Bringing in $37 million in a Series B financing, Rejuvenon Corp. plans to support the clinical development of two oncology products through Phase II testing.

The company's first product, RC1291, is a small molecule in Phase I development to treat cancer cachexia, while the second product is in preclinical testing.

"We're hoping that we can get it into the clinic by the end of 2005," said Peter Policastro, president and CEO of Rejuvenon, which is based in The Woodlands, Texas.

Rejuvenon develops early stage drugs for cancer and metabolic diseases. The company in-licensed its first portfolio of compounds in May 2001 from Novo Nordisk A/S, of Bagsvaerd, Denmark. That portfolio included RC1291 and five other developmental-stage candidates and hundreds of related structures that are ghrelin agonists. Rejuvenon holds rights to all potential indications for the products.

"It's actually a very extensive intellectual property license, which covers numerous compositions of matter and compounds," Policastro told BioWorld Today.

The six compounds came with a significant amount of animal study data. Behind RC1291, several of them are in preclinical testing, he said.

Rejuvenon's second compound expected to enter the clinic came from its in-licensing agreement with an undisclosed pharmaceutical company earlier this year. That product acts on a different target than RC1291, but it, too, is a potential therapy for an oncology indication.

Those agreements are in line with Rejuvenon's strategy to in-license small molecules with validated targets, solid intellectual property and development potential. The company searches mainly for molecules that are in the early clinical or late preclinical stage.

"We are looking to retain some control over our drugs and drug candidates, such that we have the ability to commercialize them ourselves," Policastro said. "So we're looking at a balance arrangement."

That could mean a co-promotion agreement for North American rights or forming marketing partnerships only in overseas opportunities. In any case, the company wants to take its products through the end of Phase II proof-of-principle testing, and then find a development partner to offset costs of late-stage development.

The $37 million financing will take Rejuvenon through those Phase II studies and for about two to three years, Policastro said. The company expects to enter Phase II trials with RC1291 by the end of this year.

RC1291 is a synthetic compound and a ghrelin mimetic. Ghrelin, a small endogenous protein that acts on the growth hormone secretagogue receptor (GHSR), has been shown to increase appetite in humans and in animal models of wasting disorders. RC1291 binds to and stimulates the GHSR - a target for treatment of several metabolic disorders. Unlike ghrelin, RC1291 can be delivered orally.

Cancer cachexia is a wasting disorder associated with mortality, which affects about 80 percent of cancer patients. Some therapies approved for AIDS cachexia are used off-label in cancer patients. While conventional appetite stimulants are prescribed to treat cachexia, they tend to produce weight gain through fat and water retention, instead of through increased lean body mass, Policastro said.

In addition to cancer cachexia, Rejuvenon believes RC1291 might have potential in chronic obstructive pulmonary disease cachexia, cardiac cachexia and AIDS cachexia.

"We think that those would be natural extensions for this drug," Policastro said. "There are no drugs that are approved by the FDA specifically for cancer cachexia, so this would be a first-in-class opportunity."

Rejuvenon raised $12 million in a Series A financing in the spring of 2001. Since then, it has conducted an interim financing, and now the Series B round. In total, the company has raised $52 million since being founded in March 2000 by Roy Smith, the company's chairman and chief scientific officer. Smith also serves as a professor and director of the Huffington Center on Aging at Baylor College of Medicine.

Boston-based Schroder Ventures Life Sciences led the Series B financing, which included other new investors, such as Boston Millenia Partners, Houston-based Cogene BioTech Ventures, New York-based Orbimed Advisors and Prospect Venture Partners, of Palo Alto, Calif. Previous investors, Houston-based BCM Technologies, San Francisco-based Burrill & Co. and Copenhagen, Denmark-based Novo A/S also participated. The Trout Group, of New York, served as an adviser to Rejuvenon.

As a result of the financing, three people joined the Rejuvenon board: Lutz Giebel, of Schroder Ventures; Robert Marshal, of Boston Millenia; and Carl Gordon, of Orbimed Advisors.

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