VaxGen And Kaketsuken End Smallpox Vaccine Partnership
VaxGen and the Chemo-Sero Therapeutic Research Institute of Japan have terminated by mutual consent their agreement to co-develop a next-generation, attenuated smallpox vaccine, LC16m8, for use in the United States and elsewhere.
"We continue to believe that this vaccine represents a significant advance over traditional, non-attenuated smallpox vaccines," said James P. Panek, VaxGen's President and CEO. "However, VaxGen was left with no choice but to discontinue development of the vaccine given the lack of a commitment from the U.S. government to fund its development or purchase, and our decision to discontinue biodefense activities. We are hopeful that Kaketsuken will be able to carry on the development of LC16m8 and ultimately make it available to the American people."
Under the terms of the termination agreement, VaxGen will transfer to Kaketsuken or its designee all reports, data and materials and all intellectual property rights that relate to conducting non-clinical and clinical development of LC16m8 in the U.S. In return, Kaketsuken has released VaxGen from ongoing development obligations.
LC16m8 was initially developed in Japan to address the need for an attenuated smallpox vaccine that was as effective, but safer than conventional, unattenuated smallpox vaccines. Studies involving approximately 90,000 children were conducted in Japan, where LC16m8 is currently approved and manufactured commercially. LC16m8 is a cloned virus vaccine produced in cell culture that has been shown to be less neurovirulent than unattenuated strains of vaccinia vaccines in preclinical models.