Calistoga's $40M Series C Moves PI3K Inhibitor to Trial
July 01, 2010 - Bioworld Today
By Catherine Hollingsworth
Staff Writer
Calistoga has closed a $40 million Series C financing that will be used to advance the company's pipeline of isoform-selective PI3K inhibitors aimed at blood cancers and inflammatory diseases, including its most advanced product that is headed for a registration trial.
With the added funds, Calistoga expects to be able to fund its programs through 2011 , CEO Carol Gallagher told BioWorld Today.
The Seattle-based firm is planning to move its most advanced product candidate, CAL-101, into a registration program later this year.
CAL-101 , an oral, delta selective PI3K inhibitor, was evaluated in a relatively large Phase I trial as a single agent in patients with hematologic malignancies. In the 100-patient study, CAL-101 showed activity in three disease areas.
Patients with relapsed or refractory indolent non-Hodgkin's lymphoma (iNHL), mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) showed overall response rates of 57 percent, 67 percent and 30 percent, respectively, according to Phase I data recently presented at the American Society of Clinical Oncology annual meeting.
Calistoga is now studying CAL-101 in an ongoing combination trial with Rituxan and Treanda (bendamustine), both of which are standard of care treatments for iNHL.
The planned Phase II/III registration studies, expected to begin in the fourth quarter, will evaluate CAL-101 in both single agent and combination trials. If all goes well in the registration studies, Calistoga could be ready to file for U.S. regulatory approval in late 2012 and plans to seek accelerated approval, Gallagher said.
She said that the Series C funds would get the registration trials going, but indicated that additional funding would be needed to take the product through the finish line.
Although the Phase I trial of CAL-101 evaluated the product in three different disease areas, the company will focus on specific disease areas in multiple registration trials, the first of which will likely look at iNHL, Gallagher said.
As the data matures for each disease, the company would likely file a supplemental new drug application for the additional diseases areas, she explained.
Calistoga envisions CAL-101 as a drug that could be used to add to the efficacy of currently approved treatments for iNHL, without adding to the toxicity. Overall, CAL-101 was generally well tolerated in the Phase I trial. A low incidence of hematological toxicity was observed.
But the dream combination therapy in cancer would be a regimen that displaces chemotherapy or cytotoxic drugs, Gallagher said. The Calistoga management team has the expertise to handle a marketed product. "We could build the company to commercialize in North America," she said, adding that as the company program's progress, "we will look at all strategic alternatives."
Beginning in 2002, Gallagher led the Rituxan collaboration and oncology marketing at Biogen Idec Inc. During her tenure at Biogen Idec, she led the Rituxan team when oncology sales first surpassed $1 billion and the rheumatoid arthritis and multiple sclerosis development programs were designed.
The Series C funds also will be used to move Calistoga's CAL-263 into Phase II studies for the treatment of patients with inflammatory diseases and for preclinical programs. The company is still deciding which patient group it will study in Phase II testing, but it will likely be rheumatoid arthritis, Gallagher said. That drug candidate, she said, will be studied in patients on methotrexate who are refractory to anti-TNF agents such as Enbrel.
The financing was led by Quogue Capital LLC along with existing investors Alta Partners, Amgen Ventures, Frazier Healthcare and Three Arch Partners and new investor Latterell Venture Partners.
