Cancer Drug Development Shows That Government and Private Sector can Work Together

PALM BEACH, Florida, Feb. 5, 2019 /PRNewswire/ -- Considering that yesterday, February 4, was World Cancer Day, it is encouraging that the private sector and the U.S. government are mutually trying to solve a serious problem and are in fact, working closely and in harmony with each other to reach that goal, to cure cancer in all its forms. The American Society of Clinical Oncology (ASCO), the pre-emanate professional organization representing physicians of all oncology sub-specialties who care for people with cancer, in its 2019 Annual Report on Progress Against Cancer, calls for this partnership to continue. The report says: "Now is the time to invest in the next generation of cancer cures" and "To find the next frontier in cancer vaccines, we need our nation's support for cancer research." Says Judith S. Kaur, MD, Mayo Clinic Cancer Center and Pioneer in cancer prevention & education. Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ:MBRX), Evolus, Inc. (NASDAQ:EOLS), Agenus Inc. (NASDAQ:AGEN), QIAGEN N.V. (NYSE:QGEN), Titan Pharmaceuticals, Inc. (NASDAQ:TTNP)

This FDA and private sector collaboration has been quite effective: "The number of new FDA approvals in oncology continues at a rapid pace. From November 2017 through October 2018, the FDA approved 11 new cancer therapies and 39 new uses of cancer therapies. In the same time frame in the previous year, there were 18 new cancer therapies and 13 new uses approved. The FDA, the hand of government that works the most closely with the private sector in this arena, prides itself on what this partnership has wrought: "The program has successfully enabled the development and marketing of over 600 drugs and biologic products for rare diseases since 1983. In contrast, fewer than 10 such products supported by industry came to market between 1973 and 1983. The Orphan Grants Program has been used to bring more than 60 products to marketing approval."

Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS: Moleculin Biotech, a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Status for its drug candidate WP1066 for the treatment of glioblastoma, the most aggressive form of brain tumor.

"We continue to be encouraged by the progress of the physician-led clinical trial of WP1066," commented Walter Klemp, Moleculin's Chairman and CEO, "And, now having the FDA grant Orphan Drug status for WP1066 positions us well for potential marketing of this drug. We believe that WP1066 represents a new class of drugs which we call 'Immune/Transduction Modulators' because it has demonstrated the ability in preclinical testing in animals to both stimulate a natural immune response to tumors and directly attack tumor cells by inhibiting multiple key oncogenic transcription factors, including STAT3, HIF1-α and c-Myc."

Dr. Sandra Silberman, Chief Medical Officer for New Projects at Moleculin added: "The development of WP1066 is gaining momentum.  In addition to the glioblastoma trial at MD Anderson, we have had interest from additional investigators, including Emory University and Mayo Clinic for conducting clinical trials for the treatment of pediatric brain tumors, as well as others interested in treating a range of highly resistant tumors including AML and pancreatic cancer.  Because we've seen strong anti-tumor activity in a wide range of animal models, we believe this represents an important new approach to treating many types of cancer."

The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval. Read this and more news for MBRX at: https://www.financialnewsmedia.com/news-mbrx/   

Other recent developments in the biotech industry include:

Evolus, Inc. (NASDAQ: EOLS) this week announced that the U.S. Food and Drug Administration ("FDA") has approved its lead product, Jeuveau™, for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults.

David Moatazedi, President and Chief Executive Officer of Evolus, stated, "Evolus is the first company in nearly a decade to enter the fast-growing U.S. aesthetic neurotoxin market. What makes Evolus unique is our focus on delivering performance beauty products with a customer-centric approach. We are pleased to introduce Jeuveau™, the first FDA approved neurotoxin dedicated to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure™ technology."

Agenus Inc. (NASDAQ: AGEN) late last month announced the  launch of a groundbreaking digital securities offering enabling the direct participation of accredited investors in Agenus' lead immuno-oncology asset. The proceeds from the digital securities offering, the first conducted by a publicly-traded company, will go to fund product development through FDA approval and commercialization, of the asset, with returns to investors backed by future product sales.

"Atomic Capital is deeply committed to leveraging the transformative capabilities of Distributed Ledger Technology in the pursuit of our mission to make capital smarter,"  said Alexander S. Blum, CEO of Atomic Capital. "We are privileged to be working alongside Dr. Armen and his remarkable team, bringing precision capital to precision medicine."

QIAGEN N.V. (NYSE: QGEN) recently announced that Genomics England have selected QIAGEN's QCI (QIAGEN Clinical Insights) portfolio offering on behalf of the NHS in England to support the UK's program to sequence, analysis and interpret 5 million genomes over the next 5 years.

QCI's leading position as a decision support tool for personalized, precision medicine is based on its powerful capabilities to simultaneously mine a large number of proprietary and public knowledge and data bases, many of which are expertly curated, to provide accurate and up-to-date interpretations of complex genomic data. A pivotal knowledge base for this project was QIAGEN's proprietary HGMD^® Human Gene Mutation Database offering, which is one of the key interpretation resources of QCI and offers the most comprehensive and highly curated survey of literature-based genetic mutations responsible for human inherited diseases.

Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) on January 31, 2019 provided an update on the U.S. commercial relaunch of Probuphine (buprenorphine) implant, its unique six-month treatment for Opioid Use Disorder (OUD).

Titan has successfully completed the program's planned transition from Braeburn Pharmaceuticals. Important commercialization accomplishments include the recruitment and onboarding of highly qualified commercial and medical affairs personnel for all targeted geographies; the engagement of a leading public relations agency for the re-branding of Probuphine; and the retention of a well-known government relations firm to plan and execute a new lobbying strategy for the product. Titan also reengaged with health care providers who had previously treated patients with Probuphine, providing retraining and medical liaison assistance where needed and creating an integrated sales strategy to support them and their office staff.

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