Peptimmune Inc. acquired a potential treatment for obesity and other metabolic disease indications from Genzyme Corp.
The privately held company, a spin-off from Genzyme, gained an exclusive worldwide license to develop and market an investigational drug candidate labeled GT389-255 in exchange for royalties, shared milestones and payments if the program is partnered further. More extensive financial details were not disclosed.
But Cambridge, Mass.-based Peptimmune's primary focus centers on the product's development. The company plans to file an investigational new drug application with the FDA in the next few months to begin clinical trials later this year.
"This represents a second clinical program [for us], which positions us now as a more later-stage biotechnology company," Peptimmune President Tom Mathers told BioWorld Today. "And for us, that's a transforming event. It not only draws us into an area such as obesity, with a broad market opportunity, but it also does so in a technology that we feel very comfortable with."
The product has a dual mechanism of action, serving as a pancreatic lipase inhibitor and a fat binder. It acts within the gastrointestinal tract to prevent fat digestion, and because the molecule is not absorbed, Mathers said, there is very little systemic exposure to it, which could result in fewer side effects than currently marketed therapies such as orlistat (Xenical, F. Hoffmann-La Roche Ltd.).
GT389-255 has been evaluated in a number of preclinical studies, including investigational new drug-enabling toxicology studies. Peptimmune will not conduct any further preclinical research before filing its IND.
"Clearly, there are a lot of folks at Peptimmune who share a common pedigree from Genzyme," Mathers said. "So we were aware of this program and its opportunity for some time, and perhaps because of our preferential relationship with the folks at Genzyme. But I think it's fair to say that Genzyme was actively [looking to] out-license this, and we were very aggressive in moving forward."
Genzyme, also based in Cambridge, said the product did not fit well with its internal strategies. A minority shareholder in Peptimmune, it will not have any say in GT389-255's clinical development, nor will it provide funding.
Mathers added that the company will keep its options open in terms of the product's longer-term development, given its capitalization through a $41.2 million Series A round of financing last year. (See BioWorld Today, March 12, 2003.)
"From our standpoint, we feel we can advance this program significantly down the road in clinical development," he said, "at which point we'll evaluate our options with regard to further financings, as well as partnering opportunities."
Beyond its new acquisition, Peptimmune has one clinical-stage product, PI-0824, being developed for pemphigus vulgaris. The company is midway through a Phase I study of the injectable tolerizing peptide in patients with the rare autoimmune disorder.
"This is not your classic Phase I in healthy volunteers," Mathers said. "We're hoping to establish safety, and also perhaps see hints of efficacy."
The company's pipeline also includes a pair of late-stage preclinical products - a random amino acid copolymer called CO-14 for multiple sclerosis, and a small-molecule inhibitor of cathespin S labeled MV-57471 for rheumatoid arthritis. The latter program is partnered with Medivir AB, of Huddinge, Sweden.
"We should have four clinical programs by 2005," Mathers said. "I think the strength of Peptimmune is in our experienced management team. All of our executive leadership has commercial biotechnology experience, so not just early stage but also late-stage and commercialization, which I think sets us apart from quite a few of our colleagues."
Genzyme's stock (NASDAQ:GENZ) fell 54 cents Monday to close at $42.06.