Aphton unit expands licensing, commercialization agreement for IGN311 cancer drug

By Angela McDaniels

Seattle, Feb. 7 - Aphton Corp. said its subsidiary, Igeneon GmbH, has signed a letter of intent with Korean biotechnology manufacturing company Celltrion to amend their existing licensing and commercialization agreements for clinical product candidate IGN311 and Igeneon's IGN312 antibody, according to a company news release.

Under the original agreements, Igeneon granted Celltrion an exclusive license to commercialize IGN311 in selected Asian countries, including Japan, in exchange for future milestone payments and royalties from Celltrion.

The agreement also said Celltrion will provide development and manufacturing services related to the optimization and upscaling of IGN311 and material for further clinical development.

Under the terms of the letter of intent, Igeneon would expand the existing license to permit Celltrion to commercialize IGN311 in Europe and grant Celltrion an additional license to commercialize Igeneon's IGN312 antibody in Europe and selected countries in Asia, including Japan.

In addition, for a period of time to be determined, Celltrion would have a right of first refusal to further develop and commercialize IGN101, Igeneon's cancer vaccine that is in a 760-patient phase 2/3 clinical trial.

In return, Igeneon would receive an up front payment of $5 million, milestone payments of up to $15 million and royalties on sales of each product in both territories. Celltrion would assume all clinical development costs for IGN311 in both territories.

The companies plan to begin phase 1 and phase 2 clinical trials of IGN311 in Asia soon, according to the release.

The signing of the definitive agreement is pending approval of the boards of directors of both Aphton and Celltrion.

"By committing to pay up to $20 million in up front and milestone payments, plus assuming all development costs of IGN311 in Europe and Asia, we believe that Celltrion is making a significant statement about its belief in the potential of these products," Aphton president and chief executive officer Patrick Mooney said in the release.

"In addition, Aphton would retain the rights to the products in North and South America and the rest of the world, which, based on the current terms of this expansion, would provide us with a tremendous opportunity in the future."

Aphton said IGN311 is a humanized monoclonal antibody against the Lewis Y carbohydrate antigen, a blood-group-related oligosaccharide. Lewis Y is over-expressed in up to 90% of all epithelial cancers, according to the release, and its expression on adult normal tissues is very restricted; hence IGN311 has the potential to target a broad range of carcinomas.

IGN312 is a next-generation antibody based on IGN311.

Aphton is a clinical-stage biopharmaceutical company based in Philadelphia that develops targeted immunotherapies for cancer.

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