Aprea starts recruiting a U.S. team as it preps for PhII on p53 'Holy Grail' cancer drug

Aprea's Bernd Seizinger

Stockholm-based Aprea AB is looking to add staffers on the East Coast in the U.S. after gaining an extra $51 million to spend as it ramps up mid-stage development work on its p53 drug APR-246 in ovarian cancer.

The Swedish biotech today unveiled a venture round derived from a high-profile group of transatlantic investors this morning, bringing in Versant Ventures and 5AM Ventures with participation by Sectoral Asset Management. HealthCap acted as the local lead investor and Aprea's main shareholder is KDev Investments AB, an investment vehicle owned by Karolinska Development AB (Nasdaq Stockholm: KDEV) and Rosetta Capital.

They're betting on an upcoming Phase Ib/II study of a drug that has already elicited signs of activity in reacting the tumor suppressor, a target which has been linked to a wide variety of hematologic cancers as well as solid tumors. And that target has helped push Aprea to the front of the Karolinska portfolio with the biggest round yet for an emerging drug developer in the portfolio, as well as one of the biggest rounds ever to go to a Scandinavian biotech.

Bernd Seizinger, the executive chairman of Aprea, tells me he's looking to staff up a new team somewhere in the East Coast corridor that ranges from his home in Princeton, NJ, through New York and on up to Boston/Cambridge, adding to the fewer than 10 staffers that make up the core development team in Stockholm.

The Phase II study is slated to start in the next 8 to 10 weeks as Aprea goes on the hunt for promising clinical efficacy data--something that has remained elusive for many teams that tackled p53 in the past. Seizinger, who has deep roots in the business that extends through a four-year stint at Bristol-Myers ($BMY) as well as a stretch teaching at Harvard Medical School, experienced some of that early frustration first hand.

"I've been working on p53 for a long time," he says, noting his role as one of the pioneers in introducing an assay to find small molecules that can reactivate p53. So when he heard what Aprea was trying to do, his first response was strong skepticism. What won him over to Aprea was a chance to review evidence of activity in the early-stage study along with a deep understanding of the potential for any drug that can finally reach one of the Holy Grails in biotech.

With the deep-pocket backers, Seizinger now has a fully funded runway that extends out three years. That's enough time to complete a Phase II that will start in some 30 sites in Europe and then extend to an additional 10 or so sites in the U.S. And as the Phase II runs--focusing on progression free survival, which would also be a primary endpoint in Phase III--Aprea will add exploratory studies to better determine the drug's potential.

At that point, Seizinger says frankly, the company would be in a good position to complete a trade sale to one of the many cancer drug players out there, probably in the U.S. If that doesn't pan out as hoped, there's a chance to launch an IPO on Nasdaq or go back to the investors to fund a late-stage effort.

The scientist notes that APR-246 also has potential in hitting microRNA-34a, hitting a target that could make it synergistic with a PD-L1 checkpoint inhibitor--one of the most popular targets in biotech. 

- here's the release