Intradigm this week announced a corporate reorganization that includes a $16-million cash infusion, a new management team, and the establishment of a California-based research and development facility.
While Intradigm had been prominent among the privately held players in the RNAi therapeutics field, it has been fairly quiet for the past year following the departure of its CEO John Spears and its failure to meet its goal of initiating a phase I trial of its lead drug candidate by mid-2006 (see RNAi News, 9/16/2005).
According to Mohammad Azab, Intradigm’s new president and CEO, the firm is now back on track and aiming to start that clinical study of the investigational cancer therapeutic ICS-283 by as early as the end of 2007.
He told RNAi News this week that the reason Intradigm was unable to advance ICS-283 on time was “the financing, first: The company needed to get the financial resources to do the necessary work to get [the drug candidate] into the clinic. The second big reason, which is tied to the first, was the human resources.”
But in May, Intradigm closed a $16-million financing round that included both existing and new investors. Co-leading the round was Frazier Healthcare Ventures, which is now Intradigm’s biggest shareholder, and Alta Partners.
With these funds, Azab said, the company had cash enough to bring on a new management team and set up shop in Palo Alto, Calif. — a biotech hub it hopes to tap for expertise.
Azab officially took the helm at Intradigm in July, about seven months after he stepped down as chief medical officer of QLT following a restructuring of that company.
He said he had been contacted by one of the co-leaders of Intradigm’s most recent financing before it closed “to look at the company because of my drug-development and business experience.
“They had already identified the company and had already identified that the company needed leadership,” he told RNAi News this week. Once the financing round closed in May, “they made the formal offer [to me] and I accepted.”
Also joining the company are Steven Chamow as senior vice president of chemistry, manufacturing, and control; Xiao-Dong Yang as vice president of research and preclinical development; and Mike Riley as vice president of corporate development. (For more on these hires, see this week’s People in the News.)
David Mack, an Alta director, has also joined Intradigm’s board, while Frazier General Partner James Topper has become the RNAi company’s new chairman.
Company co-founders Martin Woodle, Patrick Lu, and Puthupparampil Scaria remain with Intradigm as CSO, executive vice president, and vice president, respectively.
With the new management team in place and cash in its pocket, Intradigm has set out to fulfill its “number one priority” — advancing ICS-283 into phase I studies for solid tumors, alone or with a partner, Azab said.
“We don’t share details of our budgeting in terms of how far the cash would last — we do that internally,” he said. “But suffice it to say, this money will be sufficient for us to get to the IND stage and get to the clinic.
“Our goal is to … do this on our own and we have the financing to back that,” he added. “That doesn’t prevent us … from listening and being open to entertaining discussions with partners who are interested in our technology at any phase of development.”
ICS-283 targets the VEGF pathway, although the specific gene or genes it is designed to inhibit have not been disclosed. The drug is expected to be delivered intravenously using Intradigm’s proprietary nanoparticle technology, which consists of an RNAi payload surrounded by a polyethylene glycol coat. Binding ligands on the surface of the particle are used to direct it to specific tissues.
Despite the company’s failure to meet its development goals in the past, Azab is confident that Intradigm remains “in the running to hopefully be the first” with a systemically delivered RNAi drug in the clinic.
“The reason that the development [of ICS-283] that the company wanted to happen did not happen was the financing.”
“But … it is not straightforward,” he stressed. “There are a lot of components both from the delivery vehicle we’re using … and from the nucleic acids that we want to put in our delivery technology. This is not something that is going to happen tomorrow. It will take at least 12 months to get to the stage where this compound is in man.”
Other companies developing systemic RNAi drugs include SR Pharma subsidiary Atugen, which has said that it expects to begin phase I testing of a cancer drug in the first half of next year (see RNAi News, 11/2/2006), and Calando Pharmaceuticals, which is targeting a phase I trial for its own cancer drug in the second half of 2007 (see RNAi News¸10/26/2006).
As part of addressing its self-described first priority, Intradigm has also set up research operations in Palo Alto, Calif., which is home to a number of biotech firms as well as Stanford University.
“The drive [to move to California] was the ability to quickly build drug-development capabilities,” Azab noted. “The critical mass of expertise here is higher than anywhere else in the country.”
Currently, Intradigm has six employees at the roughly 11,000-square-foot facility in California in addition to the 11 employees at its headquarters in Rockville, Md. Azab said that while the company ultimately plans to consolidate its operations in Palo Alto, it will keep one foot on each coast “as long as there are certain deliverables and activities that are critical in Rockville.”
Among those deliverables and activities remaining in Rockville are the scientists handling the synthesis of the nanoparticles used in the company’s delivery system, Azab said. Additionally, “a lot of the biology experiments are being done there.”
He also said the company is actively recruiting scientists to fill its West Coast lab space.
“We already have one person on board and … are already in active discussions for two or three scientist positions that we have” open in Palo Alto, he said. Intradigm is also seeking a project manager to “direct the [investigational new drug] project team and the [chemistry, manufacturing, and control] development sub-team, according to the company’s website.
Azab said that he couldn’t provide a timeframe for when a complete consolidation of the firm’s two facilities might occur.