Mes: agosto 2020

SAN CARLOS, Calif., Aug. 3, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced the publication of a manuscript in Nature Cancer¹ that validates the ability of its Signatera™ personalized circulating tumor DNA (ctDNA) technology to evaluate tumor response to immunotherapy in 25 different types of solid cancer. The full study can be found here.

«Although immune checkpoint inhibitors are an effective tool for treating many types of cancer, the decision to treat beyond radiological progression can sometimes be challenging due to potential pseudo-progression,» explained Lillian Siu, MD, FRCPC, BMO Chair in Precision Cancer Genomics at the Princess Margaret Cancer Centre and lead investigator of the study. «We are delighted to have partnered with Natera on this landmark study, which shows that ctDNA-based surveillance using the Signatera test, in conjunction with imaging, can be used to identify true disease progression and thus help patients receive appropriate immunotherapy treatment.»

Pseudo-progression is a phenomenon whereby the tumor appears larger on an initial scan during treatment before shrinking on subsequent scans, and it has been reported in up to 1 in 10 patients treated with immunotherapy.^2,3 The ability to distinguish true progression from pseudo-progression, earlier in the course of treatment, has emerged as a significant unmet clinical need.

The prospective phase II INSPIRE study, led by the Princess Margaret Cancer Centre in Toronto, followed patients with advanced solid tumors being treated with the immunotherapy drug, pembrolizumab. Whole exome sequencing was performed using tumor and matched normal DNA, and then bespoke ctDNA assays were designed using Signatera technology. ctDNA assessments were made at baseline in 94 patients, and every three cycles during treatment in 73 patients where serial plasma samples were available.

In the published manuscript, the study’s authors concluded, «The findings from this prospective study suggest broad clinical utility for ctDNA-based surveillance in patients treated with immune checkpoint blockade.»

Key findings from the study include:

• Signatera technology detected ctDNA before treatment in 98% of cases (92/94), emphasizing its validity as a universal biomarker across tumor types.
• ctDNA increase after just 6 weeks of treatment, together with increasing tumor volume on imaging, was identified in 42% of patients (30/73) and predicted treatment non-response with 100% accuracy. These patients received on average 6 extra weeks of treatment that potentially could have been avoided.
• ctDNA clearance at any time point during treatment was achieved by 16% of patients (12/73) and was associated with 100% overall survival with a median of 25.4 months of followup beyond first clearance.
• All findings were independent of tumor mutational burden (TMB) and PD-L1 status.

«With over 200,000 patients per year being treated with immunotherapy,⁴ we see a significant opportunity for serial use of Signatera to help physicians determine treatment response earlier,» said Solomon Moshkevich, General Manager of Natera’s oncology business. «We think this novel application could be as significant as Signatera’s use case in early-stage colorectal cancer.»

We thank Merck for contributing the drug for this clinical trial.

About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and, in 2019, it was granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. 
Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy. Rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier, and to help optimize treatment decisions. Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Medicare has proposed insurance coverage for the use of Signatera in patients with Stage II or III colorectal cancer, and it is expected to finalize that coverage decision in 2020. Signatera has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). Although FDA is exercising enforcement discretion of premarket review and other FDA legal requirements for laboratory-developed tests in the US, certification of the laboratory is required under CLIA to ensure the quality and validity of the tests. 

About Natera
Natera is a pioneer and global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on women’s health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited labs certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, California, and Austin, Texas. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn. 

Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical or other studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in «Risk Factors» in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Contacts
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Paul Greenland, VP of Corporate Marketing, pr@natera.com

References:

1. Bratman SV, Yang SYC, Iafolla MAJ, et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nat. Cancer. 2020. https://www.nature.com/articles/s43018-020-0096-5
2. Borcoman E, Nandikolla A, Long G, Goel S, Tourneau CL. Patterns of Response and Progression to Immunotherapy. Am Soc Clin Oncol Educ Book. 2018;38:169-178.
3. Patel V. Progress on Pseudoprogression. The Pathologist. https://thepathologist.com/subspecialties/progress-on-pseudoprogression. Published 2018.
4. IQVIA™ Institute for Human Data Science Releases Global Oncology Trends 2019 Study: Record Number of Cancer Drugs Launched in 2018 across 17 Indications. IQVIA. https://www.iqvia.com/newsroom/2019/05/iqvia-institute-for-human-data-science-releases-global-oncology-trends-2019-study-record-number-of-c. Published 2019.

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SOURCE Natera, Inc.

ENGLEWOOD CLIFFS, N.J., Aug. 3, 2020 /PRNewswire/ — As social distancing continues to be the new norm, teens are finding that they’ll need to continue to adapt to a new and everchanging lifestyle. Their daily routines have been turned upside down and social distancing has made dating and social experiences basically impossible, not to mention totally awkward. And while teens are turning dates virtual with Zoom and Facetime, it’s clear that screen-mediated relationships aren’t cutting it, with more than a third of Gen Z reporting loneliness, and less than 25% feeling connected to others under stay-at-home orders.* AXE gets it and is stepping in with the help of Russell Westbrook and a crew of social influencers to address this tough situation so teens can feel comfortable transitioning to this new dating scene in a safe way.  

It’s only natural that guys are feeling nervous to reengage with others given the added pressure of new social-distancing dating rules like appropriate mask etiquette. That’s why AXE created a light-hearted take on navigating this new attraction landscape with the campaign «Smell Ready» and enlisted the help of Russell Westbrook and content creators like Donte Colley, Kenny Knox, Mytypolife, King Bach, Salice Rose and others to share their own relatable takes. 

«I’m always looking to inspire the youth and help them find their confidence,» said NBA All-Star and fashion enthusiast, Russell Westbrook, «That’s why I’m happy to partner with AXE in their mission to help teens feel confident when they’re ready to step back out into the world. » 

«AXE is here to help make the transition to this new age of dating a bit easier with a range of fragrances that will help them smell ready and get back out there with a new sense of confidence. We’re a brand that’s always been about helping guys feel attractive and confident. We want to help teens connect IRL again, but in a fun and safe way,» said Mark Lodwick AXE US Brand Director. «We’ve always used relevant content and partners to connect with our guy – from Netflix’s Sex Ed, Teen Vogue’s Virtual Prom and now to Russell Westbrook. Even with today’s unprecedented social climate, AXE continues to look for ways to breakthrough and inspire teens.

A combination of the brand’s new and classic products will be highlighted throughout the campaign. This year, the brand introduces its AXE Light Scents body spray collection (now with essential oils) and a full suite of new body washes to keep guys looking and feeling their best.   

To learn more about AXE and Smell Ready, visit www.axe.com, #SmellReady, or follow @AXE on Instagram, Facebook, Twitter and YouTube.    

PRESS CONTACT   
Caitlin Gronski  
Caitlin.Gronski@edelman.com   

GWI Coronavirus Research, April 2020: Series 8 – Health*  
«Consumer sentiment is evolving as countries around the world begin to reopen«, McKinsey Report, June 5, 2020*  

About AXE^®   
AXE, the No. 1 men’s fragrance brand in the world*, champions confidence for guys by helping them look, feel, and smell their best while navigating the attraction game. With a full line of grooming products including daily fragrance sprays, deodorants, anti-perspirants, shower gels, shampoos and styling products, AXE gives guys the tools to feel confident, self-assured, and attractive to the world around them. Visit AXE at AXE.com and follow us on Twitter, Instagram, Tumblr, and Facebook to get access to exclusive content, special promotions, and more.   

About Unilever North America   
Unilever is one of the world’s leading suppliers of Beauty & Personal Care, Home Care, and Foods & Refreshment products with sales in over 190 countries and reaching 2.5 billion consumers a day. In the United States and Canada, the portfolio includes brand icons such as: Axe, Ben & Jerry’s, Breyers, Degree, Dollar Shave Club, Dove, Hellmann’s, Klondike, Knorr, Lever 2000, Lipton, Love Beauty and Planet, Magnum, Nexxus, Noxzema, Pond’s, Popsicle, Pure Leaf, Q-tips, Seventh Generation, Simple, Sir Kensington’s, St. Ives, Suave, Talenti Gelato & Sorbetto, TAZO, TIGI, TRESemmé and Vaseline. All of the preceding brand names are trademarks or registered trademarks of the Unilever Group of Companies.     

Unilever’s Sustainable Living Plan (USLP) underpins the company’s strategy and commits to:   

• Helping more than a billion people take action to improve their health and well-being by 2020.  
• Halving the environmental impact of our products by 2030.  
• Enhancing the livelihoods of millions of people by 2020.     

The USLP creates value by driving growth and trust, eliminating costs and reducing risks. In 2018, the company’s Sustainable Living Brands grew 69% faster than the rest of the business, compared to 46% in 2017.   

Since 2010 we have been taking action through the Unilever Sustainable Living Plan to help more than a billion people improve their health and well-being, halve our environmental footprint and enhance the livelihoods of millions of people as we grow our business. We have already made significant progress and continue to expand our ambition – most recently committing to ensure 100% of our plastic packaging is fully reusable, recyclable or compostable by 2025. While there is still more to do, we are proud to have been recognized in 2018 as sector leader in the Dow Jones Sustainability Index and as the top ranked company in theGlobeScan/SustainAbility Global Corporate Sustainability Leaders survey, for the eighth-consecutive year.    

For more information on Unilever U.S. and its brands visit: www.unileverusa.com    
For more information on the USLP: www.unilever.com/sustainable-living/   

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SOURCE AXE