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Nicox first half 2016 business and financial update

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.

Epizyme Establishes Collaboration with Foundation Medicine to Support Tazemetostat Phase 2 Clinical Trial

On September 21, 2016 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapeutics, reported that the Company has entered into a collaboration agreement with Foundation Medicine, Inc. to support patient identification and enrollment for Epizyme’s ongoing Phase 2 clinical trial of tazemetostat in patients with non-Hodgkin lymphoma (NHL) (Press release, Epizyme, SEP 21, 2016, View Source [SID:SID1234515264]). Foundation Medicine’s SmartTrials Precision Enrollment Program and FoundationOne Heme panel will assist in identifying a population of individuals with NHL who harbor EZH2 mutations and constitute specific cohorts in the Epizyme trial.

Tazemetostat is Epizyme’s oral, first-in-class EZH2 inhibitor being investigated in multiple ongoing clinical trials. Early clinical data suggest tazemetostat has encouraging clinical activity and a favorable safety profile in patients with relapsed and refractory NHL.

"This agreement exemplifies our commitment to execute enrollment in our ongoing Phase 2 NHL study, particularly patients with EZH2 mutations," said Robert Bazemore, president and chief executive officer of Epizyme. "We are pleased to partner with Foundation Medicine, an industry leader and innovator in molecular information and comprehensive genomic profiling, to advance our tazemetostat clinical program and accelerate identification of patients who may benefit from this therapy."

FoundationOne Heme is Foundation Medicine’s validated, comprehensive genomic profiling assay, specifically designed for hematological malignancies and sarcomas, which identifies the unique genomic alterations in an individual’s cancer and matches the findings with relevant targeted therapy and clinical trial treatment options for patients. Through this collaboration, Foundation Medicine’s SmartTrials Precision Enrollment program will identify individuals across the U.S. living with NHL who harbor EZH2 mutations as detected by FoundationOne Heme in the course of routine clinical care. The treating physicians of these identified patients will be contacted and informed of Epizyme’s ongoing Phase 2 study of tazemetostat, including relevant details about the trial, to assist the physician in evaluating tazemetostat as a potential treatment option.

About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing Phase 2 programs in patients with NHL. It is also being studied in adult and pediatric patients with certain genetically defined solid tumors, including INI1-negative and SMARCA4-negative tumors and synovial sarcoma, and in patients with mesothelioma.

The company plans to initiate additional clinical trials of tazemetostat in 2016, including a combination with R-CHOP in collaboration with the Lymphoma Study Association and a combination with Tecentriq (atezolizumab) in collaboration with Genentech, a member of the Roche Group.

About SmartTrials Precision Enrollment Program and FoundationOne Heme
Foundation Medicine’s SmartTrials Precision Enrollment program leverages the company’s unique combination of broad collaborations with biopharma, industry-leading clinical assays and the FoundationCORE genomic knowledgebase with more than 90,000 real-world genomic profiles to overcome the major roadblocks to today’s clinical trial system, namely patient identification and access to trials.

FoundationOne Heme, an integrated DNA/RNA platform using targeted hybrid-capture next-generation sequencing, is a comprehensive genomic profile developed to detect genomic alterations with therapeutic relevance, including single-nucleotide substitutions, insertions and deletions, copy number alterations and rearrangements, which are not fully evaluated using conventional diagnostic assays. FoundationOne Heme simultaneously detects all classes of genomic alterations in the DNA of 405 cancer-related genes and employs RNA sequencing across 265 genes to capture a broad range of gene fusions, a type of alteration that is a common driver of hematologic cancers. It is designed to provide physicians with clinically actionable information to guide treatment options for patients based on the genomic profile of their cancer.

Peregrine Pharmaceuticals Provides Update on Oral Presentation of Top-Line Data from Phase III SUNRISE Trial of Bavituximab at European Society for Medical Oncology (ESMO) 2016 Congress

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.

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.

CRT and SV life sciences form Artios Pharma to focus on DNA damage response

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]).

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."

Eleven Biotherapeutics Acquires Viventia Bio to Create Targeted Protein Therapeutics Oncology Company

On September 21, 2016 Eleven Biotherapeutics, Inc. (NASDAQ: EBIO) and Viventia Bio Inc., reported that the two companies and the shareholders of Viventia entered into a definitive share purchase agreement under which Eleven Biotherapeutics agreed to, and simultaneously completed, the acquisition of Viventia (Press release, Eleven Biotherapeutics, SEP 21, 2016, View Source [SID:SID1234515276]). Under the agreement, Eleven purchased all of the outstanding capital stock of Viventia in exchange for the issuance of 4,013,431 newly issued shares of Eleven common stock, which represented approximately 19.9% of the voting power of Eleven as of immediately prior to the issuance of such shares, and the agreement by Eleven to pay to the selling shareholders certain post-closing contingent cash payments upon the achievement of specified milestones and based upon net sales related to Viventia’s lead product candidate, Vicinium.

The acquisition creates a NASDAQ-listed company focused on the development of novel therapies based upon antibody fragments genetically fused to cytotoxic proteins, or targeted protein therapeutics (TPTs), as new treatments in areas of oncology with significant unmet need. The combined company will continue to be named Eleven Biotherapeutics, and Stephen Hurly, formerly Viventia’s chief executive officer, was appointed President and Chief Executive Officer of Eleven in connection with the acquisition. Abbie C. Celniker, Eleven’s former President and Chief Executive Officer, will remain a director of Eleven Biotherapeutics.

Eleven’s pipeline now includes Viventia’s lead product candidates Vicinium and Proxinium. Vicinium is in a Phase 3 clinical trial for high grade non-muscle invasive bladder cancer (NMIBC), with topline data expected in the first half of 2018. To date, Vicinium has been evaluated in more than 100 patients. In a Phase 2 clinical trial, Vicinium demonstrated a complete response rate of 40% at three months with no drug-related serious adverse events observed in the trial.

Proxinium is expected to enter Phase 2 development in early 2017 for the treatment of late-stage squamous cell carcinoma of the head and neck. In previous clinical trials, Proxinium was generally safe and well-tolerated and showed signs of anti-tumor activity. Proxinium has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and Fast Track designation from the FDA. Both product candidates are anti-EpCAM (epithelial cell adhesion molecule) fusion proteins that have been optimized for local tumor administration.

Eleven’s pipeline now also includes Viventia’s earlier stage pipeline of next generation TPT candidates that are designed and optimized for systemic administration for the potential treatment of a broader spectrum of cancer types.

"We are excited to join with Eleven to create a company with extensive experience in engineering and developing novel protein therapeutics for local delivery that we believe may maximize efficacy and reduce toxicity. Our TPTs combine specific tumor targeting with a protein based tumor killing payload, and will be developed to serve cancer patients in areas of high unmet need. Together we have a strong Board of Directors, management team, product pipeline and technology platform, and the capital needed to support the Company’s development plans into 2018," said Stephen Hurly, Chief Executive Officer of Eleven Biotherapeutics.

"As previously announced, Eleven performed an extensive review of our strategic alternatives, and our Board of Directors believes that the acquisition of Viventia offers Eleven shareholders a compelling opportunity for enhancing long-term value," said Abbie Celniker, Ph.D., former President and Chief Executive Officer of Eleven Biotherapeutics and current member of Eleven’s Board of Directors. "Our combined company will continue to support Roche as they develop EBI-031, and will benefit from the capital contributed by this partnership, which provides the necessary funding to enable further development of Vicinium and Proxinium."

About Targeted Protein Therapeutics (TPTs)

Viventia’s drug development is currently focused on locally administered targeted protein therapeutics (TPTs) for the treatment of cancer. Viventia’s TPTs are expressed as a single fusion protein with a differentiated payload mechanism, eliminating the need for payload conjugation and multi-step manufacturing. We believe TPTs have a dual action of both directly killing the cancer cell and enhancing the local immune response.

License Agreement with Roche

On August 16, 2016, Eleven announced the effectiveness of its exclusive license agreement with F. Hoffman-La Roche Ltd. and Hoffman-La Roche Inc. (Roche) for Eleven’s IL-6 antagonist antibody technology, including EBI-031. Eleven granted Roche an exclusive, worldwide license to develop and commercialize EBI-031 and all other IL-6 antagonist antibody technology owned by Eleven. Eleven has received $30 million in payments from Roche, including a $7.5 million upfront payment in connection with the effectiveness of the license agreement, and a $22.5 million milestone payment based on the Investigational New Drug (IND) application for EBI-031 becoming effective. Under the terms of the agreement, Eleven could receive up to an additional $240 million upon the achievement of certain future regulatory, development and commercialization milestones. In addition, Eleven could be entitled to receive royalties based on net sales of potential future products containing EBI-031 or any other potential future products containing other Eleven IL-6 compounds.

Viventia Acquisition Details

Under the share purchase agreement, Eleven purchased all of the outstanding capital stock of Viventia in exchange for the issuance of 4,031,431 newly issued shares of Eleven common stock, which represented approximately 19.9% of the voting power of Eleven as of immediately prior to the issuance of such shares, and the agreement by Eleven to pay to the selling shareholders certain post-closing contingent cash payments upon the achievement of specified milestones and based upon net sales related to Viventia’s lead product candidate, Vicinium.

The acquisition was approved by the boards of directors of both companies.

Stifel, Nicolaus & Company, Incorporated acted as financial advisor and Wilmer Cutler Pickering Hale and Dorr LLP is acting as legal advisor to Eleven. Hogan Lovells US LLP acted as legal counsel to Viventia.

Management and Organization

In connection with the acquisition, Eleven’s Board of Directors elected Stephen Hurly and Leslie L. Dan, Viventia’s former Executive Chairman and largest beneficial owner prior to the acquisition, to serve as members of Eleven’s Board of Directors, and Cary G. Pfeffer, M.D., resigned from the Eleven’s Board of Directors. Stephen Hurly will serve as President and Chief Executive Officer of Eleven. Also in connection with the acquisition, Arthur P. DeCillis, M.D., Viventia’s Chief Medical Officer, was appointed as Chief Medical Officer of Eleven, and Karen L. Turbidy, Eleven’s Chief Development Officer, resigned from Eleven. In addition, Gregory Adams Ph.D., Chief Development Officer and Glen MacDonald, Ph.D., Chief Scientific Officer, will join Eleven’s management team from Viventia. John McCabe, will continue to serve as Chief Financial Officer of Eleven. Abbie C. Celniker, former President and Chief Executive Officer of Eleven, will remain a member of Eleven’s Board of Directors. Following the acquisition, an entity affiliated with Leslie L. Dan became the second largest shareholder of Eleven.