Daily Archives: April 4, 2019

Nanobiotix Announces First Ever Radioenhancer to Receive European Market Approval

NANOBIOTIX ANNOUNCES FIRST EVER RADIOENHANCER TO RECEIVE EUROPEAN MARKET APPROVAL

  • Hensify®(NBTXR3) received European market approval (CE mark) enabling commercialization in 27 European Union countries for the treatment of locally advanced soft tissue sarcoma
  • Hensify®–a first-in-class radioenhancer–offers cancer patients an innovative treatment with a broadly applicable mechanism of action
  • After positive phase II/III data, this approval represents significant step forward in establishing NBTXR3 as a major oncology treatment

Laurent Levy, CEO of Nanobiotix, commented, “We could not be more proud to receive market approval in Europe for Hensify®. This approval validates more than 15 years of hard work, cutting edge science, and a fierce commitment to changing the lives of patients. This is a significant achievement and represents just one more step in our mission to improve life for millions of people around the world.

Paris, France, and Cambridge, Massachusetts (USA) April 4, 2019 – NANOBIOTIX (Euronext : NANO – ISIN : FR0011341205), a clinical-stage nanomedicine company pioneering new approaches in the treatment of cancer, announced today that Hensify® (NBTXR3) has obtained a CE mark for the treatment of locally-advanced soft tissue sarcoma (“STS”).  Hensify® is the brand name for NBTXR3 as approved for the treatment of locally-advanced STS.

Hensify® is a first-in-class product introducing a new, physical mechanism of action. This innovative product was designed by Nanobiotix to physically destroy tumors and activate the immune system for both local control and systemic disease treatment when combined with radiation therapy. In addition to Hensify®, NBTXR3 is currently under evaluation in various other indications such as lung cancer, head and neck cancers, liver cancer, and prostate cancer.

Hensify® is an aqueous suspension of crystalline hafnium oxide (HfO2) nanoparticles designed for injection directly into a tumor prior to a patient’s first standard radiotherapy treatment. When exposed to ionizing radiation, Hensify® amplifies the localized, intratumor killing effect of that radiation. The dose of X-ray delivered to the tumor is magnified, whilst the dose passing through healthy tissues remains unchanged. Hensify® requires a single administration and will fit into current worldwide standards of radiation care.

STSs are rare cancers that develop in different types of soft tissues including fat, muscles, joint structures and blood vessels. Radiotherapy followed by surgery is part of the typical treatment regimen for STS patients in Europe. The Act.In.Sarc phase II/III trial was a prospective, randomized (1:1), multinational, open label and active controlled two armed trial of 180 adult patients with locally advanced STS of the extremity or trunk wall. The objective of the trial was to evaluate the pre-operative efficacy and the safety of Hensify® activated by radiotherapy compared to the standard of care (radiotherapy alone).

The positive Act.In.Sarc study results were presented at the 2018 ASTRO and ESMO Annual Congresses. The trial achieved its primary endpoint with a pathological complete response (<5% viable cancer cells) rate of 16.1% in the Hensify® arm compared to 7.9% in the control arm (p=0.0448). In addition, in the subgroup of patients with a more aggressive disease (histologic grade 2 and 3), a pathological complete response was achieved in four times as many patients in the Hensify® arm as in the control arm (17.1% compared 3.9%).

Similar safety profiles were observed in the Hensify® arm and the radiation therapy alone control arm. Hensify® did not impair the patients’ ability to receive the planned dose of radiotherapy and the radiotherapy safety profile was similar in both arms, including the rate of postsurgical wound complications. Hensify® was associated with grade 3-4 acute immune reactions which were manageable and of short duration. Further, Hensify® showed a good local tolerance in the trial and did not have any impact on the severity or incidence of radiotherapy-related adverse events.

Post-approval trials are planned across Europe and discussions on next steps regarding potential further development are ongoing.

About Hensify® (NBTXR3)

NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy:

  • tumors through physical cell death
  • metastasis due to immunogenic cell death leading to activation of the immune system.

NBTXR3 has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care.  The physical mode of action of NBTXR3 makes it applicable across solid tumors such as lung, prostate, liver, glioblastoma, and breast cancers.

NBTXR3 is actively being evaluated in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity or oropharynx in elderly and frail patients unable to receive chemotherapy or cetuximab with very limited therapeutic options. Promising results have been observed in the phase I/II trial regarding the local control of the tumors. In the United States, based on the discussions with the Food and Drug Administration that occurred in the first half of 2019, the Company plans to begin the clinical trial authorization process in the second half of 2019 and commence a phase II/III clinical trial in locally advanced head and neck cancers.

Nanobiotix is also running an Immuno-Oncology development program. In the United States, the Company received approval from the Food and Drug Administration to launch a clinical trial of NBTXR3 activated by radiotherapy in combination with anti-PD-1 antibodies in lung, and head and neck cancer patients (head and neck squamous cell carcinoma and non-small cell lung cancer).

The other ongoing NBTXR3 trials are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma.

Further, the company has a large-scale, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center (9 new phase I/II clinical trials in the United States) to evaluate NBTXR3 across head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers.

About NANOBIOTIXwww.nanobiotix.com

Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.

The Nanobiotix philosophy is rooted in designing pioneering, physical-based approaches to bring highly effective and generalized solutions to address unmet medical needs and challenges.

Nanobiotix’s first-in-class, proprietary lead technology, NBTXR3, aims to expand radiotherapy benefits for millions of cancer patients. Nanobiotix’s Immuno-Oncology program has the potential to bring a new dimension to cancer immunotherapies.

Nanobiotix is listed on the regulated market of Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg: NANO: FP). The Company’s headquarters are in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in Spain and Germany.

Contacts

Nanobiotix
Communications Department
+33 (0)1 40 26 07 55
+1 (617) 852-4835
contact@nanobiotix.com
 

Investor Relations Department 
+33 (0)1 79 97 29 99
+1 (646) 241-4400
investors@nanobiotix.com

Media Relations  
France – Springbok Consultants
Marina Rosoff
+33 (0)6 71 58 00 34
marina@springbok.fr
US – RooneyPartners 
Marion Janic 
+1 (212) 223-4017
mjanic@rooneyco.com

Disclaimer
This press release contains certain forward-looking statements concerning Nanobiotix and its business, including the development and commercialization of Hensify®. Such forward-looking statements are based on assumptions that Nanobiotix considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the reference document of Nanobiotix filed with the French Financial Markets Authority (Autorité des Marchés Financiers) under number D.17-0470 on April 28, 2017 as well as in its 2017 annual financial report filed with the French Financial Markets Authority on March 29, 2018 (a copy of which is available on www.nanobiotix.com) and to the development of economic conditions, financial markets and the markets in which Nanobiotix operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Nanobiotix or not currently considered material by Nanobiotix. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Nanobiotix to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Nanobiotix shares in any country.

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New vision sensor targets error proofing, identification and robotic guidance applications

Teledyne DALSA’s new BOA Spot XL delivers performance and capabilities to rival any product in its class

BILLERICA, Mass., April 04, 2019 (GLOBE NEWSWIRE) — Teledyne DALSA, a Teledyne Technologies [NYE:TDY] company and global leader in machine vision technology, announced today its new low cost BOA™ Spot XL vision sensors for industrial automation and inspection.Teledyne DALSA’s BOA Spot XL smart vision sensor

Designed for error proofing, identification, general inspection and robot guidance, BOA Spot XL vision sensors deliver the performance and capabilities to rival any product in its class. The all-in-one BOA Spot XL comes with integrated LED lighting, lens cover and easy-to-use application software, providing high value capabilities at a low cost of ownership. Robust embedded vision tools include positioning, part locating, pattern matching, measuring, feature or defect detection and identifying, including automatic reading of characters (OCR) based on a pre-trained AI (Artificial Intelligence) inference network. Additional features include extensive image preprocessors and advanced calibration for image correction and system coordinate mapping.

“BOA Spot XL vision sensors deliver the performance and capabilities of a sophisticated smart vision system,” commented Steve Geraghty, General Manager of Teledyne DALSA’s Industrial Imaging Solutions US. “This latest BOA Spot model offers manufacturers the tools and integration flexibility for a wide range of automation and inspection applications.”

Inspections using BOA Spot XL vision sensors can be triggered by parts in motion or from a PLC after being moved into a stationary position. Compatible protocols, such as Ethernet/IP and PROFINET, provide standard languages for communicating with 3rd party equipment or the factory enterprise.

Thru- and surface-mounting options and a slim form factor lend automation and system developers the benefit of positioning the BOA Spot XL in tight places.

Camera Details & Availability

The BOA Spot XL is available immediately. For more information, including product specifications and ordering details, visit the BOA Spot XL page on the Teledyne DALSA website or contact your Teledyne DALSA regional sales representative. For a downloadable image of the camera, please visit Teledyne DALSA’s online media kit.

Teledyne DALSA is part of the Teledyne Imaging group and a world leader in the design, manufacture and deployment of digital imaging components for the machine vision market. Teledyne DALSA image sensors, cameras, smart cameras, frame grabbers, software, and vision solutions are used in thousands of automated inspection systems around the world and across multiple industries including semiconductor, solar cell, flat panel display, electronics, automotive, medical, packaging and general manufacturing. For more information, visit www.teledynedalsa.com/mv.

Teledyne Imaging is a group of leading edge companies aligned under the Teledyne umbrella. Teledyne Imaging forms an unrivalled collective of expertise across the spectrum with decades of experience. Individually, each company offers best-in-class solutions. Together, they combine and leverage each other’s strengths to provide the deepest, widest imaging and related technology portfolio in the world. From aerospace through industrial inspection, scientific research, spectroscopy, radiography and radiotherapy, geospatial surveying, and advanced MEMS and semiconductor solutions, Teledyne Imaging offers world-wide customer support and the technical expertise to handle the toughest tasks. Their tools, technologies, and vision solutions are built to deliver to their customers a unique and competitive advantage.

All trademarks are registered by their respective companies.
Teledyne DALSA reserves the right to make changes at any time without notice.

Media Contacts:
Geralyn Miller
Teledyne DALSA
Tel: +1-519-886-6001 x2187
geralyn.miller@teledynedalsa.com

Sales Contacts:
Sales.americas@teledynedalsa.com
Sales.europe@teledynedalsa.com
Sales.asia@teledynedalsa.com

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/7b8edb76-22d8-4d8b-a508-986ae5d97eb7

Constellation Brands Reports Fiscal Year and Fourth Quarter 2019 Results and Fiscal Year 2020 Outlook

VICTOR, N.Y., April 04, 2019 (GLOBE NEWSWIRE) — Constellation Brands, Inc. (NYSE: STZ and STZ.B), a leading beverage alcohol company, reported today its fiscal year and fourth quarter 2019 results. A conference call to discuss the financial results and fiscal year 2020 outlook will be hosted by President and Chief Executive Officer Bill Newlands and Chief Financial Officer David Klein on Thursday, April 4, 2019 at 10:30 a.m. (eastern). Visit cbrands.com/investors/events to locate information for joining the conference call, or a live, listen-only webcast of the conference call.

About Constellation Brands
Constellation Brands (NYSE: STZ and STZ.B), a Fortune 500® company, is a leading international producer and marketer of beer, wine and spirits with operations in the U.S., Mexico, New Zealand, Italy and Canada. Constellation is the No. 3 beer company in the U.S. with high-end, iconic imported brands such as the Corona and Modelo brand families and Pacifico. Its high-quality, premium wine and spirits brands include the Robert Mondavi and The Prisoner Wine Company brand families, Kim Crawford, Ruffino, Meiomi and SVEDKA Vodka. The company’s portfolio also includes a collection of highly-rated, high-end brands such as SIMI and Mount Veeder Winery wine brands, High West Whiskey and Casa Noble Tequila, as well as new premium wine innovations such as Cooper & Thief and Spoken Barrel.

Based in Victor, N.Y., the company believes that industry leadership involves a commitment to brand building, our trade partners, the environment, our investors and to consumers around the world who choose our products when celebrating big moments or enjoying quiet ones. Since its founding in 1945, Constellation’s ability to see, meet and stay ahead of shifting consumer preferences and trends across total beverage alcohol has fueled our success and made us the No. 1 growth contributor in beverage alcohol in the U.S.

To learn more, follow us on Twitter @cbrands and visit www.cbrands.com.

MEDIA CONTACTS INVESTOR RELATIONS
Mike McGrew 773-251-4934 michael.mcgrew@cbrands.com Patty Yahn-Urlaub 585-678-7483 patty.yahn-urlaub@cbrands.com
Amy Martin 585-678-7141 amy.martin@cbrands.com Bob Czudak 585-678-7170 bob.czudak@cbrands.com
Tom Conaway 585-678-7503 thomas.conaway@cbrands.com

A downloadable PDF copy of this news release enhanced with multimedia links can be found here: http://ml.globenewswire.com/Resource/Download/4e9a1875-107f-4db6-9829-9ee5327bf73d

INVNT Secures Partnership with TEDxSydney For Tenth Anniversary Year

SYDNEY, AUSTRALIA, April 03, 2019 (GLOBE NEWSWIRE) — Following the success of TEDxSydney in 2018, INVNT, the global live brand storytelling agency™, has once again been named the official production partner for TEDxSydney, the leading platform for the propagation of Australian ideas, creativity and innovation, as the not-for-profit organisation celebrates the milestone 10-year anniversary of its flagship event on Friday, 24 May, 2019.

The role sees INVNT tasked with delivering the event for the second year running, which in 2019 embraces the theme of ‘Legacy.’ The team are responsible for designing and producing the event – which has already secured an impressive line-up of talent – including creative concepting, technical production and AV.

INVNT is also designing and producing The Hub, a dedicated area where attendees can interact between sessions, and the team are curating and creating a number of educational and thought-provoking activations within the space. These will showcase a selection of creatives, foodies, eco-warriors, technologists, artists and experts, and will include an activation from INVNT which will highlight the power of storytelling.

Importantly, INVNT will ensure the Legacy theme is woven throughout the event in strategic and thought-provoking ways, so that each and every touchpoint appeals to its audience of curious minds, game-changers, and those who seek to be inspired.

Commenting on the partnership Remo Giuffre, Founder and Licensee, TEDxSydney said: “We are thrilled to be teaming up with INVNT on such a nostalgic TEDxSydney 2019 event. Working with the INVNT agency in 2018 was a dream – nothing seemed to daunt the team as they infused their signature ‘challenge everything’ mantra into all aspects of the award-winning experience, and approached every challenge with both supreme competence and a welcome sense of calm.

“We exceeded a number of our objectives last year, including being a sell-out event attracting over 5,000 attendees – making it the biggest TEDxSydney yet. I am confident that with INVNT’s support, and the support of our many other valued partners, we will continue to kick goals in 2019 and beyond.”

Laura Roberts, Managing Director, INVNT APAC explained: “From its commitment to sustainability to passion for educating, informing and celebrating individuals from all walks of life, we love all that TEDxSydney stands for. We’re very excited to be producing the event again this year, and are committed to working with the TEDxSydney team and fellow event partners to make this very special 10-year anniversary celebration an experience to remember.”

Scott Cullather, CEO, INVNT added: “The TED brand is globally renowned and highly respected for its approach to storytelling. Audiences can always expect a stellar line-up of influential presenters who educate, inspire and entertain, all delivered within stylish and purposeful environments. We feel incredibly fortunate to be working on this culturally relevant event again in 2019, and can’t wait to share the ‘Legacy’-inspired creative concepts we’ve developed for TEDxSydney this coming May.”

For more information about TEDxSydney 2019 and to register, visit: www.tedxsydney.com

About INVNT
Founded in 2008 by Scott Cullather and Kristina McCoobery, INVNT is the global live brand storytelling agency™. The company’s “challenge everything” positioning statement helps clients including General Motors, Grant Thornton, Merck, PepsiCo, Samsung and Subway – share their stories – live – with every audience that matters. “The tribe” is INVNT’s diverse, talented and creative team behind the stories and brand experiences that people just can’t stop talking about. INVNT’s offices are strategically located in New York, London, Sydney, Detroit, San Francisco, Washington D.C., Stockholm and Singapore. For more information visit www.invnt.com

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Brea Carter
INVNT
+61 (0)423 330 082
bcarter@invnt.com

INVNT Secures Partnership with TEDxSydney For Tenth Anniversary Year

SYDNEY, AUSTRALIA, April 03, 2019 (GLOBE NEWSWIRE) — Following the success of TEDxSydney in 2018, INVNT, the global live brand storytelling agency™, has once again been named the official production partner for TEDxSydney, the leading platform for the propagation of Australian ideas, creativity and innovation, as the not-for-profit organisation celebrates the milestone 10-year anniversary of its flagship event on Friday, 24 May, 2019.

The role sees INVNT tasked with delivering the event for the second year running, which in 2019 embraces the theme of ‘Legacy.’ The team are responsible for designing and producing the event – which has already secured an impressive line-up of talent – including creative concepting, technical production and AV.

INVNT is also designing and producing The Hub, a dedicated area where attendees can interact between sessions, and the team are curating and creating a number of educational and thought-provoking activations within the space. These will showcase a selection of creatives, foodies, eco-warriors, technologists, artists and experts, and will include an activation from INVNT which will highlight the power of storytelling.

Importantly, INVNT will ensure the Legacy theme is woven throughout the event in strategic and thought-provoking ways, so that each and every touchpoint appeals to its audience of curious minds, game-changers, and those who seek to be inspired.

Commenting on the partnership Remo Giuffre, Founder and Licensee, TEDxSydney said: “We are thrilled to be teaming up with INVNT on such a nostalgic TEDxSydney 2019 event. Working with the INVNT agency in 2018 was a dream – nothing seemed to daunt the team as they infused their signature ‘challenge everything’ mantra into all aspects of the award-winning experience, and approached every challenge with both supreme competence and a welcome sense of calm.

“We exceeded a number of our objectives last year, including being a sell-out event attracting over 5,000 attendees – making it the biggest TEDxSydney yet. I am confident that with INVNT’s support, and the support of our many other valued partners, we will continue to kick goals in 2019 and beyond.”

Laura Roberts, Managing Director, INVNT APAC explained: “From its commitment to sustainability to passion for educating, informing and celebrating individuals from all walks of life, we love all that TEDxSydney stands for. We’re very excited to be producing the event again this year, and are committed to working with the TEDxSydney team and fellow event partners to make this very special 10-year anniversary celebration an experience to remember.”

Scott Cullather, CEO, INVNT added: “The TED brand is globally renowned and highly respected for its approach to storytelling. Audiences can always expect a stellar line-up of influential presenters who educate, inspire and entertain, all delivered within stylish and purposeful environments. We feel incredibly fortunate to be working on this culturally relevant event again in 2019, and can’t wait to share the ‘Legacy’-inspired creative concepts we’ve developed for TEDxSydney this coming May.”

For more information about TEDxSydney 2019 and to register, visit: www.tedxsydney.com

About INVNT
Founded in 2008 by Scott Cullather and Kristina McCoobery, INVNT is the global live brand storytelling agency™. The company’s “challenge everything” positioning statement helps clients including General Motors, Grant Thornton, Merck, PepsiCo, Samsung and Subway – share their stories – live – with every audience that matters. “The tribe” is INVNT’s diverse, talented and creative team behind the stories and brand experiences that people just can’t stop talking about. INVNT’s offices are strategically located in New York, London, Sydney, Detroit, San Francisco, Washington D.C., Stockholm and Singapore. For more information visit www.invnt.com

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Brea Carter
INVNT
+61 (0)423 330 082
bcarter@invnt.com