Why Biomarkers for Cancer Drug Development are Becoming Increasingly Imperative

Palm Beach, FL – June 30, 2020 – Reports on the global market for biomarkers may vary on the dollar amount of their projections, but they all agree that there is a substantial growth in this market for years to come. One such report from Grand View Research projected that the global biomarkers market size is expected to reach over USD 129.4 billion by 2027, exhibiting a CAGR of 13.7%, during the forecast period. However a recent report from BCC Research trumps that projection and sees higher gains even earlier! Its report says that the global market for biomarkers should grow from $78.9 billion in 2018 to $136.5 billion by 2023 at a compound annual growth rate (CAGR) of 11.6% from 2018 through 2023. Biomarker-based tests have been in existence for over a few decades but their relevance to drug development and diagnostics applications in particular has gained momentum recently. This is apparent from the increased research interest, and patent and regulatory activity with regards to biomarkers. The National Institutes of Health says that biomarkers are extremely important for the early detection and treatment of cancer. Biomarkers detect it earlier and help to provide treatments for diseases… as in the case of cancer it is more important to detect it earlier, if it can’t be detected, it becomes incurable in later stages. NIH said: “Cancer is an uncontrolled growth of a cell due to failure in the cell growth signaling system. Cure of cancer is done only by the complete removal of cancerous cells from the body, the process may sound simple but its implementation is almost impossible. There are number of problems regarding its treatment such as its early detection. Science is progressing every second and so are our expectations…. As early detection is half victory in any disease, especially cancer, this kind of research will be advantageous in the field of cancer treatment.”    Active companies in the markets this week include: Pressure BioSciences, Inc. (OTCQB: PBIO), CytoDyn Inc. (OTCQB: CYDY), QIAGEN N.V. (NYSE: QGEN), Abbott Laboratories (NYSE: ABT), PDS Biotechnology Corporation (NASDAQ: PDSB).


The reports go on to say that “Factors, such as increasing collaborations and funds for R&D activities, rising consumer awareness, a widening patient base, and technological advancements collectively augmenting market growth.  The drug discovery segment contributed the highest revenue in 2019. Pharmaceutical companies focus on extensive R&D initiatives for the development of targeted therapeutics. Coordinated strategic efforts on biomarker development remain a searing trend among drug manufacturers, academic research institutions, commercial R&D organizations, nonprofitable health foundations, and federal government biomedical regulatory and research agencies.”


Pressure BioSciences, Inc. (OTCQB: PBIO) BREAKING NEWS: Pressure BioSciences and Leica Microsystems Sign Worldwide Co-Marketing Alliance: The Power of Laser Microdissection, PBI’s PCT Platform, and Mass Spectrometry Results in Next Generation Analysis of Tumor Biopsy Tissues – Pressure BioSciences today announced that the Company has entered into a worldwide co-marketing agreement with German-based Leica Microsystems CMS GmbH, a Danaher company. This historic alliance is expected to offer transformative new empowerment to cancer research worldwide, by integrating the latest enabling technologies in capturing, isolating, and preparing precious biopsy samples for superior analysis of relevant biomarkers of disease state and treatment response.


Leica Microsystems (“Leica”) is a leading global designer and producer of innovative high-tech precision optical systems for the analysis of microstructures. It is one of the market leaders in microscopy, pathology diagnostics, and surgical microscopes. Users of Leica’s instruments and services can be found in both clinical applications and broader life science research, several surgical specializations, disciplines associated with material sciences, the manufacturing industry, forensics services, and in classrooms around the world. Leica is a Danaher company.


PBI and Leica will co-market a novel, enabling technology platform that combines the Leica Laser Microdissection (LMD) System for precise excision of specific, minute sections of biopsy tissue with PBI’s Pressure Cycling Technology (“PCT”)-based Barocycler System for rapid protein extraction and digestion for sample preparation prior to mass spectrometry analysis. Specifically, both companies will promote an integrated biomarker discovery workflow designed to quickly and efficiently collect tissue sections excised by the Leica LMD and then drop the samples into PBI’s consumable MicroTubes for rapid PCT processing. Proteins are then analyzed by mass spectrometry (MS), the global method-of-choice for high throughput and comprehensive protein analysis.


The integrated workflow of LMD and PCT was developed by Dr. Thomas P. Conrads, a nationally acclaimed protein chemist.  Dr. Conrads is the Senior Director of Women’s Health Research in the Inova Women’s Service Line; he is also Chief Scientific Officer of the Women’s Health Integrated Research Center (WHIRC) at Inova Health System.


Dr. Conrads said: “We believe that integrating LMD, PCT, and MS will improve our understanding of the complex tissue microenvironment and better enable identification of new biomarkers.  We believe that the insights gained from applying this novel workflow will result in significant improvements in the clinical management of gynecologic and other cancers.”  The global cancer biomarker market is expected to reach $136.5 billion by 2023.


Ms. Roxana McCloskey, PBI’s Global Director of Sales & Marketing, said: “The generation of reliable and reproducible data from biopsy samples is difficult, as it requires the integration of multiple and varied laboratory processes, particularly tissue extraction, sample preparation, and analysis. The innovative LMD-PCT workflow enables the reproducible and rapid extraction of proteins from precious clinical samples by combining the precision of the Leica LMD system with PBI’s versatile PCT sample preparation platform.  The ability to co-market the workflow offers the opportunity for the combined sales and marketing forces of Leica and PBI to extend the integrated LMD-PCT systems into additional research centers globally that are focused on clinical proteomics, cancer research, biomarker discovery, and precision medicine.”      Read this and more news for Pressure BioSciences at:  https://www.financialnewsmedia.com/news-pbio/


Other recent developments in the markets include:


CytoDyn Inc. (OTCQB: CYDY) recently announced the Company and the Coordinating Commission of the National Institutes of Health and High Specialty Hospitals of Mexico (NIH) have entered into a Memorandum of Understanding (MOU) to conduct a COVID-19 clinical trial with leronlimab for severe and critically ill patients, with the potential to collaborate on additional COVID-19 trials. The NIH of Mexico is an organization that coordinates the main institutions of medical care and public research in the country.


The MOU provides CytoDyn will supply leronlimab at its expense to the NIH and both parties are proceeding forward expeditiously to complete the mutually agreed protocol for this clinical trial.  Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented: “We are very pleased with the confidence demonstrated by the NIH of Mexico in our drug, leronlimab, and we are both very motivated to initiate this trial quickly to help mitigate the devastation of the COVID-19 pandemic on the citizens of Mexico. The anecdotal data received by CytoDyn (from over 70 COVID-19 critical patients who were treated under EIND in the U.S.) has impressed the NIH of Mexico and we believe with a small Phase 3 trial of only 25 patients, leronlimab could receive approval in Mexico very quickly. This Phase 3 trial is similar to our Phase 3 trial protocol in the U.S., with the exception of the number of patients.”


QIAGEN N.V. (NYSE: QGEN) recently announced the launch of novel solutions enabling faster, better analysis of genomic variations in cancer – accelerating multiple applications of Precision Medicine. QIAGEN is showcasing its broad portfolio of Sample to Insight solutions for cancer in connection with the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, being held virtually from May 29-31.


“While we serve the world’s needs for testing tools in the COVID-19 pandemic, QIAGEN also continues to deliver cutting-edge molecular solutions for cancer research and improving patient outcomes. We are fully engaged with customers in oncology, making the most of digital technologies and virtual settings such as the 2020 ASCO Annual Meeting,” said Thierry Bernard, Chief Executive Officer at QIAGEN. “Our new QCI Interpret One clinical decision support software solutions, QIAseq Pan-cancer Multimodal and QIAseq Targeted Methyl panels provide oncology researchers with valuable tools and additions for variant interpretation, liquid biopsy applications as well as comprehensive genomic profiling (CGP) and biomarker discovery. They create true Sample to Insight solutions for a variety of oncology research applications.”


Abbott Laboratories (NYSE: ABT) the company and Tandem Diabetes Care (NASDAQ: TNDM) recently announced that they have finalized an agreement to develop and commercialize integrated diabetes solutions that combine Abbott’s world-leading1 continuous glucose monitoring (CGM) technology with Tandem’s innovative insulin delivery systems to provide more options for people to manage their diabetes. The companies first announced their intention to work together in October 2019, and this resulting agreement covers the technical development of device integration and associated commercial support activities.


“We’re excited to integrate our insulin delivery systems with Abbott’s glucose-sensing technology, and we look forward to expanding options for our customers so that they can combine devices that best suit their personal needs,” said John Sheridan, president and CEO of Tandem Diabetes Care. “We are proud to have an insulin pump capable of remote software updates that can make access to future integrations possible for in-warranty t:slim X2 users at the time of release without requiring a new pump.”


PDS Biotechnology Corporation (NASDAQ: PDSB) a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, recently announced the publication of data generated by the National Cancer Institute (NCI) based on preclinical studies of PDS Biotech’s lead clinical program, PDS0101, in combination with two other investigational anti-cancer agents.  The article “Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine” by Rumfield et al. was published in the Journal for ImmunoTherapy of Cancer, and provides strong rationale for clinical evaluation of this three-component treatment combination in a recently initiated NCI-led Phase 2 clinical trial.


The results of the NCI’s preclinical study indicated that PDS0101 generated both human papillomavirus (HPV)-specific T-cells and an associated antitumor response when used as a monotherapy.  When PDS0101 was combined with two other development-stage anti-cancer agents, Bintrafusp alfa (M7824) and NHS-IL12, the data suggest the agents worked synergistically to provide enhanced tumor regression and T-cell response as compared to the agents alone.


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