This pioneering test aids oncologists in predicting recurrence and survival rates in breast cancer patients and potential eligibility for bisphosphonate treatment.

Results showing the clinical utility of the test have been published in the Lancet Oncology and the Journal of National Cancer Institute.

The MAF Test® will be available to oncologists and pathologists in Italy and will benefit an estimated 55,000 new patients annually.

This agreement follows Inbiomotion’s recent distribution partnerships for Spain and Portugal with Palex Medical,The Scientific Group for Sub-Saharan Africa and Source BioScience for United Kingdom and Ireland.

Barcelona and Milano, October 9th, 2024 – SPA Farma, a leading pharmaceutical company of innovative healthcare products and diagnostic tools, and Inbiomotion, proprietors of MAF Test® for identifying high risk early-stage breast cancer patients, have signed an exclusive agreement to start offering the MAF Test® in Italy.

The MAF Test® predicts the prognosis of breast cancer patients and helps oncologists identify patients potentially receptive to the prevention of recurrence and who may benefit from adjuvant treatment with bisphosphonates, which are commonly used to treat osteoporosis. The test also identifies those patients whose prognosis would worsen if treated or are being treated with bisphosphonates.

Breast cancer is the most common form of cancer among women, with more than 2 million new cases diagnosed globally each year. Approximately 1 in 8 women will develop breast cancer in their lifetime and, of these, 15-20% will eventually develop metastases. Having the capacity to identify those patients with a higher risk of recurrence and being able to personalize their treatment is vital for their survival and quality of life.

Thanks to this agreement, the MAF Test® could increase the survival of 8 out of 10 of the 55,000 early-stage breast cancer patients diagnosed each year.

Stefano Lombardi, CEO at SPA Farma, said, “We are thrilled to partner with Inbiomotion to bring MAF Test® to Italy, a new diagnostic biomarker for identifying high risk early-stage breast cancer patients. At SPA Farma, our mission is to develop, produce and assure accessibility to health solutions, innovative therapies and diagnostic products for in vitro diagnostics. With this partnership, we are offering oncologists a valuable prognosis tool, providing Italian patients with an improved quality of life.”

Dr. Joël Jean-Mairet, Executive Chairperson of Inbiomotion since 2012 and Executive Chairperson of Ysios Capital commented, “We are thrilled to partner with SPA Farma to bring the cutting-edge MAF Test® to Italy. This collaboration represents a significant step forward in making precision medicine accessible to more patients. At Inbiomotion, our mission has always been to transform cancer treatment by providing an innovative diagnostic tool that empower both healthcare professionals and patients to make the best possible decisions. By offering a tailored approach to cancer treatment, we can significantly improve patient outcomes, reduce the likelihood of unnecessary treatments, and ultimately enhance the quality of life for those battling breast cancer. We believe that this partnership with SPA Farma will play a crucial role in achieving these goals in the Italian market.”

Results showing the clinical utility of MAF Test® were generated using patient biopsies from two landmark clinical trials, each with more than 3,000 patients (AZURE and NSABP-B34). These results were published in The Lancet Oncology (2017) and the Journal of National Cancer Institute (2021) respectively, where it was shown that 80% of patients with breast tumors had MAF-negative tumors and that being treated with clodronate or zoledronic acid increased their disease-free survival by 14.3% and decreased their relative risk of death by 21.4%. In contrast, patients with MAF-positive tumors had no benefit, or even worse prognosis, from treatment with bisphosphonates (clodronate or zoledronic acid), irrespective of their menopausal status.

This announcement follows a recent publication in Nature Cell Biology of key data further elucidating the biology around the MAF biomarker. A team from IRB Barcelona led by ICREA researcher Prof. Dr. Roger Gomis, co-founder of Inbiomotion, revealed in such publication the mechanism by which the MAF gene amplification increases the risk of metastasis in breast cancer patients. This finding is a crucial step in understanding the molecular basis of metastasis and has relevant clinical implications for treatment.

About Inbiomotion

Inbiomotion is a spin-off of IRB Barcelona and ICREA, founded in 2011 by Prof. Dr. Roger Gomis, following the identification of the MAF gene as a biomarker to predict bone metastasis in breast cancer. Inbiomotion has developed a diagnostic kit based on the detection of MAF gene amplification, the MAF Test®, to promote precision medicine and improve the treatment of breast cancer patients. The company holds more than 200 patents and patent applications covering its proprietary MAF Test® FISH and the use of bisphosphonates in the adjuvant treatment of early-stage breast cancer patients. The company’s main investors are Ysios Capital, Caixa Capital Risc, Alta Life Sciences and the Vila Casas Foundation. For more information, please visit www.inbiomotion.com.

About SPA Farma

SPA Farma is a family-owned company owned by Aliseé Matta Echaurren, granddaughter of the founder, Rodolfo Ferrari.

The company’s legacy is deeply rooted in a long-standing heritage of innovation and success. SPA Farma made history by being one of the first company to produce and commercialize Penicillin in Italy during the immediate post-war period. This achievement was followed by the development of Lysozyme, thanks to a scientific collaboration with Sir Alexander Fleming.

In the 60s, the company expanded its business into other therapeutic areas and currently the main areas are: osteoarticular/pain, cardiometabolic, oncology and nephrology.

More recently, the company established an affiliate in Spain and Portugal

For more information, please visit www.spafarma.com.

About the MAF gene

MAF (mesenchymal aponeurotic fibrosarcoma gene, a transcription factor of the AP-1 family) is amplified in primary cancer tumors. It is associated with increased metastasis, especially bone metastasis. MAF transcriptionally controls genes such as PTHrP, which regulates metastasis-related cellular processes such as survival, initiation, metabolic rewiring and adhesion to bone marrow-derived cells and osteoclast differentiation. MAF protein interacts with the estrogen receptor, a key element in the development of breast cancer, modifying its structure. This interaction leads to DNA restructuring, which allows the activation of genes that favor metastasis, particularly in response to estrogen. These observations indicate that the MAF gene has a key hierarchical role in metastasis. The MAF gene has been found to be amplified in 20% of breast cancer patients. In the case of patients with non-metastatic breast cancer, having amplified (MAF positive) or not (MAF negative) MAF has been associated with a very different response to bisphosphonate treatment, significantly impacting the survival of patients who are MAF negative.