Biotechnology Companies Step up to Better Combat Global Outbreaks

Thursday, July 25, 2019 General News
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NEW YORK, July 25, 2019 /PRNewswire/ -- Almost every year, a contagious outbreak occurs in various regions around the world. In efforts to mitigate their spread, health officials mandate that citizens receive vaccinations. However, despite the immediate access to healthcare in many regions, people are still widely affected by these

diseases. For instance, the Democratic Republic of the Congo has been experiencing a massive Ebola outbreak which ultimately led the World Health Organization Director-General Dr. Tedros Adhanom Ghebreyesus to declare the Ebola outbreak a public health emergency of international concern. Additionally, the Ebola outbreak can potentially spread across to other global regions. For instance, in 2014, a major Ebola outbreak occurred in the African subcontinent and a traveler flying out of Africa spread the disease to the U.S., causing a public health scare. For these reasons, when global outbreaks like the Ebola epidemic occur, health officials around the world often take extensive measures. For instance, the Centers for Disease Control and Prevention sets up exit screenings at the originating country and then an entry screening at the destination. While screenings can be effective, there is still a chance that the disease can spread and as a result, medical institutions and officials need to be prepared. Moreover, the U.S. experienced its largest measles outbreak earlier in 2019, affecting a reported 695 people. However, officials were able to limit the number of deaths due to immunizations and vaccines. Overall, the occurrence of these outbreaks has led many biotechnology companies to accelerate their pipelines and develop more effective treatments. According to data compiled by Global Market Insights, the global biotechnology market was valued at USD 399.4 Billion in 2017. Additionally, by 2024, the market is forecast to surpass USD 775 Billion while registering a CAGR of 9.9% from 2018 to 2024. Pressure BioSciences, Inc. (OTC: PBIO), Merck & Co., Inc. (NYSE: MRK), Celgene Corporation (NASDAQ: CELG), Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), Array BioPharma Inc. (NASDAQ: ARRY)

While these outbreaks are a major public concern, there is also a large demand for therapies and drugs to treat cases that aren't contagious. Specifically, conditions such as cancer, autoimmunity/inflammation, infectious agents, and genetic disorders impact a significant number of people each year. In particular, cancer has a huge impact on society in the U.S. and across the world. In 2018, it was estimated that 1.73 million people were diagnosed with cancer and 609,640 people died from the disease, according to the National Cancer Institute. Generally, for cancer cases, many patients receive treatments such as chemotherapy or radiotherapy to either make the cancer cells dormant or eliminate them. Notably, an emerging treatment for cancer is targeted therapy. While chemotherapy and targeted therapy both use drugs, targeted therapy is different because it specifically targets the cancer's particular genes, proteins, and environment that aid in its spread and survival. However, chemotherapy can have serious side effects such as damaging cells in the bone marrow, hair follicles, and cells in the mouth, digestive tract, and reproductive system, leading to severe side effects. Nevertheless, biotechnology companies have aimed to develop innovative treatments that are much safer while maintaining their efficiency. In particular, therapeutic proteins have emerged because of its advantages over traditional treatments. For example, therapeutic proteins are a highly specific and complex set of functions that are less likely to interfere with normal biological processes and cause adverse effects, according to Creative Biolabs. Moreover, therapeutic proteins are well tolerated and less likely to cause immune responses. Additionally, certain protein-based drugs can control the growth and activity of immune cells and help boost your immune system to prevent cancer. "Today new avenues for cancer diagnostics and therapeutics present themselves. The choices include specific diagnostics, such as the rapidly evolving use of liquid biopsies that analyze cells and molecules spawned by the tumor and found in bodily fluids such as blood or urine, a more focused analysis of non-responders, the financial implications of future therapies, and an advocacy for a return to basic scientific research. The result of exploring these options will be a wider range of treatment choices for oncologists and a more positive outcome for patients," said Steve Brozak, President of WBB Securities, LLC, an investment bank and research firm that specializes in the biotechnology, specialty pharmaceutical and medical device sectors.

Pressure BioSciences, Inc. (OTCQB: PBIO) announced yesterday that, "it has signed a contract services agreement with a world-renown, multi-billion dollar biotherapeutics company to enhance the process manufacturing of one of their candidate protein drugs.

The manufacturing of therapeutic proteins can be a complex and challenging process. According to a report in F1000 Research (Lagasse, Feb 2017), producing a typical protein drug may include more than 5,000 critical steps. Two of the major challenges associated with manufacturing recombinant proteins are (i) the formation of aggregates, and (ii) protein misfolding. These are significant issues that can prevent a protein drug candidate from ever making it to market. PBIs BaroFold technology platform offers a unique and cost-effective way to address these manufacturing challenges.

PBI purchased the assets of BaroFold, Inc. in late 2017, including their extensive patent portfolio. Since that time, the Company has incorporated its own proprietary technology and developed a cost-effective way to improve the process manufacturing of proteins by utilizing high pressure. To capitalize on these capabilities, PBI launched the BaroFold Biopharma Services Business in January 2019.

Dr. Alexander Lazarev, Chief Science Officer of PBI, said: The BaroFold platform can be applied to the development and production of many different therapeutic proteins, can improve product safety, and is scalable and practical for standard bioprocess environments. Moreover, it offers ways to reduce or eliminate the use of aggressive chemicals in the protein manufacturing process. Thus, we believe this unique technology platform can help biopharmaceutical companies create and manufacture high quality novel protein therapeutics and biosimilars, lower the cost of existing formulations, and help protect our environment.

Protein-based therapeutics are a large and growing part of the global healthcare industry. Based on data in the THPdb database (http://crdd.osdd.net/raghava/thpdb/), there are over 200 therapeutic proteins and peptides currently approved by the FDA for clinical use in the US. These target therapies have shown significantly improved outcomes for many patients suffering from severe medical conditions, such as cancer and immunological diseases. According to a report from Research and Markets (May 2016), the global protein drug market will reach approximately $248 billion by 2020.

Richard T. Schumacher, President and CEO of PBI, commented: Our proprietary BaroFold Biopharma Services Business offers us a unique opportunity to enter the estimated $44 billion (by 2026) global bioprocess technology market (Transparency Market Research, July 2018). In addition to successfully performing contract services for two biopharmaceutical companies since the beginning of 2019, we are also in discussions with three additional biopharmaceutical companies interested in utilizing our proprietary BaroFold services for their protein drug candidates. To take full advantage of this opportunity, we have doubled the capacity of our contract services team, purchased additional sophisticated equipment, and developed new high-pressure concepts that further improve and enhance our BaroFold process scalability and its GMP compliance.

Mr. Schumacher concluded: We believe our recently launched BaroFold Biopharma Services Business could add as much as $500,000 to 2019 total revenue and significantly more to total revenue for 2020 and beyond. It is important to note that these estimates do not include the anticipated growth in Barocycler 2320EXT sales that we believe will result from biotechnology and biopharmaceutical companies developing their own manufacturing, quality control, and protein characterization applications on our leading PCT-based instrument system. These are truly exciting times for all stakeholders in PBI.

About the BaroFold Technology Platform: The BaroFold platform is a patented technology that employs carefully controlled high pressure for the disaggregation and controlled refolding of recombinant proteins into their native structures for desired drug activity. The BaroFold technology platform is transformative and practical for biopharmaceutical manufacturing processes, offering substantially reduced production costs due to its increased process yield and throughput in both mammalian and non-mammalian systems. The BaroFold technology platform is easily scalable and has been utilized for the cGMP production of pre-clinical and phase 1 through phase 3 clinical materials.

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."

Merck & Co., Inc. (NYSE: MRK) is 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, known as MSD outside the United States and Canada, recently announced that it had entered into a definitive agreement to acquire Tilos Therapeutics, a privately-held biopharmaceutical company developing therapeutics targeting the latent TGF? complex for the treatment of cancer, fibrosis and autoimmune diseases. TGF? is a potent cytokine believed to play an important role in the development of cancer and fibrotic diseases. TGF? is secreted as a complex with the protein, latency-associated peptide (LAP). LAP forms a cage around TGF?, holding the cytokine in an inactive state until it is deployed. Evidence has shown that anti-LAP antibodies block the release of TGF? from the TGF?-LAP complex with the potential to provide a novel therapeutic mechanism to reduce TGF? activity. "At Merck we continue to enhance our robust pipeline through active execution of our business development strategy," said Dr. Dean Li, Senior Vice President, discovery and translational medicine, Merck Research Laboratories. "Tilos has developed a compelling portfolio of candidates that employ a novel approach to modulating the potent signaling molecule TGF? by binding to latency-associated peptide, with potential applications across a range of disease indications."

Celgene Corporation (NASDAQ: CELG), headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. Celgene Corporation recently announced the first clinical results evaluating iberdomide (CC-220) in combination with dexamethasone in patients with relapsed and refractory multiple myeloma from the ongoing phase 1/2 CC-220-MM-001 study during an oral presentation at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The results included preliminary safety and efficacy data from the ongoing multicenter, open-label, dose-escalation study, which aims to determine the maximum tolerated dose and the recommended phase 2 dose of iberdomide in combination with dexamethasone. Iberdomide is Celgene's proprietary cereblon E3 ligase modulator (CELMoDŽ) compound with enhanced tumoricidal and immune stimulatory effects demonstrated in preclinical studies. The phase 1/2 study is expected to enroll approximately 300 participants. "While we have made tremendous progress in treating multiple myeloma, there is still a significant need for new options to address the heterogeneous nature of the disease. We are focused on exploring the potential of our next generation CELMoD compounds to help fill this gap," said Dr. Alise Reicin, President, Global Clinical Development for Celgene. "The preliminary clinical activity and favorable safety data observed with the combination of iberdomide and dexamethasone are encouraging, particularly in patients who have failed multiple lines of therapy including patients who were refractory to lenalidomide, pomalidomide and/or daratumumab."

Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) as the leader in RNA-targeted drug discovery and development has created an efficient, broadly applicable, proprietary antisense technology platform with the potential to treat diseases where no other therapeutic approaches have proven effective. Ionis Pharmaceuticals, Inc. recently announced that its partner Roche, also known as Genentech in the United States, has enrolled the first patient in a pivotal study of RG6042 (IONIS-HTTRx) for people living with symptoms of Huntington's disease (HD), a hereditary neurodegenerative disorder for which there is currently no approved disease-modifying treatment. RG6042 is the first therapy in pivotal trials designed to target the underlying cause of HD by reducing production of the toxic mutant huntingtin protein (mHTT). Ionis has earned a USD 35 Million milestone payment for the initiation of the study. "We are pleased that RG6042 has progressed to a Phase 3 study. It is the first of four or more Ionis programs that we anticipate will advance to pivotal studies this year, further proof that we are realizing the potential of our novel antisense technology to deliver transformative medicines to those who need them," said Brett P. Monia, Ph.D., Ionis' Chief Operating Officer. "Our commitment to developing antisense medicines for neurological diseases has led to the commercialization of SPINRAZA, the standard of care treatment for people with all forms of spinal muscular atrophy. Enrollment of the first patient in this pivotal trial represents substantial hope for people living with Huntington's disease and their families."

Array BioPharma Inc. (NASDAQ: ARRY) is a fully integrated biopharmaceutical company focused on the discovery, development and commercialization of transformative and well-tolerated targeted small molecule drugs to treat patients afflicted with cancer and other high-burden diseases. Pfizer Inc. and Array BioPharma Inc. recently announced that they had entered into a definitive merger agreement under which Pfizer will acquire Array, a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule medicines to treat cancer and other diseases of high unmet need. Pfizer has agreed to acquire Array for USD 48 per share in cash, for a total enterprise value of approximately USD 11.4 Billion. The Boards of Directors of both companies have approved the merger. Array's portfolio includes the approved combined use of BRAFTOVIŽ (encorafenib) and MEKTOVIŽ (binimetinib) for the treatment of BRAFV600E or BRAFV600K mutant unresectable or metastatic melanoma. The combination therapy has significant potential for long-term growth via expansion into additional areas of unmet need and is currently being investigated in over 30 clinical trials across several solid tumor indications, including the Phase 3 BEACON trial in BRAF-mutant metastatic colorectal cancer (mCRC). "We are incredibly proud that Pfizer has recognized the value Array has brought to patients and our remarkable legacy discovering and advancing molecules with great potential to impact and extend the lives of patients in critical need," said Ron Squarer, Array Chief Executive Officer. "Pfizer shares our commitment to patients and a passion for advancing science to develop even more options for individuals with unmet needs. We're excited our team will have access to world-class resources and a broader research platform to continue this critical work."

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