On September 22, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) reported it will receive payments totaling $1 million from two recently achieved Lymphoseek commercial milestones under its distribution agreements with U.S. partner Cardinal Health, Inc. (Cardinal) and European partner SpePharm AG, an affiliate of Norgine B.V. (Norgine) (Press release, Navidea Biopharmaceuticals, SEP 22, 2016, View Source;p=RssLanding&cat=news&id=2205270 [SID:SID1234515279]). Navidea will collect a $500,000 milestone payment from Cardinal based on the sale of a 100,000th patient dose of Lymphoseek (technetium Tc 99m tilmanocept) injection since launch. The Company will also receive a $500,000 payment from Norgine resulting from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion for the Lymphoseek 50 microgram kit for radiopharmaceutical preparation, a reduced-mass, single-dose vial appropriate for the radiopharmaceutical distribution model in Europe.

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"We are pleased with the meaningful progress that Navidea and its partners have made in our commercial distribution efforts in both the U.S. and Europe," said Jed Latkin, interim Chief Operating Officer and Chief Financial Officer. "These milestones reflect the growing acceptance of Lymphoseek in the U.S. for improving the outcomes in patients with melanoma, breast and oral cavity cancers and signal the expected European launch of Lymphoseek in Q42016."

Lymphoseek is approved in the U.S. by the U.S. Food and Drug Administration (FDA) for use in lymphatic mapping to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management and for guiding Sentinel Lymph Node Biopsy (SLNB) using a handheld gamma counter in patients with node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. Lymphoseek is indicated in the EU for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity.1

On September 22, 2016 Xenetic Biosciences, Inc. (OTCQB: XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company developing next-generation biologic drugs and novel orphan oncology therapeutics, reported that Scott Maguire, CEO of Xenetic Biosciences, will present at the Ladenburg Thalmann 2016 Healthcare Conference on Tuesday, September 27, 2016 at 3:30 p.m. ET in New York at the Sofitel New York (Press release, Xenetic Biosciences, SEP 22, 2016, View Source [SID1234537812]).

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During his presentation, Mr. Maguire will provide a corporate update and discuss the Company’s clinical and regulatory strategies for its product candidates currently in development in-house and with Xenetic’s biotechnology and pharmaceutical partners. The Company’s product pipeline currently includes Virexxa (sodium cridanimod), which is being evaluated for the treatment of endometrial cancer and triple negative breast cancer, ErepoXen, a polysialylated form of erythropoietin (EPO), a hormone produced by the kidneys to maintain red blood cell production and prevent anemia, and OncoHist, which is being evaluated for the treatment of acute myeloid leukemia (AML) in refractory patients and refractory non-Hodgkin lymphoma (NHL).

Mr. Maguire will also discuss Xenetic’s $100 million license deal with Shire and provide an overview of the product candidate and clinical status.

A live webcast of the presentation will be available by accessing the IR Calendar in the Investors section of the Xenetic website (www.xeneticbio.com). The webcast replay will be available approximately two hours after the presentation ends and will be accessible for 90 days.

On September 21, 2016 Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, reported its financial results for the six months ended June 30, 2016, and provided an update on its activities (Press release, NicOx, SEP 21, 2016, View Source [SID:SID1234515282]).

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"Following the recently completed transaction with GHO Capital involving our European and International commercial assets, we are now well positioned to refocus our resources on our promising R&D pipeline as we await FDA approval decisions for latanoprostene bunod and AC-170" commented Michele Garufi, Chairman and Chief Executive Officer of Nicox. "This transaction allows us to reduce our infrastructure costs by €6 million (approximately 66%) and, together with the recent financing of €18 million, to accelerate the development of our proprietary pipeline assets, including obtaining clinical proof-of-concept data for NCX 4251 and NCX 470 by the end of 2018."

Operational highlights for the six months to June 30, 2016 and post-reporting period

In August 2016, Nicox completed the transfer of its European and International commercial operations to a new pan-European ophthalmic specialty pharmaceutical company led by GHO Capital. The transaction was valued at up to €26 million and the Company received a €9 million upfront cash payment upon closing of the transaction and a minority stake in the new company.
In July 2016, Nicox completed a financing through a reserved capital increase of ordinary shares of the Company with a specific category of investors. Gross proceeds from the financing were €18 million.
On July 21, 2016, latanoprostene bunod licensee Bausch + Lomb (a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc.) announced its receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the use of latanoprostene bunod for the treatment of glaucoma. The CRL cited concerns pertaining to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb’s manufacturing facility in Tampa, Florida. The FDA’s letter did not identify any efficacy or safety concerns with respect to the latanoprostene bunod NDA or additional clinical trials needed for the approval of the NDA. Bausch + Lomb is currently working with the FDA to resolve and address the CGMP concerns. Latanoprostene bunod has the potential to generate significant revenue for Nicox through milestones (up to $132.5 million net, mainly on commercial sales targets) and royalties (potential net tiered royalties on sales from 6% to 11%).
In June, Nicox announced that the U.S. FDA had accepted the Company’s NDA for AC-170, a novel, proprietary eye drop formulation of cetirizine, targeting the treatment of ocular itching associated with allergic conjunctivitis. The FDA also granted Priority Review and assigned a Prescription Drug User Fee (PDUFA) goal date of October 18, 2016 (contingent upon the information and data provided by Nicox during the review period). Approval of the AC-170 NDA prior to December 1st, 2016 will trigger a milestone payment of $35 million in Nicox shares to former Aciex shareholders or $10 million in Nicox shares if approval of the NDA is received after this date. Nicox is currently in partnering discussions in the United States for this program.
Other Updates

• Philippe Masquida, EVP, Managing Director European & International Operations, will be leaving the company at the end of September 2016, following the successful completion of the transfer of the European and International commercial operations. Nicox sincerely thanks Philippe for his years of service and his significant contributions to the commercial business.

First-half financial summary2

The Group’s revenues have been retreated following reclassification of the European commercial business as Discontinued Operations. For information, the European and International product sales of the operations transferred to VISUfarma BV, the new Group led by GHO Capital, were €7.1 million over the first half of 2016, an increase of 50% compared to the same period in 2015.

Excluding Discontinued Operations the operating expenses for the period were €12.0 million compared to €8.8 million for the six months to June 2015. The increase in operating expenses over the period is mainly explained by costs related to the submission of the AC-170 NDA.

Excluding the Discontinued Operations, the Group recorded a net loss of €12.3 million as of June 2016, compared to a net loss of €10.1 million3 at the same date in 2015.

The Group had cash, cash equivalents and financial instruments of €12.3 million as of June 30, 2016, compared to €29 million on December 31, 2015; however, considering the financing in July of this year of €18 million gross and the €8.9 million cash payment following the transfer of the European commercial operations to VISUfarma BV, our unaudited cash, cash equivalents and financial instruments at August 31, 2016 are estimated at €34.1 million.

The half-yearly financial report will be available in French by the end of September 2016 on Nicox’s website www.nicox.com in the section Investor Information > Regulated information > Financial Information.

The procedures relating to the limited review of the interim financial statements have been carried out. The limited review report will be issued after the finalisation of the procedures required for the publication of the-first half financial report.

On September 21, 2016 CANCER RESEARCH TECHNOLOGY (CRT) – the development and commercialisation arm of Cancer Research UK – and SV Life Sciences have reported the launch of Artios Pharma, a new company formed to develop drugs targeting the DNA damage response in cancer (Press release, Cancer Research Technology, 21 21, 2016, View Source [SID1234523182]).

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Artios has licensed its two lead DNA damage response programmes from CRT and has signed a non-exclusive research collaboration agreement through which Artios will work with CRT Discovery Laboratories to progress the lead programmes, and discover and develop additional promising drug targets selected from Cancer Research UK’s portfolio of DNA damage repair research.

DNA damage response therapies target the way cancer cells repair damaged DNA. Faults in DNA repair lead to an increased risk of cancer and drive the growth of tumours. Blocking the repair mechanisms on which cancer cells rely has been shown to selectively kill them.

These DNA damage response targeted therapies have the potential to work alone or in combination with chemotherapy, radiotherapy or immunotherapy drugs.

The company’s lead programme targets the pol-theta molecule and builds on cutting-edge cell biology research from Professor Gillies McKenna’s and Dr Geoff Higgins’ laboratories at the Cancer Research UK/MRC Oxford Institute for Radiation Biology.

The pol-theta molecule is thought to control DNA repair processes in certain tumours. Knocking out the target could remove a vital path relied on by the cancer cell, causing it to die. A second highly promising programme against an undisclosed target has also been licensed to Artios.

Artios is actively building a pipeline of promising first-in-class DNA damage response therapies from leading researchers in the field. Cancer Research UK’s extensive research base will provide the foundation for CRT to provide Artios with additional new molecular targets and establish collaborative partnerships with world-class scientists in the DNA damage response field.

Under the terms of the agreements, CRT will receive research funding into its Discovery Laboratories, equity in the company, and be eligible to receive milestone payments and royalties on projects advancing through Artios’ drug pipeline.

Led by SV Life Sciences, Artios has raised series A financing of £25million ($33.2million) from Merck Ventures, Imperial Innovations, Arix Bioscience PLC, CRT Pioneer Fund (managed by Sixth Element) and AbbVie Ventures.

Dr Keith Blundy, CRT’s chief executive officer, said: "We are pleased to have worked with SV Life Sciences to bring together the Cancer Research UK academic network, a portfolio of leading DNA damage response opportunities and the CRT Discovery Laboratories’ drug discovery platform to help build a strong development pipeline for Artios. This exciting development has enabled us to leverage the expertise of the Artios management team and financing from leading venture companies to help establish a company that has the potential to bring real impact to cancer patients."

Kate Bingham, managing partner at SV Life Sciences, said: "Artios represents a unique opportunity to build a world-class DNA damage response pipeline through partnerships with leading DNA repair researchers in the UK and worldwide. We are delighted to have worked together with CRT to form this company and are pleased with the strong investor interest in Artios, reflecting the potential of DNA damage response. With the strength of their management team, Artios has the potential to disrupt the DNA damage response space and provide significant new therapies for cancer patients."

Dr Niall Martin, CEO of Artios Pharma, said: "Targeting the DNA damage response is an exciting and promising field of biology with growing interest following the recent success of PARP inhibitors. DNA damage response drug products have the potential to become established as first-line treatments, either as single agents or for use in combination with many approved therapies. It is an ideal time for Artios to be entering the field as a DNA damage response-focused, independent biotech company. We’re delighted to welcome our world-class investors to the company and to announce our first partnership with Cancer Research Technology."

On September 21, 2016 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and advancing its proprietary R&D pipeline, reported that top-line data from the Phase III SUNRISE trial of bavituximab in patients with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) will be presented as a late-breaking oral presentation at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress (Press release, Peregrine Pharmaceuticals, SEP 21, 2016, View Source [SID:SID1234515262]). Presented data will include a biomarker in the SUNRISE trial that correlated with a statistically significant improvement in overall survival for patients treated with bavituximab in combination with docetaxel compared to patients treated with docetaxel alone. Peregrine will file a new patent application directed to the use of the biomarker prior to the presentation of results at the ESMO (Free ESMO Whitepaper) 2016 Congress, which is being held October 7-11, 2016 in Copenhagen, Denmark.

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Details of the Phase III SUNRISE trial data presentation are as follows:
Presentation Number: LBA45
Presentation Title: Top-line results from SUNRISE: A Phase III Randomized Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel in Patients with Previously Treated Stage IIIb/IV Non-Squamous Non-Small Cell Lung Cancer
Date: Monday, October 10, 2016
Time: 9:15 a.m. (local time in Copenhagen)

"I want to start by thanking the patients, investigators and scientists involved in the SUNRISE trial that have made possible the continuing collection and analysis of important data from the study. While the current interim analysis is still ongoing, it is exciting to already see that a biomarker associated with positive outcomes for patients receiving the combination of bavituximab with docetaxel has been identified. In the evolving cancer therapeutic space, biomarker identification is playing an increasingly critical role in guiding clinical development strategies and trial designs," said Steven W. King, president and chief executive officer of Peregrine. "It is important to note that we are undertaking a broad biomarker analysis effort as part of the SUNRISE trial and this initial set of data is just the first of what we hope will be several findings that will help guide the bavituximab clinical program going forward. We look forward to presenting results from this ongoing analysis effort at the ESMO (Free ESMO Whitepaper) 2016 Congress, as well as other medical conferences as the additional data becomes available."

The primary goal of the biomarker analysis is to identify a biomarker profile for patients that receive the most benefit from a bavituximab-containing therapeutic regimen. As specified in the study protocol, thousands of patient samples were collected to potentially identify biomarkers associated with improved outcome for patients receiving bavituximab. Peregrine is in the process of filing a new patent application directed to the use of the initial biomarker discovery which will be presented at the ESMO (Free ESMO Whitepaper) 2016 Congress. Additional patient sample testing and analysis is ongoing and may result in other biomarkers of importance.

Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses.

Peregrine’s clinical development strategy for bavituximab is currently focused on small, early-stage proof-of-concept trials evaluating the drug in combination with other cancer treatments. The intent behind this strategy is to control research and development costs, while continuing to generate clinical data to further validate bavituximab’s combination potential that will be critical to bringing onboard a partner to help advance the program.