Pharma and Biotech Companies Significantly Investing in R&D, Focus on Rising Demand for Advanced Medicines

Tuesday, June 13, 2017 Drug News
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PALM BEACH, Florida, June 13, 2017 /PRNewswire/ --

In just over

a year ago, it's been estimated $50 billion was invested on pharmaceutical Research and Development activities majorly on oncology, diabetes, and autoimmune therapy classes, which is expected to propel the biotechnology services outsourcing market
growth. Biotechnology and Pharmaceutical Companies with developments and recent market activity this week include: Moleculin Biotech, Inc., (NASDAQ: MBRX), XBiotech Inc. (NASDAQ: XBIT), GTx, Inc. (NASDAQ: GTXI), Agenus Inc. (NASDAQ: AGEN) and TrovaGene Inc. (NASDAQ: TROV)

Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical 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 M.D. Anderson Cancer Center, today announced it has begun taking steps to file an IND with the FDA for its molecule WP1220 for the treatment of Cutaneous T-Cell Lymphoma (CTCL), a rare form of skin cancer. Read this and more news for MBRX at

Moleculin's WP1220 (aka MOL4239) has data demonstrating significant activity in preclinical studies and is being studied as a possible topical treatment for CTCL. The FDA previously granted an IND to WP1220 for development as a topical treatment of psoriasis, and although the molecule completed a Phase I clinical trial, providing initial data suggesting safety in humans, Phase II clinical trials did not demonstrate sufficient activity to warrant further development for that indication. To pursue further development of WP1220, the Company believes the data used to support the prior IND may allow for a quicker pathway to an IND for CTCL.

"Our primary focus has been further developing our most advanced and promising drug, Annamycin, for the treatment of acute myeloid leukemia," commented Walter Klemp, Chairman and CEO of Moleculin. "Nevertheless, we believe some of the less advanced technologies in our portfolio have significant potential in other cancer indications. WP1220 is a great example of such potentially useful technology, and because the FDA previously found the data package supporting an IND for WP1220 to be adequate in another context, we are hopeful that we can expeditiously move forward to studying the molecule in humans for the topical treatment of this potentially deadly skin disease." Mr. Klemp added, "Developing WP1220 for indications like CTCL may provide opportunities for strategic collaboration and out-licensing while maintaining our ability to develop other molecules to their highest and best potential. We will be actively looking for such opportunities to help fund the projects we believe hold the most potential for Moleculin stakeholders."

In other industry related developments and market activity of note: 

XBiotech Inc. (NASDAQ: XBIT) closed up 31.25% on Monday at $4.20 on over 9.1 million shares traded on the day. XBiotech Inc. announced late last week that an Independent Data Monitoring Committee (IDMC) has performed its second prospectively planned, unblinded analysis of the Phase 3 XCITE study for the Company's novel candidate antibody therapy for the treatment of colorectal cancer. The IDMC had no safety concerns from the unblinded analysis. However, the committee recommended the early termination of the study since the findings were not sufficient to meet efficacy or the threshold for continuation, which involved a prospectively defined acceptance boundary for the interim analysis of less than or equal to p = 0.08. John Simard, XBiotech President & CEO stated, "We are obviously disappointed with these findings. In the coming weeks, the Company plans to analyze the data extensively to further understand the primary and secondary endpoint data, as well as to identify populations that may have benefited from the therapy. These findings today will not affect our efforts to pursue approval of the therapy based on the successful completion of the European study, which demonstrated control of debilitating symptoms in colorectal cancer."

GTx, Inc. (NASDAQ: GTXI) closed up 99.03% on Monday at $6.15 with over 7.3 million shares traded throughout the day. The company recently announced the release of preliminary clinical data from its ongoing, open-label, Phase 2 clinical trial of enobosarm 3 mg (GTx-024) in postmenopausal women with stress urinary incontinence (SUI). An abstract entitled 'Kegels In A Bottle': Preliminary Results Of A Selective Androgen Receptor Modulator (GTx-024) For The Treatment Of SUI In Post-Menopausal Women, summarizing clinical data from the first seven patients completing 12 weeks of treatment with enobosarm, is now available on the International Continence Society's website. This proof-of-concept clinical trial is the first-of-its-kind to evaluate an orally-administered selective androgen receptor modulator (SARM) for SUI.

Agenus Inc. (NASDAQ: AGEN) closed up 4.46% Monday at $3.51 on over 1.2 million shares traded by the market close. The company recently announced the results from an ongoing Phase 1 dose-escalation trial for its anti-CTLA-4 antibody, AGEN1884, in patients with advanced solid malignancies. The results were presented during a poster session at the 2017 American Society of Clinical Oncology (ASCO) held in Chicago, IL. "We continue to advance our anti-CTLA-4 antibody trial, the antibody is well tolerated and shows early signs of efficacy, with a partial response observed in an individual patient," commented Jean-Marie Cuillerot, M.D., Chief Medical Officer.

TrovaGene Inc. (NASDAQ: TROV) closed up 19.93% on Monday with over 6.1 million shares traded by the market close. The company recently announced it has entered into an agreement with AstraZeneca to provide TroveraŽ urine ctDNA biomarker test and services. The TroveraŽ EGFR urine liquid biopsy test will initially be used in an open label prospective biomarker study evaluating whether the combined use of non-invasive testing (urine and blood testing) is as effective as tissue testing in identifying epidermal growth factor receptor (EGFR) T790M mutation status.

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This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and MNU undertakes no obligation to update such statements.

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