12/03/2019 02:01:26

Biocartis Group NV: Biocartis and Bristol-Myers Squibb Sign Collaboration Agreement for MSI Testing with Immuno-Oncology Therapies

PRESS RELEASE                                                            12 March 2019, 07:00 CET

Biocartis and Bristol-Myers Squibb Sign Collaboration Agreement for MSI Testing with Immuno-Oncology Therapies

Mechelen, Belgium, 12 March 2019 - Biocartis Group NV (the 'Company' or 'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced the signing of a collaboration agreement with Bristol-Myers Squibb Company (NYSE: BMY), a global biopharmaceutical company, aimed at the potential registration as a companion diagnostic and use of the IdyllaTM MSI test in connection with immuno-oncology therapies.

MSI ('Microsatellite Instability') is the result of inactivation of the body's so-called DNA mismatch repair (MMR) system. Consequently, errors that spontaneously occur during the normal process of DNA replication are no longer corrected, contributing to tumor growth and evolution. Understanding a person's MSI status may therefore be important for patient care. MSI-High status is found in various types of tumors[1], including approximately 15% of colorectal (CRC) tumors[2]. In addition to applications for CRC, MSI is believed to be an independent factor that may predict a patient's response to certain immunotherapies[3].

Bristol-Myers Squibb's Opdivo (nivolumab) plus low-dose Yervoy[4] (ipilimumab) is the first immuno-oncology combination treatment approved by the US Food and Drug Administration (FDA) for MSI-High or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with certain chemotherapies[5].

The fully automated IdyllaTM MSI test, that received CE-IVD marking on February 28, 2019, provides information on the MSI status[6],[7],[8] of CRC tumors within approximately 150 minutes from just one slice of FFPE[9] tumor tissue, without the need of a reference sample.

The collaboration agreement allows for joint developments and registrations of the IdyllaTM MSI test for use in a variety of indications, commercial settings and geographies. The first focus under the agreement is expected to be the registration in the United States of the IdyllaTM MSI test as a companion diagnostic test in mCRC.

Herman Verrelst, CEO of Biocartis, commented: "We are proud to announce today a collaboration with Bristol-Myers Squibb, one of the world leaders in the area of immuno-oncology therapies. It is our belief that because of the advantages of our IdyllaTMMSI test, MSI testing can potentially be made available to a broader patient population. This could open doors for a lot more patients to benefit from immunotherapies, matching the mission of Biocartis to make personalized medicine an everyday reality."

Financial details of the agreement are not disclosed.

----- END ----

More information:

Renate Degrave

Manager Corporate Communications & Investor Relations

e-mail    rdegrave@biocartis.com

tel         +32 15 631 729   

mobile   +32 471 53 60 64   

 @Biocartis_www.linkedin.com/Biocartis

About Biocartis 

Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx IdyllaTM platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology. This area represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer. More information: www.biocartis.com. Press Photo Library available here. Follow us on Twitter: @Biocartis_.

Biocartis and IdyllaTM are registered trademarks in Europe, the United States and other countries. The Biocartis trademark and logo and the IdyllaTM trademark and logo are used trademarks owned by Biocartis. This press release is not for distribution, directly or indirectly, in any jurisdiction where to do so would be unlawful. Any persons reading this press release should inform themselves of and observe any such restrictions. Biocartis takes no responsibility for any violation of any such restrictions by any person. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. This press release does not constitute an offer or invitation for the sale or purchase of securities in any jurisdiction. No securities of Biocartis may be offered or sold in the United States of America absent registration with the United States Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act of 1933, as amended.

Forward-looking statements

This press release may contain forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements speak only as of the date of this press release. Biocartis expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements.

[1] Including urothelial, prostate, pancreas, adreno-cortical, small bowel, sarcoma, mesothelioma, melanoma, gastric, and germ cell tumors (Latham et al. (2018) J Clin Oncol 36, 1-9. 10.1200/JCO. 18.00283.)

[2] Source: https://fightcolorectalcancer.org/fight/diagnosis/what-is-msi-and-mss/, last consulted on 7 February 2019.

[3] Ongoing research to support the hypothesis that MSI can be an independent factor to help predict a patient's response to certain immunotherapies, includes: Le et al. (2015) N-Eng-J-Med: 10.1056/NEJMoa1500596, showing that MMR status predicted clinical benefit of immune checkpoint blockade therapy; and Le et al. (2017) Science: 10.1126/science.aan6733, showing that MSI is associated with overall mutational and indel load of the tumor, neoantigen load, and lymphocyte infiltration of the tumor, and has been shown to be predictive for response to immunotherapies such as anti-PD-1 in a pan-cancer setting.

[4] 3 mg/kg Opdivo plus 1 mg/kg Yervoy.

[5] Treatment with fluoropyrimidine, oxaliplatin and irinotecan.

[6] Maertens et al. Annals of Oncology (2017) 28 (suppl_5): v22-v42.

[7] De Craene et al. Annals of Oncology (2017) 28 (suppl_5): v209-v268.

[8] De Craene et al. J Clin Oncol 36, 2018 (suppl; abstr e15639).

[9] FFPE = formalin fixed, paraffin embedded.

Del

Post comment

Related debate

  • 1 week
  • 1 month
  • 1 Year
13 Mar
 
Skam dig selv. Jeg synes faktisk dit udsagn er urimeligt. Vedkommende har i god tro købt lidt aktier..
15
12 Mar
DANSKE
Finans bringer i dag en liste over de højest gagerede bankfolk i EU   5000 tjener over 1 mio.€ (hera..
15
18 Mar
GOMX
SAS's emmision overtegnet så de regner med 15MUSD i provenu samlet - godt nyt for GOMSpace hvis de k..
14
14 Mar
BA
Elliot.Blot for info så har jeg cirka 14.000 timer på 737 serien og der er altid problemer når en ty..
14
14 Mar
DANSKE
Danske Bank er sværd at værdiansætte set i forhold til den situation som Danske Bank befinder sig i...
12
13 Mar
ZEAL
Der er nogle enkelt punkter som jeg har noteret mig under læsningen af Årsrapporten 2018 samt de sen..
12
18 Mar
BAVA
For mig virker det ret underligt at udmelding fra FDA om ydereligere 3mdr mere behandlingstid bliver..
11
15 Mar
PNDORA
Det forhold, at Pandora på trods af negativ analyse fra Carnegie og udbetaling af udbytte har holdt ..
11
13 Mar
VELO
https://www.marketwatch.com/press-release/organ-transplantation-market-to-ascent-exponentially-at-98..
11
12 Mar
NOVO-B
Novo er nu tæt på et pas på område for de kortsigetede. Så jeg vil være OBS på, om købssignalerne æn..
11

#

EuroInvestor: In Focus
#

#

EuroInvestor: In Focus
#

#

EuroInvestor: In Focus
#

Most read news

  • 24 hours
  • 48 hours
  • 1 week
1
HPV Vaccine Mandate Ill-Advised, States Association of American Physicians and Surgeons (AAPS)
2
AzurRx BioPharma Announces Presentation on Its Positive Phase II Data in MS1819-SD in Chronic Pancreatitis at the 2019 Digestive Disease Week Conference
3
Jumio Partners with ComplyAdvantage to Reduce AML Risk Exposure
4
Global Gaming’s X2 Games Announces the Launch of Pre-Orders for its Cutting-Edge Amazon Alexa Powered Board Game St. Noire
5
BOXX Showcases Data Science Workstation and Other Solutions at GTC

Copyright Berlingske Media 2019  Cookie- and Privacy policy  |  Cookies  |   General terms of trade  |   Terms of use and IP rights
Quote information is delivered by Morningstar.
Data is delayed 15-20 minutes according to the distribution agreements set by the different exchanges.
 
19 March 2019 10:40:24
(UTC+00:00) Dublin, Edinburgh, Lisbon, London
Version: ReleaseBuild_20190215.1 - EUROWEB3 - 2019-03-19 11:40:24 - 2019-03-19 10:40:24 - 1000 - Website: OKAY