Illumina Enters Yet Another Oncology Partnership to Capitalize on its Pan-Cancer Assay

Illumina’s last few years have been nothing but eventful. On the one hand, the company is battling antitrust regulators to accomplish its billion-dollar M&A goals, but on the other, it has continued to prosper with new oncology partnerships.

The San Diego sequencing giant has forged rich collaborations recently with top oncology companies like Loxo Oncology, Kura Oncology, Myriad Genetics, and even bigger players like Roche and Merck. These collaborations intended to leverage its NGS-based cancer test in developing companion diagnostics. Now, Kartos Therapeutics, a clinical-stage biopharma based in California, has joined the list.

On April 22nd, Illumina and Kartos announced a new partnership to co-develop a TP53 companion diagnostic using the former’s TruSight Oncology 500 (TSO 500), a comprehensive pan-cancer assay. TSO 500 is designed to identify 523 known and emerging tumor biomarkers. The product resulting from this collaboration would be the first to use TSO 500 with peripheral whole blood as a diagnostic sample type, the companies said in a statement.

“With this partnership, Illumina will expand the TruSight Oncology offerings into hematologic malignancies,” said Phil Febbo, MD, Chief Medical Officer of Illumina. “By leveraging our technology and harnessing the expertise at Kartos, we continue to advance Illumina’s commitment to develop standardized, globally distributable tools for precision oncology.”

Liquid Biopsies as a Companion Diagnostic

Liquid biopsy tests are turning to be crucial for achieving precision oncology. These tests inform physicians as to which targeted therapy is best suited for a cancer patient. This comes from the understanding that not all cancers are the same, and not every patient responds to therapies the same way.

Liquid biopsies are non-invasive and are very useful in scenarios when a patient’s tumor is inaccessible or if the tissue sample is scarce. Besides, it allows faster processing of results and is most suitable to conduct mass population testing for early detection of cancers. Early detection will significantly improve patient’s survival rate in addition to minimizing diagnosis and treatment costs.

Several companion diagnostics have slowly begun to get integrated into clinical practice. In 2020, the FDA approved two liquid biopsy NGS cancer tests as companion diagnostics; Guardant Health’s Guardant360 CDx assay and Foundation Medicines’ FoundationOne®Liquid CDx. According to statistics, the global liquid biopsy market is expected to grow to $6,014.2 million, with a CAGR of 33.4% by 2025.

Expanding the Use of KRT-232

The tumor suppressor p53 is often mutated in many cancers. Therefore, therapeutic interventions strive to restore its function and halt tumor progression. However, in the case of other cancers with wild-type p53, the tumor suppressor function is still found to be inhibited due to the direct interaction between p53 and MDM2 oncoprotein. Kartos’ KRT-232 is an MDM2 inhibitor that activates p53 to drive tumor cell death in TP53 wild-type cancers.

KRT-232 is currently evaluated against several TP53 wild-type hematological malignancies and solid tumors. The primary aim of the Illumina-Kartos collaboration is to develop companion diagnostics for blood cancers against which KRT-232 will be evaluated.

“Kartos is dedicated to developing novel, targeted therapeutics that meaningfully improve the lives of patients with cancer,” said Jesse McGreivy, MD, Chief Executive Officer and Chief Medical Officer at Kartos. “This partnership will allow us to capitalize on TSO 500 as we explore the expanded use of KRT-232, which offers a unique mechanism to restore the function of p53, one of the most critical tumor suppressor proteins, resulting in apoptosis of malignant cells across a variety of hematologic and solid tumor types.”

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Author

Rajaneesh K. Gopinath