On August 22, 2018 Nordic Nanovector ASA (OSE: NANO) reported its second quarter and first half 2018 results (Press release, Nordic Nanovector, AUG 22, 2018, View Source [SID1234553495]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CEST, see details below.

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Eduardo Bravo, CEO, commented: "I am pleased to report a quarter marked by important progress in the development of lead candidate Betalutin in follicular lymphoma (FL). The first patients in the PARADIGME trial have now been dosed. Betalutin was also granted Fast Track designation in June for relapsed or refractory 3L FL, adding to the Orphan drug designation for treating FL it received in 2014. These designations, granted based on the potential of Betalutin to address an unmet patient need in FL, could support a quicker and smoother regulatory process and path to market, if PARADIGME is successful. We are also pleased that Archer-1 has been approved in Norway and we expect the first patient to be dosed before the end of 2018.

"Betalutin is an exciting therapeutic candidate for non-Hodgkin’s lymphoma (NHL) and Nordic Nanovector is well positioned to drive its development through clinical trials. I’m excited to join the Company at this important time and look forward to working with the excellent board and management team to realise the significant potential of Betalutin and to provide a new treatment option to NHL patients who are in need of effective therapies."

Operational Highlights

• Eduardo Bravo appointed as Chief Executive Officer
o Brings more than 25 years’ experience from the biopharmaceutical industry

• First patient dosed in pivotal Phase 2b PARADIGME trial investigating Betalutin as a potential new treatment for patients with third-line relapsed antiCD20 refractory follicular lymphoma (3L R/R FL)
o Site activations continuing – as of August 21st, 41 (of 80-85) sites in 13 (of 20) countries are open for enrolment
o First data read-out targeted for 1H 2020

• Betalutin granted Fast Track designation in the US for FL
o Based on promising safety and preliminary efficacy data from the LYMRIT 37-01 study

• Phase 1b Archer-1 trial of Betalutin in combination with rituximab in second-line (2L) FL patients approved in Norway
o First patient expected to be dosed in 2H 2018

• Phase 1 study with Betalutin in DLBCL advances to next dosing level
o First dosing levels found to be safe and well-tolerated

• Further appointments to strengthen the Management Team and Board of Directors
o Maureen Deehan, PhD, appointed as Head of Corporate Development and Strategy
o Rainer Boehm, MD, elected as a member of the Board of Directors

Financial Highlights Q2 and 1H 2018

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

• Revenues for the second quarter amounted to NOK 0 (NOK 0.1 million). Revenues for the first half of 2018 were NOK 0 (NOK 0.1 million).

• Total operating expenses for the second quarter were NOK 84.5 million (NOK 76.3 million). Total operating expenses for the first half of 2018 amounted to NOK 166.8 million (NOK 142.1 million)
o Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 72.2 % of total operating expenses (71 %) for the first half of 2018.

• Comprehensive loss for the second quarter amounted to NOK 82.9 million (loss of NOK 66.3 million). Comprehensive loss for the first half was NOK 173.6 million (loss of NOK 122.1 million)

• Cash and cash equivalents amounted to NOK 570.1 million at the end of June 2018 (NOK 641.5 million at 31 March 2018 and NOK 756.6 million at 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 clinical data read-outs targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.

Betalutin has been granted Fast Track designation in the US for the treatment of patients with R/R FL.

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.

Second Quarter and First Half 2018 Results Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team in English will take place today at 8:30 am CEST at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: AKER

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 are available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentations/Interim Reports/2018.

Results presentation in Norwegian

A separate presentation of the results in Norwegian, to be hosted by Nordic Nanovector’s CFO, and its VP IR & Corporate Communications, will take place on Thursday, 23 August 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 August 22, 2018 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported the exercise by AbbVie of its exclusive license option to develop and commercialize ARGX-115, an antibody targeting the novel immuno-oncology target glycoprotein A repetitions predominant (GARP) (Press release, argenx, AUG 22, 2018, View Source [SID1234529025]).

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"We are very excited by AbbVie’s decision to exercise its option to license and develop ARGX-115, given its compelling track record in oncology. We are proud of the work that this milestone represents for argenx—both in efficiently advancing a premier Innovative Access Program candidate to clinical development and in facilitating wider recognition of the important research out of the de Duve Institute / Université Catholique de Louvain around this first-in-class target," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "Our Innovative Access Program remains a strategic priority for us, capitalizing on the combined strengths of the argenx antibody platform and the deep disease biology expertise at research institutions. We continue to seek out cutting-edge research and targets while advancing our current collaborations, all with the potential to broaden our pipeline and demonstrate our discipline as a strategic partner."

"Immuno-oncology is one of AbbVie’s key focus areas in our mission to discover and develop medicines that drive transformational improvements in cancer treatment," said Tom Hudson, M.D., Vice President, Oncology Early Discovery and Development, AbbVie. "Our collaboration with argenx over the past two years has been productive, and we look forward to continue working together to fuel scientific progress for patients."

argenx and AbbVie entered into an option and license agreement for ARGX-115 in April 2016. With the option exercise announced today, AbbVie obtains a worldwide, exclusive license to develop and commercialize ARGX-115-based products. argenx is now eligible to potentially receive development, regulatory and commercial milestone payments of up to $625 million, as well as tiered royalties on ARGX-115-based product sales, if approved. argenx also has the right to co-promote ARGX-115-based products in the EU and Swiss Economic Area.

About ARGX-115

ARGX-115 employs argenx’s SIMPLE Antibody technology and binds specifically to the protein glycoprotein A repetitions predominant (GARP), which plays a key role in the regulation of production and release of active transforming growth factor beta (TGF-β). ARGX-115 is believed to selectively limit the immunosuppressive activity of activated regulatory T-cells (Tregs), thereby stimulating the immune system to attack cancer cells. While the normal function of Tregs is to suppress certain compartments of the immune system to prevent self-directed immune responses through the release of active TGF-β, Tregs can also prevent the immune system from recognizing and suppressing pathogenic cells including cancer cells.

argenx believes the selective inhibition of TGF-β release by Tregs is potentially superior to systemic inhibition of TGF-β activity or depletion of Tregs and may give rise to therapeutic products with an improved safety profile.

ARGX-115 was discovered under argenx’s Innovative Access Program with the de Duve Institute / Université Catholique de Louvain / WELBIO and exclusively licensed under a research and option agreement in 2013.

About the Innovative Access Program (IAP)

Through the IAP, argenx collaborates closely with academic centers of excellence and emerging biotechnology companies, bringing cutting-edge antibody discovery technologies to the heart of novel target research. The extraordinary diversity of the immune repertoires comprising its SIMPLE Antibody Platform streamlines target validation, transforming novel protein discoveries into next generation therapeutic antibody programs.

On August 22, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will participate in two upcoming investor conferences (Press release, Halozyme, AUG 22, 2018, View Source [SID1234529026]).

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Dr. Helen Torley, president and chief executive officer of Halozyme, will participate in Citigroup’s 13th Annual Biotech Conference in Boston on Wednesday, September 5, 2018. Dr. Torley will represent Halozyme on a panel titled "Targeted Therapies Oncology – Aiming for the Bull’s Eye" at the conference.

On Thursday, September 6, 2018, Dr. Torley will present an overview of the company at the 2018 Wells Fargo Securities Healthcare Conference in Boston at 1:20 p.m. ET / 10:20 a.m. PT. A live audio webcast of the presentation will be available in the "Investors" section of Halozyme’s website at www.halozyme.com with an archived replay available for 90 days following the event.

On August 22, 2018 Varian (NYSE: VAR) reported its fourth quarter fiscal year 2018 earnings release date and upcoming investor meeting at the American Society for Radiation Oncology (ASTRO) Annual Meeting (Press release, Varian Medical Systems, AUG 22, 2018, View Source [SID1234529027]).

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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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Fourth Quarter Fiscal Year 2018 Earnings

The Company will report results for the fourth quarter of fiscal year 2018 after market close on Wednesday, October 23, 2018. The news release will be followed by a teleconference available to all interested at 1:30 p.m. Pacific Time. To access the teleconference call and replay:

Teleconference: Access from within the U.S. by dialing 1-877-869-3847, and from outside the U.S. by dialing 1-201-689-8261.

Replay: Access from within the U.S. by dialing 1-877-660-6853 and from outside the U.S. by dialing 1-201-612-7415, and enter conference ID 13682642. The teleconference replay will be available until 5:00 p.m. Pacific Time, Thursday, October 25, 2018.

Webcast: To access the live webcast and replay, visit the company website at: www.varian.com/investors and click on the link for Fourth Quarter Earnings Results.

Varian Investor Meeting at ASTRO

Dow Wilson, chief executive officer, and members of the executive staff will be meeting with analysts and investors at the American Society for Radiation Oncology Annual Meeting in San Antonio on Tuesday, October 23, 2018 at 8:00 a.m. Central Time.

Information about the webcast of the company’s presentation will be available through a link on the company website at www.varian.com/investors.

To attend Varian’s ASTRO investor meeting, please RSVP to Katie Glenn at [email protected]. Please RSVP by October 1, 2018.

For automatic e-mail alerts regarding Varian news and events, investors can subscribe on the company website: View Source

On August 22, 2018 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported the Company will be participating in the following upcoming investor conferences (Press release, Arcus Biosciences, AUG 22, 2018, View Source [SID1234529028]):

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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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Citi’s 13th Annual Biotech Conference in Boston on Wednesday, September 5, 2018. At 3:15 pm ET, Terry Rosen, Ph.D., Chief Executive Officer, will participate in a panel discussion entitled, "Targeted Therapies Oncology – Aiming for the Bull’s Eye."

Morgan Stanley 16th Annual Global Healthcare Conference in New York City on Thursday, September 13, 2018. At 4:40 pm ET, Terry Rosen, Ph.D., Chief Executive Officer, and Jennifer Jarrett, Chief Operating Officer and Chief Financial Officer, will participate in a fireside chat. Individuals may access the live audio webcast of the fireside chat by visiting the "Events & Presentations" section of the Company’s website at View Source A replay of the webcast will be available for 30 days following the live event.