Anyone who has had a malignant tumor removed knows the anxiety that follows. Did any traces of cancer remain, and if it returns, will doctors catch it before it’s too late? To reduce the uncertainty and improve patient outcomes, C2i Genomics Inc. has raised a $100 million series B funding round led by Casdin Capital to advance software that is 100 times more sensitive in detecting residual disease than legacy technologies.

Also participating in the round were NFX, Duquesne Family Office, Section 32, iGlobe Partners, Driehaus Capital and others. The funds will be used to accelerate clinical development and commercialization of the company’s C2 Intelligence platform, cancer diagnostics tool that uses artificial intelligence (AI) recognition and whole genome analysis to rapidly detect tiny traces of residual disease in patients’ blood.

C2i, which is based in New York with a CLIA lab in Cambridge, Mass., and an R&D center in Haifa, Israel, hopes its solution will lead to fewer cancer patients being overtreated or undertreated in that uncertain period following surgery.

Filling an unmet need

Asaf Zviran, co-founder and CEO of C2i Genomics Inc.

Current treatment efforts are often “like a shot in the dark,” said Asaf Zviran, C2i’s co-founder and CEO and himself a cancer survivor, adding that it takes more than a year for residual disease to be detected by imaging. Meanwhile, 40% to 50% of cancers recur in stage II patients of multiple cancer types.

“It’s not only that we need very efficient cancer screening methods but also very efficient and personalized treatment regimens for early-stage patients, aiming to eradicate the cancer and optimize the probability for cure,” Zviran told BioWorld.

Founded in 2019, C2i Genomics is based on technology developed at Cornell University and the New York Genome Center. The name stands for cancer control and intelligence – C2i – and derives from Zviran’s experience working on radar technologies in the Israeli military, where the concept was used to describe integrated systems for quickly gathering and analyzing intelligence and then making decisions based on that information.

C2i’s GDPR and HIPAA-compliant technology allows doctors to spot trace amounts of cancer more quickly, providing actionable insights in as little as a week to inform the next steps of care.

The decentralized, cloud-based platform, which can be deployed at point-of-care settings, is designed to culture the patient’s whole genome both from just 2 mL of blood. The AI technology employs machine learning that has been trained to recognize artifacts and remove them, as well as very sophisticated signal processing that separates the signal from noise and allows, enabling very efficient detection and quantification of tumor burden to give clinicians the amount of cancer in the patient’s blood over time.

This is what differentiates C2i from competitors, Zviran believes.

“Tens of thousands of features can be detected in every patient’s tumor,” Zviran said. “While competitors are using a few tens – 16 to 50 – of mutations in their panels, the C2i approach can capture the entire picture, analyzing all 3 billion base-pairs in the genome, and monitor the aggregated signal and the evolution of the patient’s cancer. This leads to increased sensitivity, better accuracy and provides insights about the patient’s cancer progression or resistance.”

Diagnostics, drug development

The C2 Intelligence platform currently being used for clinical and drug development research via clinical networks in the U.S., Denmark, Switzerland and Singapore. C21 plans to release clinical validation data from those endeavors later this year or in early 2022.

The company aims to release its first diagnostic indication – in colorectal and bladder cancer – in the U.S. and Europe in 2022, pending authorization. A portion of the series B funding is earmarked for regulatory and reimbursement approvals, as well as scaleup in production, commercialization and extending the global scale of the network.

The assay, which will be priced competitively at about $2,000, could save the health care system tens of thousands of dollars, Zviran said. “With detection of complete response and moving patients to watch and wait instead of radical resection of the [diseased] organ, we remove cost of more than $30,000-$50,000 of the surgery, including lifelong disability or morbidity.”

C2i also plans to use the financing to strengthen its partnerships with pharma companies – leveraging C2 Intelligence’s superior sensitivity in detection to flag postsurgical patients for adjuvant therapy or a clinical trial and in immunotherapy.

“Getting the entire somatic signature of the tumor biopsy, but also the entire response evolution and resistance emergence during the clinical trial … is very important, especially for immunotherapy where there is no specific pathway associated with response,” Zviran said.

The company is currently providing molecular monitoring for immunotherapy development in a study that started this year. He declined to disclose the pharma partner.