Gradalis, a Dallas-based life sciences startup, announced today that it has hired pharmaceutical veteran Joseph M. Limber to lead the company as it further develops its personalized vaccine for ovarian cancer.
Limber comes to Gradalis having already spent three decades in the life sciences industry. Most recently he lead Prometheus Pharmaceuticals in San Diego to a buyout two years ago by Nestlé Health Science, a subsidiary of the Swiss consumer goods company Nestlé.
As the new CEO of Gradalis, Limber says his priority will be to serve as a professional manager to guide the company as it evolves from the most early stages of a startup into a commercially viable company, namely through the company’s vaccine, Fang.
“We’re really making sure that Gradalis is clear on the vision as to where the company wants to go,” he said in an interview with Xconomy. “Having the core technology is not necessarily enough. You have to be able to efficiently and effectively develop these technologies.”
Gradalis is working on the personalized cancer vaccine, which executives say could delay recurrences of ovarian cancer in advanced stage patients by at least a year. The company reported interim results of a phase II clinical study in May at the annual meeting of the American Society of Gene and Cell Therapy in Salt Lake City.
As I wrote when we covered the study in May, the vaccine is designed to harness the power of the patient’s own immune system to fight cancer. Gradalis manufactures the vaccine from scratch for each individual patient using cells from her tumor, which are genetically modified to activate immune cells and prevent the production of proteins that tumors use to avoid detection by the immune system.
“This is true personalized medicine,” Limber said.
The Dallas-based startup, which was founded in 2005, was co-founded by outgoing CEO David Shanahan, who stays on as chairman. “Joe is an executive expert in marshaling these drugs,” Shanahan said in an interview. “I’m looking forward to assisting Joe as he navigates this. We have such confidence in him that I don’t really have any angst about where he takes the company.”
In January, the company raised $24 million in a Series B round of financing, part of a total of $44 million Gradalis has raised from a mix of institutional and private investors focused on the life sciences. The company declined to name specific investors.
Gradalis is currently involved in a phase II randomized study that has so far enrolled 72 patients with either stages 3c or 4 ovarian cancer, the most advanced stages of the disease, in which the cancer has spread to other organs. Thirteen patients received the vaccine along with standard treatment of tumor removal and chemotherapy, while seven patients received only the standard course of treatment. Gradalis expects to enroll a total of 60 women by year’s end.
In the interim analysis of data from the study released in May, the mean time between starting treatment and cancer recurring for patients receiving the vaccine was 470 days, versus 193 days for patients receiving standard treatment, according to the company. Gradalis has said there were no adverse events associated with the vaccine in the study, which is expected to run until January 2016.
Limber said his first order of business is to fine-tune the nuts and bolts of Gradalis’ business model. “You want to make sure you have all the gremlins eliminated,” he said. “I’m pretty impressed with what Gradalis has done so far.”
In addition to seeking efficiencies, Limber says he wants to find opportunities to leverage Gradalis’ institutional knowledge in other ways. In previous research, Gradalis has shown that it can manufacture its Fang vaccine for a variety of tumor types, including melanoma and colorectal, breast, ovarian, and hepatocellular cancers.
Going forward, he asked, “are there complementary technologies that are strategically relevant?”
For example, while at Prometheus, Limber supervised a program that breathed new life into existing drugs in the company’s portfolio. “We licensed pharmaceutical products that were on the decline and were able to do wonderful things with it,” he says. “We increased revenue with no new clinical data. It’s all about blocking and tackling and delivering the right message to physicians.”
For example, Prometheus licensed Proleukin from Novartis and targeted it to patients that weren’t using the drug. “This year, Proleukin should do close to $120 million,” he says.
Prometheus was doing so well that executives initially filed for an IPO in 2007 before ultimately deciding to take up Nestlé on its buyout offer.
Limber says it’s too early to think about whether an IPO would be a strategy for Gradalis, despite the current gold-rush feel of life sciences IPOs. “We’re not there yet,” he says.
Given his successful exit from Prometheus after a decades-long career in the biotech and pharmaceutical industries, why would Limber latch onto another CEO job, this time in Dallas?
“I’d rather do this than just sitting on the beach,” says Limber, who has a home in La Jolla, California. He certainly seems to have taken a shine to the Texas business ethos.
“The state has an interest in seeing high-tech companies succeed and they’re there to support that,” he added. “In California when it comes to business, it’s ‘We’ll continue the beatings until someone says stop.’”