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Next-generation biotherapy
monitoring

The right dose
for each patient

mAb-X-mise determines the plasma concentration of therapeutic mAbs prescribed as single or combination therapies at selected time points. The kit is designed to be easy-to-handle and allows optimal reliability and accuracy using mass spectrometry technology. Healthcare professionals can then use the information to personalize each mAb therapy.

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.

mAb-X-mise 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 mAb-X-mise 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 mAb-X-mise, we hope we can facilitate the adoption of this practice in the hospital, to allow individualized medicine and compensate for inter-individual variability.

We believe our diagnostics kits will enable the medical team to better manage treatment efficacy and side-effects.

 

“Developing specific bioanalytical methods meeting the requirements of routine therapeutic drug monitoring (TDM) is critical in oncology. A rising number of clinical  reports show that exposure levels of an increasing number of biologics (e.g., cetuximab, bevacizumab, trastuzumab, rituximab) and immuno-oncology drugs (e.g., ipilimumab, nivolumab) are associated with clinical outcome (efficacy, toxicity). This suggests that TDM with adaptive dosing strategies could help to optimize the efficacy/toxicity balance of monoclonal antibodies”

 

Pr Joseph Ciccolini, Aix-Marseille University & University Hospital of Marseille, France

The technology developed by Promise was successfully implemented and validated in our lab for two therapeutic mAbs. We are currently leading a collaborative project on therapeutic drug monitoring (TDM) in which we have compared data for Nivolumab quantification in plasma, obtained on two different LC-MS instruments and where samples were operated on two different sites. The data are perfectly consistent, attesting the analytical performances and robustness of Promise technology.”

 

Pr Jerome Guitton, University Hospital of Lyon, France

“Immunotherapies are routinely used to treat many different tumors, including melanoma. The efficacy of anti-PD1 and anti-CTLA4 antibody treatments is characterized by a large inter-individual variation. To date, it is not routinely possible for the clinician to determine the level of these antibodies in the blood in order to correlate their level with a risk of loss of efficacy (if under-prescribed) or a risk of increased toxicity (if over-prescribed). Having tools at our disposal to collect this information should enable us to recommend treatment adaptations if necessary and assess whether these adaptations are beneficial to the patients.”

 

Pr Stephane Dalle, University Hospital of Lyon, France

“There is a strong relevance for the therapeutic monitoring of antibodies prescribed in immuno-oncology, as it has been done for several years for tyrosine kinase inhibitorsand anti-TNFs in inflammation. There is today a frenzy around the immuno-oncology therapies available to clinicians; the next challenge will be to optimize the efficacy of each treatment while reducing toxicity and controlling costs. Therapeutic monitoring should allow this fine-tuning.”

 

Pr Sebastien Couraud, University Hospital of Lyon, France

Our range of
diagnostic kits

The range developed by Promise Proteomics includes two products:

  • a kit specifically designed for monitoring therapeutic antibodies prescribed for inflammatory diseases and
  • a second kit, targeting antibodies prescribed for the treatment of cancers.

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

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 mAb-X-mise kits.

Our team

Promise proteomics’ team is led by Dr Eric Rougemond, CEO and Dorothée Lebert, CSO and gathers the right expertises to implement successfully TDM solutions.

 

3

patents

3

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

collaborations in
Europe and US

6

collaborations in
Europe and US

Our references & awards

 

KEY REFERENCES

> Determination of Cetuximab in Plasma by Liquid Chromatography-High-Resolution Mass Spectrometry Orbitrap With a Stable Labeled 13C,15N-Cetuximab Internal Standard.

Ther Drug Monit. 2019

 

> Infliximab quantitation in human plasma by liquid chromatography-tandem mass spectrometry: towards a standardization of the methods?

Analytical and Bioanalytical Chemistry, 2017

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)

 

 

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 is currently filling the technical dossier for the CE marking for the European market
and will then seek approval by the Food and Drug Administration (FDA 510K) for the US market.
ISO9001 and ISO13485 quality certifications are also equally underway.