Exai Bio and Quantum Leap Healthcare Collaborative Announce Expanded Participation in I-SPY 2 Trial

Exai Bio signed collaboration agreement with Quantum Leap Healthcare Collaborative™ (QLHC), a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs, to broaden the use of the company’s novel, RNA-based liquid biopsy platform to monitor patients’ treatment response and disease burden in the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis).[1]

The I-SPY 2 Trial is the largest and longest-running ‘platform’ trial that provides a regulatory framework to study multiple novel therapeutic treatment arms for women with newly diagnosed, locally advanced breast cancer.

The trial series was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the U.S. Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 16 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations.

The expanded agreement is based on positive initial data using Exai’s platform in the trial, which demonstrated that oncRNAs were a significant predictor of patient outcomes.

Orphan non-coding RNAs
Exai’s liquid biopsy platform is based on the discovery of orphan non-coding RNAs (oncRNAs), a novel class of small RNA biomarkers with high sensitivity and specificity. This next phase of the collaboration is expected to increase the evidence for oncRNAs as a predictor of clinical outcomes and measurement of treatment response in a larger cohort of patients and across more therapies within I-SPY 2 Trial.

Simple, accessible and more effective
“Breast cancer patients are in need of simple, accessible and more effective tools to monitor treatment response,” said Laura Esserman, M.D., M.B.A, a surgeon and breast cancer oncology specialist practicing at the UCSF Breast Care Center, co-principal investigator of the I-SPY TRIALs and founder of QLHC.

“Liquid biopsy has the potential to enable clinicians to act and change course during treatment. Based on the initial findings using Exai’s RNA-based approach, we are excited to investigate the impact that this novel platform could have. Their technology fits into our strategy of testing new approaches and tools to predict response early in the course of care. We are broadening our collaboration to include more patients and therapies, and we are thrilled to have this opportunity.”

“At the heart of I-SPY 2, we are changing the way new treatments are developed for breast cancer, expanding indications and expediting these personalized options for patients in need,” said Laura J. van ‘t Veer, Ph.D., the Angela and Shu Kai Chan Endowed Chair in Cancer Research, UCSF, co-Leader, Breast Oncology Program, and Director, Applied Genomics, UCSF Helen Diller Family Comprehensive Cancer Center, who leads the Biomarker Working Group for the I-SPY TRIALs.

“The success of the trial depends on partnering with advanced diagnostics companies like Exai that are bringing forth the next generation of predictive and prognostic biomarkers. The role of oncRNAs in predicting clinical outcomes and informing treatment decisions for breast cancer patients is very promising,” Van ‘t Veer said.

OncRNA
OncRNAs are abundant, stable, and actively secreted from cancer cells into the blood, making them a valuable class of biomarkers. Exai combines this underlying cancer biology with artificial intelligence (AI) to identify cancer-specific patterns based on its proprietary catalog of hundreds of thousands of oncRNAs. This approach results in a universal platform for test development that is efficient, accessible, and can be used across multiple products and cancer care settings such as screening and early detection, monitoring, molecular residual disease and therapy selection.

In the monitoring and neoadjuvant setting, Exai’s unique and reliable method to determine disease burden in the blood of cancer patients does not require prior tumor sequencing or individualization of a test for each patient, can be rapidly generated, and could prove complementary and more sensitive than tests that rely on ctDNA. In addition to using oncRNAs in the therapy selection and monitoring settings, Exai has presented data supporting use in screening and early detection at the 2022 San Antonio Breast Cancer Symposium demonstrating that its RNA-based technology accurately detected breast cancer at the earliest stages and smallest tumor sizes.

“We are delighted to extend our participation in such a groundbreaking trial, and to continue to demonstrate that our RNA-based approach can more effectively inform care decisions in a larger cohort of patients and across multiple therapies,” said Pat Arensdorf, Chief Executive Officer at Exai.

“Our goal is to provide a novel tool for biopharmaceutical companies to include in clinical trials to monitor early therapy response and efficacy, predict end-points, and enrich patient populations in an effective manner.”

Clinical trial
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY) – NCT01042379

Reference
[1] Wang H, Yee D. I-SPY 2: a Neoadjuvant Adaptive Clinical Trial Designed to Improve Outcomes in High-Risk Breast Cancer. Curr Breast Cancer Rep. 2019 Dec;11(4):303-310. doi: 10.1007/s12609-019-00334-2. Epub 2019 Nov 20. PMID: 33312344; PMCID: PMC7731787.

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