On January 14, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported two upcoming presentations at the 2019 Gastrointestinal Cancer Symposium being held in San Francisco, January 17-19, 2019 (Press release, Five Prime Therapeutics, JAN 14, 2019, View Source [SID1234532642]). Data will be presented from the Phase 1/3 FIGHT Study evaluating bemarituzumab and mFOLFOX6 in advanced gastric/GEJ cancer. The study design of the randomized phase 2 study of cabiralixumab in combination with nivolumab and chemotherapy in advanced pancreatic ductal adenocarcinoma will also be presented. Here are the details of the two poster presentations:

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Title: Phase 1 Results from the Phase 1/3 FIGHT Study Evaluating bemarituzumab and mFOLFOX6 in Advanced Gastric/GEJ Cancer
Abstract Number: Board J1, Abstract #91
Poster Session: A – Cancer of the Esophagus and Stomach
Date & Time: Thursday, January 17, 19, 11:30-1pm and 5:30-6:30pm

Title: A Randomized Phase 2 Study of cabiralizumab (cabira) + nivolumab (nivo) ± chemotherapy (chemo) in Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
Abstract Number: Board Q4 Abstract #TPS465
Poster Session: B – Pancreatic, Small Bowel, Hepatobiliary
Date & Time: Friday, January 18, 2019, 11:30-1pm and 5:30-6:30pm

The poster abstracts will be available on January 14, 2019 at 5:00 PM EST at the ASCO (Free ASCO Whitepaper) Meeting Library and the posters can be found on Five Prime Therapeutics’ Scientific Publications page after presentation at the conference.

About Bemarituzumab (FPA008)

Bemarituzumab is a first-in-class, isoform-selective, humanized monoclonal antibody in clinical development as a targeted immunotherapy for tumors that overexpress FGFR2b, a splice variant of a receptor for some members of the fibroblast growth factor (FGF) family. Bemarituzumab has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) to increase direct tumor cell killing by recruiting natural killer (NK) cells. Clinical results to date suggest that the specificity of bemarituzumab avoids the dose-limiting toxicities that have been seen with less selective pan-FGFR tyrosine kinase inhibitors that act on multiple FGFRs, including FGFR2.

In December 2017, Five Prime and Zai Lab announced a collaboration for the development and commercialization of bemarituzumab in Greater China. Zai Lab will manage the Phase 3 portion of the FIGHT trial in China.

About Cabiralizumab (FPA008)

Cabiralizumab is an investigational antibody that inhibits the CSF-1 receptor and has been shown in preclinical models to block the activation and survival of monocytes and macrophages. Inhibition of CSF1R in preclinical models of several cancers reduces the number of immunosuppressive tumor-associated macrophages (TAMs) in the tumor microenvironment, thereby facilitating an immune response against tumors. Cabiralizumab is currently in clinical trials in oncology indications. Cabiralizumab is being developed under an exclusive worldwide license and collaboration agreement entered into with Bristol-Myers Squibb (BMS) in October 2015.

On January 13, 2019 Biocure Technology Inc. (CSE: CURE) (OTCQB: BICTF) (the "Company" or "Biocure") BiocurePharm, Korea ("BPK"), a wholly owned subsidiary of Biocure Technology Inc. ("CURE") reported that it has entered into a collaboration agreement with Y Biologics ("YB"), a private R&D company in Korea who is specialized in antibody therapeutics in cancer, autoimmune disease and metabolic disease (Press release, Biocure Technology, JAN 13, 2019, View Source [SID1234628759]). The purpose of this agreement is to research the effectiveness of combined treatment of Immune Checkpoint Inhibitor PD-1 (Programmed Cell Death Protein-1) developed by YB and anti-CD19 CAR T-Cell Therapy developed by BPK. BPK and YB believe that the above combined treatment could maximize anticancer effects and eventually develop a next generation anticancer treatment for solid tumors.

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BPK and YB agreed to collaborate in the following areas to verify combined therapy of YBL-006 and anti-CD19 CAR T-cell therapy;

Plan and implement pre-clinical trial(animal) for combined therapy
Conduct a study of action mechanism and bio marker of combined therapy
Development of anticancer treatment and exchange of information
And other essential items to fulfill the intended goal of the agreement
Dr. Sang Mok Lee, CEO & President of CURE explains "I am excited to see BPK collaborate with Y Biologics to take the first step to move forward to develop a next generation anticancer treatment for solid tumors. CURE will be able to commercialize a blood cancer immune therapy using CAR T Cell Therapy within 2 years and it is our ultimate goal to treat solid tumors with CAR T Cell Therapy. I believe that a successful outcome from this collaboration could bring CURE an opportunity to present epoch-marking anticancer therapy for solid tumors to life-threatening patients. This might be one of our most powerful pipeline products to give the significant returns to our loyal shareholders who have been supporting us for many years."

Y Biologics is a Korean private R&D Company specialized in antibody therapeutics in cancer, autoimmune disease and metabolic disease. It has three platform technologies to accelerate development of antibody therapeutics – Human antibody library, Receptor library and mammalian transient expression. Y Biologics has a plan to enter into a preclinical trial for YBL-006 imminently.

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 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 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.