A Conforma Therapeutics Corp. spinout, barely three months old, closed a $27.5 million Series A financing to cover Phase II trials of its only product, Calsed, to treat small-cell lung cancer.

The San Diego-based company - Cabrellis Pharmaceuticals Corp. - emerged following the $250 million May acquisition of Conforma by Biogen Idec Inc., of Cambridge, Mass. Calsed (amrubicin hydrochloride) was carved out of the deal, which focused mainly on Conforma's heat-shock protein 90 antagonists. (See BioWorld Today, May 4, 2006.)

"It's an entirely inside round, and it includes nearly everyone who had invested in Conforma," said Christopher LeMasters, Cabrellis' chief business officer and the former vice president of corporate development at Conforma.

"This is - for a Phase II clinical program - a significant commitment of funds," he said, "and we think it should be enough for us to pursue amrubicin both quickly and broadly."

By that, LeMasters means the company will conduct three trials in SCLC this year. The first, under way at several sites in the U.S., is assessing the safety and efficacy of Calsed compared to topotecan in the second-line treatment of patients that have responded to platinum-based chemotherapy.

Two other studies evaluating the drug in first-line chemotherapeutic-na ve patients and in second-line patients who are refractory to earlier platinum-based chemotherapy will begin before the end of the year. Accrual of the first trial should be completed "sometime in the first half of 2007," LeMasters said, while the second and third trials should be almost fully enrolled before the end of that year.

Other indications Cabrellis might pursue with Calsed include non-small-cell lung cancer, breast cancer and non-Hodgkin's lymphoma.

The Series A money, LeMasters said, "will get us to a point where we will have data from our Phase II trials in small-cell lung cancer."

Conforma licensed amrubicin HCL in July 2005 from Osaka, Japan-based Dainippon Sumitomo Pharmaceuticals Co. Ltd., which has sold the drug as Calsed in Japan since late 2002 for both SCLC and NSCLC. Conforma's exclusive rights to develop and market the product in North America and Europe transferred to Cabrellis upon the Biogen Idec takeover. (See BioWorld Today, July 11, 2005.)

LeMasters estimated the North American market for amrubicin "could be anywhere from $200 million to $500 million in peak sales," with the higher amount assuming approval in additional tumor types beyond SCLC.

The company's hope is to bring the drug to market on its own, building a sales force in North America, but establishing some sort of partnership for Europe.

Two things make amrubicin HCL stand out from potential competitors. Even though it is "the first totally synthetic anthracycline," LeMasters said, "its activity in tumors has been completely unlike other anthracyclines." It may work better because it appears to "exert more [topoisomerase II] activity than traditional anthracyclines," which include doxorubicin, daunorubicin and epirubicin, all made semi-synthetically starting from natural products.

Another advantage is amrubicin's lack of cardiotoxicity. In all of the studies by Dainippon Sumitomo and in more than 6,500 patients, "there have been no reports of cumulative cardiotoxicity," a common characteristic found in most other anthracyclines, LeMasters said.

Three of the 11 employees at Cabrellis started at Conforma. In addition to LeMasters, Conforma's former Chief Financial Officer John Crawford now serves as Cabrellis' chief financial and administrative officer, and Thomas Estok left his old position as chief commercial officer to lead Cabrellis as president and CEO. While it has no particular meaning, Estok came up with the name "Cabrellis" for the company.

Down the road, Cabrellis might consider bringing in more compounds from Dainippon Sumitomo and other companies. LeMasters said Cabrellis can be successful with just the one product, and the Series A financing gives it the flexibility to wait for the right opportunity.

"We're building a great development capability here," he said, "and hopefully, a commercialization capability, too. So it would make sense for us to look for more in-licensing opportunities."

Major investors that participated in the Series A include Domain Associates, of Laguna Niguel, Calif.; Forward Ventures, of San Diego; Lilly Ventures, of Indianapolis; Novo A/S, of Bagsvaerd, Denmark; ProQuest Investments, of San Diego; RBC Capital Partners, of Toronto; RiverVest Venture Partners, of St. Louis; and S.R. One Ltd., of West Conshohocken, Pa.