Daily Archives: April 2, 2019

Combination of first-in-class NBTXR3, radiotherapy, and anti-PD-1 immunotherapy demonstrate efficacy in treating resistant pre-clinical in vivo models of lung cancer

Data presented at AACR Annual Meeting 2019

  • In vivo study conducted alone or in collaboration with The University of Texas MD Anderson Cancer Center demonstrated:
    • NBTXR3 in combination with a PD-1 inhibitor enhanced an abscopal effect in both sensitive and PD-1-inhibitor-resistant lung cancer models
    • NBTXR3 in combination with a PD-1 inhibitor showed significant reduction of metastatic load in PD-1-inhibitor- sensitive lung cancer models
    • NBTXR3 in combination with a CTLA-4 inhibitor enhanced an abscopal effect in colorectal cancer models
  • Data presented by the Weill Cornell Medical College showed that NBTXR3 mode of action induced interferon (IFN-β) expression in breast cancer cell line
  • Altogether, the data presented support the ongoing clinical development plan for combinations of NBTXR3 with radiotherapy and immuno-oncology (IO) agents in multiple indications including lung- and head and neck cancers

Paris, France; Cambridge, Massachusetts (USA); April 2, 2019 – NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205 – the ‘‘Company’’) a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced preclinical data from studies currently being conducted under its collaborations with The University of Texas MD Anderson Cancer Center and the Weill Cornell Medical College. These results were presented during two poster sessions at the American Association for Cancer Research (AACR) Annual Meeting 2019, currently taking place in Atlanta, Georgia, USA from March 29 to April 3, 2019.

This initial pre-clinical set of NBTXR3/radiotherapy/IO combination data provides further insights into the immune-activation caused by NBTXR3 and strengthens the understanding of the potential systemic effects provided by NBTXR3. Thus, the Company believes it formulates sound rationale to support its clinical development program investigating the combination of NBTXR3, radiotherapy and IO agents.

Enhancement of anti-PD-1 and anti-CTLA4 efficacy by NBTXR3 nanoparticles exposed to radiotherapy Poster #3225
Yun Hu1, Ping Zhang2, Audrey Darmon2, Maria Angelica Cortez1, Sébastien Paris2, James Welsh1
1MD Anderson Cancer Center, Houston, TX; 2Nanobiotix, Paris, France

In both 344SQ_P (sensitive to anti-PD-1 treatment) and 344SQ_R (resistant to anti-PD-1 treatment) lung cancer models, the combination of anti-PD-1 + radiotherapy + NBTXR3 demonstrated both better control of the treated tumor and the distant untreated tumor as well as increased survival when compared to monotherapy. Importantly, it was observed that this combination decreased spontaneous lung metastasis formation in the anti-PD-1 sensitive 344SQ_P model.

For the CT26.WT colon carcinoma model, as previously reported, NBTXR3 activated by radiotherapy generated an abscopal effect. It was observed that administration of anti-CTLA4 monotherapy demonstrated control of both treated and distant untreated tumors, potentially indicating that the CT26.WT was sensitive to a checkpoint inhibitor. The addition of radiotherapy to anti-CTLA4 only improved the tumor control modestly compared to anti-CTLA4 alone. In contrast, the combination of anti-CTLA4 + radiotherapy + NBTXR3 in this trial showed the best control of the treated and distant untreated tumors, then any single agent or doublet combination.

NBTXR3 Potentiates Cancer-Cell Intrinsic Interferon beta Response to Radiotherapy Poster #3366
Maria Esperanza Rodriguez-Ruiz1, Karsten A Pilones1, Camille Daviaud1, Jeffrey Kraynak1, Audrey Darmon2, Sébastien Paris2 and Sandra Demaria1
1Department of Radiation Oncology, Weill Cornell Medicine, New York, USA; 2Nanobiotix, Paris, France

Data suggests that NBTXR3 enhances the effectiveness of radiation and improves tumor immunogenicity in murine breast cancer cell lines, via the induction of type-I interferon (IFN-I). In the study, NBTXR3 activated by radiotherapy amplified cancer cell intrinsic IFN-I response and showed a significant improvement in tumor control compared to radiotherapy alone with complete durable regression of tumors.

About NBTXR3

NBTXR3 is a first-in-class product candidate designed to destroy tumors and metastasis when activated by radiotherapy.

NBTXR3 has a high degree of biocompatibility and requires one single administration before the whole radiotherapy treatment. Nanobiotix believes NBTXR3 has the ability to fit into current worldwide standards of radiation care.

Nanobiotix’s broad clinical program includes seven clinical trials. In June 2018, Nanobiotix established human proof of concept for this first-in-class product candidate in its soft tissue sarcoma (STS) Phase III clinical trial.

NBTXR3 is actively being studied in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity or oropharynx in elderly and frail patients who are unable to receive chemotherapy or cetuximab and have very limited therapeutic options. Promising results from these clinical studies have been observed from the ongoing Phase I/II trial regarding the local control of tumors.

Nanobiotix is also running an immuno-oncology development program. In the United States, Nanobiotix has received approval from the U.S. Food and Drug Administration to launch a clinical study of NBTXR3 activated by radiotherapy in combination with anti-PD1 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.

The first market authorization process (CE Marking) for the STS indication is ongoing in Europe.

About NANOBIOTIX:

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. 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. At the moment, NBTXR3 does not bear a CE mark and the Company is not permitted to be place NBTXR3 on the market or put into service until it has obtained a CE mark.

Attachment

Organisations should prioritise risk function’s digital fitness to make smarter decisions

LONDON, April 02, 2019 (GLOBE NEWSWIRE) — Organisations should focus on developing stronger digital skills and capacity in their risk function in order to make more informed decisions about risk in a technology-driven world, according to the eighth edition of PwC’s Risk In Review study.

The 2019 study has found that while many organisations have already embraced new technology as part of their internal audit, risk and compliance functions they are yet to fully realise the potential benefits of using the insights to inform decisions over investment in digital transformation.

PwC’s study focuses on identifying what categories help top-performing ‘digitally fit’ risk functions stand out both in terms of their ability to strategically advise stakeholders on risk and assurance, as well as the risk function’s own ability to adapt and embed new processes required by digital transformation.

The six habits of risk functions that fuel smarter risk-taking are:

  1. Go all-in on the organisation’s digital plan
  2. Upskill and inject new talent to move at the speed of the organisation
  3. Find the right fit for emerging technologies
  4. Enable the organisation to act on risks in real time
  5. Actively engage decision makers of key digital initiatives
  6. Collaborate and align to provide a consolidated view of risks

PwC surveyed more than 2,000 CEOs, senior executives, board members, and professionals in risk management, compliance and internal audit, and interviewed dozens of executives and board members to explore what differentiates risk functions when it comes to digital transformation.

Jim Woods, Global Risk Assurance Leader at PwC says,

‘Risk professionals are at a critical juncture. As technology transforms the way we do business – from data analysis to more automation – so too do the potential risks. At the same time, digital transformation is also driving the potential for identifying risk and making smarter decisions yet the study highlights that many risk functions are not fully realising this.

‘Only 22% of chief executives who responded to PwC’s 22nd CEO Survey called the risk exposure data they receive comprehensive enough for long-term decision-making – the same figure as ten years ago. This should indicate that risk functions are not harnessing the power of abundant data available.

‘It is vital that risk professionals recognise that by improving their digital fitness they can take an active approach to becoming important partners and leaders in helping their organisations get better benefits from their digital initiatives.’

The study identifies the key components of an organisation’s ‘digital fitness’ as:

  1. Having in place the skills and competencies to strategically advise stakeholders on risk and provide assurance over the organisation’s digital initiatives
  2. Changing the risk function’s own processes, tools, and services so they’re more data driven and digitally enabled to anticipate risk events and respond to them at the pace and scale the organisation’s digital transformation requires

Jim Woods says,

‘Organisations with dynamic risk functions enjoy more effective risk management, which contributes to greater confidence in taking risks, a faster and safer digital journey, and greater-than-anticipated value from digital investments.

‘Any fitness regime can seem overwhelming at first. Yet rather than dive straight in, you should develop a plan first and then focus on the steps you need to build up your capability over time.

‘Risk professionals should take note of the plans followed by digitally fit organisations and be confident that they will start to see rapid rewards if they invest the time and resources required now.’

Being a smarter risk taker through digital transformation: 2019 Risk In Review Study is available to read here.

Notes to editors

About PwC
At PwC, our purpose is to build trust in society and solve important problems. We’re a network of firms in 158 countries with over 250,000 people who are committed to delivering quality in assurance, advisory and tax services. Find out more and tell us what matters to you by visiting us at www.pwc.com.

PwC refers to the PwC network and/or one or more of its member firms, each of which is a separate legal entity. Please see www.pwc.com/structure for further details.

© 2019 PwC. All rights reserved

Contact: David Bowden
Mobile: +44(0)7483365049
Email: david.bowden@pwc.com

Organisations should prioritise risk function’s digital fitness to make smarter decisions

LONDON, April 02, 2019 (GLOBE NEWSWIRE) — Organisations should focus on developing stronger digital skills and capacity in their risk function in order to make more informed decisions about risk in a technology-driven world, according to the eighth edition of PwC’s Risk In Review study.

The 2019 study has found that while many organisations have already embraced new technology as part of their internal audit, risk and compliance functions they are yet to fully realise the potential benefits of using the insights to inform decisions over investment in digital transformation.

PwC’s study focuses on identifying what categories help top-performing ‘digitally fit’ risk functions stand out both in terms of their ability to strategically advise stakeholders on risk and assurance, as well as the risk function’s own ability to adapt and embed new processes required by digital transformation.

The six habits of risk functions that fuel smarter risk-taking are:

  1. Go all-in on the organisation’s digital plan
  2. Upskill and inject new talent to move at the speed of the organisation
  3. Find the right fit for emerging technologies
  4. Enable the organisation to act on risks in real time
  5. Actively engage decision makers of key digital initiatives
  6. Collaborate and align to provide a consolidated view of risks

PwC surveyed more than 2,000 CEOs, senior executives, board members, and professionals in risk management, compliance and internal audit, and interviewed dozens of executives and board members to explore what differentiates risk functions when it comes to digital transformation.

Jim Woods, Global Risk Assurance Leader at PwC says,

‘Risk professionals are at a critical juncture. As technology transforms the way we do business – from data analysis to more automation – so too do the potential risks. At the same time, digital transformation is also driving the potential for identifying risk and making smarter decisions yet the study highlights that many risk functions are not fully realising this.

‘Only 22% of chief executives who responded to PwC’s 22nd CEO Survey called the risk exposure data they receive comprehensive enough for long-term decision-making – the same figure as ten years ago. This should indicate that risk functions are not harnessing the power of abundant data available.

‘It is vital that risk professionals recognise that by improving their digital fitness they can take an active approach to becoming important partners and leaders in helping their organisations get better benefits from their digital initiatives.’

The study identifies the key components of an organisation’s ‘digital fitness’ as:

  1. Having in place the skills and competencies to strategically advise stakeholders on risk and provide assurance over the organisation’s digital initiatives
  2. Changing the risk function’s own processes, tools, and services so they’re more data driven and digitally enabled to anticipate risk events and respond to them at the pace and scale the organisation’s digital transformation requires

Jim Woods says,

‘Organisations with dynamic risk functions enjoy more effective risk management, which contributes to greater confidence in taking risks, a faster and safer digital journey, and greater-than-anticipated value from digital investments.

‘Any fitness regime can seem overwhelming at first. Yet rather than dive straight in, you should develop a plan first and then focus on the steps you need to build up your capability over time.

‘Risk professionals should take note of the plans followed by digitally fit organisations and be confident that they will start to see rapid rewards if they invest the time and resources required now.’

Being a smarter risk taker through digital transformation: 2019 Risk In Review Study is available to read here.

Notes to editors

About PwC
At PwC, our purpose is to build trust in society and solve important problems. We’re a network of firms in 158 countries with over 250,000 people who are committed to delivering quality in assurance, advisory and tax services. Find out more and tell us what matters to you by visiting us at www.pwc.com.

PwC refers to the PwC network and/or one or more of its member firms, each of which is a separate legal entity. Please see www.pwc.com/structure for further details.

© 2019 PwC. All rights reserved

Contact: David Bowden
Mobile: +44(0)7483365049
Email: david.bowden@pwc.com

Chaineum acts as STO Advisor for Carthagea

Chaineum, a France-based corporate finance advisory firm and a pioneering Initial Coin Offering (“ICO”) advisor, accompanies the first French law governed “Security Token Offering” (“STO”) on behalf of its client Carthagea.

A STO is a new fundraising trend consisting in the issuance of financial securities to be registered and eventually, in the future, exchanged on a blockchain. The STO of Carthagea will be carried out in compliance with the French ordinance No. 2017-1674 of December 8, 2017, and Decree No. 2018-1226 of December 24, 2018.

As part of this transaction, Carthagea intends to raise funds for a total amount of up to €100 million. It will be carried out through a private placement of ordinary shares to qualified investors individually investing at least €100,000, under the exemption on requirement to publish a prospectus provided by the Prospectus Directive, as transposed under French law in Articles L. 411-2 I 2° of the Monetary and Financial Code and 211-2 I 3 of the General Regulations of the French Financial Markets Authority(AMF).

“This is a unique opportunity for Carthagea to consolidate its position as a key player in the field of operating nursing homes for the elderly in Tunisia. Strengthening this geographical position will allow us to pursue the transformation of luxury hotels in the country to the benefit of dependent elderly persons who sometimes suffer from neurodegenerative diseases” said Alexandre Canabal, CEO of Carthagea.

About Chaineum

Founded in 2015, Chaineum is a leading corporate finance advisory firm with a strong expertise in ICOs and STOs, and a strategic focus on both its clients’ business and blockchain technology.

https://www.chaineum.com

About Carthagea

Carthagea is a French operator of nursing homes in Tunisia. Its geographical positioning has allowed the rapid growth of its innovative concept that aimed at partially converting luxury hotels into residential facilities for dependent elderly persons, sometimes suffering from neurodegenerative diseases (Alzheimer, Parkinson, multiple sclerosis, etc.).

https://www.carthagea.fr/sto.php

Legal advisors:

Carthagea and its founders are advised by Mr. Stéphane Daniel and Mr. Daniel Arroche, Lawyers at the Paris Bar.

Investor Relations

Laurent LELOUP

Chaineum

e-mail: ll@chaineum.com

WARNING

This press release is for information purposes only and does not constitute an offer to sell or acquire financial securities or a solicitation in relation to such an offer in any country, including France.