Biotechs Seek Advancements In The Immuno-Oncology Field For Childhood Brain Tumors

Palm Beach, FL –November 12, 2019 – Doctors are 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.   According to 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. Although the concept of generating or strengthening an immune response against malignancy is by no means new, cancer immunotherapy has only recently started to receive new attention globally. A 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.”  Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ: MBRX), AbbVie Inc. (NYSE: ABBV), Nektar Therapeutics (NASDAQ: NKTR), InMode Ltd. (NASDAQ: INMD), Agenus Inc. (NASDAQ: AGEN).


The report continued: “This rapid advancement in the immuno-oncology field occurs in a timely manner for childhood brain tumors, which urgently require a new approach. Pediatric brain tumors are the leading cause of childhood cancer-related death. Immunotherapy is a powerful new approach for treating some refractory cancers; applying this ‘fourth pillar’ of cancer treatment to pediatric brain tumors is an exciting but challenging prospect.  Tumors of the central nervous system (CNS) are the most common solid tumor of childhood, and represent the leading cause of childhood cancer-related death. Although survival rates for childhood cancers overall have markedly improved over recent decades, outcomes in pediatric CNS tumors have lagged behind the dramatic gains achieved in hematological cancers….


Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWSMoleculin Announces FDA Approval of IND for its STAT3 Inhibitor in Emory University Clinical Trial – Moleculin Biotech, a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, announced that the FDA has approved a request for Investigational New Drug (“IND”) status for its drug candidate WP1066 to be used in a Phase 1 clinical trial for the treatment of children with recurrent or refractory malignant brain tumors.  The request was made by physician researchers at Emory University, including Dr. Tobey MacDonald, Professor of the Department of Pediatrics at Emory University School of Medicine, Director of Pediatric Neuro-Oncology at Aflac Cancer and Blood Disorders Center and Principle Investigator for this clinical trial. The trial will be conducted at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta.


“This FDA approval gives a green light for Emory University to begin an important clinical trial to explore a new approach to treating pediatric brain cancer,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “WP1066 is currently in a clinical trial for adult patients with glioblastoma and melanoma metastases to the brain at MD Anderson Cancer Center, and this is a logical extension of that research.  WP1066 is an inhibitor of the activated form of a protein called STAT3, a target that has been implicated in a wide range of highly resistant cancers.  Preclinical research at Emory University indicated that WP1066 had a significant anti-tumor effect on medulloblastoma cell lines, so there is a lot of encouragement regarding the opportunity to provide new hope for treating this rare condition.”    Read this and more news for MBRX at     


Other recent developments in the biotech industry include:


AbbVie Inc. (NYSE: ABBV) a research-based global biopharmaceutical company, recently announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for IMBRUVICA® (ibrutinib) in combination with rituximab for the first-line treatment of younger patients (70 years old or younger) with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The submission is based on results from the Phase 3 E1912 study – designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health. The study showed significantly improved progression-free survival (PFS) and overall survival (OS) in patients treated with IMBRUVICA plus rituximab, compared to those treated with fludarabine, cyclophosphamide and rituximab (FCR). Safety data were consistent with the known safety profile of IMBRUVICA.


Nektar Therapeutics (NASDAQ: NKTR) recently announced updated results from the first-in-human Phase 1a study of NKTR-358, a novel T regulatory (Treg) cell stimulator in development for the treatment of autoimmune and other chronic inflammatory conditions.  The data, which were presented at the 2019 Annual Meeting of the American College of Rheumatology in Atlanta, show that treatment with NKTR-358 led to a marked and selective dose-dependent expansion in the numbers and proliferative capacity of FoxP3+CD25bright Treg cells, and a measurable activation of Treg cells. These data are a continuation of initial results reported at 2019 Annual European Congress of Rheumatology (EULAR) in June 2019.


InMode Ltd. (NASDAQ: INMD) a leading global provider of innovative medical technologies, is proud to announce that it has received Health Canada Certification for multiple new products which will further expand its penetration into the Canadian market. Included in this certification are Morpheus8 and AccuTite, two clinically proven technologies which have dominated the US market as the leading choice of aesthetic solutions for physicians.


Morpheus8 is a proprietary Subdermal Adipose Remodeling Device (SARD) which has disrupted the US aesthetics market, and created a new category exclusive to InMode. The Morpheus8 certification is the first product in a line of industry leading technologies designed specifically to morph aging skin and contour the body. The triple action of fat coagulation, connective tissue contraction and bulk heating of the skin, molds the skin subdermally, and provides patients with long lasting results, without surgery and downtime.


Agenus Inc. (NASDAQ: AGEN) recently announced that it received $10M upfront for a License Agreement with UroGen Pharma Ltd. Under the agreement Agenus is providing access to zalifrelimab (AGEN1884, anti-CTLA-4 antibody) for use with UroGen’s sustained release technology for intravesical delivery in patients with urinary tract cancers.  Agenus is conducting clinical trials for zalifrelimab in combination with Agenus’ anti-PD-1 antibody balstilimab (AGEN2034) for a planned BLA filing in cervical cancer. In addition, zalifrelimab is being evaluated as a monotherapy in PD-1 refractory patients.  Under the terms of the agreement, in addition to the $10 millionupfront payment, Agenus is eligible to receive up to $200M in potential development, regulatory and commercial milestones, as well as 14-20% royalties on net sales.


“In our ongoing clinical trials, zalifrelimab and the combination of zalifrelimab plus balstilimab (AGEN2034, anti-PD-1 antibody) have delivered durable as well as curative responses in patients across a broad range of tumors.  Agenus is developing the combination in multiple solid tumors with a first planned BLA filing in 2020,” said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. “We are enthusiastic to expand the benefit of zalifrelimab through intravesical delivery to patients with urinary tract cancer in this exciting collaboration with UroGen.”


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