Breast cancer is the most common cancer diagnosed among women. Over a lifetime, approximately 1 in 8 women develop breast cancer. When treated early, survival rates at five years are 100%. However, for more advanced states, survival rates decline significantly. Over 3 million women live with a current or previous diagnosis of breast cancer. Any treatment that improves survival rates would impact not only those surviving women but also their families.

With a mission to help more women survive metastatic breast cancer, Dr. Stacy Blain and Lisa Marie Casey co-founded Concarlo Holdings LLC.  Located at the Downstate Biotechnology Incubator in Brooklyn, NY, the oncology company’s vision is to help target therapies and diagnostic testing for women with breast cancer. Patented 3 years ago by Blain, and licensed through Concarlo in 2017, their blockbuster therapeutic is a unique CDK4 inhibitor that hits 2 targets simultaneously.

Researches and oncologists test breast cancer for several chemical messengers or receptors that signal cell growth. Three of the most important receptors are: estrogen (ER), progesterone (PR), and human endothelial growth factor 2 (HER2).

Hormones are not the only signals involved in stimulating cell growth. A group of critical proteins in many cancers, called Cyclin Dependent Kinases or CDKs, control and regulate various phases of cell growth and multiplication as well.

Medications that have helped increased survival rates interrupt the cell signaling pathway treat ER, PR, and HER2 hormone-responsive tumors. However, one particular type of advanced breast cancer – ER/PR+ (endocrine responsive) and HER2 negative tumors- may become resistant to treatment after chemotherapy starts in 20,000 of the approximately 90,000 patients afflicted with breast cancer every year.

So one area of research that is booming is the investigation into medications that will regulate the CDKs in tumor cells. While the ER/PR+/HER- cancers may become resistant to treatment with hormone-blocking agents, they should still respond in theory, to chemicals that inhibit the CDK messengers.

These medications are called CDK inhibitors. In 2015, the FDA approved the first drug in this class and there are currently three approved CDK4 inhibitors – palbociclib, ribociclib, and abemaciclib- that sold nearly $5 billion in 2018.

Since then, studies have shown nearly double the rate of survival when added to existing chemotherapy treatment. However, patients treated with CDK4 inhibitors often become resistant to them. Dr. Blain’s unique research targets not only hits CDK4 that drives the cancer but also hits the target CDK2, which is the receptor making patients resistant to the therapy.

However, the presence of CDK4 receptors alone doesn’t indicate responsiveness to the medications.

Identifying biomarkers can help researchers and clinicians determine which patients will respond to therapy. Diagnostic tests that identify these biomarkers on cells can determine which tumors-and, therefore, which patients – will respond to chemotherapy.

At present, research into biomarkers that indicate response to CDK4 inhibitors is just beginning. Dr. Blain’s has identified a specific protein called p27Kip1 that shows promise as an indication of what tumors will respond to the CDK4/CDK2 therapy.

Dr. Blain’s robust research combines not only a unique dual receptor medication but also a biomarker that helps identify resistant breast cancer tumors. As a result, Concarlo Holdings will be able to contribute to life-saving and life-changing breast cancer treatment for hundreds of thousands of women every year.

Metropolitan New York provides the optimal environment for biotech entrepreneurs. Dr. Blain, an entrepreneur and Associate Professor in Cell Biology and Pediatrics at the SUNY Downstate Medical Center, leverages the shared services and equipment at the Downstate Biotechnology Incubator with her team to advance their IpY peptide inhibitor and companion ApY diagnostic innovations. For their mouse studies, Concarlo also utilizes the laboratories across the street at College of Medicine at the SUNY Downstate Medical Center, where Dr. Blain is director of the Neoplasia subunit.

In addition to Angel funding, the company received 1 million from New York based VC firm Accelerate New York Seed Fund which invests in early stage scientific, technology and engineering-based companies. This year, Concarlo is preclinical and seeking a strategic partner to help commercialize their therapeutics and diagnostics. The company’s goal is to raise an additional 7 million in the next 2 years to take them all the way to IND.