining the unique capabilities of PBI's patented pressure cycling technology ("PCT") for sample preparation, protein characterization, and biotherapeutics quality control with the Steinbeis Centre's innovative PROTEX-MS instrument for elucidating structural details of antibody interactions to create an instrument system to accelerate the development of new protein therapeutics and improve existing drug treatments.

The collaborative program will be directed by Dr. Michael Przybylski, Professor of Analytical Chemistry and Biochemistry and Director of The Steinbeis Centre, who explained the selection of PBI's PCT platform: "The high-quality digestion of proteins is an essential initial step in the discovery, analysis, and characterization of potential therapeutic proteins. In the past, we have not been fully satisfied with the results achieved when using traditional protein digestion procedures and instrumentation. However, with PBI's proprietary PCT platform, we now achieve high quality and reproducible digestion of proteins. Consequently, we believe that PCT, in combination with our innovative PROTEX-MS system, could more rapidly lead to the discovery and development of biopharmaceutical treatments for a large number of diseases resulting in substantial improvements in patient care and outcomes."

The PCT-PROTEX-MS platform will be used to elucidate critical details of how the immune response functions as the body defends against bacteria, viruses, and other harmful molecules, organisms and cells. When an immune response is generated, proteins called antibodies are produced that interact with specific molecules ("antigens") presented by these invaders, by physically fitting and binding (like a key in a lock) with specific regions on these molecules ("epitopes"). Better characterization of these epitopes on specific antigens of the invaders, and how they bind to the antibodies that recognize them, provide valuable insights into how the immune system combats disease, and how to improve the development of targeted protein therapeutics. The past decade has seen a dramatic increase in the use of targeted antibodies as effective protein therapeutics in auto-immune diseases, cancers and other life-threatening conditions.

Dr. Alexander Lazarev, Chief Science Officer of PBI, said: "We believe the PCT-PROTEX-MS platform being developed will offer the global research community a powerful new laboratory tool for the powerful, rapid, and sensitive digestion of protein and peptide antigens followed by measurement of binding affinity (strength) and identification of epitopes captured on immobilized antibodies."

Dr. Lazarev continued: "Furthermore, the potential of this new platform in the rapid discovery of new targeted therapeutics and improvement of existing treatments tailored specifically to individual patients and their conditions offer great promise for a wide range of diseases, including cancer, arthritis, Crohn's disease, transplant rejection and Alzheimer's disease."

Dr. Bradford A. Young, Chief Commercial Officer of PBI concluded: "We are delighted to be collaborating with a research team of such global stature as The Steinbeis Centre to develop a new platform technology for the characterization of binding sites on antibodies and the potential development of new and/or better protein therapeutics. This work has very important clinical applications, as it may help to develop more effective protein drugs with reduced side-effects in cancer, auto-immune, neurodegenerative and other critical diseases and conditions. We are honored that Dr. Przybylski and his team have incorporated our proprietary PCT platform as a critical component of this innovative solution. The results of this collaboration will provide PBI with another valuable and broad application area for our Barocycler instruments, and we anticipate this new instrument system will be of great interest to both current and future customers in the monoclonal antibody therapeutics market, expected to reach $218.97 billion by the end of 2023 (Zion Market Research, 2018)."

About the Steinbeis Centre for Biopolymer Analysis & Biomedical Mass Spectrometry

The Steinbeis Foundation for Technology Development is one of Germany's largest and most highly-reputed technology developing organizations.  In 2003, it founded the Steinbeis Centre for Biopolymer Analysis and Biomedical Mass Spectrometry. Professor Michael Przybylski is Director of the Centre and Chair of the Analytical Chemistry Laboratory. The Steinbeis Centre's numerous developments and inventions span the disciplines of biopolymer mass spectrometry, combined with protein- and peptide-chemical methods, tertiary structure analysis by protein-chemical modification and mass spectrometry, and the mass spectrometric determination of biopolymer recognition structures. The Steinbeis Centre invented proteolytic extraction/excision-biosensor-mass spectrometry ("PROTEX-MS") for the elucidation of protein-ligand interaction structures and peptide/protein epitopes, and has determined the structure of several membrane proteins, such as Lung Surfactant protein-C. The laboratory's current research is focused on applications of mass spectrometry and peptide biochemistry for structure and mechanism elucidation of neurodegenerative proteins; pathophysiological protein modification; vaccine chemistry; structure and epitope analysis of therapeutic antibodies; affinity-mass spectrometry of biopolymer interaction epitopes; mass spectrometric elucidation of oligomerisation/truncation pathways, and structures of "misfolding"/aggregating proteins in neurodegenerative diseases.

About Pressure BioSciences, Inc. is a leader in the development and sale of innovative, broadly enabling, pressure-based solutions for the worldwide life sciences industry. Our products are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or PCT) hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions (e.g., cell lysis, biomolecule extraction). Our primary focus is in the development of high pressure-based products for biomarker and target discovery, drug design and development, biotherapeutics characterization and quality control, food science, soil & plant biology, forensics, and counter-bioterror applications. Additionally, we are actively expanding the use of our pressure-based technologies in the following areas: (1) the use of our recently acquired protein disaggregation and refolding technology from BaroFold, Inc. to allow entry into the biologics manufacturing and contract research services sector, and (2) the use of our recently-patented, scalable, high-efficiency, pressure-based Ultra Shear Technology (UST™) platform to (i) create stable nanoemulsions of otherwise immiscible fluids (e.g., oils and water) and to (ii) prepare higher quality, homogenized, extended shelf-life or room temperature stable low-acid liquid foods that cannot be effectively preserved using existing non-thermal technologies. For more information visit: www.pressurebiosciences.com '"

For our latest "Buzz on the Street" Show featuring Pressure BioSciences, Inc. recent corporate news, please head over to: https://www.youtube.com/watch?v=4GQHw2RK0bo

Seattle Genetics, Inc. (NASDAQ: SGEN) is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in people's lives. Seattle Genetics, Inc. recently announced that its collaborator, Takeda Pharmaceutical Company Limited, received approval from the European Commission to extend the marketing authorization for ADCETRIS (brentuximab vedotin) to include ADCETRIS in combination with AVD (Adriamycin®, vinblastine and dacarbazine) in adults patients with previously untreated CD30+ stage IV classical Hodgkin lymphoma (HL). The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on December 13, 2018. As a result, Seattle Genetics will receive a milestone payment from Takeda of USD 30 Million. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL that plays a role in tumor growth and survival. "Receipt of this milestone payment reflects continued progress by our partner Takeda to expand ADCETRIS approved indications globally," said Clay Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. "We look forward to continuing our work with Takeda to establish ADCETRIS as the global foundation of care for CD30-expressing lymphomas, including Hodgkin lymphoma."

General Electric Company (NYSE: GE) subsidiary, GE Healthcare, is a USD 19 Billion healthcare business. Recently, G-CON Manufacturing, the leader in prefabricated flexible cleanroom solutions and GE Healthcare announced plans to collaborate to improve cell therapy and viral vector manufacturing by providing drug developers with a combined, flexible, and readily deployable manufacturing platform suitable for early-stage clinical or commercial production. The Companies intend to work together to incorporate GE Healthcare's modular, end-to-end cell therapy and viral vector technologies and process designs into G-CON's proprietary cleanroom technology. This means that drug developers and manufacturers can purchase a fully functional production line and environment that can be housed in a warehouse-type structure. The collaboration will also include cleanroom technology required for the manufacture of lentivirus (LV) and adeno-associated virus (AAV) vectors, a delivery vehicle for emerging gene therapy treatments. The gene therapy field is developing fast and while only a small number of treatments are approved for use, more than 200 clinical trials are underway. Catarina Flyborg, General Manager, Cell and Gene Therapy, GE Healthcare, said: "The combination of the G-CON infrastructure along with GE Healthcare's cell therapy and vector platform, will aid in reducing the time to market for cell therapies that need vector manufacturing to be on-site and connected to the overall therapy workflow. It has been designed with early-stage manufacturing processes in mind, which is the much-needed stepping stone for validating large-scale manufacturing and investment decisions in the future."

QIAGEN N.V. (NYSE: QGEN), a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. QIAGEN N.V. recently announced a broad agreement with Ares Genetics, a subsidiary of Curetis N.V., to develop innovative bioinformatics and assay solutions to accelerate research targeting the growing global health challenges posed by antibiotic-resistant bacteria. "Antibiotic-resistant diseases are an urgent threat to public health, as resistance undermines the effective prevention and treatment of an ever-increasing range of infections. This global problem cries out for molecular insights that can lead to new understanding and therapeutic approaches. Partnering with Ares Genetics to leverage their genomic content with QIAGEN's expertise in bioinformatics, NGS and PCR technologies, we will expand our portfolio of solutions to help the global community fight these infections," said Jonathan Sheldon, Senior Vice President and head of QIAGEN Bioinformatics. QIAGEN is committed to creating best-in-class Sample to Insight solutions that help combat the global crisis in antibiotic resistant pathogens. The collaboration with ARES builds on an already broad portfolio for infectious disease research tools and adds to other AMR-related initiatives. QIAGEN will leverage the AMR database from Ares Genetics with its expertise in bioinformatics, assays and services, enabling the research community to accelerate the fight against AMR."

Nektar Therapeutics (NASDAQ: NKTR) is a research-based development stage biopharmaceutical company whose mission is to discover and develop innovative medicines to address the unmet medical needs of patients. Nektar Therapeutics recently announced a presentation of new clinical data for bempegaldesleukin1 (NKTR-214) in combination with nivolumab in patients with first-line (1L) advanced or metastatic urothelial carcinoma at the 2019 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium(GU) in San Francisco, CA. Bempegaldesleukin is an investigational, first-in-class, CD-122-preferential IL-2 pathway agonist designed to provide rapid activation and proliferation of cancer-killing immune cells, known as CD8+ effector T cells and natural killer (NK) cells, without over activating the immune system. Bempegaldesleukin has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines. "Preliminary data from the ongoing PIVOT-02 trial in metastatic urothelial cancer patients demonstrated important response rates, including complete responses, in patients who were cisplatin-ineligible or refused standard of care," said Mary Tagliaferri, M.D., Chief Medical Officer of Nektar Therapeutics. "These responses were observed regardless of baseline PD-L1 expression and no relapses occurred. In this cohort of Stage IV bladder cancer patients with a median age of 70, the combination therapy was generally well tolerated with no Grade 4 or 5 adverse events reported. Of note, our translational research demonstrated that in patients with the highest unmet medical need – those whose tumors did not express PD-L1 at their baseline scan – treatment with the combination resulted in 70 percent of patients converting to PD-L1 positive expressors. These data support our development strategy in this tumor setting, including the Phase 2 PIVOT-10 study underway in cisplatin-ineligible urothelial cancer patients with low PD-L1 tumor expression."

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