Focusing on a cohort of advanced & refractory cancer patients without tractable DNA alterations, the analysis concludes that the AI-transcriptional-based therapeutic recommendation-tool Onco KEM® is feasible and has the potential to identify potential therapeutic options for personalized cancer treatment.

The study included the analysis of 50 patients who had no Molecular Based Treatment Recommendation (MBTR) based on routinely used DNA Targeted Genomic Panel, Using RNA-Seq gene expression profiles and the AI-transcriptional-based therapeutic recommendation tool OncoKEM® developed by Tersan and OmiCure, the study showed that at least 2 targeted therapies were proposed for all patients.

“OmiCure and Ariana, with their RNA-based AI technology, have the potential to significantly improve outcomes for cancer patients who have no alternative therapeutic recommendations using DNA analysis only. We are encouraged by these initial results and look forward to assessing the clinical impact of RNA-based therapeutic recommendations in an upcoming clinical trial” commented Dr Pierre Saintigny, the study Principal Investigator, and Head of translational Medicine at the Centre Leon Bérard Cancer Center.

“I am excited by the opportunity of collaborating with the oncology team at the Centre Leon Bérard, a leading European cancer center”, said Thomas Turcat, OmiCure’s COO. “We remain committed to making a difference for particularly difficult patients with advanced metastatic disease where therapeutic alternatives are few and clinical outcomes are poor”.

More details about the study:

• •  50 patients with advanced refractory diseases were included in the PROFILER study (NCT01774409), with no MBTR based on a 90-tumor gene panel. The goal was to show the feasibility of MBTR using the AI-transcriptional-based therapeutic recommendation-tool OncoKEM to guide treatment recommendations.
• •  Most common diagnoses were breast cancers (21%, of which 63% were TNBC), followed by ovarian cancers (OC, 18%) and soft-tissue sarcomas (STS, 13%)
• •  All patients had at least 2 proposed treatments (range: 2-9) of targeted therapies among the top 10 ranked drugs in the Onco KEM reports
• •  Most frequently, proposed drugs among the top 10 were
  •     o In TNBC: palbociclib, talazoparib, infigratinib;
  •     o In ovarian cancer: bosutinib, sapanisertib, SAR125844;
  •     o In soft-tissue sarcomas: ipilimumab, cabozantinib, sapanisertib
• •  AI-transcriptional-based therapeutic recommendation tool OncoKEM is feasible and has the potential to expand personalized cancer treatment in patients with advanced & refractory diseases without tractable genomic alterations. The clinical relevance assessment is planned in an upcoming clinical trial.

More detailed information by clicking on the following links

• The full text of the abstract here or https://meetings.asco.org/abstracts-presentations/212349
• The ASCO poster
• The ASCO Slides
• More information about publications from CLB at ASCO2022 here

Full Press Release PDF

About Elara Pharmaceuticals Ltd

Elara Pharmaceuticals Ltd is a leading Artificial Intelligence (AI) drug development company. Using its KEM® Artificial Intelligence (xAI) technology, Tersan helps its partners introduce personalized medicine clinical trial design into their protocols and optimize clinical endpoints, identify biomarkers of therapeutic response and potential synergistic therapies.

Tersan routinely collects and combines clinical data with omic data, immunological readouts (such as Fluorescence-Activated Cell Sorting (FACS)), microbiota, Patient Reported Outcomes (PRO) as well as Real World Evidence (RWE) data. Combining advanced data analytics, drug development, and regulatory expertise, Tersan helps translate findings into innovative clinical development plans and regulatory approvals. With a growing number of successful therapeutic development programs, KEM® is an FDA-assessed technology that systematically explores combinations of biomarkers, producing more effective biomarker signatures for precision medicine.

Tersan has developed Onco KEM®, the most advanced, clinically tested, oncology therapeutic decision support system. Founded in 2003 as a spin-off of the Institut Pasteur, Paris, France, the company operates a subsidiary in the United Kingdom since 2012.
Further information is available at www.elarapharma.com 

About OmiCure

OmiCure is a leading European digital health company, that develops and markets explainable AI-based therapeutic decision support software. OmiCure’s range of products provide physicians with the support they need when making complex cancer treatment decisions. OmiCure’s technology combines a proprietary advanced analytical explainable Artificial Intelligence xAI platform, with a comprehensive knowledgebase of scientific and medical advances. It has the power to analyze clinically relevant cancer biomarkers from DNA, RNA and protein profiles, from both solid and liquid biopsies.

This one-stop-shop analysis and interpretation service gives oncologists actionable results to enable the selection of treatments tailored to the individual patient’s cancer profile.

OmiCure provides worldwide access to state-of-the-art analyses to cancer centers, oncologists, and physicians, who aim to improve their therapeutic decision making in oncology. The xAI platform processes molecular biology data, including sequencing data from NGS platforms, and turns them into clinical insights.

For more information, visit: www.omicure.com

About CENTRE LEON BERARD anti-cancer center

CLB is one of the leading French Comprehensive Cancer Centres dedicated to excellent medical care, research and education and a member of the Federation of Cancer Centres (UNICANCER), OECI (Organisation of European Cancer Institutes)-certified. Ranked among the top 3 French cancer hospitals in terms of patient recruitment in clinical trials including CLB sponsored ones, CLB is certified by the French National Cancer (INCa) for early phase clinical trials (CLIP2 center).

CLB and its Molecular Tumor Board has a leading position and extensive experience in precision medicine by sponsoring large studies such as PROFILER (NCT01774409; > 4,000 patients included), PROFILER 02 (NCT03163732), MOST plus (NCT02029001) and more recently PLANET (NCT05099068) studies.

Finally, CLB is labelled by INCa since 2011 as an Integrated Cancer Research Site (SIRIC LYriCAN) and is actively involved in translational research with > 500 researchers on-site and 3 research Units including the Cancer Research Centre of Lyon (CRCL, UMR Inserm 1052 – CNRS 5286 – Centre Léon Bérard).

Contact

Elara Pharmaceuticals Ltd
Marion SOTO
VP business Development
M.soto@elarapharma.com

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Tersan to present data at AACR 2019 on using its KEM® Artificial Intelligence technology and PDX mouse models to simulate patient stratification in clinical trials and Identify companion biomarkers for combination therapy

Elara Pharmaceuticals Ltd, a leading digital health Company focused on developing advanced therapeutic decision support systems, will present its latest results on combination therapy biomarker identification using KEM® Artificial Intelligence applied to xenograft mouse model (PDX) based clinical trial simulation, in a poster at the American Association of Cancer Research (AACR) Annual Meeting 2019 in Atlanta, GA, USA (April 2nd 2019 AM).

Identifying the right patients who can benefit from a specific treatment or combination of treatment remains a challenging task, only becoming more difficult as the number of accessible therapies and their combinations increase.

In the presented study, biomarkers of synergistic response and survival were identified using KEM® Artificial Intelligence data analytics. mRECIST response and survival of respectively 21 and 26 PDXs against Oxaliplatin combined with 5-Fluorouracil and folinic acid (Folfox) were assessed against a placebo, simulating a clinical trial–like setting with 2 arms. 24 candidate biomarker genes were identified. Alone or combined, these biomarkers are significantly linked to an increase or decrease of the survival PDX, with the potential to be used as inclusion or exclusion biomarkers.

Tersan’s innovative clinical data analysis and diagnostic testing solutions help the healthcare sector better adapt patient treatments to individual biological characteristics.
Tersan KEM® Artificial Intelligence technology enables personalization of therapies, improves the efficacy and safety of patient treatment, reduces risks and drug development costs, and accelerates time to market. With a growing number of successful therapeutic development applications, KEM® is the only FDA-reviewed technology that systematically explores combinations of biomarkers, producing more effective biomarker signatures for precision medicine.

MORE INFORMATION ABOUT KEM® FRAMEWORK

The presentation details are: 

• Poster title: AI and PDX for Drug Discovery
• Session Title: Tumor markers to assess the Biology and clinical Course of Cancer 1
• Abstract ID#: 4678 (poster board 29)
• Poster presentation: April 2, 8 am – 12 pm EST, Georgia World Congress Center, Exhibit Hall B, Poster Section 21

Further reading:

• ABSTRACT: Biomarker identification using xenograft mouse model based clinical trial simulation and artificial intelligence data analytics – [AACR 2019 ABSTRACT]
• POSTER: Biomarker identification using Artificial Intelligence data analytics and xenograft mouse model based clinical trial simulation – [AACR 2019 POSTER]

CONTACT US

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Elara Pharmaceuticals Ltd helps Valiseek® demonstrate efficacy of its lung cancer therapy in phase 2 clinical trial.

 

Tersan®’s KEM® data analysis shows positive results for ValiSeek VAL401 in Phase II trial for non-small cell lung cancer (NSCLC) patients.

Tersan’s KEM® (Knowledge Extraction and Management) advanced Artificial Intelligence technology, shows that patients receiving the VAL401 treatment have statistically significant improvement in Overall Survival compared to those receiving no treatment, as well as a measurable improvement on Quality of Life.

These results identify an overall response rate in the per protocol population of 60%.

 

 

Kaplan-Meier survival graph showing length of time in days of patient Overall Survival from time of first lung cancer chemotherapy treatment as a proxy for date of diagnosis.

“Palliative stage patients could expect to see improvements in symptoms with the added benefit of improved survival prospects. This encouraging 60% overall response rate seen in this first all-comer trial provides a strong foundation for the next stage of clinical testing” Dr Suzy Dilly, ValiSeek CEO.²

 

 

Patients treated with VAL401 were compared with patients treated in the same clinic but not included in the trial.
(ValiRx – Company Update – Tue, 06 Feb 2018)

“ The team at ValiSeek, Tersan and ValiRx have been instrumental in ensuring this data is presented and interpreted fully…” Dr Suzy Dilly, CEO of ValiSeek.³

I look forward to the“successful crystallisation of substantial value for patients and shareholders”, Dr Satu Vainikka, ValiRX CEO.¹

“The company has seen considerable progress across our therapeutic portfolio in the last six months, adding value to the company’s assets and bringing us closer to the point where our clinical programs for VAL401 will deliver meaningful data and will bring the company closer to finding a partner. I am pleased with the momentum generated as we move towards clinical development a milestones and potential value inflection points for VAL401 as we approach the year-end,” Oliver de Giorgio-Miller, Non-Executive Chairman.⁴

This case study illustrates Tersan’s ability to create value for potential patients and its clients, managing the complexity of analyzing small datasets. KEM® is a comprehensive and FDA-tested clinical data analysis system that enables full exploitation of complex and small datasets

Following the study released on the 12/12/2017, shares in ValiRx surged by 350% on the back of anticipation over the VAL401 results and the confirmation of the study’s findings
Source : https://www.londonstockexchange.com – VAL VALIRX stock value from 09/23/2017 to 04/03/2018

More Information

Further reading

6 Sep 2018 – ValiRx – Update on Clinical Development – [Press Release Document] ⁽¹⁾

14 Jun 2018 – ValiRx – VAL401 Update – [Press Release Document]  and [Audio document]

10 April 2018: – ValiRx – Final Results for the year ended 31 December 2017 – [Press Release Document]

06 Feb 2018 – ValiRx – VAL401 Update –  [Video]

16 Jan 2018 – ValiSeek – Clinical Development Update on VAL401 – [Audio Document] and [Press Release Document] ⁽²⁾

16 Jan 2018 -VAL401: A Novel Cancer Therapeutic (Updated Jan 2018) – [One Pager Document]

12 Dec 2017 – ValiSeek – Clinical Development Update on VAL401 – [Audio Document] and [Press Release Document] ⁽³⁾

12 Dec 2017 – ValiRx unveils positive results from VAL401 Phase II lung cancer trial –  [Video]

26 SEP 2017 – ValRx – Half Year Report –  [Press Release Document] ⁽⁴⁾

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Gastric Cancer: Tersan and academic collaborators from the Gastro Glyco Explorer consortium identify a novel single marker for Microsatellite instability (MSI), a distinct molecular subtype of gastric cancer.

Gastric cancer is the second most common cause of cancer-related deaths in the world. Adapting the therapeutic choice to the molecular diversity of the disease is a key driver for providing patients with the right targeted therapy. The Academic collaborators from the Gastro Glyco Explorer consortium aim at finding novel markers for gastric cancer using data obtained from multiple platforms including the characterization of glycans.

Tumor and serum samples were gathered from 107 patients and data was generated from 9 different experimental platforms. Analyzing this complex and heterogeneous database and generating hypotheses were possible using the KEM® Artificial Intelligence technology.

Extensive data characterizing 107 patients was generated by integrating multiple experimental platforms using both tumour tissue and serum samples

Using this integrated database, KEM® generated over 450K association rules. Exploration and visualisation of subsets of strongest rules were conducted with KEM® Query using metric filtering (Top relationships with highest association rule metrics) and semantic filtering (Top relationships with clinical and pathological relevance).

Using KEM® Query, associations filtered by metrics were explored in network format to identify any hypothetical marker(s) from experimental variables.
 Staring with 848 descriptors from the serum and tissue samples of the patients, top associations rules were extracted from the integrated database and filtered using various metrics. In this example, the analysis focused on the remaining immunohistochemistry descriptor of antigen Sialyl Lewis A (SleA) (discussed in publication below). 
This antigen had been previously shown to be a predictor of prognosis in colon carcinoma patients.

 

KEM® Query interactive tool helps view complex univariate association rule networks. Through a few clicks relationships of a specific descriptor in the serum or tissue alongside its clinical characteristics can be viewed.

The integrated database and KEM® results were presented at the RECOMB-Computational Cancer Biology (CCB) conference in April 2018.

Results: Recent Publication on Novel Markers

In the recent study published in the Journal of Clinical Medicine (2018, 7(9), 256), Tersan and academic collaborators from the Gastro Glyco Explorer consortium identify a novel single marker for Microsatellite instability (MSI), a distinct molecular subtype of gastric cancer linked with PD-L1 expression.

The identified biomarker (94% specificity, 69% sensitivity, 80% NPV, 90%PPV) is a glycan antigen that may enable the identification of patients who could benefit from targeted therapy using the PD1/PD-L1 immune checkpoint pathway.

Microsatellite instability (MSI) is a distinct molecular subtype of gastric cancer. In recent years, the clinical consequences of MSI and the therapeutic opportunities to target this peculiar cancer subtype became evident.
Additionally, it has been found that MSI is linked with PD-L1 expression and several specific drugs are currently used for clinical management of gastric cancer targeting the PD1/PD-L1 immune checkpoint pathway.

Excelling with a specificity of 94% (16/17), sensitivity of 69.2% (9/13), negative predictive value of 80% (16/20), and positive predictive value of 90% (9/10) the TF antigen holds promise to be the long sought-after single biomarker for MSI status in gastric cancer.

The TF antigen is a simple glycan antigen that is aberrantly expressed in cancer cells due to alterations in the O-glycan biosynthesis pathway.
In summary, this published work presented for the first time strong evidence that TF is a novel, single marker of MSI in gastric cancer.

 

 

Thomsen-Friedenreich antigen (TF) expression in human gastric tissue samples. (a) Gastric mucosa is negative for TF, (b) Representative image of intestinal metaplasia showing that even goblet cells were negative for TF. (c) TF negative dysplasia next to TF positive carcinoma. (d–f) Well-differentiated gastric carcinomas show a typical membranous TF staining at the apical surface. (g–i) Poorly differentiated gastric carcinomas were dominated by cytoplasmic staining. (i) TF positive carcinoma cells within an infiltrated vessel

 

This finding lays the basis for a new line of research and shows great promise to significantly improve the identification of this distinct cancer subtype in the clinical setting.

More Information about KEM® FRAMEWORK

Further reading

The Thomsen-Friedenreich Antigen: A Highly Sensitive and Specific Predictor of Microsatellite Instability in Gastric Cancer, Sept 2018 – [Publication ], [Publication Full Text ],[Publication Pdf ]

Subgroups of Gastric Cancer Patients Characterized with an Integrated Large Biomarker Datasets using Association Rules [Poster] presented at RECOMB-Computational Cancer Biology (CCB) conference in Paris, April, 2018.

Elara Pharmaceuticals Ltd teams together with SIB Swiss Institute of Bioinformatics to discover novel biomarkers for gastric cancer, 2015 [Press Release (english) ],[Press Release (french) ]

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