Emerging Drug Developer: Itero Biopharmaceuticals


Itero adopts a ‘high-tech' development strategy

Bryan Lawlis, Ph.D, has found a niche in the biotech industry in which he plans to grow a new biotech company.

But don't ask him for the inside scoop about San Mateo, CA-based Itero Biopharmaceuticals, because the CEO isn't providing one.

"We have a product in development at this time and initiated preclinical activities," says Lawlis. "At this point, we haven't discussed that product, given the competitive landscape."

And don't look for a lot of press releases on its clinical progress, either.

Says Lawlis: "Our strategy will be to not discuss results in the public arenas for the next two years."

That's not to say, though, that he isn't happy to discuss the company's basic strategy.

Last week the company announced that it had gained $21 million in a Series A to back development of a pipeline of ‘added-value' follow-on proteins and antibodies. And the company inked a manufacturing pact with Biological E. Limited, an Indian firm with a long history of manufacturing biologics. In the follow-on biotech world, it's not at all uncommon for developers to keep their therapeutic programs quiet, and Itero isn't about to break that mold at this point.

Lawlis and his band of seven at Itero say they'll gear up in the virtual mode, taking a page from the high-tech playbook that calls on companies to line up low-cost partners halfway around the world as they advance new biosimilars toward approval in the U.S. and Europe.

"There's a gap in biotech between what we've been doing versus high tech," says Lawlis. "No one has utilized the opportunities out there that exist in China, India" and other countries like South Korea.

"I would say that one of the things we feel differentiates us from other companies pursuing the biosimilar protein market is the deal we struck with Biological E.," says Jerald "Jerry" Beers, senior vice president and chief commercial officer. "We're trying to learn from the high tech sector of the advantages gained by having strategic partners in other parts of the word."

Then the picture gets fuzzy again.

"We haven't discussed the next round of financing," says Lawlis. "We're doing drug development, where the burn rate is $1 million to $3 million per month," so the company has enough money on hand to get significantly down the road toward proof of concept.

"I would say that our ultimate goal is to be a commercial company," adds Lawlis. "We have a very, very experienced staff and leadership with experienced investors. Our ultimate goal is to use our expertise in product development, manufacturing and drug development and commercialization to create a product pipeline in a robust company."

This is not a platform company, he adds, but an enterprise devoted to "developing and commercializing these drugs.

"I would say that we would be looking at drugs based on our experience and knowledge in the area of how to improve products in terms of safety or efficacy, to make them more convenient for the patient," says the CEO. "We're going to be looking for ways to add value to the existing product."

And Itero is aiming at FDA approvals at a time lawmakers have yet to create a clear regulatory framework for developers seeking approvals.

"I wouldn't say there's not a pathway in the U.S.," notes Lawlis. "There is a precedent. We have many growth hormones on the market that came off patent in the ‘90s, so there is a pathway for getting those drugs approved. It's just not delineated. Our strategy is to work closely with the FDA to get filings that are approvable. In Europe, it's true they have published guidelines for various drugs that are fairly well characterized. Our strategy is to do Phase I and then Phase III and then file our drug there. In the U.S. it's not clear if a Phase II trial will be required. You do need to work through the FDA on each and every one of these."

Emerging Drug Developer: Itero Biopharmaceuticals
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