Landmark Phase 2 study demonstrates the first successful clinical application of antifibrotic therapy for breast cancer

Positive study enables valuable repositioning of new antifibrotic drug candidates by a growing number of pharma companies

SAN DIEGO, Oct. 17, 2024 /PRNewswire/ -- MeCo Diagnostics, a venture-backed startup dedicated to unlocking a new therapeutic modality for cancer, has announced a publication in Clinical Cancer Research, the leading clinical journal of the American Association for Cancer Research (AACR). The article details a successful Phase 2 study of 130 patients with breast cancer, conducted in collaboration with the Spanish National Cancer Research Centre (CNIO), following a pre-specified analysis plan to evaluate long-term survival after antifibrotic therapy. This study establishes the MeCo Score as the first clinically validated predictive biomarker for antifibrotic therapy—a fundamentally new way to fight breast cancer.

Patients with early-stage, HER2-negative breast tumors with High MeCo Scores who received nintedanib (antifibrotic therapy) plus chemotherapy experienced a 62% reduction in risk of recurrence compared to chemotherapy alone, with a median follow-up time of 9.7 years (P<0.05). This combined magnitude and duration of benefit appears unprecedented among targeted therapies which are currently FDA-approved for these patients, representing a large majority of breast cancers. Crucially, Low MeCo Scores were not associated with benefit from antifibrotic therapy, suggesting the MeCo Score is essential to leverage this promising modality.

"Our enabling research began over 10 years ago, coinciding with the start of this trial. That serendipity has now culminated in a stunning outcome: High MeCo Score patients who received a short course of antifibrotic therapy experienced a remarkable improvement in their long-term survival rate," said Dr. Adam Watson, CEO of MeCo Diagnostics.

Nintedanib will soon become a generic medicine, which could provide substantial financial relief to patients/payers if incorporated into clinical practice guidelines. A larger, pivotal trial to confirm this study has been planned, setting up the MeCo Score to potentially unlock the first low-cost, low-toxicity, targeted therapy approved for breast cancer. Moreover, the MeCo Score was designed to be drug-agnostic to facilitate repositioning of any antifibrotic drug for breast cancer—including new drug candidates that may be superior to nintedanib.

Overall, this study serves as a valuable proof of concept for this entire class of drugs under development by numerous pharma companies.

About MeCo Diagnostics Holdings, Inc.

MeCo Diagnostics™ is a seed-stage startup based in San Diego, CA, developing first-in-class predictive biomarkers to leverage antifibrotic therapy for cancer treatment. https://mecodiagnostics.com/

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SOURCE MeCo Diagnostics