Bordeaux, France — March 24, 2019 — Explicyte and Institut Bergonié have entered into a strategic collaboration to jointly drive a comprehensive translational research program focused on identifying mechanisms of resistance to immune checkpoint inhibitors in cancer patients.
Addressing Resistance to Immune Checkpoint Inhibitors
Over the last few years, cancer immunotherapies designed to mobilize the immune system against tumors have led to major clinical breakthroughs across multiple malignancies.
However, response rates remain limited in several cancer types, and immune-related adverse events continue to represent an important clinical challenge. A deeper understanding of response and resistance mechanisms is therefore essential to identify:
- predictive biomarkers of response or resistance to immune checkpoint inhibitors;
- biological mechanisms associated with primary or acquired resistance;
- new therapeutic combination strategies;
- markers associated with immune-related adverse events.
A Prospective Multicentric Translational Study
The prospective multicentric study will include cancer patients treated with PD-1 or PD-L1 antagonists according to their approved indications.
A total of 200 patients will be enrolled, with the primary objective of identifying an integrated predictive signature of immune checkpoint inhibitor efficacy. Secondary objectives include the identification of primary and secondary resistance mechanisms, as well as the prediction of immune-related adverse events.
All patients will undergo sequential collection of tumor, blood, and fecal samples at baseline, after two treatment cycles, and at disease progression.
A Multi-Technology Approach to Tumor, Blood, and Microbiome Profiling
The program will rely on a comprehensive and integrated translational workflow combining tumor, blood, fecal, clinical, and radiomics data.
Tumor biopsies will be analyzed using:
- comprehensive genomic profiling, including exome sequencing and RNA sequencing;
- quantitative multiplex immunohistochemistry;
- proteomic profiling by mass spectrometry.
Blood samples will be assessed through:
- plasma metabolomics using high-resolution LC-MS;
- PBMC immunophenotyping by flow cytometry;
- ex vivo functional immune response characterization upon immunotherapy.
Fecal samples will support microbiome-related analyses, while results from all biological platforms will be correlated with clinical outcome and radiomics features.
Explicyte’s Role as an Integrated Analytical Platform
Through this collaboration, Explicyte contributes its expertise in immuno-oncology assay development, preclinical and translational model implementation, and multiparametric experimental platform management.
Explicyte will support the generation, integration, and interpretation of functional and molecular datasets designed to better understand patient response to immune checkpoint inhibitors.
This collaboration reinforces Explicyte’s position as a specialized immuno-oncology CRO capable of supporting translational research programs from biological sample analysis to clinically relevant biomarker discovery.
Combining Clinical Excellence and Translational Expertise
“Thanks to the combination of Institut Bergonié and Explicyte expertise, including early-phase clinical trials, sequential blood and tumor sampling, and appropriate multiparametric experimental platform management, we are able to jointly drive this innovative translational research program. It will certainly generate opportunities for Explicyte and pave the way for similar approaches in the future, strongly supporting our service activities,” said Dr Alban Bessede, CEO of Explicyte.
“Many researchers have been working to validate single predictive biomarkers of immune checkpoint inhibitor efficacy. Instead, we are convinced that a multiparametric and integrated approach can fuel new discoveries, from the identification of predictive tools to the development of innovative therapeutic combination strategies. To this end, we want to create a research consortium with patients as partners, and Explicyte as a valuable analytical platform to ultimately help current and future generations of patients,” said Pr Antoine Italiano, Head of the Early Phase Trials Unit at Institut Bergonié.
About Explicyte
Explicyte is a specialty immuno-oncology Contract Research Organisation providing preclinical and translational services to support cancer immunotherapy drug discovery and development.
Its translational service offering spans cell-based assays for the screening of novel immunotherapeutics and the characterization of their mechanisms of action, through to preclinical in vivo studies using well-characterized syngeneic mouse tumor models.
Through an evolving multi-technology platform, Explicyte supports sponsors in exploring anti-tumor immune responses, identifying mechanisms of action, and developing innovative models to serve drug development programs.
About Institut Bergonié
Institut Bergonié is labelled by the French National Cancer Institute as a reference center for early-phase clinical trials in oncology and as a national referral center for the diagnosis and management of patients with sarcomas.
Between 2015 and 2018, the Early Phase Clinical Trials Unit led by Pr Antoine Italiano enabled more than 3,000 patients with advanced cancer to access early-phase clinical trials, positioning Institut Bergonié as a European leader in therapeutic innovation.
The Early Phase Clinical Trials Unit supports industry-sponsored research in patients with all types of solid tumors and hematological cancers.