Inovio Pharmaceuticals Inc. (INO) signed a licensing agreement with Chinese biomedical firm ApolloBio Corp. Under the deal, Inovio will grant exclusive rights to ApolloBio for the development and commercialization of its pre-cancer drug candidate, VGX-3100, within the Greater China market comprised of China, Hong Kong, Macao, and Taiwan.
The agreement also provisions for the potential inclusion of the Republic of Korea three years after the effective deal date. (See also, Inovio Secures Funding for MERS Vaccine.)
The DNA immunotherapy candidate VGX-3100 is designed to treat pre-cancers which originate from human papillomavirus (HPV). The deal includes the development of the drug for treating and/or preventing pre-cancerous HPV infections and HPV-driven dysplasias. It excludes treatment or prevention of HPV-driven cancers and all combinations of VGX-3100 with other immunostimulants, reports Genetic Engineering News portal.
$15M Upfront and Separate $35M Equity Investment
Inovio will receive $15 million in upfront and near-term payments and can receive another $20 million upon achieving regulatory milestones. Inovio is also eligible to receive double-digit royalties on drug sales in the licensed markets.
As the drug is on clinical hold by the U.S. Food And Drug Administration (FDA) since October 2016, the near term payments include $12 million, which will be released by ApolloBio once Inovio is successful in getting the clinical hold lifted. Due to the clinical hold, Inovio’s planned Phase 3 trials of VGX-3100 were delayed, and it expects to resume trials during the first half of 2017. (For more, see Inovio Shares Tumble on FDA Clinical Hold.)
ApolloBio has agreed to invest $35 million in Inovio in a separate transaction, once the clinical hold on VGX-3100 is lifted.
The drug works by activating certain functional T-cells which help in clearing the HPV infection, and reverse the development of precancerous cervical dysplasia. At present, there are no approved non-surgical treatments for persistent HPV infection or cervical dysplasia.
HPV is a form of sexually transmitted infection which leads to cervical cancer that kills more than 250,000 women globally. HPV affects 300 million women of which 500,000 develop cervical cancer each year.
Inovio’s stock price spiked on the deal announcement, and was trading up 2%, at $6.63 per share, on Monday morning. (See also, Inovio's Race to Kill the Zika Virus.)