APPROACH

THE PROBLEM

In contemporary oncology, we see the lack of appropriate patient stratification, resulting in drugs often being administered to patients without producing any benefit. This single problem has important consequences such as:

  • up to 90% failure rates in clinical trials
  • clinical development cost of about 1 bilion dollars per newly approved drug
  • growing cost for patient treatment, typically in the range of 10-100 thousand dollars
  • reimbursement issues, with up to 75% drugs not accessible in some countries because of their cost
  • poor clinical response, with up to 90% failure rates for some cancer types

Such issues still remain despite the development of genetic biomarkers and molecular profiling of the patient.

OUR APPROACH

The efficacy of a drug therapy is the consequence of how drug affects whole cell and tissue biology. However, current practices in precision medicine are limited to DNA mutation or genome profiling.

Functional characterization of the cell, for instance through ex-vivo analysis of response to anticancer drugs, can provide predictive information that are superior to genetic/molecular profiling, according to recent scientific literature.

At Cellply we are re-designing ex-vivo drug response analysis to support biology-driven therapy selection. Our goal is to set a new standard in precision oncology by developing a new class of instruments and technologies to unveil new clinical information deriving from live cell analysis.

Cellply develops the first diagnostic platform to predict the efficacy of the therapy
through the ex-vivo analysis of pharmacological response of patient cells and tissues

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Personalized analysis

Drug response profiles are extracted and computed for each patient/drug through ex-vivo analysis of drug response.

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Speed = precision

Cell function and viability start changing a few hours after sampling. Cellply analysis, enabled by an analytical platform made available in the clinical setting, can start right after sampling and lasts just 24 hours. Being fast means being able to capture information on cell-drug interaction while cells are still mimicking in-vivo response.

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The missing layer

In-between molecules and organisms, the biology of cells, tissues and organs constitutes information currently missing in the clinical decision-making. Cellply technology adds a new layer of information supporting better patient stratification, in combination with existing data.

PLATFORM

Cellply In-Vitro Diagnostic (IVD) test platform for personalized analysis of drug response leverages on the Open Microwell technology, a patented microfluidic platform enabling standardized and automated sample processing and image-based cell analysis. All steps, from sample preparation to drug stimulation and image-based response analysis can be performed in clinical labs within hospitals and clinics, thus reducing sample-to-analysis turnaround time. This is key to assay cell response in a time window of 24/48-hour after sampling, to minimize biases due to changes in cell function.

HIGHLIGHTS

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OPEN MICROWELL TECHNOLOGY

The Open Microwell architecture allows replacing complex, manual and error-prone lab operations with automated protocols carried out at the nanoliter scale. No cell loss occurs during fluid replacement in each microwell, allowing for precise analysis and quantification of drug efficacy. Thanks to an innovative microwell design, cells are seeded microwells acting as micro-labs where processing and analysis take place. Drugs and reagents are delivered through microfluidic channels without loosing a cell in the sample.

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CONCURRENT MULTIPLE TESTING

Multiple therapeutic conditions are assessed in parallel on more than 1,000 microwells per condition to assess the response of thousands of cells to each drug or drug combination. By comparing different treatments at different dosages, patient-drug affinity scores are computed and personalized response profiles are generated.

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IMAGING SOFTWARE

Flourescence imaging supports time-lapse and high-content analysis with single cell resolution to capture the heterogeneity of the tumor. Immunophenotypic characterization is performed to identify the tumor subpopulation in the specimen under analysis. Functional information are then extracted by analyzing cell death, apoptosis or signaling induced on target tumor cells by candidate treatments.

BENEFITS

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Standardization and automation

Device-based testing provides fully-automated and standardized analyses across different laboratories.

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Small sample size

A few thousands cells or a few microliters of sample are enough to test a specific therapeutic condition. Clinical samples in the mL range are enough for testing multiple drugs in parallel.

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Scalable

Platform-based approach enables fast and high scalability when required by companion diagnostics applications.

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Precise analysis

Image-based analysis with single-cell resolution enables precise identification of tumor cells in the sample, capturing the heterogeneity of the tumor.

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Prompt analysis

Device-based test allows drug response analysis to be brought in the clinical setting without needing complex laboratory infrastructure. Patient specimen is thus tested right after sampling, without loosing precious time possibly affecting tumor microenvironment, and cell function. No more need to turn to laboratory-developed tests (LDTs). No more need to have drugs tested remotely in specialized labs.

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Precise sample processing

"Tissue is the issue". Cellply platform advances sample preparation by integrating cell processing steps in the IVD platform, including cell staining for immunophenotipic analysis and cell function assessment. Not even one cell is lost in the process.

APPLICATIONS

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HEMATOLOGY

Cellply is developing a first generation of diagnostic kits for hematologic tumors. Our test supports the analysis of various drugs with different mechanism of action, including chemotherapies and new agents under clinical development. Among hematologic tumors, a first clinical study is currently being conducted on Acute Myeloid Leukemia (AML) with the aim to measure the correlation between the predictive information extracted from the test and the clinical response. In case of AML, the test is performed on bone marrow specimens.

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CLINICAL DEVELOPMENT

Successful development of new cancer therapies comes from knowledge-driven decision-making to minimize risks and increase success rates.
Ex-vivo analysis of drug response can bridge the gap form preclinical to clinical development providing a first insight of drug efficacy in humans.
Furthermore, the biological characterization provided by our test can complement existing genetic biomarkers to improve the understanding of the clinical response and support the identification of optimal patient sets according to functional biomarkers within clinical trials.

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COMPANION DIAGNOSTICS

Cellply platform, currently being developed to become the first IVD tool for ex-vivo drug response analysis, qualifies as the ideal solution for generating Companion Diagnostic (CDx) products. Device-based analysis brings CDx to the clinic, enabling accelerated sample-to-result, simplifying sample management. Once a regulatory clearance as an IVD will be obtained, use of our platform for CDx will reduce risks coming from post-market surveillance, possibly generated in the case of laboratory-developed tests whose regulatory oversight during the approval phase is limited.

COMMERCIAL/PARTNERING OPPORTUNITIES

We are interested in opening collaborations for co-development projects, to support the development of new anticancer drugs within specific programs
as well as to collaborate with clinicians to explore how our approach can traslate into an improved standard of care.

CONTACT US

ABOUT US

Cellply is a biomedical company focused on the development of near-patient diagnostic systems aiming at defining anticancer drug response profiles on ex-vivo patient samples through the analysis of the biological response.

Leveraging on a patented microfluidic technology, highly-integrated cell processing and analysis methods are supported and drug testing in the clinical setting is enabled with a high degree of automation and standardization.

VISION

Cellply considers optimized patient stratification as the means for improving the standard of care in cancer therapeutics and, at the same time, reducing the economic burden currently faced by the healthcare system and industry.

MISSION

Cellply aims at changing the way patient stratification is performed by introducing tools currently missing in the clinical setting to match the right drug with the right patient by means of personalized and individualized drug response profiles. With an approach consistently different from existing trends based on molecular and genomic patient profiling, Cellply mission is to complement such approaches to optimize patient-drug matching.

OUR STORY

CellPly’s Missing Layer Analysis allows unique biology-based diagnostics, which predict drug-patient response and enables 24H diagnosis, through a fully automated standardized test.

  • 1

    Dec. 2013

    Cellply is founded in Bologna, Italy

  • 2

    Feb. 2014

    Italian Angels for Growth, IMI Fondi Chiusi and Zernike-Meta Ventures invest €2.1m in a first investment round

  • 3

    Feb. 2016

    First platform prototype completed and installed in clinic

  • 4
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    May 2016

    Cellply initiates a scientific and clinical collaboration with the Hematology Dept., Sant'Orsola Hospital, Bologna

  • 5

    Dec. 2016

    First clinical results on AML patients presented at ASH congress, San Diego, CA

TEAM

FOUNDING TEAM

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Massimo Bocchi

CEO and Co-founder at CellPly

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Prof. Roberto Guerrieri

Co-founder at CellPly

BOARD MEMBERS & SCIENTIFIC ADVISORS

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Antonio Leone

Board Member at CellPly

elizabethrobinson
Elizabeth Robinson

Board Member at CellPly

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Prof. Giovanni Martinelli

Scientific Advisor

prof-alessandroquattrone
Prof. Alessandro Quattrone

Scientific Advisor

INVESTORS

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NEWS

Read more about our latest news posts and be informed.

CONTACT US

Drop us a line or give us a ring. We love to hear from you and are happy to answer any questions.

OPERATING OFFICE

CellPly s.r.l.
Via Giuseppe Massarenti 61
40138 Bologna
ITALY

REGISTERED OFFICE

CellPly s.r.l.
Via Fondazza 53
40125 Bologna
ITALY

CONTACTS

Phone: +39 051 0397670
Fax: +39 051 0420705
e-mail: info@cellply.com