Positive Developments for Treating Patients With Recurrent Malignant Tumors Significant for Novel Therapeutic Strategies

Palm Beach, FL – (November 1, 2018) – Multiple myeloma (MM) known as a plasma cell malignancy that affects 14,000 patients per year are fueling the development and clinical activities for new therapies to treat these malignancies. Recent clinical trial results are suggesting that Stat3 Inhibitor – WP1066 may reduce Stat activation through a unique mechanism which may have therapeutic potential for the treatment of human B-cell for certain cancer and tumor conditions.  Recent activities such as an approach to develop immuno-stimulating STAT3 inhibitors have taken steps forward as a result in multiple collaborations with some of the most prestigious cancer centers in the world that may improve the ability to treat a broader range of the most difficult cancers.  Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ:MBRX), Strongbridge Biopharma plc (NASDAQ:SBBP), Kindred Biosciences Inc. (NASDAQ:KIN), Pfizer Inc. (NYSE:PFE), Array BioPharma Inc. (NASDAQ:ARRY).


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 positive progress in the Phase 1 clinical trial of its immuno-stimulating STAT3 inhibitor, WP1066, with initial results showing bioavailability of the drug in patients.


“Although this data is preliminary, it represents a significant milestone for the development of WP1066,” commented Dr. Donald Picker, Moleculin’s Chief Science Officer.  “In the first two cohorts of the Phase 1 study, we are already seeing measurable levels of the drug in the patient’s plasma resulting from oral administration.  Knowing we can deliver drug this way opens the door for further development and expanded clinical activity.”


Walter Klemp, Moleculin’s Chairman and CEO added, “We believe WP1066 is a first-in-class compound capable of stimulating a natural immune response in animal models while directly attacking tumors by modulating transcriptional activity and repressing what we call ‘oncogenic transcription factors.’  Chief among these is STAT3, considered a master regulator of tumor progression.  While activity in animal models has been very promising, one of the goals of this trial was to determine the potential for bioavailability in humans.  The initial positive indications of this clinical trial increase our confidence that WP1066 has the potential to become an important drug in the treatment of certain cancers. The initial demonstration of human bioavilability is an important milestone.”       Read this and more news for MBRX athttps://financialnewsmedia.com/news-mbrx/


Other recent developments in the biotech industry include:


Strongbridge Biopharma plc (NASDAQ:SBBP) recently announced it has entered into an agreement for Novo Nordisk to acquire the rights to MACRILEN™ (macimorelin) in the United States (U.S.) and Canada. MACRILEN is the first and only FDA-approved oral drug indicated for the diagnosis of adult growth hormone deficiency (AGHD). “We are proud to enter into this MACRILEN agreement with Novo Nordisk, a global leader in endocrinology, as it aligns with our strategic objective to maximize the potential of MACRILEN while we continue to prepare for the potential regulatory approval of RECORLEV™ (levoketoconazole),” said Matthew Pauls, president and chief executive officer of Strongbridge Biopharma. “The upfront payment and equity investment from Novo Nordisk will significantly strengthen the Company’s overall financial position and marks a tremendous step forward in Strongbridge’s continued evolution as a company dedicated to rare diseases,” Pauls added.


Kindred Biosciences Inc. (NASDAQ:KIN) recently announced positive topline results from its pilot effectiveness study of KIND-016, a fully caninized, high-affinity monoclonal antibody targeting interleukin-31 (IL-31), for the treatment of atopic dermatitis in dogs. Atopic dermatitis is the leading reason owners take their dog to the veterinarian, and the current market size is over $500 million annually and growing rapidly. In addition, KindredBio announced that the U.S. Patent and Trademark Office has issued a patent (Patent No. 10,093,731) for KindredBio’s anti-IL31 antibody. The study was a randomized, blinded, placebo-controlled, pilot laboratory study that enrolled 32 dogs to assess the effectiveness of KIND-016 at three doses. A single dose of KIND-016 was administered on day 0 and itching was induced at weeks 1, 2, 3, 4, 6, and 8 with an injection of canine IL-31.


Pfizer Inc. (NYSE:PFE) recently announced it has entered into a non-exclusive clinical development agreement with Novartis (NVS) to investigate one or more combination therapies for the treatment of non-alcoholic steatohepatitikins (NASH). The companies will conduct both non-clinical and Phase 1 clinical studies of Pfizer’s investigational therapies, including an Acetyl CoA-Carboxylase (ACC) Inhibitor (PF-05221304, currently in Phase 2), a Diacylglycerol O-Acyltransferase 2 (DGAT2) Inhibitor (PF-06865571, Phase 1) and a Ketohexokinase (KHK) Inhibitor (PF-06835919, Phase 2), together with Novartis’s tropifexor, a non-bile acid, Farnesoid X receptor (FXR) agonist. With three assets in development, and several first-in-class pre-clinical candidates under investigation, Pfizer is building a robust NASH program, which was entirely developed in-house and targets NASH through multiple, diverse pathways of the disease. The collaboration with Novartis helps Pfizer to explore combination approaches at an early stage.


Array BioPharma Inc. (NASDAQ:ARRY) earlier this week, the company reported results for its first quarter of fiscal 2019 and provided an update on the progress of its key commercial products and clinical development programs. “We have received positive feedback from the melanoma community and our team continues to execute a robust U.S. launch of BRAFTOVI + MEKTOVI for patients with BRAF-mutant melanoma. We were also delighted BRAFTOVI + MEKTOVI received European Commission approval in September,” said Ron Squarer, Chief Executive Officer. “Our BEACON CRC Phase 3 trial continues to advance and is supported by Breakthrough Therapy Designation. We look forward to the interim analysis of the BEACON CRC trial in the first half of 2019.”


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