Inovio and China’s ApolloBio have agreed to tweak their exclusive licensing deal formed about a year ago over Inovio’s DNA immunotherapy VGX-3100, which is designed to treat precancers caused by HPV.
The new deal boosts the upfront payment ApolloBio pays Inovio for Greater China rights to VGX-3100 to $23 million from an original $15 million. The two also removed a previous provision that allowed ApolloBio to purchase up to $35 million worth of Inovio’s stock.
Other terms remain unchanged, including the $20 million in potential milestones and potential geographic inclusion of South Korea.
Inovio’s president and CEO Joseph Kim said in a statement that the adjustment “preserves the best interest” for the company’s shareholders and that ApolloBio’s familiarity with the Chinese market could help "accelerate VGX-3100 development" by adding study patients in China. ApolloBio focuses on bringing new cancer candidates to the Chinese market through in-licensing.
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Inovio touts VGX-3100 as the first HPV-specific immunotherapy that could reduce the risk of cervical cancer without the need for an invasive surgical procedure. It works by activating CD 8 T cells to clear HPV 16 and 18 infections in precancerous settings which, without proper care, can progress into cancer.
The most advanced product in Inovio’s pipeline, VGX-3100 was reportedly able to eliminate high-grade cervical dysplasia in 50% of women in its phase 2b trial, among 80% of whom the HPV infection was also cleared—which surgeries couldn’t achieve. Through a post-hoc analysis of biomarker and immunologic data, Inovio also identified factors that could predict success of the treatment.
The therapeutic vaccine was previously put on an FDA clinical hold, but Inovio still managed to lure ApolloBio while that hold was in place. After apparently meeting the agency’s request for more information regarding its Cellectra 5PSP delivery device, the Plymouth Meeting, Pennsylvania-based vaccine maker moved the candidate into phase 3 in June 2017. Another phase 2 trial, testing the therapy in vulvar dysplasia caused by HPV is also underway, and another study in anal neoplasia is expected to commence this year.
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There are HPV prophylactic vaccines available on the market, notably Merck & Co.’s Gardasil and Gardasil 9, but according to the CDC, only 43% of teens completed the schedule; the virus causes 30,700 cancers in men and women in the U.S. alone each year. Currently, surgical excision of precancerous lesion is the primary treatment for cervical dysplasia, but it’s associated with the obvious disadvantage of pain and bleeding, and it’s unable to deal with the underlying HPV infection.
The new Chinese collaboration with ApolloBio also comes at a time when HPV vaccines draw new interest in China with the recent local approvals of GlaxoSmithKline’s Cervarix and Merck’s Gardasil. Driven by the late-July launch in China, Cervarix sales in the third quarter were up 50% on constant exchange rate, reaching £37 million ($50 million) in the country, GSK reported.
However, despite a rise in publicity, concerns regarding HPV vaccines’ uptake in the country linger, especially as they’re not covered by national insurance. In Chinese mainland, Cervarix currently costs a person 1,740 Chinese yuan ($260) to finish the three-dose regimen, and Gardasil is about 38% more expensive than that.