Clinical Trials for Evolving Targeted Therapies Fueling Gains for Brain Tumor Therapeutics Market
Palm Beach, FL – July 15, 2020 – An array of reports have projected that the global brain tumor drugs market will continue to rise for the next several years. One earlier report from January 2019 said that the Global Brain Tumor Therapeutics Market Will Reach $2.0 Billion by 2023. A more recent report from ReportLinker projected that The global Brain Tumor Therapeutics market size is expected to gain market growth in the forecast period of 2020 to 2025, with a CAGR of 10.0% in the forecast period of 2020 to 2025 and will expected to reach USD $1552.3 million by 2025, from USD $1060.2 million in 2019 and the most recent report from Market Reports projected that The global brain tumor therapeutics market has been estimated to reach USD $2.74 billion in 2023. The market is expected to register a CAGR of 11% during the forecast period 2018 to 2023… and a Business Research Company said that the global brain tumor drugs market was valued at about $2.4 billion in 2018 and is expected to grow to $3.41 billion at a CAGR of 9.2% through 2022. All project continued growth for the market in the coming years. Active biotech and pharma companies in the markets this week include CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL), VBI Vaccines Inc. (NASDAQ: VBIV), INmune Bio, Inc. (NASDAQ: INMB), Merck & Co., Inc. (NYSE: MRK).
A recent MarketWatch report said: “Increasing incidence of Brain Cancer has resulted in upsurge the demand for brain cancer across the globe which is driving the market. In addition, increased focus on precision medicine is also fueling the global brain tumor therapeutics market… Few brain cancer specific drugs and their high cost is acting as a restraint for Brain Tumor therapeutics market. Although various pharmaceutical companies are spending heavily on R&D activities which can bring more treatment options to the market in future.”
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) BREAKING NEWS: CNS Pharmaceuticals Completes Drug Product Manufacturing Strategy for Berubicin – CNS Pharmaceuticals, a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today provided an update on the manufacturing strategy for Berubicin drug product, its lead drug candidate for the treatment of glioma brain tumors.
In June, CNS Pharmaceuticals successfully engaged USA-based Pharmaceutics International, Inc., (Pii) and Italian BSP Pharmaceuticals S.p.A., (BSP), respectively, for the production of Berubicin drug product. The Company decided to implement a dual-track drug product manufacturing strategy in order to mitigate both COVID-19 related risks, as well as to diversify its supply chain and reduce the risk that inefficiencies could impact the Company’s clinical timeline. The Company’s decision to have both a European and United States manufacturer also provides for localized availability of Berubicin for the upcoming Phase I Pediatric and Phase II adult studies in Poland and the U.S. Phase II trial. As previously announced, CNS completed synthesis of Berubicin Active Pharmaceutical Ingredient (API) and has now shipped API to two companies, Pii and BSP, that will prepare an injectable form of Berubicin ready for clinical use. This is an important step to allow CNS to initiate clinical studies in GBM patients.
“Our decision to contract both Pii and BSP represents a key part of our overall strategy to get Berubicin back into clinical trials as soon as possible,” stated John Climaco, CEO of CNS Pharmaceuticals. “Importantly, we felt it prudent to diversify our production strategy given the difficulty of predicting COVID-19 related risks and supply chain constraints. With our laser focus on initiating our Phase 2 trial by the end of the 2020, we believe the decision to engage both manufacturers positions us optimally to continue to execute on our timeline and reduce the risks of delays.” Read this full release and more news for CNSP at: https://www.financialnewsmedia.com/news-cnsp/
Other recent developments in the biotech industry include:
Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) recently announced the initiation of an investigator-sponsored trial (IST) being conducted by Imperial College London to evaluate the efficacy of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of COVID-19 pneumonia. Fostamatinib, marketed in the U.S. as TAVALISSE® (fostamatinib disodium hexahydrate) tablets, is approved in the U.S. and Europe as a treatment for adult chronic immune thrombocytopenia (ITP).
SYK is a key mediator of immunoreceptor signaling in a host of inflammatory cells. Studies of severe acute respiratory syndrome (SARS) and other acute viral respiratory infections suggest that the pathogenesis relies on a series of SYK-dependent events involving activation of C-type lectin receptors (CLR) and immunoglobulin Fcg receptors (FcgR) in multiple cell types. Such SYK-mediated processes result in excessive cytokine and chemokine release, neutrophil activation associated with extensive NETosis (a highly inflammatory and thrombogenic type of cell death), and endothelial cell stimulation leading to vascular endothelium leakage and edema in the lungs. Together, these events can contribute to acute respiratory distress syndrome (ARDS), micro-thrombosis and associated systemic complications.
INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, recently announced that the Medicines and Healthcare products Regulatory Agency (MHRA; the UK equivalent of the FDA) has given approval to initiate a Phase I clinical trial of INKmune, a novel therapy to prime the patient’s own NK cells to attack their cancer, in patients with high-risk Myelodysplastic Syndrome (MDS) (EUDRACT 2019-004820-40). This single center Phase I trial will be the first-in-man study using INKmune. Based on the current environment and timetable of its clinical site, INmune Bio is targeting the study initiation in the 2nd half of this year.
“Patients with MDS are mostly elderly; in this population high-dose chemotherapy or bone marrow transplant are usually too toxic,” said Dr. Marion Wood, consultant hematologist and the medical director for this INKmune program. “With this clinical trial, we hope to show that INKmune will provide an effective and better tolerated therapeutic option for those patients who are poorly served by current therapies.” Patients with high-risk MDS will be enrolled to receive at least 3 doses of INKmune therapy via intravenous infusion, without the need for any type of conditioning therapy or pretreatment. The Phase I trial, called Laurel, will include at least 9 patients enrolled at a single center in the UK and has the capacity for an extension cohort.
Merck & Co., Inc. (NYSE: MRK) known as MSD outside the United States and Canada, recently announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). This sBLA is based on data from the pivotal Phase 3 KEYNOTE-204 trial, in which KEYTRUDA demonstrated a significant improvement in progression-free survival (PFS) compared to brentuximab vedotin (BV), a current standard of care in this patient population. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct. 30, 2020.
“Classical Hodgkin lymphoma accounts for more than nine in 10 cases of Hodgkin lymphoma, which impacts approximately 7,400 patients a year in the U.S. For patients with classical Hodgkin lymphoma who do not achieve remission after first-line treatment, there is a particularly poor prognosis due to the limited options available,” said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “We look forward to working with the FDA to bring KEYTRUDA to more patients with classical Hodgkin lymphoma after initial treatment.”
VBI Vaccines Inc. (NASDAQ: VBIV) a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, recently announced that updated Part B data from its ongoing Phase 1/2a study of VBI-1901, the company’s cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (GBM) patients is being presented in an e-poster at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting II, June 22-24, 2020.
Emerging data from the ongoing Phase 1/2a study suggest that patients with a normal baseline CD4+/CD8+ T cell ratio may be more likely to experience delayed progression or tumor reduction, reflected as a tumor response. Five out of the six tumor responses seen to-date, including a recently confirmed partial response (PR), defined as a tumor reduction of more than 50% per the Response Assessment in Neuro-Oncology (RANO) criteria, suggest that the biomarker may predict patients most likely to respond to, and derive clinical benefit from, treatment with VBI-1901. Based on the data seen to-date, VBI is exploring a randomized, controlled, registrational clinical study for the next phase of development, which, subject to approval from regulatory bodies, could begin in 2021. In parallel, enrollment in the Phase 1/2a Part B study arm of VBI-1901 in combination with GSK’s AS01B adjuvant systems continues, with immunologic and tumor data expected in Q4 2020.
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