(Filing, 10-Q, Generex, JUN 5, 2015, View Source [SID:1234505371])

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On June 5, 2015 Janssen Research & Development reported Janssen has initiated the rolling submission of its Biologic License Application (BLA) for daratumumab to the U.S. Food and Drug Administration (FDA) for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and an IMiD (Press release, Johnson & Johnson, JUN 5, 2015, View Source [SID:1234505372]). Daratumumab – an investigational human anti-CD38 monoclonal antibody – received Breakthrough Therapy Designation by the U.S. FDA for this set of patients in May 2013. A rolling submission allows the company to submit portions of the regulatory application to the FDA as they are completed.[1]

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In August 2012, Janssen Biotech, Inc. and Genmab A/S entered into an agreement which granted Janssen a worldwide exclusive license to develop, manufacture and commercialize daratumumab. With the exception of one study sponsored globally by the French multiple myeloma cooperative group, Intergroupe Francophone du Myelome (IFM), Janssen is the global sponsor of all current and future clinical studies for daratumumab.

Multiple myeloma is an incurable blood cancer.[2] Approximately 26,850 new patients will be diagnosed with multiple myeloma and approximately 11,240 people will die from the disease in the U.S. in 2015.[3] Patients who relapse after treatment with standard therapies, including PIs or IMiDs, have poor prognoses and few treatment options.[4]

The regulatory submission for daratumumab will be primarily supported by data from the Phase 2 MMY2002 (SIRIUS) monotherapy study announced in May 2015 at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), along with additional data from four other studies, including the Phase 1/2 GEN501 monotherapy study.

"Despite therapeutic advances over the last 10 years, multiple myeloma remains an incurable disease, and many people eventually relapse or grow resistant to available therapies, which has underscored the need for newer medicines with novel mechanisms of action," said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen. "We are proud of the Breakthrough Therapy Designation daratumumab received and look forward to working in close collaboration with the FDA during its review."

Daratumumab is the second medicine in the Janssen oncology portfolio to receive Breakthrough Therapy Designation, which is intended to expedite the development and review time for a potential new medicine. If approved, daratumumab would be commercialized in the U.S. by Janssen Biotech, Inc.

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.[5] Multiple myeloma is the third most common blood cancer in the United States (U.S.), following only leukemia and lymphoma.[6] Globally, it is estimated that 114,251 people will be diagnosed and 80,019 will die from the disease.[7] While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.[8]

About Daratumumab
Daratumumab is an investigational human monoclonal antibody (mAb) that binds with high affinity to the transmembrane ectoenzyme, CD38, on the surface of multiple myeloma cells. It induces rapid tumor cell death through diverse mechanisms of action.[9] Five Phase 3 clinical studies with daratumumab in relapsed and frontline settings are currently ongoing. Additional studies are planned or underway to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma and non-Hodgkin’s lymphoma.

On June 5, 2015 Oncolytics Biotech reported that its 2015 Annual Meeting of Shareholders will be held on Monday June 8th, 2015 at 2:30 pm CT (3:30 pm ET) at the Wyndham Grand Chicago Riverfront, 71 East Upper Wacker Drive, Chicago, Illinois (Press release, Oncolytics Biotech, JUN 5, 2015, View Source [SID:1234505235]).

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Following the business portion of the meeting, Dr. Brad Thompson, President and CEO of Oncolytics, will discuss recent progress in the development of REOLYSIN as a potential cancer therapeutic.

A live audio webcast of the presentation will begin at approximately 3:00 pm CT (4:00 pm ET) and be available at: View Source;s=1&k=A26C8F4F6DCBD6F8AE9F2E855714E514 or on the company’s website at www.oncolyticsbiotech.com. It is recommended that listeners log on 10 minutes in advance of the presentation to register and download any necessary software.

An audio replay will be accessible following the presentation at View Source

On June 4, 2015 Navidea Biopharmaceuticals reported that four presentations of Manocept data from Kaposi’s Sarcoma (KS) studies are scheduled at the 18th International Workshop on Kaposi’s Sarcoma Herpesvirus (KSHV) and Related Agents in Hollywood, Florida from June 30 – July 3, 2015 (Press release, Navidea Biopharmaceuticals, JUN 4, 2015, View Source;p=RssLanding&cat=news&id=2056585 [SID:1234505429]). This research highlights a very likely new approach to the origin of KS supported by preclinical and clinical imaging studies. In addition, data will be presented demonstrating the therapeutic potential for Manocept therapeutic conjugates. MT1001 is a proprietary agent designed to target cells expressing the mannose receptor (CD206) and destroy the cell and its contents. Data will be presented demonstrating MT1001’s ability to target KS and KS tumor-associated macrophages by selectively binding to CD206. Details of the presentations are listed below.

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Poster Session:

Date: July 1, 2015
Title: In Vivo Localization and Potential for Therapeutic Targeting of Kaposi’s Sarcoma (KS) With A Novel CD206 Localizing Agent
Authors: M McGratha,b*, J Zhanga, T Maurera, S Behra, B Abbruzzesec, J Sandersc, P Braccia,b, FO Copec (*Presenter)

aUniv of California-San Francisco; bAIDS & Cancer Specimen Resource, SFGH c Navidea/Macrophage Therapeutics

Poster Session:

Date: July 1, 2015

Title: Imaging and Therapeutic Potential for Kaposi’s Sarcoma (KS) In Non-Cutaneous Foci with a Novel CD206 Localizing Agent

Authors: B Abbruzzesea*, FO Copea, J Zhangb, T Maurerb, S Behrb, J Sandersa, P Braccib,c, M McGrathb,c (*Presenter)

aNavidea/Macrophage Therapeutics; bUniv of California-San Francisco; cAIDS & Cancer Specimen Resource, SFGH

Poster Session:

Date: July 1, 2015

Title: Kaposi’s Sarcoma (KS) is a Macrophage (MO) Tumor Resulting from a Fusion CD206+MOs and Lymphatic Endothelium

Authors: FO Copea*, J Zhangb, T Maurerb, B Abbruzzesea, J Sandersa, S Behrb, P Braccib,c, M McGrathb,c (*Presenter)

aNavidea/Macrophage Therapeutics; bUniv of California-San Francisco; cAIDS & Cancer Specimen Resource, SFGH

Oral Session: Translational Studies. KSHV Malignancies Associated with HIV/AIDS

Date: July 2, 2015
Title: Manocept, a Novel CD206 Targeting Agent for Potential Use in Treatment of Kaposi’s Sarcoma

Authors: Rongzhen Zhanga, Frederick O. Copeb, Joshua Walkerc, Ken Williamsc, Ekaterina Maidjia, Cheryl Stoddarta, Paige M. Braccia, Michael S. McGratha* (*Presenter)

aUniversity of California San Francisco; bNavidea/Macrophage Therapeutics; cBoston College

On June 4, 2015 OPKO HEALTH, INC. (NYSE:OPK) and Bio-Reference Laboratories, Inc. (NASDAQ:BRLI) reported that the companies have signed a definitive merger agreement under which OPKO will acquire Bio-Reference Laboratories (Press release, Opko Health, JUN 4, 2015, View Source [SID:1234506549]). Bio-Reference Laboratories is the third largest full service clinical laboratory in the United States and is known for its innovative technological solutions and pioneering leadership in the areas of genomics and genetic sequencing. Under the terms of the agreement, which has been approved by the Boards of Directors of both companies, holders of BRLI common stock will receive 2.75 shares of OPKO common stock for each share of BRLI common stock. Based on a closing price of $19.12 per share of OPKO common stock on June 3, 2015, the transaction is valued at approximately $1.47 billion, or $52.58 per share of BRLI common stock. The Companies expect the transaction to be completed during the second half of 2015. Closing of the transaction is subject to approval of Bio-Reference Laboratories’ shareholders and other customary conditions.

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OPKO intends to leverage the national marketing, sales, and distribution resources of Bio-Reference Laboratories to enhance sales of its 4Kscore test, a blood test that provides a patient’s specific personalized risk score for aggressive prostate cancer as well as other OPKO diagnostic products under development.

Through GeneDx, Bio-Reference Laboratories’ genetic sequencing laboratory, and GenPath Diagnostics, its Oncology and Women’s Health business units, Bio-Reference Laboratories has accumulated a vast array of genetic and genomics data that OPKO will make available to industry and academic scientists to enhance their drug discovery and clinical trial programs.

"I have long admired Bio-Reference Laboratories which, for almost 30 years, has enjoyed an impressive record of organic growth through constant innovation and clinical awareness," commented Phillip Frost, M.D., OPKO’s Chairman and Chief Executive Officer. "Bio-Reference Laboratories is a true success story that has culminated in cutting edge diagnostic solutions accompanied by a worldwide franchise in the diagnosis of rare diseases. GeneDx was the first commercial laboratory to offer next generation sequencing for rare disorders and almost a quarter of a million patients have benefited from these services including almost 20,000 patients who have undergone exome analysis. Their newly introduced sequencing services for use in oncology are both innovative and impressive."

"Over the years we have learned that diagnostics are integral to drug discovery," commented Marc Grodman, M.D., Bio-Reference Laboratories’ Chairman, CEO and President. "This has never been more apparent than today when new sequencing technologies have afforded us the opportunity to understand the biological basis of disease in far greater depth. At Bio-Reference Laboratories we have prided ourselves in finding disruptive diagnostic solutions that are clinically relevant. Dr. Frost is a visionary in the pharmaceutical world who, during a legendary career, has demonstrated the foresight to see new clinical applications for therapeutics before others. I am thrilled that I will be working and learning from him in the coming years as we seek to leverage our outstanding capabilities to improve lives of patients. In addition to identifying a synergistic partner for the value we have built over the past three decades, we are pleased that our shareholders will be rewarded by being able to share in the upside of the combined company."

OPKO intends to allow laboratory operations to continue seamlessly but with enhancement from OPKO’s pipeline of diagnostic products. The current diagnostic services of OPKO will be merged with the Bio-Reference Laboratories operations throughout the country. Bio-Reference Laboratories’ national presence will add valuable distribution capability to OPKO’s diagnostic services. Bio-Reference Laboratories is a full service clinical laboratory that can provide key areas of opportunity for OPKO’s services. Moreover, the seasoned management team at Bio-Reference Laboratories will bring valuable market intelligence to the combined operations.

Dr. Grodman continued, "Bio-Reference Laboratories has been a pioneer in commercial laboratory use of next generation sequencing for diagnostic purposes. GeneDx believes it was the first commercial laboratory in the world to offer next generation genetic sequencing panels based on specific clinical symptoms; it has maintained its leadership position in offering advanced panels, sophisticated analysis, in-depth reporting, and by scaling these tools to a high-volume commercial environment. Bio-Reference Laboratories has accumulated a plethora of genetic and genomics data that will be invaluable to the drug discovery programs at OPKO and other drug developers. The Bio-Reference Laboratories data is diagnostic, or disease-related, and therefore provides an important connection between disease, treatment and cure."