Palm Beach, FL – October 1, 2020 – The global market for brain tumor therapeutics is projected to see significant growth over the next several years. A brain tumor is an abnormal growth of tissue in the brain or central spine that can disrupt proper brain function. Although there are standard treatments such as surgery and chemotherapy, targeted therapy is on the rise and is the focus of much of the R&D in the market. Targeted therapy is a treatment that targets the tumor’s specific genes, proteins, or the tissue environment that contributes to a tumor’s growth and survival. This type of treatment blocks the growth and spread of tumor cells and limits the damage to healthy cells. A report by Grand View in 2015 said that the global brain tumor diagnosis and therapeutics market size was valued at USD 354.9 million and was expected to grow at a CAGR of 8.1%through 2025. The rising prevalence of such cancer and the growing geriatric population are key drivers expected to nurture growth of the brain tumor diagnosis market worldwide. Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ: MBRX), Clovis Oncology, Inc. (NASDAQ: CLVS), GlaxoSmithKline plc (NYSE: GSK), Merck & Co., Inc. (NYSE: MRK), AstraZeneca PLC (NASDAQ: AZN).
Another report in 2019 by BCC Research projected that the global market for brain tumor therapeutics should grow from $1.1 billion in 2018 to reach $2.0 billion by 2023 at a compound annual growth rate (CAGR) of 12.9% for the period of 2018-2023. The continued growth of the market was evident in a recent survey from 360Market Updates which 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. The report said that growth is affected due to the increasing incidence of brain cancer and focus on precision medicine. It 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.”
Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS: Moleculin Announces Positive Interim Results in Pediatric Brain Tumor Phase 1 Clinical Trial at Emory University – WP1066 demonstrates activity in DIPG, rare form of pediatric brain tumor – Moleculin Biotech, a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting significant unmet needs in the treatment of tumors and viruses, announced preliminary first cohort data from the Emory University physician-sponsored clinical trial being conducted at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta by Dr. Tobey MacDonald, Professor of Pediatrics and Director of the Pediatric Neuro-Oncology Program. He is studying the use of WP1066 (AflacST1901), a proprietary Moleculin drug candidate, as a potential treatment for childhood brain tumors. The first three patients in the trial received treatment at a dose level of 4 mg/kg with no adverse events related to WP1066 and the study will now proceed to the next higher dose of 6 mg/kg. One of these patients with diffuse intrinsic pontine glioma (DIPG), showed an apparent response to the treatment with both clinical improvement and radiologic reduction of tumor size.
Dr. MacDonald stated, “We are very pleased that this trial has successfully completed the first cohort without any safety issues and will now progress to the second cohort at an escalated dose level. We must, of course, be very careful not to draw any conclusions from such preliminary data, but to have an objective response in a DIPG patient is frankly, unexpected.”
Mr. Walter Klemp, Chairman and CEO of Moleculin, “When you look at the clinical trial history of DIPG, despite approximately 200 clinical trials, no drug has shown significant activity in this disease, so we find this initial activity particularly encouraging. WP1066 is an immuno-stimulating p-STAT3 inhibitor and has been shown to stimulate immune responses that successfully modulate oncogenic transcriptional activity in tumor cells and repress their ability to drive tumor growth. Coupled with the activity we have recently seen with WP1220, a close analog to WP1066, in its proof of concept clinical trial for the topical treatment of cutaneous t-cell lymphoma, we are more committed than ever to determine the full potential of this new class of p-STAT3 inhibitors. We now have six drug candidates, with three of them showing human activity, so we need to be careful not to confuse this p-STAT3 inhibitor pipeline with the recent announcement regarding our antimetabolites and their potential to treat viruses. We have placed a high priority on reducing risk for our investors by creating what we call ‘multiple shots on goal,’ and the events of this week are showing just how effective that strategy has been.”
Mr. Klemp concluded, “Consistent with our history of providing clinical trial updates on a cohort-by-cohort basis, we look forward to updating investors on the continued progress of this trial as additional cohorts are completed. For more information regarding the design of this study, please refer to https://clinicaltrials.gov/ct2/show/NCT04334863.” Read this full release and more news for MBRX at: https://www.financialnewsmedia.com/news-mbrx/
Other recent developments in the biotech industry include:
Clovis Oncology, Inc. (NASDAQ: CLVS) recently announced the data being presented as e-posters at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. These include initial data from the Phase 1b part of the LIO-1 study of lucitanib in combination with Opdivo, new analyses of data from the pivotal Rubraca ARIEL3 and TRITON2 studies, initial data from the Phase 1b part of the SEASTAR study arm of Rubraca with Trodelvy™ (sacituzumab govitecan-hziy), and the first presentation of preclinical data for FAP-2286 Clovis’ novel peptide-targeted radionuclide therapy.
“We are very pleased to present these encouraging initial datasets for our pipeline compounds lucitanib and FAP-2286 today, as well as data further characterizing and confirming the established safety profile of Rubraca in advanced ovarian and prostate cancers, which we believe provides additional, valuable information to physicians and their patients,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We are enthusiastic about the potential of our clinical development programs for each of our three compounds and remain committed to exploring the full depth and breadth of our pipeline to transform the cancer treatment landscape and hopefully improve outcomes for patients.”
GlaxoSmithKline plc (NYSE: GSK) recently announced the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for the treatment of adult and pediatric patients aged 12 years and older with Hypereosinophilic Syndrome (HES) for ≥ six months without an identifiable non-hematologic secondary cause. The approval makes Nucala the first and only targeted biologic treatment to be approved for patients with this eosinophil-driven disease in the US.
Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “HES is a complex, life-threatening condition that impacts nearly 5,000 patients in the US. Today’s approval gives these patients access to a biologic treatment for the first time and demonstrates our commitment to maximizing Nucala’s impact on eosinophil-driven diseases.”
Merck (NYSE: MRK), known as MSD outside the United States and Canada, recently announced first-time data from the pivotal Phase 3 KEYNOTE-590 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-based chemotherapy (cisplatin plus 5-fluorouracil [5-FU]) for the first-line treatment of patients with locally advanced or metastatic esophageal and gastroesophageal junction (GEJ) cancer. In the study, KEYTRUDA in combination with chemotherapy significantly improved overall survival (OS), reducing the risk of death by 27% [HR=0.73 [95% CI, 0.62-0.86]; p<0.0001], versus chemotherapy in all randomized patients. KEYTRUDA in combination with chemotherapy also significantly improved progression-free survival (PFS), reducing the risk of disease progression or death by 35% or more than a third [HR=0.65 [95% CI, 0.55-0.76]; p<0.0001] in all randomized patients. With these results, KEYTRUDA is the first anti-PD-1 therapy in combination with chemotherapy to show superior OS, PFS and objective response rates (ORR) versus chemotherapy, the current standard of care, for these patients regardless of histology or PD-L1 expression status.
AstraZeneca PLC (NASDAQ: AZN) and Merck (MRK) recently announced final results from the Phase III PROfound trial that showed LYNPARZA (olaparib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus enzalutamide or abiraterone in men with metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 or ATM gene mutations, a subpopulation of homologous recombination repair (HRR) gene mutations. Patients had progressed on prior treatment with new hormonal agent (NHA) treatments (i.e., enzalutamide and abiraterone).
Prostate cancer is the second-most common type of cancer in men. An estimated 191,930 men in the United States will be diagnosed with prostate cancer in 2020. Approximately 20-30% of men with mCRPC have an HRR gene mutation.
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