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Apath, Celsis to Help Biopharmas Screen HCV Drug Candidates for Efficacy, Toxicity

Celsis International this week announced that its Celsis In Vitro Technologies division has signed an exclusive global development agreement with Apath to help its biopharma clients evaluate hepatitis C drug candidates for efficacy and cytotoxicity.
“Celsis will essentially take this on as one of the services that we offer, and we will promote the use of Apath’s IP portfolio and contract with biopharma customers,” said Judy Madden, Celsis’ vice president of strategic development in an interview with CBA News. Apath will perform the assays on behalf of the drug makers on a fee-for-service basis, Madden added.
According to its Web site, Apath has developed an antiviral screening platform based on multiple viral replicons, or subgenomic, self-replicating RNA molecules that contain all the nucleotide sequences required for RNA replication, transcription, and translation, but are not themselves infectious.
Apath’s technology is based on the work of company founder Charles Rice, Paul Olivo, president and CSO of Apath, told CBA News this week.
For its part, Celsis’ IVT group provides cell-based assays that are used broadly in drug development and drug discovery, and is not focused on any particular therapeutic area.
“This is the first area that we have entered into that is really therapy-specific,” said Madden.
Celsis has had an interest in HCV as a market for the last couple of years, and has looked at a few different ways that it might approach that opportunity, Madden said. She said Celsis acquired In Vitro Technologies about 18 months ago and has made it a product and service portion of the company.
Celsis IVT provides in vitro hepatocyte products and development services to the biopharma industry.
Madden said that more than 100 biopharma companies have active HCV drug development programs. “Apath actually approached us with the opportunity to work with them, and that is really how the two companies first got together.”

“The two companies have agreed to keep on the table the possibility of expanding the partnership wherever the market may take it.”

Apath was interested in partnering with a company with a strong background in hepatocytes, “and we found Celsis,” said Bob Roth, Apath’s vice president for strategic operations. “They ended up being a dynamic CRO that was already out there on the market, and they turned out to be a good fit for Apath.” 
Olivo added that Apath has had this antiviral screening capability for awhile, and “we have been approached by various companies to do screening, and we have considered doing it, but we were concerned that we did not have the infrastructure and did not want to build the infrastructure to create a service arm.”
He said Apath decided the best approach was to partner with a company that had the marketing, service capabilities, and the client base that Apath lacked. 
“When we looked at opportunities to build an HCV service, one of the primary limitations that we ran into was our freedom to operate, and it was in fact Apath’s IP portfolio that we kept bumping into,” Madden said.
The replicon-based technology platform has been developed and certainly used and validated by Apath for its internal purposes, said Madden. “We have the organization and infrastructure in place to promote and market the program, with which we plan to go market immediately.
“I think to the extent that … HCV therapeutics remain a target, and an elusive one to date, an opportunity will exist for Apath’s technology to be used,” she added.
The next step in the collaboration would be to present this technology and this service to biopharma companies who have HCV programs, and begin to scope out the numbers and kinds of compounds that they would like to have evaluated, and begin to set up agreements to do that on their behalf, Madden said.
Apath believes that the partnership with Celsis will grow beyond HCV, said Olivo. 
“The two companies have agreed to keep on the table the possibility of expanding the partnership wherever the market may take it,” he said.
Indeed, Olivo said Apath’santiviral screening platform is applicable to other RNA viruses, and the company has received federal grants to perform biodefense-related antiviral drug discovery. The company also has a program for respiratory syncytial virus.
Apath wants to use portions of the revenue that it generates from the Celsis deal, as well as the revenue it generates from other activities, to advance its drug discovery service, said Olivo, “either alone or in collaboration with a large pharmaceutical company to eventually get our antiviral compounds into the clinic.”       

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