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QIAGEN and Neuron23 have announced a collaboration to develop a companion diagnostic for the biotech’s LRRK2 inhibitor, which is currently in the late stages of preclinical development for Parkinson’s disease. This will be the first such test for Parkinson’s if both products are approved.

Neuron23 is an early stage biotechnology company developing precision medicines for genetically defined neurological and immunological diseases. Mutations in the LRRK2 gene are one of the most common causes of familial Parkinson’s disease and individuals who inherit gain of function mutations in LRRK2 are at higher risk to develop the disease in later life. Additionally, there is emerging evidence that LRRK2 activity may play a role in a subset of the larger population of patients with non-familial Parkinson’s disease and other conditions.

Under the agreement, QIAGEN will develop and validate a clinical trial assay to detect a combination of biomarkers discovered by Neuron23 that together predict the responsiveness of Parkinson’s disease patients to a LRRK2 inhibitor. Financial terms of the agreement were not disclosed.

The assay for this collaboration will be integrated into a next-generation sequencing (NGS) workflow. Parallel development of the diagnostic assay and the therapeutic will allow the companies to submit the application to the U.S. Food and Drug Administration (FDA) for premarket approval of the diagnostic test in tandem with the new drug application for Neuron23’s LRRK2 inhibitor.

“We are excited about this partnership as this is the first companion diagnostic to be developed for Parkinson’s disease. This collaboration combines the leading expertise of Neuron23 in drug discovery, data science, and machine learning with QIAGEN’s long-standing experience and global leadership in companion diagnostic development,” said Nancy Stagliano, PhD, CEO of Neuron23.

“The development of a companion diagnostic identifying this sub-population of Parkinson’s disease patients will de-risk the clinical development of Neuron23’s LRRK2 inhibitor and help identify individuals who may benefit from this disease-modifying therapy. We are excited to be working with an industry leader on the first companion diagnostic developed for Parkinson’s disease,” she added.

Founded in 2018, Neuron23 closed a $100 million Series C in March 2022, bringing the company’s total financing to date to $213.5 million.

“The collaboration with Neuron23 shows the rapid momentum precision medicine is gaining in disease areas outside oncology,” said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics at QIAGEN. “Our expertise in blood- and NGS-based molecular testing from Sample to Insight will enable Neuron23 to run a clinical trial for a drug candidate that may have the potential to modify the course of an inexorable neurodegenerative disease in a genetically defined population.”

LRRK2 is a complex, multidomain protein found in neurons and many other tissues and cell types throughout the body. Recent investigations have shown that small-molecule LRRK2 inhibitors can be neuroprotective, suggesting that therapies targeting LRRK2 could be beneficial in a larger population of patients.

No laboratory tests are currently available for the diagnosis of non-genetic cases for Parkinson’s disease. Usually, the disease is diagnosed based on medical history and neurological examination. Although no cure currently exists for Parkinson’s disease, therapies are used to alleviate some symptoms.

QIAGEN has ten PCR-based companion diagnostic indications that are FDA approved, including therascreen EGFR for non-small cell lung cancer (NSCLC), therascreen KRAS for colorectal cancer and NSCLC, therascreen FGFR for urothelial cancer, therascreen PIK3CA for breast cancer based on tissue or plasma samples and the therascreen BRAF kit for colorectal cancer.

Currently, QIAGEN reports it is working with more than 25 leading pharmaceutical and biotechnology companies to develop and commercialize companion diagnostic tests for their drug candidates—a deep pipeline of potential future products to advance precision medicine for the benefit of patients.

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