A University of South Florida spin-out founded on the strength of cancer immunotherapy discoveries made at the school recently achieved a pair of development and financial milestones that has USF hoping for one of its most lucrative biotech-transfer deals to date.
IRX Therapeutics, which spun out of USF in 1994, announced last month that it has raised $25 million in a Series A financing round, which it will use to further develop its cancer and viral disease product platform, especially IRX-2, the company’s lead cancer therapeutic.
The financing comes in the wake of IRX disclosing positive data earlier this year from a Phase II clinical trial of IRX-2, also known as citoplurikin, for treating late-stage head and neck squamous cell cancer patients, and subsequently announcing that it is now preparing to launch a global, Phase III clinical trial for the immunotherapeutic, which has received Fast Track designation from the US Food and Drug Administration.
According to Valerie Landrio McDevitt, director of patents and licensing at USF, the company is on the precipice of being one of the university’s biggest biotech spinout successes to date.
“It certainly is one with potential in the biotech area,” Landrio McDevitt told BTW this week. “It’s certainly our first one to get [regulatory] approval [for a] Phase III [trial], which is a significant thing — especially in biotech, where it seems like not everything gets to the Phase III point. Biotech doesn’t happen overnight. The medical device stuff has moved faster, but in true therapeutics — it just seems to take longer.”
Landrio McDevitt said that USF has a “traditional” licensing agreement with IRX that has provided some financial benefit to the university in the form of undisclosed milestone payments over the past decade, but will bear the most significant financial benefit if citoplurikin can reach market.
The National Cancer Institute estimated that about 39,000 people had the malignancy in the US in 2005. Meanwhile, according to IRX, there are 500,000 new cases of head and neck cancer worldwide each year, and about 50,000 new cases in the US. Analyst estimates for the disease’s market size have hovered in the $400 million range for the past few years.
The disease is associated with high rates of recurrence and mortality and is highly immunosuppressive. The current standard of care is primarily curative surgery followed by radiation therapy or, in some cases, chemoradiation, IRX said, and there is currently no approved neoadjuvant therapy for these patients.
“Certainly we try to pay some attention to the market, and in head and neck cancer, a lot of people are chasing it because there really is no effective treatment,” Landrio McDevitt said.
IRX was founded by John Hadden, an early pioneer in the field of immunopharmacology who founded the immunopharmacology program at Memorial Sloan-Kettering Cancer Center in the 1970s. Hadden joined the faculty of the USF Medical School in 1982; and, after founding IRX in 1994, Hadden became chairman in 1998.
“Biotech doesn’t happen overnight. The medical device stuff has moved faster, but in true therapeutics – it just seems to take longer.”
The company is now led by his son, John Hadden II, who serves as president and CEO. The elder Hadden has since retired, and IRX no longer has a formal research collaboration with USF. But IRX’s development has been of particular interest to USF, which to this day maintains a close relationship with the company, Landrio McDevitt said.
“A lot of these things don’t survive, and a lot of them tend to be closer relationships than when you license something to a big pharma, as far as day-to-day, helping them out, doing diligence,” Landrio McDevitt said.
As an example, USF has worked with IRX over the years on patent prosecution, diligence questions, or obtaining funding. In fact, USF participated in the $25 million Series A financing, although its investment amount has not been disclosed.
“It seems John [Hadden] and I talk on a regular basis,” Landrio McDevitt said. “There have been points where we’ve had to move milestones, and where we’ve had to delay payments, or change things around a little bit because things didn’t go exactly in the direction as expected.
“I don’t think it’s anything unusual; it’s pretty standard tech-transfer stuff if you’re trying to support the company,” she added.
USF hopes to draw attention to IRX’s progress in particular because it hopes to demonstrate that its recent increase in life sciences research and licensing activity has begun to pay dividends for the university and for the state of Florida — although IRX is now based in New York.
“It’s one of these things where you want to give some kudos when you can, and highlight the fact that this is the kind of thing we want to do with all of our startups,” Landrio McDevitt said. “We want to work with them and get these things to the next stage.
“Obviously we’d love for all our startups to stay in Florida, but we’re interested in helping these startups in general – especially in biotech, since USF’s president [Judy Genshaft] has put a significant focus on the biotech program here, and we’ve been doing a lot more biotechnology transfer.”