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 21, 2018 Sensei Biotherapeutics, Inc., a privately-held biopharmaceutical company developing immuno-oncology therapies that teach the immune system to recognize and attack cancer, reported the appointment of Ildiko Csiki, M.D., Ph.D., as Chief Medical Officer (Press release, Sensei Biotherapeutics, AUG 21, 2018, View Source [SID1234529015]). Dr. Csiki brings nearly two decades of leadership experience in oncology drug development and research, most recently serving as Vice of President of Immuno-Oncology Clinical Development at Inovio Pharmaceuticals.

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"It is with great excitement that we welcome such an accomplished oncologist and clinical leader to Sensei. Ildiko brings an outstanding intellect, expertise and passion for patients to our team," said John Celebi, CEO of Sensei Biotherapeutics. "She is joining Sensei at a time when we are taking bold steps in discovering and developing the next generation of cancer immunotherapies, and we look forward to her contributions to building our oncology drug development capabilities and developing the clinical strategies for SNS-301 and the other programs in our pipeline."

Dr. Csiki joins Sensei at a pivotal time with promising clinical data from the Phase I trial of its lead drug candidate SNS-301 expected in the fall of 2018, and the continued development of its proprietary SPIRIT drug development platform that is generating a pipeline of innovative immuno-oncology therapies.

"I am excited to join Sensei and have the opportunity to play a leadership role in advancing innovative immuno-oncology drug candidates and bring new medicines to cancer patients," said Ildiko Csiki, CMO of Sensei Biotherapeutics "Our SPIRIT platform offers an innovative mechanism for detecting and eliminating cancer. I am eager to move forward with the clinical program for Sensei’s lead drug candidate, SNS-301, as well as creating the clinical strategy for the company’s pipeline of immuno-oncology therapies with the potential to have a profound impact for cancer patients."

In her most recent role, Dr. Csiki served as Vice of President of Immuno-Oncology Clinical Development at Inovio Pharmaceuticals where she led the advancement of Inovio’s DNA-based cancer immunotherapies based on T cell immunotherapeutic vaccines, including responsibility for overseeing clinical programs, clinical strategy, medical monitoring and regulatory submissions. Previously, Dr. Csiki was a Senior Director of Oncology Clinical Development at Merck, as a clinical development lead for pembrolizumab (Keytruda), and she was Director of Clinical Development at GSK focused on a lymphoma and other oncology programs. Before that, Dr. Csiki was an Assistant Professor in the Perelman Cancer Center at the University of Pennsylvania where she had an active clinical practice and a translational science laboratory focused on thoracic malignancies. She holds an M.D. and Ph.D. from Vanderbilt University School of Medicine. Her postdoctoral training included an internship in Internal Medicine and residency in radiation oncology at Vanderbilt and subsequently, a Holman Pathway Research Fellowship.

On August 21, 2018 Genprex, Inc. (NASDAQ: GNPX), a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, reported that company management will present at the following upcoming investor and industry conferences (Press release, Genprex, AUG 21, 2018, View Source [SID1234529016]):

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Event: H.C. Wainwright 20th Annual Global Investment Conference
Date: September 6, 2018
Time: 5:30 PM EDT
Location: New York, NY
Presenter: Dr. Julien Pham, President and COO
Event: Newsmakers in the Biotech Industry
Date: September 7, 2018
Time: 1:30 PM EDT
Location: New York, NY
Presenter: Dr. Julien Pham, President and COO

On August 21, 2018 Agilent Technologies Inc. (NYSE: A) reported that the U.S. Food and Drug Administration (FDA) has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use in urothelial carcinoma (Press release, Agilent, AUG 21, 2018, View Source [SID1234529017]).

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The assay is now approved to identify patients with urothelial carcinoma who may benefit from KEYTRUDA, an anti-PD-1 therapy manufactured by Merck (known as MSD outside the United States and Canada), as a first-line treatment option. KEYTRUDA is approved for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 10] as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic to identify patients with urothelial carcinoma for treatment with KEYTRUDA. This follows previous FDA approvals for PD-L1 IHC 22C3 pharmDx in non-small cell lung cancer (NSCLC), gastric or gastroesophageal junction (GEJ) adenocarcinoma, and cervical cancer.

"Anti-PD-1 therapies are a promising treatment class for many cancer types, and early PD-L1 testing can provide critical information to physicians managing urothelial carcinoma patients," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "By expanding the use of PD-L1 IHC 22C3 pharmDx, Agilent strives to address the unmet need for treatment options in patients who are ineligible for cisplatin-containing chemotherapy. Through these efforts, we maintain our commitment to bringing companion diagnostics to the market in support of groundbreaking immuno-oncology therapeutics."

Urothelial carcinoma is the fifth most common cancer in the United States, with an estimated incidence of 81,000 new cases in 2018 alone.1 For patients with advanced/metastatic urothelial carcinoma, cancer-related mortality has not improved in the past 30 years and the five-year survival rate is approximately 15%.2 Additionally, age- and disease-associated comorbidities affect patient eligibility for standard cisplatin-containing chemotherapy.3-5 For patients ineligible for cisplatin-containing chemotherapy, there is a significant unmet need for new, effective treatments.3,4

KEYTRUDA is a humanized monoclonal antibody that increases the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells. KEYTRUDA and other targeted immunotherapies are revolutionizing cancer treatment, and their therapeutic value is being demonstrated across a growing list of cancer types.

Agilent is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy. Agilent developed PD-L1 IHC 22C3 pharmDx in partnership with Merck. PD-L1 IHC 22C3 pharmDx also helps physicians identify NSCLC, cervical cancer, and gastric or GEJ adenocarcinoma patients for treatment with KEYTRUDA. PD-L1 expression in urothelial carcinoma, cervical cancer, and gastric or GEJ adenocarcinoma tissues is interpreted using Combined Positive Score (CPS). PD-L1 expression in NSCLC tissues is interpreted using Tumor Proportion Score (TPS).

References: 1. Noone AM, Howlader N, Krapcho M, Miller D, Brest A, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA, eds. SEER Cancer Statistics Review, 1975-2015. National Cancer Institute. View Source November 2017 SEER data submission. Published April 2018. Accessed August 16, 2018. 2. Gupta S, Gill D, Poole A, Agarwal N. Systemic immunotherapy for urothelial cancer: current trends and future directions. Cancers. 2017;9(15):1-14. 3. Bellmunt J, Mottet N, De Santis M. Urothelial carcinoma management in elderly or unfit patients. EJC Suppl. 2016;14(1):1-20. 4. Balar AV, Castellano D, O’Donnell PH, et al. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): A multicentre, single-arm, phase 2 study. Lancet. 2017;18(11):1483-1492. 5. Galsky MD, Hahn NM, Rosenberg J, et al. Treatment of patients with metastatic urothelial cancer "unfit" for cisplatin-based chemotherapy. J Clin Oncol. 2011;29(17):2432-2438.

On August 21, 2018 Medtronic plc (NYSE: MDT) reported financial results for its first quarter of fiscal year 2019, which ended July 27, 2018 (Press release, Medtronic, AUG 21, 2018, View Source;p=RssLanding&cat=news&id=2364225 [SID1234529340]).

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The company reported first quarter worldwide revenue of $7.384 billion, a decrease of 0.1 percent as reported, or an increase of 6.8 percent on an organic basis, which adjusts for the divestiture of its Patient Care, Deep Vein Thrombosis (Compression), and Nutritional Insufficiency businesses to Cardinal Health that occurred in the second quarter of fiscal year 2018, and a $78 million positive impact from foreign currency. As reported, first quarter GAAP net income and diluted earnings per share (EPS) were $1.075 billion and $0.79, respectively. As detailed in the financial schedules included through the link at the end of this release, first quarter non-GAAP net income and diluted EPS were $1.601 billion and $1.17, respectively, both increases of 4 percent. Adjusting for the divestiture and a positive 5 cent impact from foreign currency, first quarter non-GAAP diluted EPS increased 9 percent.

First quarter U.S. revenue of $3.864 billion represented 52 percent of company revenue and decreased 4.4 percent as reported, while it increased 6.4 percent on a comparable basis, which adjusts for the divestiture. Non-U.S. developed market revenue of $2.406 billion represented 33 percent of company revenue and increased 4.0 percent as reported and 5.5 percent on a comparable, constant currency basis. Emerging market revenue of $1.114 billion represented 15 percent of company revenue and increased 7.6 percent as reported and 11.2 percent on a comparable, constant currency basis.

"We are executing against our plan, growing our markets and driving share gains across multiple businesses and geographies," said Omar Ishrak, Medtronic chairman and chief executive officer. "Our execution is not only on the top line, but also down the P&L, as we delivered margin expansion through our Enterprise Excellence program while increasing our investment in R&D."

Cardiac and Vascular Group
The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic, Peripheral & Venous (APV) divisions. CVG worldwide first quarter revenue of $2.811 billion increased 6.2 percent, or 5.0 percent on a constant currency basis. CVG revenue performance was driven by strong, low-double digit growth in CSH, mid-single digit growth in APV, and low-single digit growth in CRHF, all on a constant currency basis.

– CRHF first quarter revenue of $1.426 billion increased 2.6 percent, or 1.4 percent on a constant currency basis. Arrhythmia Management grew in the low-single digits on a constant currency basis, driven by high-teens constant currency growth in AF Solutions and the high-thirties constant currency growth of TYRX in Infection Control. Results were also driven by mid-single digit growth in Pacing, led by the adoption of the Micra Transcatheter Pacing System and the Azure wireless pacemaker.

– CSH first quarter revenue of $917 million increased 12.2 percent, or 10.9 percent on a constant currency basis, led by high-teens constant currency growth in transcatheter aortic valves on the global strength of the CoreValve Evolut PRO. Coronary grew in the high-single digits on a constant currency basis, driven by double digit constant currency growth of drug-eluting stents and guide catheters.

– APV first quarter revenue of $468 million increased 6.6 percent, or 5.2 percent on a constant currency basis, led by mid-teens constant currency growth in endoVenous on strong demand for the VenaSeal(TM) closure system. Peripheral Vascular grew in the mid-single digits on a constant currency basis, driven by strong PTA balloon growth globally and drug-coated balloon growth in international markets. Aortic grew in the low-single digits on a constant currency basis, driven by growth in thoracic stent grafts.

Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. MITG worldwide first quarter revenue of $2.052 billion decreased 17.5 percent as reported, or increased 4.9 percent on a comparable, constant currency basis. MITG revenue performance included mid-single digit growth in SI and low-single digit growth in RGR, both on a comparable, constant currency basis.

– SI first quarter revenue of $1.397 billion increased 5.8 percent on a comparable, constant currency basis, driven by low-double digit constant currency growth in Advanced Energy on the strength of the LigaSure(TM) vessel sealing instruments with innovative nano-coating. Advanced Stapling grew in the mid-single digits, driven by strong demand for Tri-Staple(TM) 2.0 endo stapling specialty reloads and the Signia(TM) powered stapler.

– RGR first quarter revenue of $655 million increased 2.9 percent on a comparable, constant currency basis. GI grew in the mid-single digits on a comparable, constant currency basis. Respiratory and Patient Monitoring grew in the low-single digits on a comparable, constant currency basis, with high-single digit constant currency growth in capnography and ventilation.

Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Spine, Brain Therapies, Specialty Therapies, and Pain Therapies divisions. RTG worldwide first quarter revenue of $1.949 billion increased 7.7 percent, or 6.8 percent on a constant currency basis. Group results were driven by mid-teens growth in Brain Therapies and Pain Therapies, with low-single digit growth in Specialty Therapies and flat results in Spine, all on a constant currency basis.

– Spine first quarter revenue of $652 million increased 0.5 percent, or decreased 0.3 percent on a constant currency basis. When combined with the company’s sales of enabling technology used in spine surgeries, which is recognized in the Brain Therapies division, global Spine revenue increased in the mid-single digits on a constant currency basis, driven by the success of the company’s Surgical Synergy strategy.

– Brain Therapies first quarter revenue of $599 million increased 14.8 percent, or 13.6 percent on a constant currency basis, driven by high-teens constant currency growth in Neurovascular and Neurosurgery. Neurovascular had strong growth in stents, flow diversion, and access products. Neurosurgery growth was led by strong capital equipment sales of the O-arm2 surgical imaging system, StealthStation S8 surgical navigation system, Mazor X(TM) robotic guidance system, and Visualase MRI-guided laser ablation system.

– Specialty Therapies first quarter revenue of $384 million increased 4.1 percent, or 3.3 percent on a constant currency basis. Results were led by mid-single digit constant currency growth in ENT.

– Pain Therapies first quarter revenue of $314 million increased 16.7 percent, or 15.6 percent on a constant currency basis. The division had strong, low-twenties growth in Pain Stimulation on the strength of the recently launched Intellis(TM) platform for spinal cord stimulation, as well as low-double digit growth in Targeted Drug Delivery and high-single digit growth in Interventional Pain, all on a constant currency basis.

Diabetes Group
The Diabetes Group is now organized into the Advanced Insulin Management (AIM) and Emerging Technologies divisions. Diabetes Group worldwide first quarter revenue of $572 million increased 27.4 percent, or 26.3 percent on a constant currency basis. The group is experiencing strong global demand for its new sensor-augmented insulin pump systems.

– AIM first quarter revenue grew in the mid-twenties on a constant currency basis, driven by the ongoing U.S. launch of the MiniMed 670G hybrid closed loop insulin pump system with the Guardian sensor 3 continuous glucose monitor (CGM). In international markets, AIM delivered high-teens constant currency growth on the continued strength of the MiniMed 640G system.

– Emerging Technologies first quarter revenue grew in the high-sixties on a constant currency basis, driven by the U.S. launch of the Guardian Connect CGM system with Sugar.IQ(TM) personal diabetes assistant.

Guidance
The company today updated its fiscal year 2019 revenue growth and EPS guidance.

For fiscal year 2019, the company is increasing its organic revenue growth guidance from a range of 4.0 to 4.5 percent to a range of 4.5 to 5.0 percent. If recent exchange rates hold for the remainder of the fiscal year, the company’s fiscal year 2019 revenue would be negatively affected by approximately $420 million to $520 million.

For fiscal year 2019, the company is increasing its implied constant currency non-GAAP diluted EPS growth forecast from a range of 8 to 9 percent to a range of 9 to 10 percent. At recent rates, foreign exchange is expected to be neutral to fiscal year 2019 EPS versus a 5 cent benefit prior. As such, despite the increased constant currency EPS growth outlook, the company is maintaining its diluted non-GAAP EPS guidance in the range of $5.10 to $5.15.

"We are excited about the growth opportunities in our end markets, and we are bullish about our competitive position," said Ishrak. "Our pipeline of innovation, invention, and disruption has never been stronger. We are also putting the pieces in place to improve free cash flow conversion, creating additional capital that can be returned to shareholders and reinvested to drive future growth, all with a goal of creating long-term shareholder value."

Webcast Information
Medtronic will host a webcast today, August 21, at 8:00 a.m. EDT (7:00 a.m. CDT) to provide information about its businesses for the public, analysts, and news media. This quarterly webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at newsroom.medtronic.com. Medtronic will be live tweeting during the webcast on our Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com.

Financial Schedules
To view the first quarter financial schedules and non-GAAP reconciliations, click here. To view the first quarter earnings presentation, click here. Both documents can also be accessed by visiting newsroom.medtronic.com.