PRINCETON, N.J.
Advaxis, Inc., (OTCBB: ADXS) (“Advaxis” or the “Company”), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that it has entered into a Memorandum of Understanding (MoU) with FusionVax, Inc. (“FusionVax”) setting forth the main terms under which Advaxis will, subject to the entry of a definitive agreement, exclusively license its lead clinical stage product candidate, ADXS-HPV, to FusionVax for Asia.
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. FusionVax develops its licensed technologies through collaborations with top academic leaders at prestigious medical centers in Asia including: National Taiwan University, Taipei Medical University, and Mackay Memorial Hospital Medical Center.
Dr. HunChi Lin, Chief Executive Officer of FusionVax, commented, “We are very pleased to have the opportunity to collaborate with Advaxis to develop vaccines for the treatment of cervical cancer, a cancer that is the leading cause of the death of Chinese women.”
Under the terms of the MoU, Advaxis will exclusively license the rights to ADXS-HPV to FusionVax 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.
Under the terms of the MoU, 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 well-positioned to further develop ADXS-HPV clinically and to realize its commercial value in Asia across multiple HPV-associated cancers,” commented Daniel J. O’Connor, Senior Vice President, Chief Legal and Business Development Officer of Advaxis.
“With five studies currently in the field in four indications, we continue to broaden our data. This MoU is the first milestone on Advaxis’ path to future licensing opportunities,” commented Thomas A. Moore, Chairman and Chief Executive Officer of Advaxis.
About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. Advaxis immunotherapies are based on a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete antigen/adjuvant fusion protein(s) designed to redirect the powerful immune response all human beings have to the bacterium to the cancer itself.
ADXS-HPV is being evaluated in 5 clinical trials for HPV-associated diseases: recurrent/refractory cervical cancer (Phase 2, India), locally advanced cervical cancer (Phase 2, GOG/NCI US study, Clinical Trials.gov Identifier NCT01266460), CIN 2/3 (Phase 2, US study, Clinical Trials.gov Identifier NCT01116245), head & neck cancer (Phase 1/2, CRUK study, Clinical Trials.gov Identifier NCT01598792), and anal cancer (Phase 1/2, BrUOG study, Clinical Trial.gov Identifier NCT01671488). Over fifteen (15) distinct constructs are in various stages of development, developed directly by the Company and through strategic collaborations with recognized centers of excellence such as: the National Cancer Institute, Cancer Research – UK, the Wistar Institute, the University of Pennsylvania, the University of British Columbia, the Karolinska Institute, Brown University Oncology Group, and others. For more information please visit: advaxis.com | Facebook | twitter | LinkedIn
Forward-Looking Statements
This news release contains forward-looking statements, including, but not limited to: statements regarding ADXS-HPV, its clinical stage product candidate, and immunotherapies, as well as statements regarding the entry into a definitive licensing agreement with FusionVax, as well as Advaxis’ ability to develop ADXS-HPV further clinically and realize its commercial value in Asia, the generation of additional data regarding ADXS-HPV, and future licensing opportunities. Such forward-looking statements are subject to a number of risks and uncertainties, such as those described in the “Risk Factors” section in Advaxis’ Annual Report on Form 10-K for the fiscal year ended October 31, 2012, which is available at www.sec.gov, as well as its other filings with the Securities and Exchange Commission. Advaxis undertakes no obligation to revise these forward-looking statements to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.
CONTACT
Advaxis, Inc.
Diana Moore, 609-452-9814
Director, Investor
Relations & Business Development
ir@advaxis.com
