Novelix Pharmaceuticals Inc., formed a year and a half ago to compile a portfolio of small molecules created by its founders, recently selected its first four products for development, with the lead candidate expected to reach the clinic by the end of the year.

The Pasadena, Calif.-based company completed in-licensing activities just last month, gaining exclusive rights to a group of potential cancer therapeutics from the University of Southern California, including NVX-144, a small-molecule targeted drug aimed at treating cancers resistant to standard treatment.

"We're now sitting on more than 100 designed small molecules," said Burkhard Jansen, CEO, who co-founded the company along with the rest of the management team to focus specifically on small molecules designed to treat cancer.

What sets Novelix apart from other companies, Jansen said, is that the founders, some of whom are affiliated with the university, created and brought in the entire portfolio.

"That's highly unusual," he told BioWorld Today. "Usually, you have an assortment of compounds, in-licensed here and there."

The company's lead drug, NVX-144, was invented by USC's Nouri Neamati, co-founder and vice president of developmental therapeutics. Co-founder and Novelix Chairman Timothy Triche collaborated in that compound's characterization.

Designed to induce the anticancer gene interleukin-24 (IL-24), NVX-144 has shown activity in preclinical studies against lung, colon, prostate and breast cancer. The drug is "easy to make and synthesize, and has shown efficacy and activity at the nanomolar level," Jansen said, adding that IL-24 regulation has become "an attractive strategy with other treatment concepts, such as gene therapy."

He referred to Austin, Texas-based Introgen Therapeutics Inc.'s work with its gene therapy cancer candidate, INGN 241, an MDA-7/IL-24 protein, which has shown promising preclinical data in promoting tumor cell death. Introgen's lead gene-therapy product, Advexin, which supplies the p53 protein, is in Phase III studies in head and neck cancer.

"We've paid attention to the exciting work they've done," Jansen said, "but given the choice between small molecule and biologic gene therapy, we think the small-molecule approach is more streamlined, and most are geared toward oral administration."

NVX-144 is expected to enter Phase I development by the end of 2006. Novelix plans to evaluate the drug initially in colon and lung cancers.

Behind NVX-144, the company has NVX-188, an alpha v beta 3 integrin inhibitor designed to inhibit tumor growth, metastasis and angiogenesis. Clinical testing on that drug likely will begin in 2007. Then there's NVX-207, a sterol analogue that has shown efficacy in dogs in studies of treatment-resistant squamous-cell carcinoma and sarcoma, and is set to begin Phase I trials in late 2007 or early 2008. The fourth pipeline product is NVX-117, an MDM2 inhibitor aimed at enhancing p53 to regulate cell death. Clinical trials for that compound are projected to start in 2008.

Novelix was incorporated in June 2004, but "really got started in early 2005, when I moved from Vancouver to Pasadena, where the other founders were located," said Jansen. "We started raising our first bit of money and started building our legal and intellectual property infrastructures."

The company has raised more than $700,000. Over the next five years, Jansen said, Novelix expects to need about $32 million to advance compounds into clinical development and, if possible, through Phase II studies.

After that, "we're definitely going to be looking for partners," he said. "We want to provide liquidity for shareholders as early as possible, so we might even contemplate an earlier-stage partnership."

Jansen said the company already is in contact with large pharma and biotech companies interested in the designed small-molecule candidates.

While Novelix might consider in-licensing a later-stage complementary compound to add to its pipeline, Jansen said the company already has more compounds "than we could ever have the money to develop."

The company now has seven employees and likely will add a few more over the next year, as its lead product gets closer to the clinic.

Along with Jansen, Neamati and Triche, the rest of Novelix's management team includes: Jonathan Buckley, vice president of bioinformatics; Jeremy Teraoka, chief financial officer; and Poul Sorenson, vice president of preclinical development.

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