Lori Kunkel takes acting CMO role at gene therapy firm Tocagen

Tocagen CEO Marty Duvall (Tocagen)

Tocagen has named Lori Kunkel, M.D., as its acting chief medical officer following the departure of Asha Das, M.D., who is leaving because of “unforeseen and immediate personal matters.”

Kunkel—who has been a Tocagen board member since 2015—is taking over the position on a temporary basis while the cancer gene therapy specialist launches a search for a permanent hire to replace Das, who has been at the company for three years and was made CMO in March 2017.

Kunkel joins Tocagen from Loxo Oncology, where she was formerly acting CMO and is also a member of the board, having previously held positions at Pharmacyclics and Proteolix.

The CMO handover comes at a critical juncture for Tocagen, as it starts to transition to an end-to-end biopharma company. Its lead program, Toca 511/Toca FC, is in a phase 3 trial (Toca 5) for recurrent high-grade glioma (HGG), a type of brain cancer, that is heading for a second interim data readout in the first half of 2019, with a final analysis expected at the end of the year.

Meanwhile, the company is also running a phase 1b exploratory study of the therapy in advanced solid tumors (Toca 6), planning a trial in newly diagnosed HGG (Toca 7), and expecting to start trials of a second candidate targeting PD-L1 before year end.

“On behalf of the management team and board of directors, we are thankful for the significant contributions Asha has made over the past three years,” said Tocagen CEO Marty Duvall in a statement. He stressed that the handover wouldn’t have an impact on Tocagen’s current business plans or development timelines: “With Lori's remarkable track record in the biotechnology industry coupled with her deep familiarity of our program and clinical data we look forward to working closely with her to advance our cancer-selective gene therapy platform, and our lead product candidate.”

Toca 511/Toca FC is a two-part therapy that aims to deliver local chemotherapy to tumor cells and spare healthy tissues. The Toca 511 portion is sequence coding for an enzyme (cytosine deaminase) that is delivered using Tocagen’s retroviral replication vector technology, which is taken up by tumor cells. That is followed by dosing with a prodrug (Toca FC) that is only converted to a cell-killing drug by the enzyme. The therapy has both FDA breakthrough designation and priority medicine (PRIME) status from the EMA.

Tocagen also added to its team recently by appointing Mohamed Ladha as head of commercial, tasked with building the team that will sell the gene therapy—if approved—to a target group of around 80 clinical centers.

Duvall said at the Stifel conference this week that Toca 511/Toca FC is a “half-billion-dollar opportunity” in the U.S. recurrent HGG market alone, assuming 50% penetration of the 8,000 or so eligible patients and pricing in line with checkpoint inhibitors. The company wants to sell it alone in the U.S. and seek partners elsewhere in the world.