By Dr. Roberta Vezza Alexander

On May 3, 2018, San Diego Entrepreneurs Exchange (SDEE) held their annual flagship event, Get to know your neighbors, at Green Acre in Campus Point.

The event was sponsored by Maxcyte and Alexandria Real Estate, which provided the space. Before the event, the networking reception was a nice opportunity to chat, sip wine and beer, and snack on delicious pizza. As always, numerous providers of services and equipment for the life sciences showcased their products on tables around the room.

Randy Schreckhise spoke about SDEE’s mission and events, which range from panel discussions and workshops to help entrepreneurs, to a Holiday party and monthly happy hours at New English brewery.

After representatives of 9 companies gave their 30-second pitch to promote their businesses, Jonathan Lim, MD took the stage.

Jonathan is the cofounder and CEO of Ignyta, a fully owned subsidiary of Roche. He spoke about Ignyta’s unlikely journey to precision medicine and shared some important lesson learned. First and foremost, think about the core values that you and your company will live by: believe in your mission and what you want to accomplish, but also understand when it is time to pivot. Crucible moments are inevitable, so be prepared: do not overreach during good times, and do not panic during bad times. Finally, be uncompromising in pursuing the best possible strategy for the success of your company and in choosing the best possible team members.

Precision medicine is the science of using a drug targeting a specific molecule only in the patients who are most likely to benefit from it. Companion diagnostic tests are necessary to identify these patients; Ignyta got its start in the diagnostic space as NexDx. A dispute led to a name change, and the name Ignyta was chosen because it evokes ignition, catalysis, and energy. In addition, dropping the Dx part of the name allowed for a more flexible business model. The company goal was to measure epigenetic changes in the DNA of patients with joint pain to predict who would develop rheumatoid arthritis. Although preliminary studies were promising, a larger study in collaboration with the University of Leiden was not successful: the area under the ROC curve of the assay with Ignyta’s chip was exactly 0.5.

This setback led to a pivot. Patrick O’Connor’s Actagene and Ignyta combined their assets and decided to integrate diagnostics and therapeutics for oncology indications. The hunt for targets led to the Italian company Nerviano Medical Sciences, the acquisition of Entrectinib, and the filing of the initial public offer.  

Entrectinib inhibits 5 tyrosine kinases and is efficacious in solid tumors associated with NTRK, ROS-1, or ALK rearrangements. Although these gene rearrangements are rare, they can occur in many types of tumors. Ignyta has a CLIA certified and CAP accredited laboratory to identify these mutations and, thus, the patients that are likely to respond to the treatment.

Jonathan shared the stories of 2 patients: a middle aged man and a 20-month old baby, who had a remarkable and quick response to Entrectinib. Because this drug can penetrate the blood brain barrier, it shrank not only the primary tumors but also the brain metastasis. After the treatment, the baby went from lethargic to alert, and could eat and interact with his mother.

While Ignyta’s stock price has fluctuated over the years, 2016 was particularly brutal. Various circumstances during the Fall of 2016 led to a pipeline reprioritization and, worst of all, Patrick died of brain cancer. The year 2017 was marked, not only by scientific achievements, but also with discussions with various companies about a possible acquisition. These discussions culminated, after nail- biting negotiations and just before Christmas 2017, with a merger agreement with Roche. As Roche is a leader in oncology and personalized medicine, the acquisition gives Ignyta a global reach and the possibility to bring Entrectinib and other precision medicine solutions to patients around the world.