On April 19, 2018 Amgen (NASDAQ:AMGN) reported that it will report its first quarter 2018 financial results on Tuesday, April 24, 2018, after the close of the U.S. financial markets (Press release, Amgen, APR 19, 2018, View Source;p=RssLanding&cat=news&id=2343565 [SID1234525542]). The announcement will be followed by a conference call with the investment community at 2 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

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Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event. (Press release, Amgen, APR 19, 2018, View Source;p=RssLanding&cat=news&id=2343565 [SID1234525542])

On April 19, 2018 The Board of Shire (the "Board") confirms that it has received three conditional proposals from Takeda regarding a possible offer for the Company, on 29 March 2018 (the "First Proposal"), 11 April 2018 (the "Second Proposal") and 13 April 2018 (the "Third Proposal") (Press release, Shire, APR 19, 2018, View Source [SID1234525577]).

The First Proposal comprised £28 per share in new Takeda shares, to be listed in Japan and in the US through an ADR listing, and £16 per share in cash, representing a potential value of £44 per share and approximately £41 billion for the total issued and to be issued share capital of the Company. Based on Takeda’s current market capitalisation, Shire shareholders would own approximately 50 per cent. of the enlarged Takeda.

Following a thorough review of the First Proposal with its advisers and a Board meeting on 8 April 2018, the Board unanimously rejected the First Proposal, concluding that it significantly undervalued the Company, its growth prospects and pipeline.

The Board has since received two further proposals:

the Second Proposal comprised £28.75 per share in new Takeda shares, to be listed in Japan and in the US through an ADR listing, and £16.75 per share in cash, representing a potential value of £45.50 per share, only a marginal increase to the First Proposal, and approximately £43 billion for the total issued and to be issued share capital of the Company. Based on Takeda’s current market capitalisation, Shire shareholders would own approximately 51 per cent. of the enlarged Takeda; and
the Third Proposal also comprised £28.75 per share in new Takeda shares, to be listed in Japan and in the US through an ADR listing, and £17.75 per share in cash, representing a potential value of £46.50 per share and approximately £44 billion for the total issued and to be issued share capital of the Company. Based on Takeda’s current market capitalisation, Shire shareholders would own approximately 51 per cent. of the enlarged Takeda.

The Board met again and thoroughly considered the Third Proposal with its advisers and unanimously rejected it, concluding that it continues to significantly undervalue the Company and Shire’s growth prospects and pipeline.

Following the Board meeting on 14 April 2018 which rejected the Third Proposal, at the Board’s request Shire’s advisers entered into a dialogue with Takeda’s advisers to discuss whether a further, more attractive, proposal may be forthcoming and to understand the basis on which such a proposal would be made.

The Board and management of Shire remain committed to enhancing shareholder value and are focused on fully evaluating internal and external opportunities to maximise value for shareholders, including any further proposals from Takeda.

This announcement is made without the consent of Takeda.

On April 19, 2018 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported interim results from its randomized, active controlled, open-label, multi-center Phase 3 ADAPT trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma. Based on these results, the Company has decided to discontinue the trial (Press release, Argos Therapeutics, APR 19, 2018, View Source [SID1234525543]).

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As previously reported, a total of 462 patients with previously untreated advanced or metastatic renal cell carcinoma were enrolled in the ADAPT trial and randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib (combination arm) vs. sunitinib monotherapy (control arm) after undergoing cytoreductive nephrectomy. The Company recently submitted a protocol amendment to the U.S. Food and Drug Administration providing for four co-primary endpoints focused on various measures of survival. Based upon review of the interim data, the Company does not believe that it would achieve these endpoints if the trial were to be continued. After consulting with the principal investigators of the trial, the Company has therefore decided to discontinue the trial and has informed the FDA of its decision.

The most recent interim analysis was conducted after 51 new events (deaths) had occurred since the time of the February 2017 interim analysis. Median overall survival for the intent-to-treat patient population, one of the four co-primary endpoints, was estimated using the Kaplan-Meier method. The estimated median overall survival for the combination arm was 28.2 months (95% Confidence Interval (CI): 23.4, 35.2) compared to 31.2 months (95% CI: 23.0, 44.5) for the control arm. The hazard ratio was 1.10 (95% CI: 0.85, 1.42). The two other co-primary endpoints that were evaluated at this time, including overall survival for the patients who remained alive at the time of the February 2017 interim analysis and overall survival for all patients for whom at least 12 months of follow-up was available, also did not demonstrate a favorable result. A fourth endpoint, five-year survival, was not evaluated because there was insufficient data at this time to perform this analysis.

Based on a review of the status of its internal programs, resources and capabilities, Argos plans to explore a wide range of strategic alternatives that may include a potential merger or sale of the Company, among other potential alternatives that could maximize both near and long-term value for our shareholders. The Company has retained Stifel, Nicolaus & Company, Incorporated to serve as its financial advisor in the process.

Argos does not have a defined timeline for the exploration of strategic alternatives and is not confirming that the process will result in any strategic alternative being announced or consummated. Argos does not intend to discuss or disclose further developments during this process unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate.

Argos also today reported that it does not expect to regain compliance with The Nasdaq Capital Market continued listing requirements by the April 24, 2018 deadline. As a result, Argos expects that its common stock will be delisted from The Nasdaq Capital Market and that trading in the Company’s common stock on The Nasdaq Capital Market will be suspended effective at the open of business on April 23, 2018. The Company has filed an application to transfer trading and quotation of its common stock to the OTCQB Venture Market, operated by OTC Markets Group Inc., under its current trading symbol "ARGS," effective as of April 23, 2018. Quotation and trading information for the common stock will be available on www.otcmarkets.com.

On April 19, 2018 Epigenomics AG (FSE: ECX, OTCQX: EPGNY) reported promising results from two clinical studies published in EBioMedicine supported by Cell Press and The Lancet, demonstrating high accuracy of Epigenomics’ proprietary epigenetic circulating biomarker mSEPT9 in detecting liver cancer among patients with cirrhosis (Press release, Epigenomics, APR 19, 2018, View Source [SID1234525523]).

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The two independent clinical studies (observational/case-control) included 289 cirrhosis patients with or without liver cancer from France (initial study) and Germany (replication study). Overall, the mSEPT9 test demonstrated high sensitivity of 90.6 percent at a specificity of 87.2 percent (using the "2 out of 3" algorithm). Importantly, a triple-negative mSEPT9 test had the highest negative predictive value for excluding liver cancer (97.2 percent), whereas a triple-positive mSEPT9 test had the highest positive predictive value for retaining a diagnosis of liver cancer (91.5 percent).

The results from the replication study were consistent with those of the initial study with regard to all diagnostic accuracy measures. Furthermore, the mSEPT9 blood test exhibited higher diagnostic accuracy compared to alpha-fetoprotein (AFP), which has been widely used as a diagnostic marker for liver cancer.

"The detection of liver cancer, one of the deadliest cancer types worldwide, still represents a high medical need," said Abderrahim Oussalah MD, PhD, Department of Molecular Medicine at the University Hospital of Nancy (France). "Findings from two independent clinical studies reveal that the mSEPT9 test constitutes a promising opportunity in this respect. As more clinical evidence is needed, we have initiated a further, prospective clinical study with 440 patients in order to confirm the diagnostic accuracy of mSEPT9 in the diagnosis of liver cancer (SEPT9-CROSS study, ClinicalTrials ID: NCT03311152). Future prospective studies should assess the mSEPT9 test in a screening algorithm for patients with cirrhosis to improve risk prediction and the personalized therapeutic management of liver cancer."

According to the World Health Organization, liver cancer is the fifth most common cancer in men and the seventh in women, and ranks second in annual cancer mortality rates worldwide, with liver cancer diagnosed in more than 700,000 people annually. Major risk factors for liver cancer include cirrhosis, infection with hepatitis B or C virus, alcoholic liver disease, and non-alcoholic fatty liver disease.

"We are very excited about the promising clinical results of our mSEPT9 blood test in the diagnosis of liver cancer", said Jorge Garces, President & Chief Scientific Officer of Epigenomics AG. "In the future, an accurate blood test could offer the opportunity to closely monitor patients at high risk for developing liver cancer."

The full-length paper is available here: View Source(18)30116-6/pdf

On April 19, 2018 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that data from pre-clinical studies supporting the potential of prexigebersen (BP1001, liposomal Grb2 antisense), in the treatment of solid tumors in gynecologic malignancies were presented in a poster at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), which took place in Chicago, IL (Press release, Bio-Path Holdings, APR 19, 2018, View Source [SID1234525544]).

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The poster titled, "Grabbing GRB2: The use of Liposome-incorporated Grb2 antisense oligonucleotides as a novel therapy in gynecologic malignancies," was presented by Olivia D. Lara, M.D., University of Texas MD Anderson Cancer Center, Department of Gynecologic Oncology during the Experimental and Molecular Therapeutics Poster Session. The data summarize results from studies investigating the expression of GRB2 in a series of in vitro experiments in high-grade serous (HGSC) and uterine (UC) carcinoma models. The study also examined the biological effects of prexigebersen in HGSC mice models (OVCAR 5), first in a dose-defining experiment then in combination with standard dose paclitaxel.

The data showed there was an eighty-six percent (86%) decrease in tumor burden (p<0.05), and multinodular burden (p<0.01) in the combination prexigebersen/paclitaxel group compared to control. In addition, there was no apparent toxicity with mice on combination therapy losing less weight than the paclitaxel-only group (P = 0.005).

"We are delighted to present these very encouraging findings at this year’s AACR (Free AACR Whitepaper) before an audience of the world’s leading cancer researchers and clinicians," stated Peter H. Nielsen, chief executive officer of Bio-Path Holdings. "Our research continues to suggest that prexigebersen-based combination therapy may offer an attractive method for targeting solid tumors and these findings establish the GRB2/GAB2 complex as an important target for prexigebersen. We look forward to advancing this promising therapy in gynecologic and other solid tumor cancers and plan to initiate first-in-human studies as early as the end of this year."