Biotech Advancements in the Immuno-Oncology Field for Pediatric and Adult Brain Tumors

Financialnewsmedia.com News Commentary

PALM BEACH, Florida, Dec. 11, 2019 /PRNewswire/ -- For the last half century, if not more, doctors have been working to learn more about brain tumors, ways to prevent them, how to best treat them, and how to provide the best care to people diagnosed with a brain tumor, and to generally find newer and more effective ways to fight all cancerous cells. A recent article in Scientific American said: "On any given day, there are often more than 100 news articles focused on cancer, many of which speak to new and promising studies or breakthroughs in a research lab." According to various recent articles and reports tracking the new trends in immunotherapy for pediatric brain tumors, recent advances in cancer immunotherapy have improved outcomes for several human cancers, and in some cases have produced dramatic responses in patients. Today much research is focused on attacking the cancerous cells growth… whereby denying these cells energy, they will die. The idea is that by using targeted therapies only the cancerous cells will be affected. Active biotech and pharma companies in the markets this week include CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), Neoleukin Therapeutics, Inc. (NASDAQ: NLTX), Avid Bioservices, Inc. (NASDAQ: CDMO), Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH), Abeona Therapeutics Inc. (NASDAQ: ABEO).

There is another type of cancer treatment, however, known as cell metabolic therapy, which has been researched and discussed for decades without producing viable treatment options. Cell metabolic therapy targets the mitochondria—energy producers—of cancer cells, shutting down their growth and preventing them from spreading. If we remove the energy source that these cells use to power their attack on the body, we can stop the disease dead in its tracks. There are many reasons why cell metabolic therapy has failed in previous decades, but recent data are demonstrating that it is finally turning a corner. Both the metabolic and immuno-oncology fields have been making great strides. A Cell.com report said: "Immunotherapy has demonstrated remarkable success in improving overall survival in Phase II–III trials in tumor subtypes such as melanoma and leukemia. This novel approach has been a welcome addition to the oncologist's conventional armamentarium of surgery, chemotherapy, and radiation, especially in the relapsed and/or refractory disease setting."

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) BREAKING NEWS:  CNS' Berubicin Awarded $5.8 Million Non-Dilutive Grant from EU/Polish National Center Through its Development Partner - CNS Pharmaceuticals, a biotechnology company specializing in the development of novel treatments for brain tumors, announced that its partner, WPD Pharmaceuticals ("WPD"), a Polish corporation founded by Dr. Waldemar Priebe, the founder of the Company, was awarded a $5,798,875 grant from the EU/Polish National Center for Research and Development under the Smart Growth Operational Program 2014-2020 (the "EU Grant").

The Company previously entered into a sublicense agreement with WPD, in which WPD committed to a $2.0 million minimum expenditure on the development, testing, regulatory approval, and commercialization of Berubicin over a three –year period. WPD's subsequent development project, "New approach to glioblastoma treatment addressing the critical unmet medical need" (the "WPD Project"), received the grant co-financed by the European Union under the Smart Growth Operational Program 2014-2020, Priority I: Support for Research and Development work by Enterprises, Measure 1.2: Sectorial Research and Development Programs, Sectorial Program InnoNeuroPharm. The main goal of the WPD Project is to implement the world's first multicenter pediatric Phase I clinical trial to determine maximum tolerated dose (MTD) and Phase IB and II clinical trials in adults, to assess the efficacy of Berubicin. Proceeds from the grant will be used independently by WPD Pharmaceuticals in order to fulfill its commitment arising from its sublicense agreement with the Company.  

"The EU Grant represents an important milestone for the advancement of our novel anthracycline, Berubicin, especially in pediatric settings," commented CEO of CNS, John M. Climaco. "We believe this grant will allow our partner, WPD Pharmaceuticals, to fulfill its commitment arising from its sublicense agreement with us in a manner that is capital-efficient and non-dilutive to the CNS. Additionally, this EU Grant and our partnership with WPD presents an opportunity to potentially accelerate our efforts to bring Berubicin to patients around the world." Read this and more news for CNSP at:  https://www.financialnewsmedia.com/news-cnsp/     

Other recent developments in the biotech industry include:

Neoleukin Therapeutics, Inc. (NASDAQ: NLTX) a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, recently announced the formation of a Scientific Advisory Board comprised of leaders in the fields of de novo protein design, structural biology and immunology. "This distinguished group of scientific leaders will provide Neoleukin with advice and guidance as we continue expanding our research and development efforts, including our pioneering work in de novo design of protein therapeutics," said Daniel-Adriano Silva, Ph.D., Vice President Head of Research at Neoleukin.

Avid Bioservices, Inc. (NASDAQ: CDMO) recently announced financial results for the second quarter of fiscal 2020 ended October 31, 2019. Highlights Since July 31, 2019:

"During the second quarter of 2020, we strengthened multiple core areas of our business," said Rick Hancock, interim president and chief executive officer of Avid. "Our business development effort continues to be wide reaching and robust. Our reputation in the industry for quality and regulatory success continues to grow allowing us to engage with a broadening pool of potential new customers and expand our relationships with existing customers. 

"Operationally, we continue to improve and enhance our equipment, facilities and systems.  The opening of our new process development lab, the successful completion of our annual maintenance overhaul, and the planned installation of a new pharmaceutical grade water system in calendar 2020 all reflect the dedication we have to maintaining the highest standards possible.

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) recently announced positive efficacy and safety results from its pivotal AURORA Phase 3 trial of voclosporin, in combination with mycophenolate ("MMF") and low-dose corticosteroids, in the treatment of lupus nephritis ("LN").

"This extraordinary pivotal data confirms voclosporin's ability to achieve statistically significant improvements in clinically meaningful endpoints for this complex disease, with a comparable safety profile to the current standard of care," said Neil Solomons, M.D., Chief Medical Officer of Aurinia. "This data represents a significant advance for people living with LN, which can lead to irreversible kidney damage, eventual kidney failure and death."

Abeona Therapeutics Inc. (NASDAQ: ABEO) recently announced that the U.S. Food and Drug Administration (FDA) has removed its clinical hold and provided clearance to proceed with the VIITAL™ study, the Company's pivotal Phase 3 clinical trial evaluating EB-101 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The FDA removed the clinical hold following the Company's submission of additional data points on transport stability of EB-101 to clinical sites. Abeona expects to initiate the VIITAL™ study in first quarter of 2020.

"The Abeona team has worked diligently to provide a prompt and thorough response to the FDA, enabling us to proceed with our pivotal Phase 3 trial for EB-101," said João Siffert, M.D., Chief Executive Officer of Abeona. "Recently published long-term follow up data from our Phase 1/2 trial leaves us increasingly confident that EB-101 can provide durable healing for large, chronic wounds that afflict many RDEB patients. We are now focused on initiating the VIITAL™ study in the first quarter of 2020. "

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