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Global Biotech Market Primed for Growth With Renewed Research and Development Efforts

NEW YORK, March 5, 2019 /CNW/ -- Diseases are commonplace around the world, especially in regions that don't have access to adequate healthcare. They present themselves as various groups such as cancers, diabetes, skin, bacterial, as well as many more. Additionally, within those larger groups resides a wide-ranging and diverse sub-sector. Pre-existing hereditary conditions or environmental impacts are some of the most common ways patients develop diseases. Moreover, the endless classification of medical conditions has led many institutions to develop certain treatments to target specific conditions. However, when compared to large segments like cancer, some sectors do not receive adequate research and development opportunities, prompting many companies to dive into those fields. The number of industry players expanding into these fields of study is causing a disruptive scene to form within the overall biotechnology marketplace. According to data compiled by The Insight Partners, the global biotechnology market was valued at USD 218.01 Billion in 2017 and is expected to reach USD 471.33 Billion by the end of 2025. Additionally, the data suggests that the market is expected to register a CAGR of 10.5% during the forecast period. The market is expected to be propelled by the growing number of R&D expenditures and outsourcing activities by both private and government bodies. Furthermore, the rising number of future conferences and workshops is also expected to bolster the industry's growth. Pressure BioSciences, Inc. (OTC: PBIO), Voyager Therapeutics, Inc. (NASDAQ: VYGR), Immunomedics, Inc. (NASDAQ: IMMU), MacroGenics, Inc. (NASDAQ: MGNX), Prothena Corporation plc (NASDAQ: PRTA), XBiotech Inc. (NASDAQ: XBIT) 

Within the biotechnology market, some sectors are expected to witness faster growth than others. Specifically, the antibody market is among one of the largest biotechnology sectors which are also projected to exhibit attractive growth, as biotechnology companies are accelerating research and development within the antibody marketplace to deliver effective and efficient treatments for patients. According to data by Persistence Market Research, the global next-generation antibody therapeutics market is expected to exceed USD 6.75 Billion by 2022, growing at a CAGR of 13%. The rising prevalence of chronic disorders is also expected to be a major factor fueling the industry. Moreover, treatments such as monoclonal antibodies are expected to be highly efficient in delivering safer and more effective options for patients, even as many patients cannot afford treatment due to high costs. "While antibodies are very efficient, their cost-effectiveness has always been discussed owing to their high costs, accumulating to more than one billion dollars from preclinical development through to market approval. Because of this, therapeutic antibodies are inaccessible to some patients in both developed and developing countries," said University of Sydney researchers, Zehra Elgundi, Mouhamad Reslan, Vicki Sifniotis, and Veysel Kayser. " The growing interest in biosimilar antibodies as affordable versions of therapeutic antibodies may provide alternative treatment options as well potentially decreasing costs. As certain markets begin to capitalize on this opportunity, regulatory authorities continue to refine the requirements for demonstrating quality, efficacy and safety of biosimilar compared to originator products."

Pressure BioSciences, Inc. (OTCQB: PBIO) announced yesterday, "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 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 offers great promise for a wide range of diseases and conditions, including cancer, arthritis, Crohn's disease, and transplant rejection."

Dr. BradfordA. Young, Chief Commercial Officer of PBI concluded: "We are delighted to becollaborating with a research team of such global stature as The Steinbeis Centreto develop a new platform technology for the characterization of binding siteson antibodies and the potential development of new and/or better proteintherapeutics. This work has very important clinical applications, as it may helpto develop more effective protein drugs with reduced side-effects in cancer,auto-immune, neurodegenerative, and other critical diseases and conditions. We are honoredthat Dr. Przybylski and his team have incorporated our proprietary PCT platformas a critical component of this innovative solution. The results of this collaborationwill provide PBI with another valuable and broad application area for our Barocyclerinstruments, and we anticipate this new instrument system will be of greatinterest 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 & BiomedicalMass 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.

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Voyager Therapeutics, Inc. (NASDAQ: VYGR) is a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases. Voyager Therapeutics, Inc. and AbbVie (NYSE: ABBV), a global biopharmaceutical company, recently announced an exclusive, global strategic collaboration and option agreement to develop and commercialize vectorized antibodies directed at pathological species of alpha-synuclein for the potential treatment of Parkinson's disease and other diseases (synucleinopathies) characterized by the abnormal accumulation of misfolded alpha-synuclein protein. The delivery of sufficient quantities of antibodies across the blood-brain barrier is one of the major limitations of current biologic therapies for neurodegenerative diseases that require frequent systemic injections with large amounts of antibodies. Voyager's vectorized antibody platform and approach aim to circumvent this limitation by delivering, with a potential one-time intravenous administration, the genes that encode for the production of therapeutic antibodies utilizing Voyager's blood-brain barrier penetrant adeno-associated virus (AAV) capsids. This approach could result in the potential for higher levels of therapeutic antibodies in the brain compared with current systemic administration of antibodies. "Our scientific platform allows us to develop unique AAV gene therapies that are designed to knock down disease-causing gene expression, increase the expression of missing proteins, or enable the expression of therapeutic antibodies through vectorization," said Andre Turenne, President and Chief Executive Officer of Voyager Therapeutics. "We are excited to expand our efforts towards pathological species of alpha-synuclein given its role in the progression of disease, and AbbVie is the ideal partner to advance this new target and therapeutic modality."

Immunomedics, Inc. (NASDAQ: IMMU) is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer and other serious diseases. Immunomedics, Inc. and Samsung BioLogics Co., Ltd. recently announced that the companies have entered into a long-term manufacturing partnership agreement under which Samsung will manufacture Immunomedics' proprietary humanized antibody, hRS7, at its manufacturing facilities in Incheon, South Korea. Technology transfer and engineering runs for the new antibody production are currently underway, with commercial production expected to begin in 2020, subject to regulatory approval. "This agreement is an important part of our overall strategy to further enhance our supply chain and continue to improve our cost-structure," said Dr. Morris Rosenberg, Chief Technology Officer of Immunomedics. "We look forward to working closely with Samsung BioLogics, a world-renowned contract manufacturer, to ensure we have sufficient long-term supply of our lead antibody-drug conjugate, sacituzumab govitecan, as we advance it into additional patient segments and earlier lines of breast and urothelial cancers, as well as broadening into other cancer indications and expanding the company's ex-US geographic footprint."

MacroGenics, Inc. (NASDAQ: MGNX) is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. MacroGenics and Zai Lab Limited (NASDAQ: ZLAB), a Shanghai-based innovative biopharmaceutical company recently announced that the companies have entered into an exclusive collaboration and license agreement involving three immuno-oncology (I-O) programs from MacroGenics' pipeline of product candidates: Margetuximab, an immune-optimized anti-HER2 monoclonal antibody currently being evaluated in Phase 3 metastatic breast cancer with anticipated topline results in the first quarter of 2019; MGD013, a first-in-class bispecific DART® molecule designed to provide coordinate blockade of PD-1 and LAG-3 for the potential treatment of a range of solid tumors and hematological malignancies; An undisclosed multi-specific TRIDENT™ molecule in preclinical development. "We believe Zai Lab is an ideal partner to enable us to expand MacroGenics' global efforts to address patient populations with high unmet medical needs such as gastric cancer," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "Zai has a strong track record of rapidly progressing the development of innovative product candidates in China and is well on its way to building its commercial platform. Zai is strongly positioned to take advantage of a growing pharmaceutical market in this region."

Prothena Corporation plc (NASDAQ: PRTA) is a clinical-stage neuroscience company focused on the discovery and development of novel therapies with the potential to fundamentally change the course of progressive, life-threatening diseases. Prothena Corporation plc recently reported its financial results for the fourth quarter and full year 2018. In addition, the Company provided 2019 financial guidance and an update on its R&D programs. Prasinezumab (PRX002/RG7935), a potential treatment for Parkinson's disease, is a monoclonal antibody designed to target alpha-synuclein and is the focus of the worldwide collaboration with Roche. Prothena published results from the Phase 1b multiple ascending dose study of prasinezumab in patients with Parkinson's disease in JAMA Neurology. The paper is entitled "Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti–α-Synuclein Monoclonal Antibody, in Patients With Parkinson Disease: A Randomized Clinical Trial." PRX004, a potential treatment for ATTR amyloidosis, is a monoclonal antibody designed to target and clear the pathogenic, non-native forms of the TTR protein (misTTR) without affecting the native, or normal tetrameric form of the protein. Prothena said it achieved first-in-human dosing in a Phase 1 clinical study of PRX004 in patients with hereditary ATTR (hATTR) amyloidosis. The Phase 1 study will inform possible future studies and will include the use of Prothena's proprietary misTTR assay as a pharmacodynamic measure of the levels of non-native TTR species in plasma of patients across multiple hereditary TTR mutations. "In 2018, we continued to advance our neuroscience pipeline of novel investigational therapeutics towards key milestones," said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. "We initiated a first-in-human Phase 1 study of PRX004 in patients with hereditary ATTR amyloidosis and remain on track to report preliminary data later this year. In addition, enrollment in the Phase 2 PASADENA study of prasinezumab in patients with early Parkinson's disease has been completed by our colleagues at Roche, and we expect data from this study in 2020. Looking ahead, we continue to advance our discovery pipeline of novel targets under our collaboration with Celgene, as well as our proprietary and differentiated program in abeta, and expect to initiate cell line development of a lead candidate for both our tau and abeta programs this year."

XBiotech Inc. (NASDAQ: XBIT) is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. XBiotech recently announced that breakthrough results from its Phase 2 clinical trial of its antibody therapy, bermekimab, were presented at a late-breaking oral presentation during the annual meeting of the American Academy of Dermatology (AAD) being held in Washington, DC. The presentation titled, "Bermekimab is a Rapid and Effective Treatment for Atopic Dermatitis (AD)" took place on Saturday, March 2 at 1:10pmET in Ballroom A and will be presented by international dermatology expert, and lead researcher in the development of approved therapies for atopic dermatitis, Eric Simpson, M.D, M.C.R. Professor of Dermatology at Oregon Health & Science University, School of Medicine. The results being presented by Dr. Simpson demonstrate that bermekimab treatment resulted in rapid and significant improvement of disease in patients with moderate-to-severe AD. After only 7 weeks of treatment, 71% of patients that received a 400mg bermekimab weekly regimen had at least 75% reduction in their disease, as measured by the Eczema Area and Severity Index (EASI) score (this compares to 44-51% of patients achieving 75% improvement in EASI score after 16 weeks therapy as reported for two Phase III clinical trials for the existing FDA approved biological drug for AD). Moreover, within 7 weeks, using patient reported Numerical Rating Scale (NRS) for itch and pain, patients receiving the 400mg bermekimab treatment regimen had 71% reduction in itch and an 84% reduction in pain (this compares to 36-41% reduction in itch [pain was not reported] after 16 weeks of treatment with the existing approved therapy for AD). XBiotech Chief Executive Officer John Simard commented, "We are thrilled to have Dr. Simpson present these findings at the AAD tomorrow. We expect these results to enable the advancement of a new and very important treatment for what is a rather under appreciated disease in terms of its severity and wide-spread impact on the lives of people around the world."

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