Breakthrough Anti-cancer Drug Candidates Targeting Potential Best-in-class Therapies for 2018

Thursday, February 15, 2018 Drug News
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PALM BEACH, Florida, February 15, 2018 /PRNewswire/ -- News Commentary 


year was a remarkable year which saw the coming-of-age advanced oncology therapies, important advances in neurology and a record number of drug approvals. Cancer immunotherapies at large have been some of the most sought-after treatments in all of the
life sciences. North America has dominated the novel drug delivery systems in the cancer therapy market in recent years whilst more and more R&D and capital enters the industry seeking the newest and most advanced therapies. Growing prevalence of cancer coupled with growing demand for personalized medicine are anticipated to propel the growth of the industry as biotech and big pharma target novel therapies and the latest, innovative treatments. The introduction of leading edge immunotherapies coupled with increasing demand for accurate diagnostic technologies are likely to trigger market growth for companies such as: Moleculin Biotech, Inc. (NASDAQ: MBRX), Nektar Therapeutics (NASDAQ: NKTR), Valeant Pharmaceuticals International Inc. (NYSE: VRX), Pfizer Inc. (NYSE: PFE), DBV Technologies S.A. (NASDAQ: DBVT).

Moleculin Biotech, Inc. (NASDAQ: MBRX) BREAKING NEWS: Moleculin Biotech, a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center ("MD Anderson"), today announced that, pursuant to its continued collaboration with MD Anderson it has developed and licensed what it believes, based on preclinical testing, is a major breakthrough in its effort to develop a new cancer treatment that selectively kills highly resistant tumors.   "We believe our unique approach to develop immuno-stimulating STAT3 inhibitors just took a major step forward," commented Walter Klemp, Chairman and CEO of Moleculin. "Our WP1066 portfolio has already resulted in multiple collaborations with some of the most prestigious cancer centers in the world and now this new discovery could dramatically improve our ability to treat a broader range of the most difficult cancers, and especially pancreatic cancer."  Dr. Don Picker, Moleculin's Chief Science Officer, explained, "The scientific community recognizes the potential for small molecule immuno-stimulating STAT3 inhibitors to become a game-changer for treating cancer patients. We believe this discovery may not only dramatically improve our ability to develop and deliver such therapies, it may also help support a new mechanistic understanding of oncogenic transcriptional activity. Specifically, we now have preclinical evidence to suggest we are capable of controlling a process known as 'ubiquitination' to block the activated form of STAT3, an important oncogenic transcription factor. The study of the role of ubiquitination in cancer is cutting edge science and appears to hold great promise. And, given the desperate lack of treatment options for indications like pancreatic cancer, we believe clinical researchers across the country have been eagerly awaiting a breakthrough like this." Read this and more news for Moleculin Biotech at:   "In developing our current lead STAT3 inhibitor, WP1066, for brain tumors, we have focused on its oral bioavailability and brain uptake," continued Dr. Picker, "but at the same time we have continued our quest to expand this portfolio by the creating alternative inhibitors with increased bioavailability and altered tissue and organ distribution that are not affected by first-pass metabolism. The lead molecule resulting from this new discovery is called WP1732 and it not only appears to share the same key mechanistic properties with WP1066, it has markedly different organ distribution and its dramatically increased solubility makes it ideal for administration via standard IV injection. Importantly, preclinical testing has also shown that WP1732's properties make it a promising candidate for treating pancreatic cancer, one of the most resistant and deadly forms of cancer."   "So much has happened in the past few months, it's important to recap where we are," added Mr. Klemp. "Moleculin has three potential breakthrough disruptive technologies - (1) Annamycin, an anticancer agent that is active against multidrug resistant tumor cells and has been designed to be non-cardio toxic (unlike currently approved drugs in this class), (2) immuno-stimulating STAT3 inhibitors like WP1066 and, now, WP1732, and (3) WP1122, a metabolic inhibitor that has been shown in preclinical testing to effectively block the energy supply required by cancer cells to function and proliferate. Since our IPO in June 2016, we have accelerated to the point of having two drugs, Annamycin and WP1066, beginning clinical trials in the near term."

In other pharma and biotech developments in the markets:  

Nektar Therapeutics (NASDAQ: NKTR) and Bristol-Myers Squibb Company (NYSE: BMY) announced the companies have executed a global strategic development and commercialization collaboration for Nektar's lead immuno-oncology program, NKTR-214. Under the collaboration, the companies will jointly develop and commercialize NKTR-214 in combination with Bristol-Myers Squibb's Opdivo (nivolumab) and Opdivo plus Yervoy(ipilimumab) in more than 20 indications across 9 tumor types, as well as potential combinations with other anti-cancer agents from either of the respective companies and/or third parties. NKTR-214, a CD122-biased agonist, is an investigational immuno-stimulatory therapy designed to selectively expand cancer-fighting T cells and natural killer (NK) cells directly in the tumor micro-environment and increase PD-1 expression on those immune cells.

Valeant Pharmaceuticals International Inc. (NYSE: VRX) earlier in the week, Ortho Dermatologics, a division of Valeant Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application for JEMDEL™1 (halobetasol propionate 0.01%) (IDP-122) lotion with a PDUFA action date of Oct. 5, 2018 . If approved, JEMDEL will be the first high-potency topical steroid treatment for plaque psoriasis with dosing for as long as eight weeks. In the clinical trials, the most common adverse event was upper respiratory tract infection. "The impact of psoriasis can be devastating for the millions of patients who live with the pain and stigma of this lifelong chronic condition," said Joseph C. Papa, Chairman and CEO, Valeant. "If approved, we believe JEMDEL will be an important option for patients with plaque psoriasis."

Pfizer Inc. (NYSE: PFE) recently announced its once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with moderate-to-severe atopic dermatitis (AD). The Phase 3 program for PF-04965842 initiated in December and is the first trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program. "Achieving Breakthrough Therapy Designation is an important milestone not only for Pfizer but also for patients living with the often devastating impact of moderate-to-severe atopic dermatitis, their providers and caregivers," said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. "We look forward to working closely with the FDA throughout our ongoing Phase 3 development program with the hope of ultimately bringing this important new treatment option to these patients."

DBV Technologies S.A. (NASDAQ: DBVT) recently announced that the U.S. Food and Drug Administration (FDA) has agreed that the available efficacy and safety data for Viaskin Peanut supports the submission of a Biologics License Application (BLA) for the treatment of peanut allergy in children four to 11 years of age. The FDA provided written responses to the clinical pre-BLA meeting package submitted by the Company, which reflect agreement on the content of the clinical module of the BLA for Viaskin Peanut. DBV remains on track to submit its BLA in the second half of 2018. "We are pleased with this positive step forward in our progress towards potential approval of Viaskin Peanut, and appreciate the feedback we received from the FDA supporting submission of our BLA," said Dr. Pierre-Henri Benhamou, Chairman & Chief Executive Officer of DBV Technologies.

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