On May 30, 2018 Nordic Nanovector ASA (OSE: NANO) reported its results for the first quarter 2018 (Press release, Nordic Nanovector, MAY 30, 2018, View Source [SID1234553502]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CET, see details below.

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Tone Kvåle, CFO and Interim CEO, commented: "We have been focusing our efforts, since the beginning of the year, on getting PARADIGME approved and started. While our progress with the start-up of this pivotal study has been encouraging, we saw reason in April to announce adjustments to the timelines for its duration and are now targeting the first data read-out from the study in the first half of 2020.

"We remain convinced of the significant potential of Betalutin based on the promising clinical data generated to-date. We also believe that PARADIGME provides a robust trial design to generate the data needed to support our regulatory and commercialisation strategy for Betalutin to become an important new treatment option for 3L FL patients."

Operational Highlights Q1’18

• Start-up activities ongoing for pivotal Phase 2b PARADIGME trial investigating Betalutin as a potential new treatment for patients with third-line relapsed/refractory follicular lymphoma (3L R/R FL)

o As at May 29th, 23 sites in 8 countries are open for enrolment

• Malene Brondberg appointed as Vice President, IR and Corporate Communications

Events after Q1’18

• Luigi Costa stepped down as CEO

o Tone Kvåle appointed as Interim CEO in addition to existing role as CFO

o Search for new CEO underway

• PARADIGME timelines revised with first results targeted for 1H 2020 (previously 2H 2019)

o Start-up activities and site initiations progressing

• Clinical development of Humalutin postponed for the foreseeable future as resources are re-focused on PARADIGME and the Betalutin development programme

Financial Highlights Q1 ‘18

(Figures in brackets = same period 2017 unless otherwise stated)

• Revenues in the first quarter 2018 amounted to NOK 0 (NOK 0.1 million).

• Total operating expenses for the quarter were NOK 82.3 million (NOK 65.8 million).

o Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 76.2 % of total operating expenses in the first quarter 2018 (72.2 %).

• Operating loss for the quarter was NOK 82.3 million (loss of NOK 65.7 million).

• Comprehensive loss for the quarter was NOK 90.7 million (loss of NOK 55.8 million).

• Cash and cash equivalents as at 31 March 2018 amounted to NOK 641.5 million, down from NOK 756.6 million at the end of 31 December 2017.

Outlook

Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Betalutin, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile for R/R FL, based on the promising results from the LYMRIT 37-01 Phase 1/2a clinical study. The company’s pivotal Phase 2b PARADIGME trial with Betalutin in 3L R/R FL is underway with initial data read-outs from the study targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.

Nordic Nanovector intends to maximize the value of Betalutin across other stages of FL, NHL and other haematological cancer indications.

The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Current cash resources are expected to be sufficient to reach data read-out from PARADIGME in 1H 2020.

Presentation and webcast – First quarter 2018 results and webcast

A presentation by Nordic Nanovector’s senior management team will take place at 8:30 am CEST on 30 May at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: NYLAND

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2018 from 7:00 am CEST the same day.

Results presentation in Norwegian

As announced in April, a separate presentation of the results in Norwegian, to be hosted by Nordic Nanovector’s CFO and Interim CEO, and its VP IR & Corporate Communications, will take place on Thursday, 31 May 2018 at 8:30 am CEST at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: VIPPETANGEN

To attend the meeting please email – [email protected]

The presentation will NOT be recorded as a webcast

On May 30, 2018 In a few days’ time, the ASCO (Free ASCO Whitepaper) Annual Meeting will take place in Chicago, USA (1-5 June 2018) (Press release, EORTC, MAY 30, 2018, View Source [SID1234526948]).

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"This year’s theme "Delivering discoveries: expanding the reach of precision medicine" focuses on making precision medicine a reality by driving progress and expanding its reach so that every patient can have the opportunity to benefit," Dr. Bruce Johnson, ASCO (Free ASCO Whitepaper) President.

EORTC reported it will present the results of several studies:

Oral presentations
Fifteen-year results of the randomised EORTC trial 22922/10925 investigating internal mammary and medial supraclavicular (IM-MS) lymph node irradiation in stage I-III breast cancer. (Abstract 504)
Oral Abstract Session: Breast Cancer – Local/Regional/Adjuvant

Time: Monday, June 4, 2018, 8:00 AM – 11:00 AM

Authors: Philip Poortmans, Sandra Collette, Henk Struikmans, Karin De Winter, Erik Van Limbergen, Carine Kirkove, Volker Budach, Karine Peignaux-Casasnovas, Ernest Vonk, Desiree van den Bongard, Sofia Rivera, Daniel Zips, Geertjan Van Tienhoven, Matthias Guckenberger, Roxolyana Abdah-Bortnyak, Alain Fourquet, Harry G. M. Bartelink

Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine +/- oxaliplatin in locally advanced rectal cancer: Final results of PETACC-6. (Abstract 3500)
Oral abstract Session: Gastrointestinal Cancer

Time: Tuesday, June 5, 2018, 9:45 AM – 12:45 PM

Authors: Hans-Joachim Schmoll, Karin Haustermans, Timothy Jay Price, Bernard Nordlinger, Ralf Hofheinz, Jean-Francois Daisne, Jaak Janssens, Baruch Brenner, Peter Schmidt, Hans Reinel, Stephan Hollerbach, Karel Caca, Florian W.B. Fauth, Carla Hannig, John Raymond Zalcberg, Niall C. Tebbutt, Murielle E. Mauer, Sandrine Marreaud, Manfred P. Lutz, Eric Van Cutsem

Poster presentations
Activity and safety of crizotinib in patients with advanced, metastatic alveolar soft part sarcoma (ASPS) with rearrangement of TFE3: European Organization for Research and Treatment of Cancer (EORTC) phase 2 trial 90101 CREATE. (Abstract 11540)
Poster Session: Sarcoma

Time: Saturday, June 2, 2018 – 8:00 – 11:30 AM

Authors: Patrick Schöffski, Agnieszka Wozniak, Bernd Kasper, Steinar Aamdal, Michael Gordon Leahy, Piotr Rutkowski, Sebastian Bauer, Hans Gelderblom, Antoine Italiano, Lars H Lindner, Ivo M. Hennig, Sandra J. Strauss, Branko Zakotnik, Alan Anthoney, Birgit Geoerger, Jean-Yves Blay, Peter Reichardt, Winette TA van der Graaf, Sandrine Marreaud, Silvia Stacchiotti

Doxorubicin plus dacarbazine (DoDa), doxorubicin plus ifosfamide (DI) or doxorubicin alone (Do) as first line treatment for advanced leiomyosarcoma (LMS): A retrospective study from the EORTC Soft Tissue and Bone Sarcoma Group (STBSG). (Abstract 11574)
Poster Session: Sarcoma

Time: Saturday, June 2, 2018 – 8:00 – 11:30 AM

Authors: Lorenzo D’Ambrosio, Nathan Touati, Jean-Yves Blay, Giovanni Grignani, Ronan Flippot, Anna Malgorzata Czarnecka, Sophie Piperno-Neumann, Javier Martin Broto, Roberta Sanfilippo, Daniela Katz, Florence Duffaud, Bruno Vincenzi, Bernd Kasper, Daniel P. Stark, Filomena Mazzeo, Armin Tuchscherer, Saskia Litiere, Ward Sents, Hans Gelderblom, Alessandro Gronchi, on behalf of the EORTC STBSG

BEST OF: A phase III study assessing the best of radiotherapy (Intensity Modulated RadioTherapy, IMRT) compared to the best of surgery (Trans-Oral Surgery, TOS) in patients with T1-T2, N0 oropharyngeal squamous cell carcinoma (OPSCC). (Abstract TPS6098)
Poster Session: Head and Neck Cancer

Time: Saturday, June 2, 2018, 1:15 – 4:45 PM

Authors: Christian Simon, Carmela Aves Caballero, Catherine Fortpied, Mererid Evans, Petri Koivunen, Jean-Jacques Stelmes, Maria Urbanowicz, Jean Bourhis, Frank Zimmermann, Jens Peter Klussmann, Andreas Dietz, Giuseppe Spriano, C. Rene Leemans, Susanne Singer, Inge Tinhofer, Joanne Patterson, Silvana Quaglini, Keith Hunter, Vincent Gregoire

Hope for salivary gland cancer (SGC): EORTC HNCG/UKCRN 1206 randomized phase II study to evaluate the efficacy and safety of chemotherapy (CT) vs androgen deprivation therapy (ADT) inpatients with recurrent and/or metastatic androgen receptor (AR) expressing SGC (NCT01969578). (Abstract TPS6099)
Poster Session: Head and Neck Cancer

Time: Saturday, June 2, 2018, 1:15 – 4:45 PM

Authors: Laura Locati, Carmela Aves Caballero, Catherine Fortpied, Federica Perrone, Pasquale Quattrone, Kevin Harrington, Vincent Gregoire, Lisa F. Licitra

EORTC 1559-HNCG: A pilot study of personalized biomarker-based treatment strategy or immunotherapy in patients with recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN)—"UPSTREAM". (Abstract TPS6095)
Poster Session: Head and Neck Cancer

Time: Saturday, June 2, 2018, 1:15 – 4:45 PM

Authors: Rachel Galot, Lisa F. Licitra, Christophe Le Tourneau, Joel Guigay, Inge Tinhofer, Anthony Hee Kong, Carmela Aves Caballero, Catherine Fortpied, Anne-Sophie Govaerts, Dominiek Staelens, Tiana Raveloarivahy, Jean-Francois Laes, Jean-Luc Re Canon, Stéphanie Henry, Esma Saada-Bouzid, Jean-Pascal H. Machiels

Updated results of the INTELLANCE 2/EORTC trial 1410 randomized phase II study on Depatux –M alone, Depatux-M in combination with temozolomide (TMZ) and either TMZ or lomustine (LOM) in recurrent EGFR amplified glioblastoma (NCT02343406). (Abstract 2023)
Poster Session: Central Nervous, System Tumors

Time: Saturday, June 2, 2018, 1:15 PM – 4:45 PM

Authors: Martin J. Van Den Bent, Pim French, Marica Eoli, Juan M. Sepúlveda, Anna Maria Elisabeth Walenkamp, Jean-Sebastien Frenel, Enrico Franceschi, Paul M. Clement, Michael Weller, Iris de Heer, Jim Looman, Jyotirmoy Dey, Scott Krause, Hao Xiong, Peter J Ansell, Sarah Nuyens, Maarten Spruyt, Joana Brilhante, Thierry Gorlia, Vassilis Golfinopoulos

A randomized doubled blind phase II study exploring the safety and efficacy of nintedanib (BIBF1120) as second line therapy for patients (pts) with differentiated thyroid carcinoma (DTC) progressing after first line therapy: EORTC 1209. (Abstract 6021)
Poster Discussion Session: Head and Neck Cancer

Time: Saturday, June 2, 2018, 4:45 – 6 PM

Authors: Martin Schlumberger, Kate Newbold, Baktiar Hasan, Sandrine Marreaud, Samson Assele, Lisa F. Licitra, Patrick Schoffski, Sophie Leboulleux, Laura Locati, Yann Godbert, Vincent Rohmer, Barbara Jarzab, Salvatore Domenico, Oliver Edgar Bechter, Sylvie Zanetta, Jaume Capdevila, Ellen Kapiteijn, Lars Bastholt

EORTC-ESSO 1409 GITCG: A prospective colorectal liver metastasis database with an integrated quality assurance program (CLIMB). (Abstract 3558)
Poster Session: Gastrointestinal Cancer

Time: Sunday, June 3, 2018, 8:00 – 11:30 AM

Authors: Carmela Aves Caballero, Lucia Carrion Alvarez, Henrik Nilsson, Theo Ruers, Perrine Senellart, Michel Rivoire, Stefan Stattner, Florian Primavesi, Roberto Troisi, Thomas Gruenberger, Jan Heil, Andreas Schnitzbauer, Nuh N. Rahbari, Rutger-Jan Swijnenburg, Hassan Zakria Malik, Mladjan Protic, Anouk Neven, Murielle E. Mauer, Graeme John Poston, Serge Evrard

On May 30, 2018 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported its Chief Executive Officer, Jeff Wolf, will present a corporate overview at the 2018 BIO International Convention on Wednesday, June 6th, at 2:45 PM, Eastern Time, held at the Boston Convention and Exhibition Center in Boston, MA (Press release, Heat Biologics, MAY 30, 2018, View Source [SID1234526967]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The BIO International Convention allows for public and private companies to provide formal presentations, request face-to-face meetings with biotech investors and executives, attend educational sessions and engage in networking opportunities. For more information, please visit: View Source

On May 30, 2018 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep
understanding of the human immune response, reported that John A. Orwin, President and Chief Executive Officer, will present at the Jefferies 2018 Global Healthcare Conference on Wednesday, June 6, 2017 at 2:30 p.m. Eastern Time in New York, NY. Mr. Orwin will provide an overview of Atreca’s technologies, programs and progress (Press release, Atreca, MAY 30, 2018, View Source [SID1234526987]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On May 30, 2018 AzurRx BioPharma, Inc. (NASDAQ:AZRX) ("AzurRx" or the "Company"), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, reported the appointment of Dr. James Pennington as the Company’s Chief Medical Officer (Press release, AzurRx BioPharma, MAY 30, 2018, View Source [SID1234526949]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are delighted to welcome Jim to the senior management team as we rapidly advance our clinical programs," commented Thijs Spoor, CEO of AzurRx BioPharma. "Jim is a highly accomplished pharmaceutical industry executive with extensive medical and clinical experience, as well as hands-on experience in regulatory affairs. His appointment is timely as 2018 is shaping up to be a pivotal year for AzurRx, with a number of upcoming and potentially value enhancing milestones including the initiation of the MS1819 Phase 2 study in cystic fibrosis patients and the filing of the investigational drug application ("IND") in the U.S. for MS1819. We look forward to Jim’s leadership and contributions as these programs move forward."

"I am excited to join the AzurRx team at this exciting time for the Company," said Dr. Pennington. "We look forward to initiating a cystic fibrosis study later this year. MS1819, which has generated promising interim results in the ongoing study in chronic pancreatitis patients, addresses a billion-dollar market in exocrine pancreatic insufficiency. It has the potential to become best in class due to the high pill burden, patient compliance issues, and manufacturing/supply chain challenges of the current animal-derived therapies."

Dr. Pennington brings over 30 years of experience in the pharmaceutical industry. He served as Vice President at Bayer Corporation where, under his direct supervision, Bayer received ten product approvals from the U.S. Food & Drug Administration ("FDA") and ten product approvals from foreign regulatory authorities. Dr. Pennington also held senior positions at multiple therapeutics companies, including CMO roles at Anthera Pharmaceuticals and CoTherix Inc. and Senior VP of Research, Development and Clinical Affairs at Alpha Therapeutics Corp. Dr. Pennington has participated in many FDA pre-IND meetings and has also participated in several FDA Advisory Panel meetings. He has served on various editorial boards as well as professional societies, such as the American Association of the Advancement of Science. He is involved in academia and is currently Clinical Professor of Medicine at the University of California in San Francisco. Dr. Pennington holds a B.A. from the University of Oregon and an M.D. from the University of Oregon Medical School and is Board Certified in internal medicine and infectious diseases.