Assistant Managing Editor

Amid the flood of data reported at last month's American Society of Clinical Oncology (ASCO) meeting, small biotech CDG Therapeutics Inc. emerged from a decade of stealth with the first clinical data for its p28 peptide program.

Though established back in 2001 by founder Tapas K. Das Gupta, who heads the surgical oncology department at the University of Illinois, the Chicago-based firm didn't really get going until five or six years ago. Its work to date has centered on advancing discoveries made at the University of Illinois, College of Medicine, showing that redox proteins, azurin in particular, have the ability to enter malignant cells and restore the apoptotic function, said David Volk, president and CEO.

After isolating that activity, CDG began isolating peptides and discovered a method of producing those peptides synthetically.

While the firm has several redox programs early in development, limited capital meant "we had to pick our favorite child," he told BioWorld Today. That turned out to be azurin-derived p28, a peptide aimed at treating p53-positive tumors that's believed to have apoptotic effects as well as anti-angiogenic.

The rest of the biotech community got a first look at the activity of p28 in June, when CDG was slotted for an oral presentation at the massive cancer conference.

It's rare for a Phase I-stage program to get that kind of attention at the huge cancer meeting, and the presentation marked a "watershed moment" in terms of interest in p28, Volk said. "It was a turning point in the company."

Phase I data from 15 patients with advanced cancer showed that p28 was safe and well tolerated, with no adverse events and no dose-limiting toxicity observed. Volk also noted that there also were no reports of immunogenicity, an impressive feat for a peptide product

Efficacy data were promising, too, with p28 showing direct effect on tumor cells as a monotherapy.

There was a nearly 60 percent response, as measured by tumor regression using RECIST criteria. And "it seems to work well in a lot of different tumors," he added.

Six patients showed stable disease (among those melanoma and colon cancer patients), two showed partial regression (melanoma and prostate cancer) and two showed complete regression, with one of those, a melanoma patient, remaining alive a year and a half after starting the trial, with no evidence of measurable disease.

Phase II is next, and CDG has submitted a Phase II protocol for FDA review. But before starting the trial, the company needs to complete a financing round. At the same time, it will be looking at prospective partnerships, Volk said.

So far, CDG has managed to fund operations on about $12.5 million in angel money. "Venture has migrated to the later stage," he noted.

But the firm is hoping that its ASCO debut will help attract investors.

CDG, which has about 15 full-time employees, has a sponsored research agreement with the University of Illinois.