Advaxis has exclusively licensed its lead clinical-stage product candidate, ADXS-HPV, to FusionVax. Under the terms of the agreement, Advaxis will license the rights to ADXS- HPV for the Asia territory, exclusive of India, for all indications. In exchange, FusionVax will pay Advaxis an up-front payment, certain event-based financial milestones, an annual exclusive licensing fee, and an annual net sales royalty in countries with issued patents.
In exchange for the up-front payment, Advaxis will provide FusionVax an equal amount of Advaxis common stock. FusionVax will be responsible for conducting clinical trials and pursuing commercialization of ADXS-HPV in Asia and, in exchange, Advaxis will pay FusionVax net sales annual royalty on ADXS-HPV in the U.S. of less than 1%. The companies will share all data generated from their respective clinical trials.
Advaxis and FusionVax will work together over the next six months to enter into a definitive exclusive licensing agreement based upon these terms. FusionVax has agreed to place into escrow a portion of the first event-based milestone pending the execution of a definitive licensing agreement.
FusionVax is a private Taiwan-based biopharmaceutical company developing immunotherapies for the treatment of HPV-associated cancers. It is committed to in-licensing and developing early- to late-phase product candidates with primary disease targets of cervical cancer and lung cancer with a secondary focus on treatments for CIN, oropharyngeal cancers, and genital warts.
ADXS-HPV is being evaluated in five clinical trials for HPV-associated diseases: recurrent/refractory cervical cancer (Phase II, India), locally advanced cervical cancer (Phase II, GOG/NCI U.S. study), CIN 2/3 (Phase II, U.S. study), head & neck cancer (Phase I/II, CRUK study), and anal cancer (Phase I/II, BrUOG study).