On December 19, 2017 Aviragen Therapeutics Inc. and Vaxart, Inc. presented Investor Presentation (Presentation, Nabi Biopharmaceuticals, DEC 19, 2017, View Source [SID1234522710]).

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On December 19, 2017 Array BioPharma (Nasdaq: ARRY) reported that it has entered into a clinical trial collaboration agreement with Pfizer to investigate the safety and efficacy of several novel anti-cancer combinations, including Array’s MEK inhibitor, binimetinib, with Pfizer’s investigational PARP inhibitor talazoparib, and avelumab*, a human anti-PD-L1 IgG1 monoclonal antibody (Press release, Array BioPharma, DEC 19, 2017, View Source;p=RssLanding&cat=news&id=2323331 [SID1234522694]).

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The companies are entering into this collaboration to explore the potential benefits of combining molecularly targeted therapeutics with the body’s innate cancer-fighting abilities using immunotherapy.

"Array is excited to announce this partnership with Pfizer, an established global leader in Oncology therapeutics," said Ron Squarer, Chief Executive Officer, Array BioPharma. "These novel approaches combining targeted therapy and immunotherapy hold great potential to help patients fighting cancer in different indications, with an initial main focus on lung and pancreatic cancer."

"Preclinical data indicate that combining binimetinib with an immune checkpoint inhibitor and talazoparib could be a rational combination to test in the clinic," said Chris Boshoff, M.D., Ph.D., Senior Vice President and Head of Immuno-Oncology, Early Development and Translational Oncology, Pfizer Global Product Development. "We are looking forward to initiating the clinical studies with Array BioPharma to explore anti-tumor activity across various novel combination strategies, including both doublet and triplet approaches."

Under the terms of the agreement, Array and Pfizer will collaborate on a Phase 1b clinical trial to explore a series of novel combinations, investigating the safety and efficacy of the combination of binimetinib, avelumab and talazoparib across various tumor types. A multi-arm clinical trial is expected to establish recommended doses of different regimens combining the drugs. Initially the focus will be in non-small cell lung cancer (NSCLC) and pancreatic cancer, and additional indications will be explored at a later stage. The study is expected to begin by the third quarter of 2018, and results will be used to determine optimal approaches to further clinical development of these combinations.

Under the collaboration agreement, the trial will be sponsored and funded by Pfizer, with Array providing binimetinib supply.

*Avelumab is jointly developed by Merck KGaA, Darmstadt, Germany and Pfizer. Avelumab is under clinical investigation for treatment of NSCLC and pancreatic cancer and has not been demonstrated to be safe and effective for these indications. There is no guarantee that avelumab will be approved for these indications by any health authority worldwide.

About Binimetinib
MEK is a key protein kinase in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as melanoma, colorectal and thyroid cancers. Binimetinib is a late-stage, small molecule MEK inhibitor which targets key enzymes in this pathway. Binimetinib is an investigational medicine and is not currently approved in any country.

Binimetinib is being studied in clinical trials in advanced cancer patients, including the Phase 3 COLUMBUS trial in patients with BRAF-mutant melanoma and the Phase 3 BEACON CRC trial in patients with BRAF V600E-mutant colorectal cancer.

About Avelumab
Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models. Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

Avelumab is currently being evaluated in the JAVELIN clinical development program, which involves at least 30 clinical programs, including nine Phase III trials, and more than 7,000 patients across more than 15 different tumor types, including gastric/gastroesophageal junction, non-small cell lung cancer, renal cell carcinoma and ovarian cancer. For a comprehensive list of all avelumab trials, please visit clinicaltrials.gov.

Indications in the US
The FDA granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Safety Information from the US FDA Approved Label
The warnings and precautions for BAVENCIO include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions), infusion-related reactions and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO for mMCC and patients with locally advanced or metastatic UC include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.

For full prescribing information and medication guide for BAVENCIO, please see www.BAVENCIO.com.

About Talazoparib
Talazoparib is an investigational anti-cancer compound called a PARP (poly ADP ribose polymerase) inhibitor. Preclinical studies suggest that talazoparib is highly potent and has a dual mechanism of action, with the potential to induce tumor cell death by blocking PARP enzyme activity and trapping PARP on the sites of DNA damage. Talazoparib is currently being evaluated in advanced germline (inherited) BRCA+ breast cancer as well as other cancer types with deficiencies in DNA damage repair (DDR). Talazoparib has not been approved by any regulatory authorities for the treatment of any disease.

On December 19, 2017 Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that it will be presenting at the Biotech Showcase in San Francisco, CA being held on January 8-10, 2018 (Press release, Navidea Biopharmaceuticals, DEC 19, 2017, View Source [SID1234522712]). Dr. Michael Goldberg, Chief Executive Officer of Navidea, will be giving a presentation and meeting with investors.

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Event: Biotech Showcase
Presentation Date: Monday, January 8, 2018
Presentation Time: 10:00 am PT
Location: Hilton San Francisco Union Square, San Francisco, CA

For investors attending the Biotech Showcase, please contact Navidea Investor Relations to schedule a meeting with management at [email protected].

The presentation will be webcast live and remain available for 90 days following the presentation. To access the webcast, please visit the Investors presentations tab of the Investors section of the Navidea website at www.navidea.com.

On December 19, 2017 Medtronic plc (NYSE: MDT) reported that Bob White, previously Senior Vice President and President of Medtronic’s Asia Pacific (APAC) Region, has been named Executive Vice President and President of Medtronic’s Minimally Invasive Therapies Group (MITG) (Press release, Medtronic, DEC 19, 2017, View Source;p=RssLanding&cat=news&id=2323341 [SID1234522698]). In addition, the company announced that Chris Lee, Senior Vice President and President of Medtronic’s Greater China Region, will assume the position of APAC Region President. Lee will remain the Interim President of the Greater China Region until a permanent successor is named in the coming weeks. These leadership changes are effective immediately.

The leadership changes are a result of Bryan Hanson’s departure to become President and CEO of another public, medical technology company, effective today. Hanson was the former Executive Vice President of MITG.

"We are pleased to name Bob White and Chris Lee to these new leadership assignments. Their extensive knowledge and expertise of the Medtronic businesses and regions involved – as well as their demonstrated track records of success – will ensure continuity to our overall business strategies and objectives," said Omar Ishrak, Chairman and CEO of Medtronic. "Bob is uniquely qualified to take on the MITG role given his prior leadership experience in the former Covidien company and his most recent role as President of our APAC region, where he was responsible for advancing MITG and our three other groups in the region. Chris has strong experience across Asia Pacific, having previously led the operations of several leading pharmaceutical companies in the region. Both Bob and Chris have strong records of delivering results, and I look forward to working with them in their new roles."

"We thank Bryan for his contributions to Medtronic through the Covidien acquisition, its integration into Medtronic and to its current, solid performance as the Minimally Invasive Therapies Group," added Ishrak. "We wish him and his family well with his new endeavor."

Bob White joined Medtronic upon the close of the Covidien acquisition by Medtronic in 2015 as President for the APAC Region, based in Singapore. In this role, White was responsible for the commercial growth of Medtronic’s business in the region, including leadership for Medtronic’s four main product and therapy groups, regional business development efforts, government and partner development strategies, talent development and retention, and the operations of the company’s enabling functions. Under White’s leadership, the region has grown its revenue from $2.1 billion in fiscal year 2015 to $3.4 billion in fiscal year 2017.

White’s previous leadership positions with Covidien included serving as President of the Respiratory and Monitoring business and President of Emerging Markets. Prior to his time at Covidien, White held various leadership positions with General Electric and IBM.

Chris Lee joined Medtronic from Bayer HealthCare in 2012 and has served as the President of the Greater China Region, based in Shanghai, since that time. Medtronic’s Greater China Region includes China, Hong Kong, and Taiwan. Lee is responsible for all Medtronic commercial operations in the region, talent development and retention, and has served as the principal liaison with the Chinese government. Under Lee’s leadership, the region has maintained double digit revenue growth, having grown its revenue from $0.6 billion in fiscal year 2012 to $1.6 billion in fiscal year 2017.

Prior to joining Medtronic, Lee worked for Bayer HealthCare, where he led their Asia Pacific region, based in Singapore, and their Greater China Region, based in Beijing. In previous assignments, Lee led operations for Korea, Vietnam, Japan, Australia and New Zealand and other sub-regions in Asia Pacific for both Bayer and Bristol Meyers Squibb.

About the Medtronic Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group is organized into the Surgical Innovations and the Respiratory, Gastrointestinal & Renal divisions. The Group had revenues of $9.9 billion in fiscal year 2017.

On December 19, 2017 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that the European Union’s (EU) European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has requested that the Scientific Advisory Group (SAG) on Oncology provide an opinion on aspects of the ongoing Marketing Authorization Application (MAA) relating to a potential conditional approval for rucaparib (Press release, Clovis Oncology, DEC 19, 2017, View Source;p=RssLanding&cat=news&id=2323324 [SID1234522703]). The exact date for the SAG meeting has not yet been set but we expect it to take place in early February 2018.

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The SAG on Oncology is convened at the request of the EMA to provide independent recommendations on scientific or technical matters related to pediatric and adult clinical oncology and hematology, or on any other scientific issue relevant to the work of the Agency that relates to this area.

"We continue to have as our priority the submission and potential approval for the maintenance treatment indication in advanced ovarian cancer in the EU," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We anticipate that initiating the process to submit a new MAA for maintenance next month is the quickest path to provide the potential benefit of rucaparib to more women in the EU with advanced disease. Of course, if we receive an approval for the treatment indication in the second quarter, and we file a variation to the treatment MAA, we anticipate the potential maintenance approval would be swifter."

The CHMP application for the treatment indication currently under review was submitted during the fourth quarter of 2016 and was based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA-mutant ovarian cancer who had progressed after two or more prior chemotherapies. All 106 patients received rucaparib orally 600 mg twice daily as monotherapy until disease progression or unacceptable toxicity. Objective response rate (ORR) and duration of response (DOR) were assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The most common Grade 3/4 adverse event was anemia.

Both the variation to the MAA or a new MAA submission will be based on data from the phase 3 ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied. ARIEL3 is a double-blind, placebo-controlled trial of rucaparib that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer. The primary efficacy analysis evaluated three prospectively defined molecular sub-groups in a step-down manner: 1) BRCA mutant; 2) HRD-positive; and finally, 3) the intent-to-treat population, or all patients treated in ARIEL3. Both the variation to the MAA or the new MAA filing will be directed at the broader intent-to-treat or "all comers" population.

Clovis announced positive topline results from the ARIEL3 clinical trial in June 2017. The comprehensive dataset from the trial was presented at the 2017 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Conference in Madrid, Spain,i and subsequently published in The Lancet.ii

About Rucaparib

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. In December 2017, the US Food and Drug Administration (FDA) accepted the Company’s supplemental New Drug Application (sNDA) for rucaparib for a second-line or later maintenance treatment indication in ovarian cancer based on the ARIEL3 data. The FDA granted Priority Review status to the application with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018. In December 2017, the CHMP referred the rucaparib MAA for the ovarian cancer treatment indication to the SAG on Oncology for review. The SAG meeting to discuss the rucaparib MAA is anticipated in February 2018. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for rucaparib.