Sanofi Pasteur, the vaccines division of Sanofi, recently expanded an agreement with French monoclonal antibody provider Vivalis to discover a fully human monoclonal antibody against an undisclosed infectious disease target.
The deal expands on a 2010 agreement between the two French companies that focused on a different infectious disease target, also undisclosed. Sanofi has exclusive access to Vivalis' array-based VivaScreen platform for the discovery of antibodies targeting "clinically significant" infectious diseases, and will obtain worldwide exclusive development and commercialization rights for the discovered antibodies, according to a statement.
As part of the deal, Vivalis could receive milestone payments of up to €35 million ($46.9 million), as well as royalty payments associated with product sales. In addition, Sanofi Pasteur will continue to finance collaborative research activities, the firms said.
Lyon-based Vivalis has credited its VivaScreen array-based screening platform for securing both deals with Sanofi.
"Thanks to this technology we have access to very rare monoclonal antibodies," Philippe Guillot-Chêne, Vivalis' senior director of business development, told BioArray News.
"In certain pathologies, the number of lymphocyte B cells circulating in the blood is very, very low," Guillot-Chêne said. "With traditional technology there is no chance to have access to them, but with our technology we can have access to rare lymphocyte B cells," he noted. Using arrays, the firm can collect one specific lymphocyte B cell in a sample containing 200 million cells, Guillot-Chêne claimed.
Vivalis relies on its VivaScreen platform to generate fully human therapeutic antibodies. The process involves isolating B-lymphocytes from donors, and then isolating, activating, and expanding them in order to screen selected antibodies by functional or binding assays, according to Guillot-Chêne. The target B-lymphocytes are then removed using a single-cell microarray platform and used to produce fully human monoclonal antibodies.
Vivalis developed the VivaScreen platform over the past two years. It is based on technology gained through two acquisitions. In January 2010, Vivalis spent €3.7 million to acquire Lyon-based Humalys, which had developed its Humalex platform for discovery of fully human monoclonal antibodies produced by activated and immortalized B lymphocytes isolated from selected human donors.
In April 2011, Vivalis obtained an exclusive license to the ImmunoSpot Antibody Assay on a Chip, or ISAAC, platform from Toyama, Japan-based Stem Cell World for an undisclosed sum.
The VivaScreen assay is a combination of the two technologies. It involves the collection of a blood sample from a donor and the isolation of B lymphocytes, which is performed using the Humalex platform. This is followed by running the cells on an array designed to target certain desired cells, then performing antibody cloning and antibody gene expression profiling using the ISAAC technology, according to Vivalis.
The ISAAC technology has been described in several publications, including a Nature Protocols paper that appeared last year.
Guillot-Chêne said that Vivalis' array platform is manufactured in Japan by another company that he declined to name. According to one paper describing the technology, the chips were made at the Toyama Industrial Technology Center.
The arrays used are 7 mm x 7 mm in size, and contain 250,000 microwells per chip, each of which contains an antigen that can be used to capture an antibody of interest. The only limitation of the technology, Guillot-Chêne said, is that Vivalis must have the antigen to capture the desired antibody and that the antigen must be "very pure" to be used on the array.
Guillot-Chêne said that he is unaware of any other human monoclonal antibody suppliers that use microarrays to target antibodies of interest. "I think we are the only one with this combination," he said.
At least two firms, Arrayit and Life Technologies' Invitrogen division, sell protein arrays for antibody profiling.
According to Guillot-Chêne, Vivalis is offering VivaScreen to other pharmaceutical companies, but the deal with Sanofi is the only one that has been publicly discussed. The firm's other clients remain undisclosed. Vivalis is also using VivaScreen to discover antibodies internally that it can later license out to other firms.
Founded in 1999, Vivalis has offices in Nantes, France; Lyon; and Toyama and employs 125 people, Guillot-Chêne said. The public firm is listed on NYSE Euronext. Last month it reported full-year 2011 revenues of €10.3 million, a 112 percent spike over 2010 revenues. Much of the surge was attributable to its licensing revenues, which rose 119 percent to €8.2 million from €3.8 million in 2010. Service revenues, to which VivaScreen sales contribute, grew 86 percent to €2 million from €1 million the prior year.
Last month the firm opened a new facility in Lyon to offer its VivaScreen antibody discovery services to customers in North America and Europe (BAN 1/31/2012).
The new facility is based in Lyon's Gerland Biotechnology Cluster, which also counts Sanofi Pasteur, Merial, Genzyme, and the French Institute for Protein Biology and Chemistry as resident companies and institutions.
Guillot-Chêne said that the new lab will combine the firm's Humalex functional testing and ISAAC high-throughput screening services in one place. Previously, Humalex testing was conducted in Lyon and ISAAC assays were run in Japan.
The company is planning to open a similar facility offering VivaScreen in Toyoma.
"Our plan is to have the same [offering] in Japan," said Guillot-Chêne, adding that the Lyon lab will serve North American and European customers, while the second lab will serve Asian customers.
The firm is making these investments to meet demand, from pharma in particular. Guillot-Chêne said that monoclonal antibodies are "very attractive" to pharma, as they can be used to develop treatments for numerous conditions, from neurological diseases to oncology.
He also said that the widespread use of antibiotics in recent decades has made current antibiotics inefficient, in which case "the only way to cure the patient is to give the patient an antibody to stimulate the immune system."
Screening services are just part of Vivalis' overall offering. In addition to VivaScreen, Vivalis also offers research and commercial licenses for its EB66 cell line, derived from duck embryonic stem cells, to pharmaceutical and biotechnology companies for the production of therapeutic and prophylactic viral vaccines, virosomes, and recombinant proteins.
The firm also performs discovery and development, up to preclinical evaluation, of novel small-chemical molecules identified with its 3D-Screen platform. The company also offers as a service custom 3D-Screen assays directed against target proteins of interest.
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