On November 6, 2018 Alkermes plc (Nasdaq: ALKS) reported that its corporate presentation will be webcast live at the Credit Suisse 27th Annual Healthcare Conference on Tuesday, Nov. 13, 2018 at 10:20 a.m. MT (12:20 p.m. ET/5:20 p.m. GMT) from Scottsdale, Arizona (Press release, Alkermes, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375640 [SID1234530867]). In addition, Alkermes’ corporate presentation will be webcast live at the Jefferies London Healthcare Conference on Wednesday, Nov. 14, 2018 at 4:00 p.m. GMT (11:00 a.m. ET) from London, U.K. These presentations may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

On November 6, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform reported that it will report its financial results for the third quarter ended September 30, 2018, and provide a business update on Wednesday, November 14, 2018 after the close of the U.S. financial markets (Press release, RXi Pharmaceuticals, NOV 6, 2018, View Source [SID1234530887]).

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A live audio webcast will begin at 4:30 p.m. EDT. The webcast link is available under the "Investors – Events and Presentations" section of the Company’s website, www.rxipharma.com. The event may also be accessed by dialing toll-free in the United States: +1 844-376-4678. International participants may access the event by dialing: +1 209-905-5958.

An archive of the webcast will be available on the Company’s website approximately two hours after the presentation.

On November 6, 2018 Nordic Nanovector ASA (OSE: NANO) reported its third quarter 2018 results (Press release, Nordic Nanovector, NOV 6, 2018, View Source [SID1234553487]). 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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Eduardo Bravo, CEO, commented: "The latest updated clinical results from a once-only administration of Betalutin, to be presented at ASH (Free ASH Whitepaper) in December, highlight the very promising clinical profiles of the two dosing regimens that are being evaluated in patients with relapsed/refractory indolent NHL. We are working hard to advance the PARADIGME study to confirm these results in a trial with 130 patients and to enable the selection of the best dosing regimen for our regulatory submissions. We are also pleased that Betalutin has received PIM designation in the UK reflecting the high unmet medical need of the FL patient population as well as the potential of Betalutin to offer therapeutic benefits to these patients. Both the PIM and Fast Track designations (granted by the FDA in June) provide opportunities for enhanced dialogue with health authorities and a route to bring Betalutin to patients quicker. We have a clear focus on delivering results from PARADIGME in 1H 2020 and in building further value in Nordic Nanovector from our CD37-targeting approach to treating patients with NHL."

Operational Highlights
• Abstract reporting promising clinical results from LYMRIT 37-01 trial with Betalutin published ahead of poster presentation at ASH (Free ASH Whitepaper)
o Overall response rates of 69% in Arm 4 (100 mg/m2 lilotomab followed by 20 MBq/kg Betalutin) and 64% in Arm 1 (40 mg lilotomab followed by 15 MBq/kg Betalutin) in relapsed/refractory follicular lymphoma patients
o Median duration of response of 13.3 months for all patients (20.5 months for those with a complete response)
o Well tolerated with predictable and manageable safety profile

• Site activations and patient recruitment progressing for pivotal Phase 2b PARADIGME trial
o As of 5 November, 51 (of 80-85) sites in 16 (of 20) countries are open for enrolment
o First US site in Long Beach, CA open for enrolment

Betalutin granted Promising Innovative Medicine (PIM) Designation in the UK for the treatment of advanced relapsed/refractory FL

• First patient dosed in Phase 1b Archer-1 trial of Betalutin in combination with rituximab in second-line (2L) FL patients

• Promising results from a collaborative R&D project to develop a CD37-targeted alpha therapy published in abstract ahead of ASH (Free ASH Whitepaper) presentation
o Next-generation targeted alpha therapy comprises Nordic Nanovector’s chimeric anti-CD37 antibody (NNV003) linked to lead-212 for treating B-cell malignancies

Financial Highlights Third Quarter 2018

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

• Revenues for the third quarter amounted to NOK 0 (NOK 0.1 million).

• Total operating expenses for the third quarter were NOK 76.9 million (NOK 72.7 million). Total operating expenses for the first nine months of 2018 amounted to NOK 243.7 million (NOK 214.9 million)
o Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 73.0 % of total operating expenses (71.0 %) for the first nine months of 2018.

• Comprehensive loss for the third quarter amounted to NOK 75.4 million (loss of NOK 85.9 million). Comprehensive loss for the first nine months of 2018 was NOK 249.1 million (loss of NOK 207.9 million)

• Cash and cash equivalents amounted to NOK 499.7 million at the end of September 2018 (NOK 570.1 million at 30 June 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 1/2 clinical study. The company’s pivotal Phase 2b PARADIGME trial with Betalutin in 3L R/R FL is underway with the initial clinical data read-out targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.
Betalutin has been granted Fast Track and PIM designations in the US and UK, respectively, for the treatment of patients with R/R FL.
Nordic Nanovector intends to maximize the value of Betalutin and other CD37-targeting opportunities 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.

Third Quarter 2018 Results Presentation and Webcast

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

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: HOLMENKOLLEN

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.

With a pedigree stretching back almost a quarter of a century, BIO-Europe is not only Europe’s largest partnering conference but, according to a recent analysis by 1stOncology™ (also covering BIO International and BIO Asia), it is also one of the world’s richest displays of cancer drug development companies under one roof! With over 600 oncology companies from more than thirty different countries present at BIO-Europe 2018, this is truly a global event. Many of these have also just presented their latest scientific/clinical advancements at the freshly completed European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (ESMO 2018) congress. Now coming together at the BIO-Europe 2018 meeting they represent more than 5,500 cancer drugs, from discovery to marketed, and are responsible for more than 40% of the world’s current output in cancer R&D, see pipeline breakdown below.

These new cancer drug technologies are being developed from a wide array of organizations, from centuries old universities such as Jagiellonian University (Poland) founded in 1364, to startup companies like Cedilla Therapeutics (USA) and Epigene Therapeutics (Canada), both founded in 2018. Regardless of age they are all coming together at BIO-Europe 2018 to engage with global life science partners.

The global nature of this meeting is revealed when looking at the top nations with cancer drug developing companies present at this year BIO-Europe. It is no surprise to see the United States in first place with 190 companies, UK in second with 48 and Japan is in third place with 41 companies. Please see below table for the top ten nations at BIO-Europe 2018.

In today’s fast moving climate where a company can go from an idea to a public company in a blink of an eye, roughly one third of the 600 cancer companies are publicly traded at various stock exchange markets around the world. No less than seven of these have gone through their initial public offering in 2018 alone, namely ARMO BioSciences, ASLAN Pharmaceuticals, Autolus, BeiGene, Forty Seven, MorphoSys and Sutro Biopharma.

The number of cancer startups, founded in the last five years, present at the BIO-Europe meetings amount to almost fifty, see table below for breakdown per year.

The sizeable cancer pipeline of more than five and a half thousand drugs represented at BIO-Europe is a based on a very diverse selection of technologies and discoveries in cancer biology. Almost one third of these are Immune-Oncology (I-O) drugs including Immune Checkpoint drugs, Cancer vaccines, Bispecific immunomodulators, CAR/TCR therapies and Oncolytic virotherapies, see breakdown by type of I-O drugs below.

In the spotlight of this year’s Nobel Prize in Physiology or Medicine, companies at BIO-Europe feature nearly 300 different immune checkpoint drugs. Other hot progress areas in cancer therapeutics include DNA Damage Response (DDR) drugs, epigenetic therapies, Protein Kinase Inhibitors (PKIs) and Antibody-Dug Conjugates (ADCs).

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On November 5, 2018 FLX Bio, Inc., a clinical-stage, biopharmaceutical company focused on the development of oral small-molecule drugs that target drivers of cancer and other immune-related disorders, reported that it has established a clinical trial collaboration agreement with Merck (known as MSD outside the U.S. and Canada) to conduct a Phase 1/2 study evaluating the safety and efficacy of the combination of KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy , and FLX Bio’s investigational oral small molecule CCR4 inhibitor, FLX475, in patients with multiple types of cancer (Press release, FLX Bio, NOV 5, 2018, View Source [SID1234530726]).

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The open-label, dose-escalation and cohort expansion Phase 1/2 study is enrolling patients with multiple types of cancer at leading cancer centers across the United States, Australia and Asia. In addition to evaluating the safety and tolerability of FLX475 as a monotherapy and in combination with pembrolizumab, the study will evaluate changes in the tumor microenvironment and the antitumor activity of both monotherapy and combination therapy. For more information please visit clinicaltrials.gov identifier NCT03674567.

"We are extremely pleased to collaborate with Merck, an established leader in the field of cancer immunotherapy," said Brian Wong, M.D., Ph.D., CEO of FLX Bio. "KEYTRUDA is an anti-PD1 immunotherapy that has demonstrated efficacy in a range of cancers. FLX475 targets a novel mechanism to selectively inhibit the recruitment of regulatory T cells (Treg) into the tumor, where Treg potentially suppress the anti-tumor immune response; thus FLX475 has the potential to deepen and broaden the efficacy of KEYTRUDA when combined. We are excited to collaborate with the Merck team to evaluate the efficacy of a combination of FLX475 and KEYTRUDA which we believe could substantially improve patient outcomes."

Keytruda is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About FLX475
FLX475 is a best-in-class oral, small molecule antagonist of CCR4 which selectively blocks suppressive regulatory T cells in tumor tissue and promotes a durable anti-tumor immune response. FLX Bio has completed a study of FLX475 in healthy volunteers, demonstrating that the compound is safe with excellent pharmacokinetic and pharmacodynamic properties. In preclinical studies, FLX475 inhibited tumor growth and increased tumor regression as a single agent. In addition, FLX475 enhanced the anti-tumor effects of various checkpoint inhibitors as well as immune agonist antibodies. FLX475 also has the potential to enhance cell-based immunotherapies such as CAR-T and cancer vaccines. In contrast to depleting antibody approaches, FLX475 selectively blocks the recruitment of regulatory T cells to the tumor site and does not deplete cells beneficial to an anti-tumor response or regulatory T cells in healthy tissue.