Heat Biologics Doses First Patient in New Cohort of its Expanded Phase 2 Trial of HS-110 in Combination with Merck’s KEYTRUDA® in Non-Small Cell Lung Cancer Trial

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.

Biocure Signs a Collaboration Agreement with Y Biologics

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.

Publication Reports Role of Dopamine Receptors in Cancer and ONC201 Response

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."

Johnson & Johnson Announces completion of Offer for Ci:z Holdings Co., Ltd.

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]).

Dr. Reddy’s to Release Q3 FY19 Results on February 1, 2019

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.