Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, announced recent advances in its EpiCheck® Next Generation Sequencing (NGS) platform and lung cancer detection program for early stage disease. The company also recently secured an additional $22 million in funding, as an extension to the previously announced $55 million financing, bringing the total capital raised in 2021 to $77 million, to rapidly advance the next generation of its highly sensitive lung cancer product and drive a multi-center prospective trial for clinical validation. Additionally, the company strengthened its leadership team with the appointment of Catherine Schnabel, Ph.D., as its chief scientific officer.

“Nucleix has incredible momentum as we enter 2022. We have the core methylation technology, the capital and a robust clinical program to advance Lung EpiCheck® for early lung cancer detection,” said Chris Hibberd, chief executive officer of Nucleix. “EpiCheck is an ultra-sensitive technology for the detection of methylation changes and is compatible with both next-generation sequencing (NGS) and polymerase chain reaction (PCR) platforms. We are utilizing the NGS application of EpiCheck for deep discovery, to reveal new biomarkers for the early detection and monitoring of cancer. To demonstrate this capability, we conducted a side-by-side analysis which compared the EpiCheck NGS platform against conventional bisulfite approaches, using stage I lung cancer patients. While EpiCheck revealed many promising markers that are indicative of early-stage disease, the bisulfite approach only identified 1% of what EpiCheck detected. This result strengthens our belief that the EpiCheck technology sees biology that other approaches miss. We look forward to advancing research and product development in this area, both on our own and through collaborative efforts.”

Nucleix’s Lung EpiCheck is a simple blood test that analyzes changes in multiple methylation markers to screen for lung cancer, with a focus on testing high-risk individuals based on smoking history. Currently there are very few options for early lung cancer detection and only 10% of the nearly 15 million high-risk smokers recommended to receive low-dose CT imaging adhere to current guidelines.1 Lung EpiCheck has been optimized to focus on sensitivity, so that patients have a better chance for early detection and successful treatment.

“Lung cancer remains a leading cause of death globally, due to its high incidence and late-stage diagnosis. Most patients are currently diagnosed with late-stage lung cancer, though research has shown that five-year survival rates are up to 10 times greater when lung cancer is detected early2,” said Hibberd. “We are advancing Lung EpiCheck to detect minute cancer epigenetic signals with greater sensitivity. Detecting lung cancer earlier increases the chances of patients having long-term benefit.”

Multi-Center Clinical Trial Initiated

In a peer-reviewed, published study, Nucleix’s Lung EpiCheck detected 85% of early-stage lung cancers among individuals at high risk for developing the disease based on their age and smoking history. Nucleix is now leveraging its deep discovery NGS platform to advance an improved version of the assay and recently launched a prospective, multi-center clinical study aiming to enroll approximately 5,000 patients.

Key Executive Appointed

Catherine Schnabel, Ph.D., joins Nucleix with more than 25 years of scientific experience and achievement in molecular and cellular biology. Previously the chief scientific officer of Biotheranostics Inc., Schnabel brings significant expertise developing and translating genomic technologies into commercial products that are new standards of care. At Nucleix, Schnabel will oversee R&D, product development and strategic research programs.

“With the company poised for tremendous success in the liquid biopsy field, I am thrilled to be joining the Nucleix team at such an incredibly exciting time, given its core strength in methylation and the potential to transform early lung cancer screening,” said Schnabel.

New Financing Secured

Following the success of its $55 million financing announced in April 2021, Nucleix extended this financing in December 2021 by securing an additional $22 million in an investment led by Sands Capital. This brings the total capital raised in 2021 to $77 million.

“The Nucleix team has successfully executed on a number of fronts this year and demonstrated their ability to discover and translate new biology using the ultra-sensitive EpiCheck platform,” said Parker Cassidy, Partner at Sands Capital. “We’re excited to partner with the team as they help transform cancer care.”

About Nucleix

Nucleix is a liquid biopsy company revolutionizing cancer treatment with earlier disease detection at a time when intervention can bring the greatest impact for patients. Leveraging NGS and PCR-based epigenetics, the Company’s pioneering testing approach uses methylation-based identification for early-stage and recurring cancer detection. The Company’s non-invasive EpiCheck® platform delivers highly accurate and sensitive results, all while providing a seamless testing option for patients and the healthcare system. The Company is building an EpiCheck franchise, beginning with the Bladder EpiCheck® testing kit, marketed in Europe for bladder cancer recurrence. The Company is advancing a Lung EpiCheck test toward commercialization for high-risk individuals, while advancing additional tests for high-risk diseases. For more information, please visit: https://www.nucleix.com.

1 U.S. Preventive Services Task Force. Lung Cancer: Screening. 2021; https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening
2 American Lung Association. Lung Cancer Fact Sheet. 2020; https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/resource-library/lung-cancer-fact-sheet