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BioGenes Hopes Role in EU-Funded Alzheimer's Biomarker Project Will Raise Profile in US


Berlin antibody firm BioGenes is hoping that its participation in cNeupro, a European initiative to discover protein biomarkers for dementia, will raise its profile abroad.

The deal, for which BioGenes will develop only monoclonal antibodies, will enable the vendor to share ownership of the antibodies with cNeupro, and to pocket royalties on the ones that lead to commercial products.

Earlier this month, BioGenes announced it will replace Farallone Therapeutics as a participant in cNeupro to develop specific monoclonal antibodies directed at dementia with a particular focus on Alzhemier's disease.

BioGenes, which will participate in the program for one and a half years, will be supplying the antibodies for the project. "Guys from other companies and institutions are developing or searching for new markers, and we are the guys who [will be] producing the antibodies against them," CEO Alexander Knoll told ProteoMonitor recently.

The antigens for the antibodies will come from other partners in cNeupro. BioGenes will not characterize the antibodies, leaving that step instead to other firms.

Knoll, who declined to disclose the financial terms of his firm's participation in cNeupro, said he expects to begin work on the project next month after it receives the antigens.

In an e-mail, cNeupro co-coordinator Hermann Esselmann said the project asked BioGenes to participate after Farallone left due to "non-accession to the contract," meaning it did not sign the final contract with the EU.

"Therefore, cNeupro was looking for a substitute … to replace Farallone" and chose BioGenes because of its expertise in antibody development, Esselmann said.

BioGenes, which deals only with diagnostic antibodies and not therapeutic antibodies, specializes in highly sophisticated antibody development and has successfully developed monoclonal antibodies against all kinds of antigens — peptides, soluble proteins, membrane proteins, phosphorylated antigens, small organic molecules like haptens, ologo- and polysaccharides, as well as highly toxic substances, Esselmann said. "Monoclonal antibodies developed by BioGenes can be used to produce high-affinity molecules that can bind to biomarkers."

For its part, BioGenes decided to participate in cNeupro because it believes it may lead to more business. Although the firm has been in existence for 16 years, it has had limited visibility, particularly in markets outside of Europe. According to Knoll, cNeupro is a step toward remedying that.

While BioGenes once concentrated its sales efforts closer to home, in recent years, its focus has shifted overseas, and now more than half of its sales come from outside of Germany.

Participating in cNeupro will allow people "to see the company is doing a very interesting project," Knoll said. "The PR we [get] from this project will have a big impact on the company."

He added that an undisclosed US company has already expressed interest in its antibodies.

In addition, because BioGenes' customers have primarily been pharmaceutical firms, including Pfizer, Bayer, Schering-Plough, Novartis, and Roche, all of the antibodies it has created have been owned by its clients. BioGenes has also worked with these companies in assay-development and quality-control projects, Knoll said.

The deal with cNeupro, however, would give it shared ownership with the consortium over the antibodies it develops.

"We have rights on the antibodies that we produce, and … if a product arises from [our work] we will have royalties from that," Knoll added.

The company records about €2 million [$2.5 million] in sales annually with an annual growth of 3 to 5 percent, which Knoll said he expects to hold steady even with the current financial downturn.

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"We do not see any crisis in the pharmaceutical branch," he said. "We have a lot of customers coming now with bigger and more interesting projects to our company."

The work it will be doing for cNeupro is simple and straightforward, he added. BioGenes develops monoclonal and polyclonal antibodies, but for this project, it will be working only with monoclonal ones, making it "a very easy type of project," Knoll said.

For monoclonal antibody production, the company utilizes the "classical hybridoma technology," though Knoll said the company has tweaked the method "to be more effective than other companies. For instance, we reduced dramatically the amount of antigen one has to use to produce a monoclonal antibody up to 10-fold, and shortened the time of development from at least six months to nine months to about three, four months, and reducing the cost of development."

While he said that there was no special technology involved, "we have redeveloped some steps of the classical hybridoma technology [and] put a lot of efforts and knowledge into that field and changed some parameters … [and] automated some steps."

A 'Most Promising' Approach

Currently comprising four industry partners and 15 universities and research institutions, cNeupro kicked off two years ago with €3 million [$3.8 million] in funding from the EU over three years.

The goal of the initiative is to discover protein biomarkers and develop novel cerebrospinal fluid and blood-multiplex assays for the "accurate, early, differential, and possibly predictive diagnosis of AD," Esselmann, told ProteoMonitor. Esselman helps cNeupro coordinator and principal investigator Jens Wiltfang to manage the project.

"Using a CSF-based guided discovery of biomarkers to develop novel blood-based multiplex assays is highly promising and may be used as well to support the development of novel approaches for molecular neuroimaging," Esselmann added.

In protein biomarker research, cancer may be the only disease area that surpasses neurodegenerative diseases in terms of the amount of research that has been done and is still being carried out. In Alzheimer's in particular, there is no shortage of work being conducted.

But according to Esselmann, one aspect of cNeupro that separates it from other collaborative efforts is its focus on neurochemical dementia diagnostics, which he said is "one of the most promising approaches for the more accurate early diagnosis of dementias and, mostly importantly, their prediction."

By defining European standards of operation for pre-analytical sample handling, sample storage, and assay conditions, cNeupro hopes to improve the performance of CSF-based NDD. As the initiative proceeds, CSF quality surveys will be conducted, "gold standard" CSF samples will be devised, and NDD reference centers will be created in Hungary and Portugal, he added.

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