Intellikine and MMRC commence INK128 Phase I trial in multiple myeloma

Intellikine, a leader in the development of small molecule drugs targeting the PI3K/mTOR pathway, and the Multiple Myeloma Research Consortium (MMRC) today announced the initiation of a phase I trial of INK128, a novel, orally-available small molecule kinase inhibitor of the TORC1 and TORC2 complexes, in patients with multiple myeloma.

“This is an important step along the development path for INK128 and we hope this drug may benefit patients one day.”

Intellikine received a $1 million Biotech Investment Award (BIA) in December 2009 from the Multiple Myeloma Research Foundation (MMRF), an affiliate organization of the MMRC. The award supported both the pre-clinical development of INK128, as well as helped move it forward into clinical trials as a potential treatment for multiple myeloma.

"The scientific rationale and pre-clinical data for INK128 as a treatment for multiple myeloma is extremely strong," said Pamela M. Klein M.D., Chief Medical Officer, Intellikine. "This is an important step along the development path for INK128 and we hope this drug may benefit patients one day."

The phase I trial is a dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single agent INK128 in multiple myeloma. The trial will be initiated exclusively at MMRC sites, including Dana-Farber Cancer Institute, Boston, MA; University of California San Francisco, San Francisco, CA; Washington University, St Louis, MO; and Hackensack University Medical Center, Hackensack, NJ.

"We are very excited to work with Intellikine to accelerate the development of INK128," said Kathy Giusti, Founder and CEO of the MMRF and MMRC. "The rapid startup of this trial is a testament to Intellikine and the MMRC, and the value of industry partnerships, which are critical to our strategy of moving promising new treatments to myeloma patients faster."

The mTOR kinase represents a central node in human cancer biology and has become an important target for oncology drug development. Unlike other drugs targeting the pathway, INK128 directly inhibits the activity of both the TORC1 and TORC2 complexes, key components of the PI3K/mTOR signaling pathway in multiple myeloma. By inhibiting both TORC1 and TORC2, INK128 more potently inhibits mTOR kinase and may provide for greater efficacy.

Multiple myeloma is a type of blood cancer that originates in plasma cells. It is the most common type of white blood cell cancer and the second most common blood cancer. In 2010, more than 20,000 adults in the United States will be diagnosed with multiple myeloma and nearly 11,000 people are predicted to die from the disease.