On January 11, 2019 Oncoceutics, Inc. reported the publication of a research article in the scientific journal Clinical Cancer Research that describes the dysregulation of specific dopamine receptors by human cancers (Press release, Oncoceutics, JAN 11, 2019, View Source [SID1234558363]). The article also defines therapeutic opportunities associated with selective targeting of these receptors in tumors by ONC201 and other imipridones, Oncoceutics’ novel class of small molecule cancer therapies.

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The research findings show that DRD2 is the specific member of the dopamine receptor family that is most often dysregulated in human cancers, implicating it as a therapeutic target for selective antagonism. Overexpression of this receptor was seen across a wide range of human cancers, with the strongest expression detected in neurooncology and neuroendocrine tumors. Further studies showed that selective antagonism of DRD2, while avoiding other receptors, is critical to maximizing anticancer efficacy, a key feature of ONC201.

This report also finds that another dopamine receptor, DRD5, negatively influences the sensitivity of tumor cells to ONC201. Combining the expression of these two dopamine receptors provides a biomarker tool to identify additional types of cancer that respond to ONC201 beyond its current lead indication in H3 K27M-mutant glioma, which appears to be one of many mechanisms that can produce this biomarker signature.

"Decades of research have shown that G protein-coupled receptors (GPCRs) such as dopamine receptors, are hijacked by tumors to support their growth and survival," said J. Silvio Gutkind, PhD, Associate Director of Basic Science at University of California, San Diego. "It is rewarding to finally see the clinical translation of one of these therapeutic concepts with ONC201. This compound is clearing the path for other GPCR-targeting agents, including additional imipridones in development, to address a previously untargeted axis in cancer."

"We are excited and compelled by the clinical results that we are seeing with ONC201 in patients with specific types of high grade gliomas," said Joshua Allen, PhD, senior author of the article and Senior Vice President of Research and Development, Oncoceutics. "Our findings in this research article provide a molecular compass that points to additional indications, within and beyond gliomas, that we can study in the lab and the clinic to help more cancer patients with this novel therapy."

On January 11, 2019 Johnson & Johnson (NYSE: JNJ) reported that the conditions to its public tender offer for all of the outstanding shares of Ci:z Holdings Co., Ltd. (TYO: 4924) (the "Company") not already held by Johnson & Johnson or its affiliates that was previously announced on October 23, 2018, have been satisfied and the offering period for the tender offer has expired (Press release, Johnson & Johnson, JAN 11, 2019, View Source;johnson-announces-completion-of-offer-for-ciz-holdings-co-ltd-300776682.html [SID1234532626]).

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There were 20,004,934 shares of the Company tendered in the tender offer, representing 41% of the outstanding shares of the Company. Johnson & Johnson will acquire all tendered shares for ¥5,900 per share and will purchase additional shares of the Company through the acquisition of CIC Corporation ("CIC"), the ownership vehicle of the Company’s founder, Dr. Yoshinori Shirono. As of the expiration of the offering period, the shares tendered in the tender offer, together with shares already held by Johnson & Johnson or its affiliates and the shares to be acquired through the acquisition of CIC, will give Johnson & Johnson an aggregate ownership interest in the Company of 89%. The settlement of the tender offer and the acquisition of CIC will be completed by January 17, 2019. Following settlement of the tender offer and the acquisition of CIC, Johnson & Johnson plans to acquire the remaining shares of the Company that were not tendered in the tender offer through a share consolidation under Japanese law during the first half of 2019 and take appropriate actions to delist the Company from the Tokyo Stock Exchange.

Additional information on the tender offer and settlement procedures is available to the Company’s shareholders in the tender offer registration statement for the transaction filed on EDINET in Japan. Copies of an English translation of the tender offer explanatory statement, which includes all the information described in the tender offer registration statement, may be obtained by contacting Johnson & Johnson’s tender offer agent, SMBC Nikko (IBG_M&[email protected]).

On January 11, 2019 Dr. Reddy’s Laboratories (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that it will announce results for the quarter ended December 31, 2018 on Friday, February 1, 2019 after the Board Meeting (Press release, Dr Reddy’s, JAN 11, 2019, View Source [SID1234532623]).

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Summary of Events

Event

Date and Time

Medium

Release of financial results

February 1st, after the Board Meeting

Email, Media, Company website, Business wire

Press meet presentation

Will be available on the Company’s website

URL available on Company’s website, www.drreddys.com

Earnings Call

February 1st, 6:30 PM IST / 8:00 AM EST

Hosted by the Company

(Details below)

Playback of Earnings Call

After the earnings call till February 7th

Details below

Transcript of the Earnings call

Will be available on the Company’s website

URL available on Company’s website, www.drreddys.com

Earnings Call

Following the release, the management of the Company will host an earnings call to discuss the Company’s financial performance. (Dial In and other details given below)

Play Back

The play back will be available after the earnings call, through February 7th, 2019. For play back dial in phone No: 022 7194 5757 / 022 6663 5757, and Playback Code is 37176.

Conference Dial-In Numbers

Universal Access Number:

+91 22 6280 1219

+91 22 7115 8120

Local Access Number:

Available all over India

+91 70456 71221

International Toll Free Number:

USA: 1 866 746 2133

UK: 0 808 101 1573

Singapore: 800 101 2045

Hong Kong: 800 964 448

No password/pin number is necessary to dial in to any of the above numbers. The operator will provide instructions on asking questions before and during the call.

On January 11, 2019 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that it has entered into an exclusive License Agreement with Knight Therapeutics Inc. (TSX: GUD) that grants Knight the exclusive right to commercialize NERLYNX (neratinib) in Canada (Press release, Puma Biotechnology, JAN 11, 2019, https://investor.pumabiotechnology.com/press-release/puma-biotechnology-and-knight-therapeutics-enter-exclusive-license-agreement-commercia [SID1234532621]).

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Puma Biotechnology filed a new drug submission for NERLYNX with Health Canada in July 2018 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy. Under the terms of the License Agreement, Knight will be responsible for all commercial activities and future regulatory submissions for NERLYNX in Canada. Puma will receive upfront and milestone payments up to $7.2 million USD throughout the term of this agreement, as well as double digit royalties on net sales of NERLYNX in Canada.

"Our new agreement with Knight demonstrates our commitment to bringing NERLYNX to patients around the world while continuing to focus our commercial resources on the U.S. market," stated Alan H. Auerbach, Chief Executive Officer and President of Puma. "We are confident this new partnership will help patients in Canada access NERLYNX at the earliest opportunity."

"We are excited to partner with Puma to offer a new treatment option to Canadian breast cancer patients," said Jonathan Ross Goodman, Chief Executive Officer of Knight. "While adjuvant trastuzumab-based therapy has been shown to reduce the risk of recurrence in early stage HER2-positive breast cancer, up to 25% of patients treated with adjuvant trastuzumab will have a recurrence. NERLYNX has been shown to significantly reduce the risk of recurrence in those patients who were previously treated with trastuzumab."

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets.

On January 10, 2019 EMMAC, the European independent medical cannabis company, is reported a research collaboration with Imperial College London to deliver a long-term comprehensive research programme designed to inform and shape the future of the medical cannabis therapeutic industry (Press release, EMMAC Life Sciences, JAN 10, 2019, View Source [SID1234554039]). The programme aims to investigate mechanisms of action of cannabis-based medicinal products related to several clinical applications including pain and cancer, as well as characterise cannabis-based medicinal products in disease models with particular focus of chronic pain, spasticity and cancer.

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The initial clinical study, which is currently going through regulatory approval processes, is a feasibility randomised controlled trial of patients undergoing major hepatopancreatobiliary surgery evaluating the efficacy of perioperative cannabinoids on pain, nausea and vomiting. The first stage, conducted with the Imperial Clinical Trials Unit (ICTU) and involving comprehensive patient and public involvement activities, is estimated to be completed by March 2019.

Under the terms of the Collaboration Agreement signed between the parties EMMAC will fund research staff for an extendable 3-year period to explore the basic science opportunities uncovered through clinical trials.

Strategic Highlights

Collaboration Agreement with Imperial College London;
EMMAC to fund research staff for an extendable 3-year period to explore the basic science opportunities uncovered through clinical trials;
Research provides valuable data and intellectual property in relation to the use of cannabinoids to treat acute pain, nausea and vomiting;
EMMAC expected to partner with Imperial on additional cannabinoid research programmes focused across different therapeutic areas;
Partnership with world-renowned institution confirms EMMAC as a European leader in research supporting the growing medical cannabis industry.
Professor Nagy Habib, Professor of Hepatobiliary Surgery at Imperial College London, said: "We are delighted to partner with EMMAC Life Sciences and to collaborate on this exciting research programme. Translational research lies at the heart of our academic aims at Imperial College London and our first collaborative project illustrates the potential scope of cannabinoids to improve the quality of life and outcomes of patients undergoing surgery. As we gain a greater understanding of the therapeutic properties for a range of clinical conditions, this research will inform a portfolio of basic science work packages. This project is therefore the first step of a broad research programme aimed at shaping the global future of medicinal cannabinoid therapeutics."

Antonio Costanzo, CEO of EMMAC, commented: "The strategic partnership with Imperial College London puts EMMAC at the very forefront of research in the UK into the medical benefits of cannabis in relation to pain relief. As an industry, all participants must recognise that significant further research is needed to improve the understanding of the medical benefits of cannabis, with basic science and much greater clinical data under-pinning what we consider to be a huge potential market with enormous public health benefits (for patients and clinicians). We are delighted to partner with Imperial in relation to this important work. Imperial is one of the leading research institutions for science and medicine globally and we are delighted they have chosen EMMAC as their partner as they begin their work in this field. The expectation is that the research partnership with Imperial will be extended throughout Europe, with Imperial working with leading European institutions as the clinical trials commence."