Biotech Brief: Optimism Rising for Cancer Treatment Advancements in 2019

PALM BEACH, Florida, April 17, 2019 /PRNewswire/ -- The American Association for Cancer Research (AARC) recently released an article that interviewed Nobel Laureate, Fellow of the AACR Academy, and immunotherapy pioneer James P. Allison, PhD  and  AACR President-elect and precision medicine expert Elaine Mardis, PhD about what they see happening in 2019. The article said: "In 2018, we witnessed significant momentum in several hot areas of cancer research, including immunotherapy and precision medicine. Researchers have amassed exponential amounts of knowledge in these areas of scientific inquiry in recent years, and 2018 saw many of these gains culminate into innovative treatments for cancer patients. Overall, in 2018, the U.S. Food and Drug Administration (FDA) approved 18 new cancer therapeutics and expanded the use of 10 previously approved treatments to include new types of cancer.   Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ:MBRX), Teva Pharmaceutical Industries Limited (NYSE: TEVA), Sesen Bio, Inc. (NASDAQ: SESN), Rexahn Pharmaceuticals, Inc. (NYSE: RNN), Axsome Therapeutics, Inc. (NASDAQ: AXSM).

What major milestones do experts think we will hit in 2019? The AARC asked Nobel Laureate, Fellow of the AACR Academy, and immunotherapy pioneer James P. Allison, PhD , who said: "The field of immunotherapy is exploding," began Allison, professor and chair of the Department of Immunology and executive director of the Immunotherapy Platform at The University of Texas MD Anderson Cancer Center in Houston, Texas. "For the first time, we have several different immunotherapy approaches that are yielding potentially curative treatments for cancer, with some patients remaining cancer-free a decade or more after treatment." AACR President-elect and precision medicine expert Elaine Mardis, PhD added: "I'm excited about the progress we have made so far in our quest to be more precise in our treatment approaches," concludes Mardis. "I realize that there are significant hurdles to overcome, especially with difficult-to-treat cancers, but I can't help but think that with all the intelligence and acquired knowledge that we have today, and the combinatorial approaches to cancer treatment development being tested right now, that we will continue to be successful as we move forward."

Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS: Moleculin Biotech, a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced that its ongoing sponsored research at The University of Texas MD Anderson Cancer Center has now demonstrated that Annamycin is able to significantly improve survival in an aggressive form of triple negative breast cancer metastasized to the lungs in animal models.

"Annamycin Found to be Active Against Metastatic Lung Cancer in Pre-Clinical Testing"

"We know that Annamycin was previously shown to be significantly more potent than doxorubicin in both Lewis lung carcinoma in vivo and small cell lung cancer in vitro models," commented Walter Klemp, Moleculin's Chairman and CEO.  "Now we are seeing significant activity against triple negative breast cancer that has metastasized to the lungs.  This particular animal model used in our testing is considered to represent a very aggressive form of cancer. We believe our success in increasing the survival rate in mice with this tumor model in combination with the previously observed high uptake of Annamycin by the lungs is a promising indication that supports additional clinical research in lung and metastatic lung cancers."    Read this and more news for MBRX at:  https://www.financialnewsmedia.com/news-mbrx/    

Other recent developments in the biotech industry include:

Teva Pharmaceutical Industries Limited (NYSE: TEVA) (TASE: TEVA) recently announced the launch of a generic version of AndroGel ^®i (testosterone gel) 1.62% CIII in the U.S.   Testosterone Gel 1.62% CIII is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired), and hypogonadotropic hypogonadism (congenital or acquired).

With nearly 500 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in eight generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

Sesen Bio, Inc. (NASDAQ: SESN) closed up over 19% on Tuesday at $1.35 trading over 11.8 Million shares by the market close while also edging up further in afterhours trading.  Sesen Bio, a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, recently reported operating results for the fourth quarter and full year ended December 31, 2018. The Company also reported new, preliminary analyses from the Company's Phase 3 VISTA trial further demonstrating the activity of Vicinium treatment in patients with high-risk non-muscle invasive bladder cancer (NMIBC).

"2018 was a year of tremendous progress towards our goal of bringing Vicinium to patients with BCG-unresponsive NMIBC, setting us up for a transformational 2019," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We are well underway with our Phase 3 VISTA trial designed to support the full approval of Vicinium for patients with NMIBC. The totality of the efficacy and safety data generated to date in our Phase 3 VISTA trial, and the compelling benefit-risk profile, give us confidence in the approvability of Vicinium for this indication. Due to the limited treatment options, once patients become BCG-unresponsive, their choice is to either undergo a life-altering, complicated surgery of complete bladder removal or live with a highly-progressive cancer. "

Rexahn Pharmaceuticals, Inc. (NYSE American: RNN)  a clinical stage, biopharmaceutical company focused on oncology, and BioSense Global LLC, a New Jersey- and Suzhou, China-based biopharmaceutical company, recently announced a collaboration and license agreement to advance the development and commercialization of RX-3117 for pancreatic cancer and other cancers in Greater China.

Under the agreement, Rexahn will grant BioSense an exclusive license to develop and commercialize RX-3117 in Greater China. Rexahn will receive an upfront payment and will be eligible to receive additional development, regulatory and commercial milestones up to a total of $226 million contingent on achieving regulatory and commercial goals related to pancreatic cancer and additional indications.

Axsome Therapeutics, Inc. (NASDAQ: AXSM) a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, recently announced that Duke University has completed its topline analysis of the Phase 2 trial of AXS-05 for smoking cessation treatment. The analysis showed that AXS-05 met the prespecified primary endpoint and significantly reduced daily smoking as compared to the active comparator bupropion. The trial was conducted at the Duke Center for Smoking Cessation under a research collaboration between Axsome and Duke University. The Phase 2 study was a randomized, double-blind, active-controlled trial, in which 58 adult smokers were treated either with AXS-05 (45 mg dextromethorphan/105 mg bupropion), or the active comparator bupropion (105 mg), twice daily, and assessed over a 3-week period.

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