Infinity craters after lead drug flunks PhII cancer study

Posted under Blog, Companies, Diagnostics, Funding, Infinity Pharmaceuticals, Medical Devices, Medical Supply, pancreatic cancer, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Infinity Pharmaceuticals' ($INFI) lead therapy failed a critical mid-stage hurdle as investigators moved to shut down a study for pancreatic cancer after the treatment in combination with a common chemotherapy failed to outperform the placebo-chemo combo in improving the overall survival of the metastatic patients involved. Investors wasted no time in registering their distress at the news, cutting the value of Infinity's shares in half in a matter of minutes. By mid-day Infinity shares had regained some of their value, with the stock down about 40%. 

Investigators enrolled 122 patients in the Phase II trial, dividing them into two groups which were treated with saridegib (IPI-926) and gemcitabine or the placebo combo. But a preliminary analysis "showed a difference in survival favoring the placebo plus gemcitabine arm due to a higher rate of progressive disease in the saridegib plus gemcitabine arm."

The failure marks a significant setback for Infinity, a Cambridge, MA-based developer which has vowed to make itself into "one of the next great biotechs in the country," as CEO Adelene Perkins told FierceBiotech in a briefing earlier this week. Saridegib, a Hedgehog pathway inhibitor, has been one of its brightest hopes, with the potential to impact a variety of cancers.

"While the outcome of this study is disappointing, we continue to believe in the therapeutic potential of Hedgehog pathway inhibition. As the Hedgehog pathway plays distinctly different biological roles in myelofibrosis and chondrosarcoma, our Phase 2 trials in these disease settings are ongoing," said Julian Adams, Ph.D., the head of R&D at Infinity.

Perkins noted in their release that the company still has 6 clinical trials underway for three programs, giving it more opportunities to reach the goal line. "We remain committed to our vision of building a sustainable company that discovers, develops and delivers important new therapies to patients," she affirmed.

- here's the press release

Related Articles:
Infinity inks $488M pact on Intellikine's PI3K portfolio
Roche rushes new cancer drug to regulators on Ph2 data

Mundipharma tacks on $50M to cancer alliance with Infinity

Posted under Blog, blood cancer, Companies, Diagnostics, Funding, Infinity Pharmaceuticals, Medical Devices, Medical Supply, Mundipharma International, Pharmaceuticals, Startups, Universities, Videos by Ryan McBride

Infinity Pharmaceuticals ($INFI) has some new wiggle room in its budget to develop its PI3K inhibitor intended to combat blood cancers and inflammation. Mundipharma International, Infinity's partner on the drug, agreed to pump more than $50 million into the program and other candidates in 2013, building on the alliance formed between the two companies in 2008, Infinity said Tuesday.

The Cambridge, MA-based developer's PI3K inhibitor, IPI-145, is in two Phase I clinical trials, including one to test the safety and tolerance in healthy volunteers and a second that will enable the company to gauge the activity of the drug in patients with advanced hematologic cancers. Mundipharma, headquartered in Cambridge, U.K., initially committed $75 million to Infinity when the two companies formed the alliance in 2008, Mass High Tech reported.

Infinity reported Tuesday that IPI-145 is the only inhibitor of the PI3K-delta and gamma enzymes in clinical development, and data from the Phase I studies of the drug are expected in 2012.

"Since our alliance began in 2008, Infinity has advanced and expanded its portfolio of innovative product candidates," Antony Mattessich, regional director of Europe at Mundipharma, said in a statement. "Infinity's productivity and track record in achieving its development objectives make the company an ideal partner, and we look forward to an ongoing collaboration which we hope will yield multiple best-in-class treatments that address significant unmet medical needs."

Separate from the R&D funding, Infinity has taken a $50 million line of credit from Mundipharma and said Tuesday that it has drawn the full amount of the credit line.

- here's the release
- see MHT's coverage

Related Articles:
Infinity gets $75M for cancer partnership
Infinity halts late-stage cancer trial, shares plunge
Infinity inks $488M pact on Intellikine's PI3K portfolio