Ardigen finalized the registration of two clinical studies
Last month, Ardigen finalized the registration of two observatory clinical studies at ClinicalTrials.gov:
- “BioForte Technology for in Silico Identification of Candidates for a New Microbiome-based Therapeutics and Diagnostics” – NCT04136470
- “AImmune – Artificial Intelligence Algorithm for Identification of Immunogenic Neoepitopes of Cancer to Predict and Boost Patient’s Response to Immunotherapies” – NCT04145232
A total of 130 patients with non-small cell lung cancer (NSCLC) and 30 patients with renal cell carcinoma (RCC) will be recruited for these studies. Patients are receiving routine immunotherapy for the respective indications (anti-PD1, anti-PDL1 and/or anti CTLA4 antibodies).
For both clinical studies, the collection of peripheral blood (PBMC), tumor biopsy (FFPE) and stool samples will be performed for each patient before treatment. Samples will be sequenced by next-generation sequencing platform (PBMC, FFPE) and long-read sequencing technology (stool). In parallel, Ardigen will also collect follow-up information of responses to treatment. Collected samples and associated data will be used to develop and validate Ardigen’s unique technologies: Translational Microbiome Platform (BioForte) and Personalized Cancer Vaccine Design and Biomarker Discovery Platform (A.I.mmune).
The Translational Microbiome Platform technology aims to in silico determine candidates for novel microbiome-based therapeutics and diagnostics. The platform, combining the expertise in Artificial Intelligence and biology, discovers functional features present in gut microbiome. Insight into selected features leads to the discovery of biomarkers, novel drugs, immunostimulatory microbial agents or definition of therapeutic bacterial consortia. In perspective, the Translational Microbiome Platform technology can replace the long and expensive laboratory procedure for this kind of research. The project is funded by The National Centre for Research and Development (POIR.01.01.01-00-0347/17).
The goals of the Personalized Cancer Vaccine Design Platform and Biomarker Discovery Platform technologies are to perform complex analyses of patients’ tumor and immune system state to identify predictive biomarker of response and cancer neoantigens that have therapeutic potential.
The key challenges to be solved using this Personalized Cancer Vaccine Design technology is to predict for each patient which neoepitopes are:
- -likely to bind to HLA,
- -presented on the tumor cell surface,
- -recognized by the T-cell receptor and
- -capable of inducing stable immunogenic response
- -unlikely to be tolerogenic or cause adverse effects.
The presence of such epitopes is required for immunotherapy in order to have an effect on the disease.
The characterization of those epitopes would enable the design of strategies for boosting immune responses which could have an impact on the development of personalized cancer vaccines and adoptive cell therapies.
The key challenges to be solved using the Biomarker Discovery Platform technology is to comprehensively analyze thousands of factors weeding out predictive biomarkers of response to immune checkpoint blockade, and prognostic for other immunotherapies.
The project is funded by Małopolskie Centre of Entrepreneurship (RPMP.01.02.01-12-0301/17).
ClinicalTrials.gov is a resource which provides the public with easy access to information about clinical studies on a wide range of diseases and conditions conducted on human volunteers. This database is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).
Read more at:
https://clinicaltrials.gov/ct2/show/NCT04136470
https://clinicaltrials.gov/ct2/show/NCT04145232
