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Biotech Companies Endeavor to Address Global Health Issues

FinancialBuzz.com News Commentary

NEW YORK, Sept. 18, 2019 /PRNewswire/ -- The global burden of diseases continues to grow each year, despite ongoing medical advancements. The Institute for Health Metrics and Evaluation (IHME) highlighted in a report that between 1950 and 2017, there were a total of 359 new diseases and injuries added to the fatal and non-fatal list of conditions. Some of the most common cases include cancer, heart conditions, stroke, respiratory infections, lung diseases, Alzheimer's, diabetes, and kidney diseases. While some of these conditions are unpreventable, conditions such as cancer and heart issues can be resolved or their spread slowed with innovative treatment and medicine. For instance, patients suffering from cancer typically undergo therapies such as chemotherapy or radiotherapy. Chemotherapy and radiotherapy are two of the most common cancer treatments and are aimed towards prolonging life expectancy, controlling or eradicating malignant cells. And despite its effectiveness, biotechnology companies are continuing to develop new and innovative treatments such as targeted therapies or personalized treatments. Nonetheless, while biotechnology companies are progressing within the industry, each year more and more cases of medical conditions are emerging throughout the world. However, some regions tend to have a more developed healthcare system and can immediately address the needs of their patients. On the other hand, underdeveloped regions typically lack adequate access to proper healthcare, which ultimately results in a large number of fatalities and untreated people. The IHME said in 2017 that regions such as Canada, Japan, Australia, and western Europe had the highest life expectancies. Meanwhile, the central and southern regions in Africa had the lowest life expectancies. And despite the disparities between the developed and underdeveloped regions, biotechnology companies are slowly moving towards addressing the overall global matter. According to data compiled by Global Market Insights, the global biotechnology market was valued at USD 399.4 Billion in 2017 and is expected to witness a CAGR of 9.9% from 2018 to 2024. Pressure BioSciences, Inc. (OTC: PBIO), Merck & Co., Inc. (NYSE: MRK), Pfizer Inc. (NYSE: PFE), GlaxoSmithKline plc (NYSE; GSK), AstraZeneca PLC (NYSE: AZN)

Customarily, most cancer patients receive similar treatment depending on their specific type of cancer and the stage progression. However, researchers began to notice that treatments were more effective for some people, while others received experienced little to no response. As such, researchers realized that genetics differences in each patient can influence how they respond to the treatment. For instance, a patient who can process medicine much faster than others would likely require a higher dose of medicine for it to be effective. Moreover, some patients experience severe side effects from specific cancer drugs, making the process unbearable. And in certain instances, doctors will either prescribe an additional medicine or lower the dosage to reduce the painful side effects. Overall, the evolution of personalized treatments has completely reshaped how medical practitioners approach cancer therapy. Notably, researchers have begun to collect tissue samples in order to search for and better understand potential cancer biomarkers. Specifically, formalin-fixed paraffin-embedded (FFPE) and fresh frozen biopsy tissue samples have become widely practiced methods in clinical preservation. Generally, researchers use these tissues to search for specific proteins which can then be used as a diagnosis to indicate which cancer drugs would be the most effective, according to Biochain. Furthermore, biotechnology researchers can accelerate discoveries of new therapies and drugs that can be used towards curing or slowing cancers. "We have yet to realize the full potential of precision medicine, but we are making significant headway," said Eva Kiesler, former Senior Science Editor at Memorial Sloan-Kettering Cancer Center, and Meredith Begley, Health and Medical writer at Memorial Sloan-Kettering Cancer Center. "Options for many people with cancer have dramatically improved through targeted therapies that reverse the effects of specific gene mutations in their tumor cells."

Pressure BioSciences, Inc. (OTCQB: PBIO) announced last week, "the publication of two scientific journal articles, led by independent teams of  scientists in China and Australia, reporting excellent results with PBI's Pressure Cycling Technology ("PCT") platform in processing preserved formalin-fixed paraffin-embedded ("FFPE") and fresh frozen biopsy tissue samples for discovery and elucidation of cancer biomarkers and potentially for use in clinical diagnostics based upon these markers.  The Chinese team from Westlake University (Hangzhou, China) purchased their first two PCT platforms in 2017 and subsequently purchased four additional PCT systems.  The Australian Proteome of Human Cancer ("ProCan") team bought their first PCT system in 2016 and have subsequently added five more PCT platforms.

FFPE preserved tissue samples are an invaluable resource for retrospective studies of disease progression and response to therapy, because the disease outcome associated with the tissue and patient's treatment history are known. Effective studies on these sample sets can accelerate discoveries of new therapies, drugs, and preventive strategies. FFPE has been long-established as the most common technique worldwide for the preservation of tissues for later study.  Archival repositories exist that contain a total of millions to a billion or more FFPE tissue samples.  However, the analysis of FFPE samples has historically been problematic. FFPE preservation techniques were designed for permanence and stability – hence it is challenging to reverse this fixation and to liberate and extract the important biomolecules relevant as cancer biomarkers.  Significantly, both publications cited here, together with other publications (See PBI Website), now report excellent results using the PCT sample preparation platform for comprehensive and reliable extraction and presentation of important proteins for analysis, from both FFPE and fresh frozen tissue samples.

Mr. Richard T. Schumacher, President and CEO of Pressure BioSciences, commented: 'It is estimated (Nature volume 448, pages 959–962, 23 August 2007) that well over one billion archival FFPE tissue samples exist in pathology and other laboratories worldwide. We believe there are millions of new FFPE tissue samples processed and stored each year. These samples offer the promise of unveiling invaluable information that can lead to the development of new treatments, cures, and preventive measures for cancer and many other diseases. However, up to now, it has been very difficult to extract this information from biomolecules in FFPE samples.'

Ms. Roxana McCloskey, Director of Marketing and Sales at PBI, said: 'We believe that our PCT platform is establishing itself as the method of choice for the superior extraction of potential biomarkers and their presentation for the effective proteomic analyses that will propel the growth of this huge market. We expect this exciting, now proven application of our PCT Platform for protein biomarker discovery in fresh frozen and FFPE biopsy samples to manifest itself in increased instrument sales starting in the second half of 2019.'

The global cancer biomarkers market alone is expected to exceed more than US $157 Billion by 2022 (MarketWatch - January 8, 2019).

In their publication High-throughput proteomic analysis of FFPE tissue samples facilitates tumor stratification, Professor Tiannan Guo, Laboratory Director at Westlake University, explained: 'We developed the PCT-SWATH/DIA method of coupling pressure cycling technology for sample preparation with a high throughput mass spectrometry workflow, to analyze FFPE tissue proteomes. We showed that our workflow is a robust and reproducible proteomic method to analyze FFPE tissues from both bulk tissue and tiny biopsy samples as well as sectioned tissue slices.'

Dr. Guo continued, 'We believe that the vast reservoirs of historical FFPE tissue samples accumulated in biobanks worldwide offer enormous potential using our methods for biomarker discovery, by leveraging thepracticality and superiority of PBI's PCT sample preparation platform for maximizing the diversity and abundance of results from FFPE samples (over even fresh frozen samples), followed by mass spectrometry analysis in the PCT-SWATH/DIA workflow.'

Professor Phil Robinson, Co-Director of ProCan, stated: 'The key to clinical application of tissue-based proteomics is to adapt to the practical requirements of clinical workflow. Our results from FFPE tissues following PCT sample preparation are consistent with other reports showing that high quality data can be generated and that the scale and scope of quantifiable proteins is comparable to that obtained from fresh frozen tissues.'

Professor Robinson continued: "After samples are collected, tissue lysis and digestion protocols must be rapid, efficient, reproducible and broadly applicable to tissues of different kinds and from different source laboratories. In addition, the methodology should be adaptable for integration of robotics to facilitate high throughput where possible. ProCan has instituted the use of pressure cycling technology (PBI Barocyclers) to achieve consistent and superior lysis and digestion of tissue samples." (Addressing the challenges of high-throughput cancer tissue proteomics for clinical application: ProCan®).

About Westlake Institute for Advanced Study (now Westlake University)

Westlake Institute for Advanced Study ("WIAS") is a non-profit research institute dedicated to the advancement of natural sciences and the frontiers of engineering disciplines.  Located in the beautiful Cloud Town of Xihu District, Hangzhou, China, WIAS strives to represent the scientific strength of China, to influence the nation's future, and to promote inclusive development and progress. WIAS, now grown into Westlake University, aims at establishing a top-level research-oriented global university.  At WIAS, scientific knowledge and technological advancement are utilized to have a real-life impact on the world and to benefit human beings. Leading talent with innovative spirit and capabilities are trained to become the driving force of China's development.

About ProCan: The Australian Cancer Research Center Foundation International Centre for the Proteome of Cancer ("ProCan") is located in newly renovated laboratory facilities at the Children's Medical Research Institute ("CMRI") near Sydney, Australia. The goal of ProCan is to analyze over 70,000 cancer samples from all over the world over the next 5 years, with over 10,000 samples completed to date. This will enable a better understanding of cancer, as well as provide a means of personalized precision diagnosis and treatment, giving clinicians the information needed to decide on the best option for each individual patient. CMRI is an official collaborator of the US National Cancer Institute's Cancer Moonshot initiative, with a key objective to accelerate what would normally take ten years of cancer research to completion in five years.

About Pressure BioSciences, Inc: Pressure BioSciences, Inc. (OTCQB: PBIO) 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 PCT-based products for biomarker and target discovery, drug design and development, biotherapeutics characterization and quality control, soil & plant biology, forensics, and counter-bioterror applications. Additionally, major new market opportunities have emerged in the use of our pressure-based technologies in the following areas: (1) the use of our recently acquired, patented technology from BaroFold, Inc. (the "BaroFold" technology) to allow entry into the bio-pharma contract 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., CBD Oil 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."

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Merck & Co., Inc. (NYSE: MRK), for more than a century, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Merck recently announced that first-line treatment with KEYTRUDA, Merck's anti-PD-1 therapy, in combination with chemotherapy demonstrated improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) in a pooled analysis of a subgroup of patients with advanced nonsquamous and squamous non-small cell lung cancer (NSCLC) whose tumors do not express PD-L1 (tumor proportion score [TPS] <1%) from three randomized trials. Patients with nonsquamous NSCLC with EGFR or ALK genomic tumor aberrations were ineligible. Results – from KEYNOTE-189, KEYNOTE-407 and KEYNOTE-021 (Cohort G) – were consistent with those observed in the overall study populations across all three trials. Findings were featured in an oral presentation at the IASLC 2019 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain (Abstract #MA25.01). "The goal of our robust lung cancer clinical development program has always been to extend survival for patients who are diagnosed with this deadly and aggressive disease," said Dr. Jonathan Cheng, Vice President, Oncology Clinical Research, Merck Research Laboratories. "In this pooled analysis of three randomized KEYNOTE studies in advanced non-small cell lung cancer, KEYTRUDA in combination with chemotherapy demonstrated an improvement in overall survival compared to chemotherapy alone among newly diagnosed patients whose tumors do not express PD-L1."

Pfizer Inc. (NYSE: PFE) applies science and our global resources to bring therapies to people that extend and significantly improve their lives. Pfizer Inc. recently announced the successful completion of its acquisition of Array BioPharma Inc., advancing breakthrough science for the discovery, development and commercialization of targeted small molecule medicines to treat cancer and other diseases of high unmet need. As Array becomes part of Pfizer, it brings an impressive existing portfolio that includes the approved combined use of BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) for the treatment of BRAFV600E or BRAFV600K mutant unresectable or metastatic melanoma, with significant potential for long-term growth via expansion into additional areas of unmet need. Additionally, BRAFTOVI and MEKTOVI are being investigated as a potential first-in-class combination for the treatment of BRAF-mutant metastatic colorectal cancer (mCRC), based on compelling interim results from the pivotal Phase 3 BEACON trial, setting the stage to create a potentially industry-leading franchise for colorectal cancer alongside Pfizer's existing expertise in breast and prostate cancers. "We are proud to bring Array's exceptional scientific talent and broad pipeline into Pfizer," said Mikael Dolsten, Pfizer Chief Scientific Officer and President, Worldwide Research, Development and Medical. "Combined with Pfizer's leading research and development capabilities, today's announcement strengthens our potential to translate advanced science and technologies into the breakthroughs that change patients' lives."

GlaxoSmithKline plc (NYSE; GSK) is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GlaxoSmithKline plc recently announced positive results from PRIMA (ENGOT-OV26/GOG-3012), the Phase 3 randomized, double-blind, placebo-controlled, study of ZEJULA (niraparib) as a maintenance therapy in patients with first-line ovarian cancer following platinum-based chemotherapy. The study met its primary endpoint of a statistically significant improvement in progression-free survival for women regardless of their biomarker status. Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, said: "Almost 300,000 women around the world are diagnosed with ovarian cancer every year, yet only about 15% of patients are currently eligible to receive PARP inhibitors as their initial therapy. These exciting data demonstrate that ZEJULA has the potential to significantly benefit even more women with this devastating cancer."

AstraZeneca PLC (NYSE: AZN) has a deep-rooted heritage in oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. AstraZeneca will unveil a series of breakthrough data across multiple cancer types in its mission to one day eliminate cancer as a cause of death at the European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain, 27th of September to the 1st of October 2019. With 63 abstracts, including 7 oral presentations, the Company will demonstrate its leadership in precision medicine and immunotherapy. Dave Fredrickson, Executive Vice President, Oncology, said: "The practice-changing data we are presenting at ESMO 2019 demonstrates our commitment to make prolonged survival a realistic outcome. By using biomarkers to define optimal treatment and match innovative precision medicines to the patients who can best benefit from them, our dynamic Oncology pipeline and pioneering research continue to deliver new potential medicines across multiple deadly cancers."

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