On December 9, 2021 Exai Bio, a next-generation liquid biopsy company, reported it has raised a $67.5 million Series A financing to accelerate development of its non-invasive, RNA-based liquid biopsy platform for early cancer detection (Press release, Exai Bio, DEC 9, 2021, View Source [SID1234596709]). The financing was led by leading life sciences and tech investors Section 32 and Casdin Capital, with participation from Two Sigma Ventures, who have been integral to advancing cancer diagnostics and artificial intelligence/machine learning technologies.

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Exai Bio’s platform delivers unprecedented clinical insight into cancer biology from non-invasive blood samples enabling early and accurate diagnosis of cancer to inform personalized care treatments. Unlike first generation liquid biopsy tests which measure circulating tumor DNA (ctDNA) mutations and/or epigenetic markers (such as ctDNA methylation or fragmentation patterns), Exai Bio’s proprietary platform measures cell-free RNA profiles, analyzing them using advanced artificial intelligence and machine learning algorithms. Specifically, Exai Bio is focused on orphan non-coding RNA (oncRNA), small RNA sequences not seen in normal tissue but abundant in tumors. In liquid biopsy samples, these tumor-specific oncRNAs translate to higher sensitivity and specificity, ultimately enabling a more accurate diagnosis as compared to ctDNA-based liquid biopsy tests. Exai Bio’s approach is applicable across multiple unmet needs in cancer.

"Exai Bio is the first company founded to explore the important role of oncRNA in early and more accurate cancer detection and its important impact on improved patient outcomes and health economics," said Patrick Arensdorf, chief executive officer, Exai Bio. "Combining oncRNA technology with cutting-edge machine learning and artificial intelligence to decipher tumor signals and understand the active biology of disease, Exai Bio’s next generation liquid biopsy platform provides actionable information to help inform accurate clinical decisions."

Exai Bio’s next generation liquid biopsy platform was developed based on groundbreaking research conducted by Hani Goodarzi, PhD, assistant professor of Biochemistry and Biophysics, a member of the Bakar Computational Health Sciences Institute and the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco (UCSF), and co-founder and scientific advisor for Exai Bio. Dr. Goodarzi’s research, published in Nature, 2018, was the first to identify breast cancer-specific oncRNA and its role as a robust promoter of breast cancer metastasis. The paper also identified the opportunity to utilize oncRNA for early cancer detection via liquid biopsy.

Since 2018, Dr. Goodarzi’s research into oncRNA has continued, and today, Exai Bio’s liquid biopsy platform has been utilized in multiple studies, most notably including the I-SPY 2 study collaboration with UCSF. I-SPY 2 is a neoadjuvant, adaptive clinical trial designed to improve outcomes in individuals with high-risk breast cancer.

Dr. Goodarzi will present data from I-SPY 2 at the San Antonio Breast Cancer Symposium in San Antonio, Texas. The poster, "Tumor-released circulating orphan non-coding RNAs reflect treatment response and survival in breast cancer," demonstrates that the changes in tumor-released oncRNA content of the blood are a significant predictor of clinical outcomes. The study results show that oncRNA "fingerprints" are blood-accessible and enable building predictive models of tumor response. These data will be presented on Thursday, December 9th, 2021 at 7:00 AM Central Time.

Dr. Goodarzi commented, "It’s incredibly rewarding that our early research and the discovery of tumor specific-RNA can have such a meaningful impact on early cancer detection and therapy selection, and potentially improve health outcomes for so many people diagnosed with cancer. The data in the neoadjuvant breast cancer setting is significant, as early stage breast cancer has been a difficult target for ctDNA-based liquid biopsy approaches. I look forward to the continued development of our platform and its exploration in a broad range of cancers."

Exai Bio holds the exclusive license for the development and commercialization of its next generation liquid biopsy platform from the UCSF Innovation Ventures’ Office of Technology Management & Advancement, which leads licensing and business development efforts on behalf of the university.

Exai Bio is led by an experienced founding management team and advisors including:

Patrick Arensdorf, founder and chief executive officer, formerly Chan Zuckerberg Biohub, Bluestar Genomics, ImmuMetrix (acquired by CareDx), Intersect ENT (acquired by Medtronic)
Babak Alipanahi, PhD, founder and chief scientific officer, formerly Google Health, 23andMe, Deep Genomics
Nelson Lee, chief administrative officer, formerly Lawrence J. Ellison Institute for Transformative Medicine (USC), Evidation Health, Crescendo Bio (acquired by Myriad)
Kimberly Chau, vice president clinical operations, formerly CELLective Dx, Kyphon (acquired by Medtronic), Scios (acquired by Johnson & Johnson), Corgentech
Hani Goodarzi, PhD, founder and scientific advisor, UCSF, Rockefeller, Princeton, 2021 Vilcek Prize for Creative Promise in Biomedical Sciences
Robert Warren, MD, clinical advisor, UCSF Surgical Oncology Research Lab
Michael Pellini, MD, managing partner at Section 32, commented, "Exai Bio is delivering clinically meaningful advances in liquid biopsy approaches with the potential to significantly improve cancer care. The ability of Exai Bio’s platform to detect and utilize oncRNA as a cancer signal reveals important insights into cancer biology that can lead to earlier and more accurate cancer detection and diagnosis and better inform personalized treatment options."