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NeXT generation of biotherapy monitoring by mass spectrometry 

a PERSONALISED dose
for each patient

mAbXmise determines the plasma concentration of monoclonal antibodies prescribed as single or combination therapies at selected time points. Its unique technology is based on mass spectrometry and allows multiplex measurement (several mAbs at once) with high analytical performances. The kit is designed to be easy-to-use and allows optimal reliability and accuracy using LC/MS technology. Healthcare professionals can then use the information to personalize treatment and manage patient care[1]

 

WHAT IS THERAPTIC DRUG MONITORING?

“A few years ago, I would say that LC/MS is not suitable for mabs because LC/MS is more suitable in measuring small molecules and it’s very complicated to measure proteins and mabs. Today, the method is more reliable and can be successfully used with generic kits. With the kits, it’s easier to implement them in clinical practice. The instructions are very clear.”

Pharmacologist, The Netherlands

Our range of
diagnostic kits

mAbXmise is a unique commercial ready-to-use kit approach, based on mass spectrometry, including stable-labelled mAbs as Internal Standards, and CE-IVD. There are numerous benefits to using mAbXmise kit technology:

  • mAbXmise helps reduce the chance of toxicity: Overexposure can be anticipated by monitoring drug concentration in blood[2]

  • mAbXmise is more cost-effective than other methods for patient receiving combination therapies (or treated conjointly with 2 monoclonal antibodies). mAbXmise multiplex assay enables the determination of concentrations of both mAbs in one single experiment, saving time and money[1]

  • Mass spectrometry produces an analytical robustness compared to immunoassays[3]

 

CONTACT US

Our PRODUCTS

The range developed by Promise Proteomics includes 7 products

and cover 6 therapeutic areas:

 

INFLAMMATION : Infliximab; Adalimumab; Obinutuzumab; Secukinumab; Tocilizumab; Ustekinumab; Vedolizumab

ONCOLOGY : Bevacizumab; Rituximab; Cetuximab; Trastuzumab; Nivolumab; Pembrolizumab; Ipilimumab

TRANSPLANTATION & RHEUMATOLOGY : Abatacept; Belatacept

HEMOPHILIA : Emicizumab

HEMATOLOGY : Eculizumab; Ravulizumab

ANTI-DRUG ANTIBODIES INFLAMMATION : ANTI-Infliximab; ANTI-Adalimumab

INCLUDED IN EACH KIT :

-96 well plate coated with stable labelled mAbs (internal standards)

-6 Calibrators

-2 Quality Controls

-Suited buffers and solutions

-Specific consumables

-Protease

Our technology step-by-step

Key assets

From the patient’s blood sample to the monitoring of therapeutic antibodies,
mAbXmise diagnostic kits are:

EASY-TO-USE

sample preparation with mAbXmise labelled

internal standards added to blood sample

MULTIPLEX

quantitative analysis

using mass spectrometry,

measuring simultaneously

several therapeutic mAbs

ACCURATE

measurement of therapeutic mabs

with 100% accuracy and

specificity according to

the peptide signature

Therapeutic Drug Monitoring

Therapeutic drug monitoring consists of measuring the plasma concentration of a drug, so as to adjust the dosing and maintain its target plasma concentration.

Since the 2000s, monitoring of therapeutic antibodies has begun to emerge in the management of inflammatory diseases and oncology, with immunological methods.

mAbXmise uses a different approach. It lies on mass spectrometry, a particularly sensitive and above all extremely specific technology. The technology allows the therapeutic antibody in the sample to be measured very accurately.

We believe the onset of mAbXmise technology will dramatically change the way biologics are monitored in the future.

Current treatment regimens are still either single-dose or calculated on the basis of patient weight, whereas there is increasing evidence of inter-patient variability due to several factors such as age, gender, pathological state and others.

With mAbXmise, we hope we can facilitate the adoption of this practice in the hospital, to allow individualized medicine by personalizing the frequency of administration, compensate for inter-individual variability and reducing treatment costs.[1]

     

 

mAbXmise kits are in vitro diagnostic medical devices intended for healthcare professionals. These are monoclonal antibody quantification kits: see the specific instructions for more information

Our company

Promise Proteomics was created in 2010 as a spin-off of CEA Grenoble (France). This medtech company is currently wholly owned by the Aguettant group and is directed by Dr Eric Rougemond.

 

Since 2013, Chief Scientific Officer of Promise, Dorothee Lebert, has led ambitious and collaborative R&D programs which have allowed to develop the technology, on which the diagnostic kits for personalized medical applications are based.

 

Capitalizing on its unique know-how in the production of internal standards for protein assays and its recognized expertise in mass spectrometry-based quantification methods, Promise Proteomics is placing its skills at the service of healthcare professionals through its mAbXmise kits.

OUR INTEGRATED COMPANY

Innovation, Development, Industrialization, Production capacities, Market Acess & Regulatory affairs, Quality are the expertises gathered by the company.

 

 

4

patents

4

patents

7

articles on Therapeutic
Drug Monitoring

7

articles on Therapeutic
Drug Monitoring

>10

years of expertise
in proteomics

>10

years of expertise
in proteomics

> 6

TDM projects in
our pipeline

> 6

TDM projects in
our pipeline

Our references & awards

 

KEY REFERENCES

> Cross-Validation of a Multiplex LC-MS/MS Method for Assaying mAbs Plasma Levels in Patients with Cancer: A GPCO-UNICANCER Study.

Pharmaceuticals. 2021

 

> Quantification of infliximab and adalimumab in human plasma by a liquid chromatography tandem mass spectrometry kit and comparison with two ELISA methods.

Bioanalysis 2022

AWARDS

> Awardee of the Proof-of-concept program for ambitious R&D programs in public-private partnership, addressing a medical need in Oncology (2017)

 

> Semifinalist of AACC’s disruptive technology award session rewarding the next innovative testing solution that will transform patient care (2018)

 

The related patents numbers are :

US11543416, US11053303, US11630111, EP3165928, EP3165922, and EP3457139

 

Pilot clinical study at Lyon University Hospital (HCL, France)

Launched in 2017, MADMAS study aims at developing a dosing method to monitor plasma levels of nivolumab, pembrolizumab and ipilimumab and to draw a exposure-response correlation in patients with lung cancer and melanoma.

Quality Affairs & Regulatory affairs

Promise proteomics kits are now CE IVD marked.

Promise proteomics is also ISO9001 / ISO13485 certified and will then seek approval by the Food and Drug Administration (FDA 510K) for the US market.

 

[1] Marin, C.; et al. Cross-Validation of a Multiplex LC-MS/MS Method for Assaying mAbs Plasma Levels in Patients with Cancer: A GPCO-UNICANCER

Study. Pharmaceuticals 2021, 14, 796. https://doi.org/10.3390/ph14080796

[2] Broué, F. Advantages of monitoring biotherapies in oncology. La Lettre du Cancérologue, 90-91. 2022

[3] Millet A, Khoudour N, Guitton J, Lebert D, Goldwasser F, Blanchet B, Machon C. Analysis of Pembrolizumab in Human Plasma by LCMS/HRMS.  Method Validation and Comparison with Elisa. Biomedicines. 2021 May 30