On January 14, 2019 Omeros Corporation (Nasdaq: OMER), reported unaudited preliminary revenue results for the fourth quarter ended December 31, 2018 (Press release, Omeros, JAN 14, 2019, View Source [SID1234532632]).

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Omeros’ preliminary (unaudited) total and OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% revenues for the fourth quarter of 2018 are expected to be a record high at approximately $22.0 million compared to $4.6 million in 3Q 2018 and $13.8 million in the prior year fourth quarter. The increase from the prior periods reflects strong demand for OMIDRIA from ambulatory surgery centers (ASCs) and hospitals following reinstatement of pass-through reimbursement for OMIDRIA on October 1, 2018.

As of December 31, 2018, days of wholesaler inventory on hand were consistent with historical norms.

Increased utilization within commercial insurance and Veterans Health Administration systems contributed to the increased revenues.

Units sold by wholesalers to ASCs and to hospitals (sell-through) as well as the number of purchasing hospital accounts for the fourth quarter 2018 each also represent a record high.

Annualized run rate of weekly net sales in December was approximately $100 million.

Consistent with Omeros’ strategy, growing revenues from OMIDRIA are increasingly funding the progress across the company’s pipeline, including the advancement of its OMS721 Phase 3 program in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). As reflected in an update recently submitted to clinicaltrials.gov, Omeros plans to keep the ongoing HSCT-TMA registration trial open through the submission, filing and review of the Biologics License Application (BLA) and the Marketing Authorization Application (MAA) in the U.S. and Europe, respectively, to collect additional data. These data are expected to help provide healthcare professionals and payers with additional supporting information on the clinical use and value of OMS721 once approved. The update submitted by Omeros to clinicaltrials.gov has no effect on the overall timing, content or requirements of the OMS721 HSCT-TMA program, including the BLA and MAA, and the program remains on track.

"We are very pleased that demand for OMIDRIA, in its first quarter of restored separate payment, has not only returned quickly to the levels experienced prior to the expiration of pass-through reimbursement but that quarterly revenue and sell-through results are already setting new high-water marks," said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "We are also encouraged by the expanding coverage seen by commercial and Medicare Advantage payers and, with the addition of

OMIDRIA to its national formulary, by the VA. All of these data underscore the importance both of improved outcomes with OMIDRIA and of separate payment to ensuring patient access to the drug’s benefits. As expected, revenues from sales of OMIDRIA ramped up throughout the fourth quarter, and we look forward to continued revenue growth in 2019 as we prepare to commercialize OMS721 for the treatment of stem cell transplant-associated TMA."

Omeros has released OMIDRIA fourth-quarter preliminary revenues for the purpose of providing transparency in the unique setting of reinstatement of pass-through status and does not currently intend in the future to make public preliminary sales revenues on a routine basis. The company expects to release complete fourth-quarter and full-year 2018 financial results and to host a conference call by March 1, 2019

On January 14, 2019 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing therapies designed to activate a patient’s immune system against cancer, reported that it has dosed its first patient in its Phase 2 clinical trial investigating HS-110 in combination with Merck’s anti-PD1 checkpoint inhibitor, KEYTRUDA (pembrolizumab), in patients with advanced non-small cell lung cancer (NSCLC) (Press release, Heat Biologics, JAN 14, 2019, View Source [SID1234532631]). This expansion of the Company’s Phase 2 trial into first-line maintenance treatment with Keytruda follows positive interim results reported last year on previously treated patients receiving HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, Opdivo (nivolumab). Heat will continue to dose patients with HS-110 in combination with Opdivo as well.

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The Company amended its Phase 2 master protocol to include additional patient cohorts in the front-line maintenance setting for advanced NSCLC. Patients in these cohorts will have received a minimum of 9 weeks of pembrolizumab, with or without chemotherapy, and will begin maintenance treatment receiving HS-110 with pembrolizumab ± pemetrexed. Patients will be evaluated for objective response rate as well as progression-free and overall survival.

Daniel Morgensztern, MD, Associate Professor of Medicine and Director of Thoracic Oncology, Washington University School of Medicine and lead investigator for this trial, commented, "Results from the ongoing Phase 2, multicenter clinical trial combining HS-110 with Bristol-Myers Squibb’s checkpoint inhibitor nivolumab (Opdivo), suggest that HS-110 may enhance the efficacy of checkpoint inhibitors in patients with advanced lung cancer. Expanding this trial to include Merck’s anti-PD-1 checkpoint inhibitor pembrolizumab (KEYTRUDA) is an important next step in evaluating the broad potential of this platform technology."

Jeff Wolf, Heat’s CEO, further noted, "The expansion of this trial to include a combination of HS-110 with KEYTRUDA is in line with our strategy to combine our T-cell activation platform with multiple checkpoint inhibitors. We are very excited to begin dosing patients in this cohort."

New interim data on those patients in this ongoing Phase 2 trial that have been treated with the HS-110 plus nivolumab combination have been selected for oral presentation at the 2019 ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium on February 28. To learn more about the trial, visit www.heatbio.com. Additional details can also be found at www.clinicaltrials.gov via NCT02439450.

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 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]).