Amgen (NASDAQ:AMGN) and Advaxis, Inc. (NASDAQ:ADXS) announced a global agreement for the development and commercialization of Advaxis' ADXS-NEO, a novel, preclinical investigational cancer immunotherapy treatment that is designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor. This collaboration brings together Amgen's development expertise in immuno-oncology with Advaxis' MINE™ (My Immunotherapy Neo-Epitopes) program, which is uniquely positioned to develop a customized approach to cancer treatment.
Under the terms of the agreement, Amgen receives exclusive worldwide rights to develop and commercialize ADXS-NEO. Amgen will make an upfront payment to Advaxis of $40 million and purchase $25 million of Advaxis common stock. Amgen will be fully responsible for funding clinical and commercial activities. Advaxis will lead the clinical development of ADXS-NEO through proof-of-concept, retain manufacturing responsibilities, and receive development, regulatory and sales milestone payments of up to $475 million and potential high single digit to mid-double digit royalty payments based on worldwide sales.
"Amgen's collaboration with Advaxis leverages and enhances our development and commercialization expertise in novel immuno-oncology treatments," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to partnering with Advaxis to advance this highly targeted and patient-specific treatment option for patients."
"Amgen is a pioneer in the science of using living cells to develop biologic medicines, making them an incredibly strong partner to develop and commercialize Advaxis' MINE," said Daniel J. O'Connor, president and chief executive officer at Advaxis. "With Amgen's resources, worldwide reach and a culture that embraces science and innovation, we are positioned to accelerate the clinical development program for ADXS-NEO to improve the lives of those who suffer from cancer."
The Advaxis Lm Technology™ utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to produce and deliver tumor antigen/adjuvant fusion proteins within antigen presenting cells with the goal of generating strong, T-cell-mediated immunity. For ADXS-NEO, DNA from each patient's primary tumor and/or metastases as well as normal cells, is sequenced and compared to identify mutations in genes coding for potential neo-antigens in the cancer. Advaxis then engineers and manufactures patient-specific Lm-LLO (listeriolysin O) vectors capable of immunizing them against neoepitopes exclusive to their cancer. After the ADXS-NEO infusion, neoepitope peptides corresponding to each patient's cancer-associated mutations are delivered directly into their antigen presenting cells by Lm-LLO, where they can stimulate cellular immune responses against multiple neoepitopes simultaneously. Clinical trials for ADXS-NEO are expected to begin in 2017.
About MINE™ (My Immunotherapy Neo-Epitopes) / ADXS-NEO
MINE™ (My Immunotherapy Neo-Epitopes) and ADXS-NEO are designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in each individual patient's tumor. This strategy, using massive parallel sequencing, eliminates the need for predictive algorithms and enables the development of truly personalized immunotherapies that can be manufactured in a manner that is cost-effective and timely for patients.
MINE™ will evaluate the immunologic and anti-tumor activity of this patient tumor-specific, neoepitope-based immunotherapy. Advaxis and Amgen will use learnings from MINE to identify and target neoepitopes using Lm Technology™ and later develop patient specific immunotherapy constructs that incorporate the neoepitope sequences identified in the patient's tumor cells. Clinical studies using ADXS-NEO are in development.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
About Advaxis, Inc.
Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology™, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer-fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology™ immunotherapy, axalimogene filolisbac (AXAL), targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted AXAL orphan drug designation for each of these three clinical settings, as well as a Special Protocol Assessment for the Phase 3 AIM2CERV trial in patients with high risk, locally advanced cervical cancer. AXAL has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the European Medicines Agency's Committee for Advanced Therapies. Advaxis has two additional immunotherapy products in human clinical development: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2-expressing solid tumors. Advaxis has received Fast Track Designation for ADXS-HER2 for the treatment of patients with newly-diagnosed, non-metastatic, surgically-resectable osteosarcoma and for AXAL for the treatment of high-risk locally advanced cervical cancer.