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BIOPHARMA

OPTIMIZING CLINICAL TRIALS FOR BIOPHARMA COMPANIES

Since our founding, CND Life Sciences has been on a mission to advance the care of patients who face the potential diagnosis of neurodegenerative diseases. We believe partnering with biopharma companies is an important way help to move scientific research forward.

Why Partner with CND Life Sciences?

Our proven cutaneous neurodiagnostics platform puts us in a unique position to aid biopharmaceutical companies in their quest to develop novel drugs that could change the course of debilitating conditions like Parkinson’s disease, dementia with Lewy bodies, and multiple system atrophy

As the industry advances and promising investigational drugs emerge, the need for convenient, objective, and precise diagnostic tools and reliable biomarkers has never been greater. 

The members of CND’s Medical and Scientific teams are world experts in central nervous system diseases and pathological detection of neurological disorders in the peripheral nervous system. Our team is made up of clinicians, industry experts, and investigators in pharmaceutical clinical trials. CND applies core diagnostic technologies that are foundational to our testing methodologies for:

  • Alpha-synuclein detection, visualization, and quantification
  • Intraepidermal nerve fiber density measurement
  • Autonomic neuropathy evaluation
  • Assessment of other cutaneous markers

Our services can help companies enroll the right patients for trials, use biomarkers that can provide crucial insights, and analyze target engagement to increase chances of success

Introducing NerValence™
A Digital Breakthrough for Cutaneous Biomarkers

A novel computer-assisted technology to aid the detection, visualization, and quantification of neurological biomarkers in the skin.

NerValence is a first-of-its-kind system developed by CND in close collaboration with Visiopharm, a world leader in applying deep learning methodologies to enable precision pathology. NerValence pinpoints synuclein pathology in cutaneous nerves while quantifying and measuring its volume over time. This breakthrough technology is used exclusively by CND pathologists and researchers at the company’s CLIA-certified laboratories to support accurate diagnosis of Parkinson’s disease, dementia with Lewy bodies, and other synucleinopathies, while creating novel capabilities for biopharmaceutical clinical trials. NerValence also generates other insights on neurological markers in cutaneous tissue to help reveal distinct signatures of disease.1

  • AI-assisted detection and quantitation of phosphorylated alpha-synuclein (P-SYN)
  • Delineation of intra-axonal P-SYN deposition and characterization of biosignatures
  • Used in biopharma trials for identification and measurement of other important pathological markers

NerValence is a pathology assistance tool for CND’s cutaneous neurodiagnostic tests and associated biomarker services. NerValence and CND’s cutaneous neurodiagnostic tests, including the Syn-One Test, are laboratory developed tests designed and used exclusively at CND’s CLIA-certified laboratories.

NerValence: AI-assisted Synuclein Detection

After digital acquisition of skin biopsy sections, NerValence is able to quantify and display P-SYN deposits

Heatmap displaying P-SYN deposition with brighter color representing larger deposit

Nerve bundle (green) immunostained with protein gene product 9.5 (PGP9.5)

Nerve bundle (green) with colocalized intra-axonal P-SYN (red)

NerValence quantitation of nerve fiber area (blue) and quantitation of P-SYN deposition (magenta)

Analyzing Cutaneous Biosignatures for Parkinson’s Disease and Related Disorders

CND’s Syn-One technology analyzes cutaneous biosignatures, including patterns of synuclein deposition in dermal nerves, to generate more precise and meaningful insights when assessing a patient’s unique neuropathology. As many neurogenerative diseases feature overlapping symptoms, co-pathologies, and inherently different severities and courses, the future of therapeutic interventions relies on early detection of disease, as well as more precise delineation of a patient’s pathologic signature. The skin provides a unique window into the central nervous system, and CND will continue to study and perfect methods to detect and characterize neuropathologies that can be addressed with more and more specific therapeutic solutions.

Read the synuclein signatures research study published in Neurology

Clinical Trial Solutions

CND continues to work with biopharmaceutical partners to accomplish two primary clinical trial goals:

  • Increase patient homogeneity of of each trial by helping to identify patient-subjects who show objective pathological proof of disease by detecting phosphorylated alpha-synuclein in dermal nerves. This reduces the risk of enrolling patient-subjects assumed to have phosphorylated alpha-synuclein as the underlying disease driver but have a different pathology. This technology also supports post-hoc analyses to determine if drug non-response occurred in patient-subjects who did not have the suspected disease after all.
  • Evaluate target engagement by assessing and quantifying changes in alpha-synuclein deposition in dermal nerves at different time points after the investigational drug is administered. Demonstrating biomarker effects as part of the trial has become an essential part of the study equation, along with correlation to clinical impact. CND is working with clients to monitor and measure if the drug effects can be seen through a series of analyses of synuclein deposition in the skin and other potential markers.

The Syn-One Research Test is used in each stage of clinical development, whether as a formal inclusion criterium, exploratory endpoint, or in post-hoc analyses. CND conducts customized analytical services for each client including an upfront assessment of Syn-One’s application to their clinical development program, ensuring alignment with inherent mechanisms of action and hypothesized alpha-synuclein effects.

Interested in learning more?

Email biopharma@cndlifesciences.com

Important NIH SBIR and Academic Clinical Studies
In addition to our work with biopharmaceutical clients, CND has an active clinical research program through NIH SBIR grants and collaboration with prominent academic centers around the US.

1Gibbons C, Wang N, Rajan S, et al. Cutaneous α-synuclein signatures in patients with multiple system atrophy and Parkinson disease. Neurology. 2023;100(15):e1529-e1539.