Start-up company Innovive Pharmaceuticals Inc. added a second compound to its pipeline by licensing rights to a dual Bcr-Abl/Lyn kinase inhibitor from Nippon Shinyaku Co. Ltd.

New York-based Innovive gained worldwide development rights, except for Japan, to NS-187, now designated INNO-406, an oral compound aimed at treating Gleevec-resistant chronic myelogenous leukemia.

There are about 20,000 CML patients in the U.S., but that is expected to grow by 3,000 or 4,000 patients each year. Gleevec (imatinib mesylate), a Bcr-Abl inhibitor, is sold by Basel, Switzerland-based Novartis AG and was the first approved therapy for CML.

"However, we started seeing Gleevec resistance occurring in a couple of ways," said Steven Kelly, president and CEO of Innovive. The rate of Gleevec-resistant and refractory patients is estimated from 4 percent to 13 percent of the treated CML population, Innovive said.

One way resistance occurs is through mutations in the Bcr-Abl gene. Another way involves the up-regulation of pathways - the Lyn kinase pathway is the most predominant - that bypass Bcr-Abl.

"Nippon Shinyaku did the work to identify a compound that would have higher Bcl-Abl activity to overcome mutations and that would also affect the Lyn kinase pathway," Kelly told BioWorld Today.

Innovive said research published about the compound shows that it appears to be 25 to 55 times more potent than Gleevec in vitro, and at least 10 times as effective as Gleevec when it comes to suppressing the growth of Bcr-Abl-bearing tumors. The drug also demonstrated activity in 12 of 13 Gleevec-resistant cell lines.

Kelly said the company saw data presented by Nippon, of Kyoto, Japan, at the annual American Society of Hematology meeting in Atlanta last month and "were very interested" in the compound, which "was specific to the exact resistance that occurs in CML."

Financial terms of the deal were not disclosed, though Kelly said it was a "standard type of deal," involving a "modest up-front" payment and back-end royalties. Innovive's plan is to "get it into the clinic as rapidly as possible," he said, anticipating a pre-investigational new drug application meeting within the next month and an IND submission later in the quarter, with the goal of starting trials around the middle of the year.

The company's first product, INNO-105, recently began a Phase I study in pancreatic cancer. Innovive gained worldwide rights to that compound from Pennsylvania State University in May. INNO-105, a naturally occurring molecule, is designed to inhibit cell growth and division by interacting with the opioid growth factor receptor found on the nuclear membrane of cancer cells, including those associated with pancreatic, head and neck, colon, neuroblastoma and renal-cell cancers.

Founded 18 months ago with a focus on oncology and hematology, Innovive's strategy is to in-license development-stage products.

"We're not investing a great deal of money in research," Kelly said, adding that the company's aim now is to "acquire things that are at the IND or Phase I stage and translate those into rapid clinical results." Over the next year, Innovive, which just added its fifth employee, plans to announce the acquisition of another technology and intends to conduct a Series A financing. Kelly said Innovive also will "begin exploring routes to become a publicly traded company."