Explosion of Latest Clinical Studies and Results Reinvigorating Immunotherapy Market

Tuesday, December 4, 2018 Clinical Trials News
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Financialnewsmedia.com News Commentary

PALM BEACH, Florida, December 4, 2018 /PRNewswire/ --

Leaders

in the oncology industry are working relentlessly to develop a wide variety of treatments and applications for cancer. Recent data published from clinical trial results of innovative immunotherapy applications illustrates a promising outlook for the
future of the cancer treatment and immunotherapy markets. Cancer diagnoses are rising around the world as the population ages, demonstrating a strong need for advanced treatment methods. Spending on the development of various treatments is quickly rising, with Markets and Markets estimating the immunotherapy market to reach a valuation of $119 Billion by 2021. Growth forecasts continue to rise as the successful development of inhibitors continues to be a prevailing trend. The reality is immunotherapy is incredibly valuable for the people who can actually benefit from it, but the real question may be, how many will and why my big and small biotechs are taking the issue head-on. Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ:MBRX), Tesaro Inc. (NASDAQ:TSRO), Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), Clovis Oncology Inc. (NASDAQ:CLVS), Atossa Genetics Inc. (NASDAQ:ATOS).

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 its own sponsored research has now confirmed a recent published study demonstrating the ability of its clinical-stage immuno-stimulating STAT3 inhibitor, WP1066, to inhibit a key immune checkpoint target known as PD-L1.

"We have known for some time that WP1066 had the potential to stimulate a natural immune response," commented Dr. Donald Picker, Moleculin's Chief Science Officer. "But, this data suggests that our drug may be capable of having a major impact on the field of checkpoint blockades. With this information combined with findings from other recently published studies demonstrating the impotant role of STAT3 in cancer immunology, we plan to run additional in vitro and in vivo studies, some of which are already underway, with WP1066 in combination with well-known checkpoint inhibitors to gather more data on this response."

Walter Klemp, Moleculin's Chairman and CEO added, "This potential was initially reported in a 2017 Japanese study (Journal of clinical and experimental hematopathology, Vol. 57 No.1, 21-25, 2017), but we have now been able to confirm this activity with our own sponsored research at MD Anderson. Also, very recent independent research (Front Pharmacol. 2018 May 22;9:536. doi: 10.3389/fphar.2018.00536. eCollection 2018.) has linked STAT3, HIF1-a and c-Myc (all targets of WP1066) to the mechanism (a ligand known as PD-L1) believed to be largely responsible for resistance to current checkpoint blockade therapies. We believe this could put WP1066 center-stage in the field of immunotherapy. It's potentially a tremendous breakthrough for our company." Read this and more news for MBRX at: https://www.financialnewsmedia.com/news-mbrx/ Other recent developments in the biotech industry include: Tesaro Inc. (NASDAQ:TSRO) and GlaxoSmithKline plc (NYSE: GSK) also announced they have entered into a definitive agreement pursuant to which GSK will acquire TESARO, an oncology-focused company based in Waltham, Massachusetts, for an aggregate cash consideration of approximately $5.1 billion (Ģ4.0 billion). The proposed transaction significantly strengthens GSK's pharmaceutical business, accelerating the build of GSK's pipeline and commercial capability in oncology. TESARO is a commercial-stage biopharmaceutical company, with a major marketed product, Zejula (niraparib), an oral poly ADP ribose polymerase (PARP) inhibitor currently approved for use in ovarian cancer. PARP inhibitors are transforming the treatment of ovarian cancer, notably demonstrating marked clinical benefit in patients with and without germline mutations in a BRCA gene (gBRCA). Zejula is currently approved in the US and Europe as a treatment for adult patients with recurrent ovarian cancer who are in response to platinum-based chemotherapy, regardless of BRCA mutation or biomarker status.

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) recently announced that tradipitant met the primary endpoint in VLY686-2301, a Phase II clinical study in patients with idiopathic and diabetic gastroparesis. The study also showed that tradipitant was well tolerated with comparable rates of adverse events between the tradipitant and placebo groups. "The results of the VLY686-2301 study pave the way for further development of tradipitant as potentially the first new drug for gastroparesis in almost 40 years. The highly clinically meaningful and significant improvements observed in the primary endpoint of nausea, the significant increase in nausea free days, and the reported overall symptom improvement, suggest a potential breakthrough discovery in the treatment of the millions of people estimated to have gastroparesis" said Mihael H. Polymeropoulos MD, Vanda's President and Chief Executive Officer.

Clovis Oncology Inc. (NASDAQ:CLVS) recently announced that the United States Patent and Trademark Office issued United States Patent 10,130,636 with claims directed to methods of treating cancer with high dosage strength rucaparib camsylate formulations. The patent claims cover methods of treating cancer with commercial Rubraca product, including all commercial dosage strengths (200, 250 and 300mg). The high dosage strength rucaparib formulation patent expires in 2035, and will join multiple patents directed to rucaparib, rucaparib camsylate, and methods of treatment as the 11th Orange Book-listed patent for rucaparib. "We have multiple families of patents protecting Rubraca in the U.S., including composition of matter, salts/polymorphs, dosage forms and formulations, and methods of use, and we continue to add new patents, including this high dosage strength method of treatment patent," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Each additional patent provides further protection for Rubraca, and this is relevant not only to our current indications in ovarian cancer, but also to multiple potential additional indications based on our ongoing and substantial clinical development programs."

Atossa Genetics Inc. (NASDAQ:ATOS) opened the week by announcing that the FDA has approved an "expanded access" of Atossa's proprietary oral Endoxifen in the preoperative setting in a U.S. patient awaiting surgery for breast cancer. Steven C. Quay, Ph.D., MD, President and CEO commented, "A physician recently contacted Atossa and requested our proprietary oral Endoxifen for a pre-menopausal, estrogen-receptor positive (ER+) breast cancer patient awaiting surgery. In this setting, the recommended preoperative endocrine systemic therapy is typically an aromatase inhibitor and a drug for ovarian suppression. The patient's physician was reluctant to use this preoperative therapy as it typically induces menopause and can have other potentially serious side effects. We worked with the physician to apply to the FDA to provide "expanded access" (formerly known as compassionate use) to this patient under an Investigational New Drug (IND) application. We are very pleased to report that the FDA approved this single-patient study, and the patient is currently receiving our proprietary oral Endoxifen preoperatively."

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