FinancialBuzz.com News Commentary
New York, NY (7/31/2020) – According to the World Health Organization, cancer is the leading cause of mortality globally, accounting for approximately 9.6 million deaths in 2018. The three key categories of drugs used for cancer, based on their mechanism of action, are cytotoxic drugs, targeted drugs, and hormonal drugs. A report by Medgadget indicates that the cancer therapeutic drugs market has witnessed strong growth in recent years, thanks to increasing drug approvals and emergence of biosimilar products for cancer treatment. In addition, increasing healthcare spending for cancer related applications has led to mounting R&D investments for emerging new cancer drugs that are highly effective and carry fewer side-effects. AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC), Bluebird bio, Inc. (NASDAQ: BLUE), Exelixis, Inc. (NASDAQ: EXEL), Guardant Health, Inc. (NASDAQ: GH), GlaxoSmithKline plc (NYSE: GSK)
The cancer diagnostics market is a crucial factor influencing the oncology industry. Increasing incidence of cancer across the globe creates demand for new diagnostic tools designed for early detection. Lung cancer, breast cancer and colorectal cancer are the most common forms. Yet, recent advancements in cancer diagnostics include the liquid biopsy technique, which is driving the demand for oncology diagnostics. Liquid biopsy allows for the detection of cancer through multiple markers present in the blood, saliva, or urine of the cancer patient and is an advanced tool in cancer detection. Additionally, liquid biopsy is non-invasive in nature, further increasing the customer preference for the cancer test. And, according to Global Market Insights, Inc., the cancer diagnostics market size was valued over USD 97.2 Billion in 2018 and is expected to expand at an 8% CAGR from 2019 to 2025.
AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC) announced breaking news earlier this week that, “it had completed over 180,000 Cancer Differentiation Analysis (“CDA”) based tests as of July 15, 2020.
AnPac Bio had previously completed more than 169,000 CDA-based tests as of March 31, 2020. From April 1, 2020 to July 15, 2020, the Company completed over 10,000 commercial CDA-based tests and over 1,000 CDA-based tests for research purposes, which increased the cumulative number of CDA-based tests to over 180,000.
‘We are honored to have achieved this milestone, which demonstrates the market-wide acceptance of our products. We offer a comprehensive product offering to meet different customers’ needs and to address this large and growing market. Our CDA-based test can detect and assess an individual’s overall risk of having or developing cancers, and a cancer risk assessment report is the final product of the test. The report presents the analytical parameters that our CDA test uses, including the PTF, CTF and overall CDA values,’ said Dr. Chris Yu, CEO and Chairman of AnPac Bio.
Dr. Chris Yu continued, ‘Our CDA-based test is advanced in many ways. Unlike conventional cancer screening and detection approaches such as imaging technology and tissue biopsy, our CDA test uses liquid-based technology to detect the risk of cancer and non-cancerous diseases. It is minimally invasive, side effect-free and highly automated. Because it focuses on changes in cancer-related biophysical properties as a disease progresses, we believe that our CDA test can be used for multiple purposes, including early cancer screening and detection, and assistance in cancer diagnosis, prognosis and recurrence.’
About AnPac Bio – AnPac Bio is a biotechnology company focused on early cancer screening and detection, with 128 issued patents as of June 30, 2020. With two certified clinical laboratories in China and one CLIA and CAP accredited clinical laboratory in the United States, AnPac Bio performs a suite of cancer screening and detection tests, including CDA (Cancer Differentiation Analysis), bio-chemical, immunological, and genomics tests. In a 2019 market research report by Frost & Sullivan, AnPac Bio ranked third worldwide and first in China among companies offering next-generation early cancer screening and detection technologies in terms of the number of clinical samples for cancer screening and detection, based on approximately 41,700 clinical samples as at May 2020. AnPac Bio’s CDA technology platform has been shown in retrospective validation studies to be able to detect the risk of over 20 different cancer types with high sensitivity and specificity. For more information, please visit: https://www.Anpacbio.com.”
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Bluebird bio, Inc. (NASDAQ: BLUE) and Bristol Myers Squibb announced on July 29th, the submission of their Biologics License Application to the U.S. Food and Drug Administration for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma. This submission provides further details on the Chemistry, Manufacturing and Controls module to address the outstanding regulatory requests from the FDA in May 2020 following the original BLA submission from March 2020. The submission is based on results from the pivotal Phase 2 KarMMa study evaluating the efficacy and safety of ide-cel in relapsed and refractory multiple myeloma patients exposed to an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Results from the study were shared during an oral presentation as part of the American Society of Clinical Oncology 2020 Virtual Scientific Program.
Exelixis, Inc. (NASDAQ: EXEL) announced on July 20th, the initiation of CONTACT-03, a global phase 3 pivotal trial of cabozantinib in combination with atezolizumab in patients with inoperable, locally advanced or metastatic renal cell carcinoma who progressed during or following treatment with an immune checkpoint inhibitor as the immediate preceding therapy. CONTACT-03 is part of a clinical trial collaboration between Exelixis and Roche that includes two additional phase 3 pivotal trials – CONTACT-01 in patients with metastatic non-small cell lung cancer who have been previously treated with an immune checkpoint inhibitor and platinum-containing chemotherapy and CONTACT-02 in patients with metastatic castration-resistant prostate cancer who have been previously treated with one novel hormonal therapy – both initiated in June 2020. “The treatment landscape for metastatic kidney cancer is rapidly evolving as the use of immune checkpoint inhibitor-based regimens move to earlier lines of therapy,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “More data are needed to better understand the sequential use of treatments for this patient community, and we look forward to learning more about the potential role of the combination of cabozantinib and atezolizumab following checkpoint inhibitor therapy in this pivotal trial with our partner Roche.”
Guardant Health, Inc. (NASDAQ: GH) announced on July 30th, a strategic collaboration with Radius Health, Inc. to pursue regulatory approval of the Guardant360® CDx as a companion diagnostic for elacestrant (RAD1901), an investigational selective estrogen receptor degrader being studied in the treatment of advanced ER-positive, HER2-negative breast cancer resistant to CDK4/6 inhibitors in combination with hormone therapy. “Given breast cancer’s inherent tumor heterogeneity and the high prevalence of bone metastasis in advanced disease, our Guardant360 liquid biopsy can help overcome the challenges of tissue and bone biopsies to reveal significantly more actionable mutations, including ESR1 mutations, which may play a role in resistance and which are being studied in Radius’ EMERALD trial,” said AmirAli Talasaz, Ph.D., Guardant Health President. “For patients with CDK4/6 resistant tumors, for whom few other treatment options exist, potential therapies such as elacestrant may represent a promising option.”
GlaxoSmithKline plc (NYSE: GSK) announced on July 24th, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending the approval of belantamab mafodotin as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: “Today’s positive opinion from the CHMP is an important step in helping patients suffering from relapsed or refractory multiple myeloma who currently have limited options and poor outcomes. If approved, belantamab mafodotin will provide patients and physicians across much of Europe with a first-in-class anti-BCMA treatment option that works differently from other available therapies for this incurable disease.”
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