Biotechs Strive to Combat Rising Cancer Mortality Rates

NEW YORK, Oct. 7, 2019 /PRNewswire/ -- Cancer is a disease that involves the abnormal growth of cells which results in the formation of a tumor. The abnormal cells have a tendency to spread to other local tissues and may also spread to different parts of the body through the blood and the lymphatic systems. Numerous factors have been attributed to the development of cancer, such as smoking, tobacco chewing, exposure to carcinogens, genetic factors and even viruses. Overall, the number of cancer cases is increasing with the growing aging population and a marked increase in the diagnostic rates of the disease. Mortality rates for cancer are extremely high across the globe and it is currently among the top leading causes of death worldwide. Notably, the global cancer therapeutics market should grow from USD 128.1 Billion in 2018 to USD 182.0 Billion by 2023, at a compound annual growth rate (CAGR) of 7.3% for the period of 2018-2023, according to BCC Research. Generally speaking, the cancer therapeutics market is highly crowded due to the availability of a large number of cytotoxic, hormonal and targeted therapeutics. However, demand for target therapeutics and combinatorial treatments remains high as they are some of the most effective treatment modalities for cancer. Now, cancer immunotherapy is also gaining traction among the industry with development of immunocheckpoint inhibitors as a separate class of drug. Pressure BioSciences, Inc. (OTC: PBIO), CEL-SCI Corporation (NYSE: CVM), AbbVie Inc. (NYSE: ABBV), Bristol-Myers Squibb Company (NYSE: BMY), Abbott Laboratories (NYSE: ABT)

Previously, detecting cancer early on was challenging, but the advancement of early screening technology has allowed patients to receive therapy before their cancer worsens. Targeted therapy is also becoming a popular treatment among patients because it specifically targets cancerous cells without damaging blood cells. Now, there is also a growing demand for personalized medicine, which is expected to create new opportunities within the market. Personalized medicine tailors treatment towards the patient's characteristics such as his or her specific molecular structure and genetic profile. However, the biggest hindrance is the cost of some of these therapies. For an average patient, it is difficult to obtain the monetary funds necessary to pay for effective treatments. For instance, the U.S. Food and Drug Administration approved tisagenlecleucel to treat patients with acute lymphoblastic leukemia, a drug which genetically re-engineers the patient's own T-cells to attack the leukemic cells. This was the first cell-based gene therapy approved in the U.S. and is priced at USD 475,000 for a course of treatment. Biotechnology companies are now tasked with developing effective treatments but also at an affordable cost. "Ultimately, I want to access the best available therapies for the people I treat: the ones most likely to bring meaningful improvements in their quality and length of life, and the ones that reduce the toxicity associated with treatment," said Ajay Aggarwal, Oncologist at Guy's and St Thomas' NHS Trust in London, "Any new cancer therapy, drug or not, should undergo robust evaluation for outcomes that truly matter to individuals. As it is, limited finances are too often being directed from evidence-based therapies to those that promise false hope."

Pressure BioSciences, Inc. (OTCQB: PBIO) announced last week, "the Company's patented pressure cycling technology ("PCT") platform was featured as an integral part of a new, innovative workflow for the analysis of proteins from cancer biopsy samples. This workflow was presented in a plenary session at the Annual Meeting of the International Gynecologic Cancer Society ("IGCS") on September 21, 2019 in Rio de Janeiro, Brazil. The mission of the IGCS is to improve the care and outcomes for women with gynecologic cancer worldwide through education, training and public awareness.

According to Dr. Larry Maxwell, MD, gynecologic oncologist and Chair of OB-GYN at Inova Fairfax Hospital, 'the conventional use of chemotherapy in ovarian cancer treatment is being rapidly replaced by biologic therapeutics that target the cancer (the "seed") and also the micro-environment (the "soil") in which it grows. Being able to collect small tissue specimens and characterize them across multiple genomic and proteomic platforms will enable us to markedly enhance our ability to develop companion diagnostics and prognostics as well as identify targets for future therapeutic strategies. Technology provided by Pressure BioSciences has become an essential requirement for our novel workflow in meeting our goals.'

Gynecologic malignancies include ovarian, uterine, and cervical cancers. Together they are responsible for approximately 35,000 deaths annually in the United States with ovarian cancer ranking fifth in cancer deaths among women (Aurora Healthcare and the Centers for Disease Control and Prevention). According to Acumen Research and Consulting (2018), the global ovarian cancer diagnostics market alone is forecasted to grow at a CAGR around 5.9% over the forecast time frame and reach around US $1.8 billion by 2026. New, improved methods to detect these cancers are vitally needed to support the design and development of better treatments through enhanced precision medicine. The IGCS is committed to addressing this critical issue.

Dr. Thomas Conrads, a nationally acclaimed protein chemist, is the Senior Director of Women's Health Research at the Inova Women's Hospital. Dr. Conrads' group was invited to present their innovative workflow for analyzing cancer tissue proteins at the IGCS meeting. The presentation titled Interim Analysis of Ovarian Cancer by the US National Cancer MOONSHOT'S Tri-Federal (DOD/NCI/VA) Applied Proteogenomic Organizational Learning and Outcomes (APOLLO) Research Network, was made by Dr. Maxwell. Data demonstrated the feasibility of proteogenomic characterization of known-patient tumors for specimen preparation in support of large-scale analyses in the U.S. Cancer Moonshot's APOLLO program. This program focuses on genetic sequencing and proteomic analysis of tumors in order to develop clinically actionable molecular panels for precision medicine and personalized health.

The novel workflow developed by Dr. Conrads and his colleagues integrates the Leica Microsystems' laser microdissection (LMD) platform and PBI's PCT platform, enabling micro-scale quantitative proteomics and phosphoproteomics on a ThermoFisher Scientific mass spectrometry (MS) instrument. LMD is a state-of-the-art method for precise excision of cells from biopsy tissues at microscopic scale by a laser. Excised cells are delivered directly into PBI's MicroTubes for critical sample preparation, including rapid and efficient high-quality cellular protein release. Proteins are then analyzed by mass spectrometry (MS), the global method-of-choice for high throughput and comprehensive protein analysis.

Dr. Conrads commented: 'We are very pleased to have been invited to present the results of our work in gynecologic cancer research in a plenary session at this important international meeting. The novel workflow developed by our group integrates and operationalizes state-of-the art techniques: laser microdissection (LMD), pressure cycling technology (PCT), and mass spectrometry (MS) to improve our understanding of the complex tissue microenvironment and, in this case, to enable identification of biomarkers associated with women's cancers. We believe that the insights we gain from applying this novel workflow will result in significant improvements in the clinical management of gynecologic cancer.'

Dr. Nate Lawrence, Senior Consultant to PBI, said, 'Precision medicine promises a paradigm shift in the diagnosis and treatment of disease. This shift is highly dependent on the generation and evaluation of high-quality data generated during comprehensive analyses of each patient's tumor samples. Although critical to precision medicine the generation of such data from biopsy samples has been difficult to date, as it requires the integration of multiple and varied laboratory processes, including tissue extraction, critical sample processing, and analysis. The innovative workflow developed by Dr. Conrads and his colleagues combines the precision of Leica Microsystems' state-of-the-art LMD system on the frontend with the superior analytical capabilities of Thermo Scientific's mass spectrometer on the backend. In the middle, integral to connecting these two superb instrument systems, is the speed, robustness, reproducibility, and versatility of PBI's PCT Barocycler system.'

Mr. Richard T. Schumacher, President and CEO of PBI, concluded: 'We were delighted to see PBI's Barocycler system featured in its pivotal position in this important new tumor processing workflow that Dr. Conrads and his colleagues have presented: the critical enabling step after LMD excision and before MS analysis. Based on results to date, we believe that the number of laboratories worldwide performing laser microdissection followed by mass spectrometric analyses will increase at a steady but significant rate, that our Barocycler system will remain a critical part of this workflow, and that the adoption of this novel new workflow should result in a measurable increase in Barocycler sales over the coming months and 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., 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."

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CEL-SCI Corporation (NYSE: CVM) believes that boosting a patient's immune system while it is still intact should provide the greatest possible impact on survival. CEL-SCI Corporation recently announced that the Independent Data Monitoring Committee (IDMC) for the Company's pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) has completed its recent review of the Phase 3 study data. The data from all 928 enrolled patients were provided to the IDMC by the clinical research organization (CRO) responsible for data management of this Phase 3 study. The IDMC made the following recommendation: The IDMC recommendation is to continue the trial until the appropriate number of events have occurred. IDMCs are committees commonly used by sponsors of clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials, especially when the trials involve patients with life threatening diseases, and when, as in cancer clinical trials, they extend over long periods of time. CEL-SCI's Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer. Per the study's protocol, newly diagnosed patients with advanced primary squamous cell carcinoma are treated with the Multikine treatment regimen for 3 weeks prior to receiving the Standard of Care (SOC), which involves surgery, radiation and/or concurrent radiochemotherapy. Multikine is designed to help the immune system "see" the tumor at a time when the immune system is still relatively intact and thereby it is better able to mount an attack on the tumor. The aim of treatment with Multikine is to increase the body's immune system against the tumor prior to SOC.

AbbVie Inc. (NYSE: ABBV) is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. AbbVie recently announced that MERU, a Phase 3 trial evaluating Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer (SCLC), demonstrated no survival benefit at a pre-planned interim analysis for patients receiving Rova-T as compared with placebo. The overall safety profile was generally consistent with that observed in previous studies. The MERU trial is being closed, and the Rova-T research and development program has been terminated. AbbVie will move forward prioritizing other development programs within its oncology pipeline. An Independent Data Monitoring Committee (IDMC) recommended terminating MERU due to lack of survival benefit for patients receiving Rova-T compared with the placebo control arm based on results at a pre-planned interim analysis. Results from the MERU trial will be presented at a future medical meeting and/or published in a peer-reviewed medical journal. "Small-cell lung cancer continues to be one of the most difficult-to-treat cancers where there is a significant need for transformative therapies. We are disappointed with this outcome for the patients who suffer from this disease," said Margaret Foley, M.D., Vice President, Global Head of solid tumor development, AbbVie. "We remain committed to researching and developing other therapies with the potential to transform care for patients with small-cell lung cancer and other malignancies."

Bristol-Myers Squibb Company (NYSE: BMY) is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Bristol-Myers Squibb Company recently announced updated results from studies evaluating Opdivo (nivolumab) and Yervoy (ipilimumab), alone or in combination, in patients with advanced or metastatic melanoma. These analyses (Abstracts #9533, #9568 and #9551) were featured on Monday, June 3 at the American Society of Clinical Oncology 2019 Annual Meeting in Chicago. An analysis exploring long-term quality of life (QoL) and symptom burden in the Phase 3 CheckMate -067 study found that QoL was maintained during the treatment-free interval (TFI) – the period where a patient is off study treatment and free of subsequent therapy – in patients with previously untreated unresectable or metastatic melanoma following discontinuation of therapy with Opdivo or Opdivoplus Yervoy. Patient reported outcome (PRO) scores were maintained from last on-treatment visit to follow-up 1 (30 days after the last dose) or follow-up 2 (84 days after follow-up 1) for patients who discontinued treatment. PRO scores remained stable beyond follow-up 2 for the EQ-5D-3L (measures of mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which were collected at survival follow-up visits every three months in the first year and then every six months. "These latest results provide further support for the long-term scientific rationale for combining Opdivo and Yervoy for the treatment of advanced melanoma," said Arvin Yang, M.D., Ph.D., development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. "We will continue to evaluate the combination in these patients, as it also provides us with a wealth of valuable scientific information on the impact of immuno-oncology therapy in this population."

Abbott Laboratories (NYSE: ABT) is a global healthcare leader that helps people live more fully at all stages of life. Abbott recently announced the company had received U.S. Food and Drug Administration (FDA) approval for the most advanced MitraClip™ heart valve repair device to treat mitral regurgitation. The latest approval for the fourth-generation MitraClip device, MitraClip G4, puts new enhancements into the hands of physicians across the U.S. by delivering an expanded range of clip sizes, an alternative leaflet grasping feature and facilitation of procedure assessment in real time to offer doctors further options when treating mitral valve disease. The MitraClip device repairs leaky mitral valves without open-heart surgery and is delivered to the heart through a small incision in the leg. The device clips portions of the leaflets, or flaps, of the mitral valve together to reduce the backflow of blood (known as mitral regurgitation, or MR), restoring the heart's ability to pump oxygenated blood more efficiently. To date, MitraClip has helped treat more than 80,000 people worldwide suffering from both primary and secondary MR and is supported by the industry's most extensive body of clinical evidence, including the recent results of the landmark COAPT™ Trial published in The New England Journal of Medicine in September 2018. "We are continually innovating the MitraClip technology based on the experience of the physicians implanting the device so we can truly help them improve the lives of their patients," said Neil Moat, M.D., Chief Medical Officer of Abbott's structural heart business. "With the fourth generation of MitraClip, we set out to build a system that would help physicians individualize the therapy to each patient and deliver even more features that can treat both primary and secondary mitral regurgitation."

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