PRINCETON, N.J., Feb. 11, 2015 -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, has entered into a clinical trial collaboration agreement with Incyte Corporation (Nasdaq:INCY) to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy, ADXS-HPV (ADXS11-001), with Incyte's investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360). The Phase 2 multicenter, open-label, preoperative window-study will evaluate the safety and efficacy of ADXS-HPV as a monotherapy and in combination with epacadostat in approximately 20 patients with Stage I-IIa human papillomavirus (HPV)-associated cervical cancer.
Both ADXS-HPV and epacadostat are investigational cancer immunotherapies, a new class of treatments that use the body's own immune system to help fight cancer.
"We are excited to collaborate with Incyte and to evaluate epacadostat in combination with our leading Lm-LLO immunotherapy candidate, ADXS-HPV," said Daniel J. O'Connor, Chief Executive Officer of Advaxis. "In previous and ongoing studies, a single treatment cycle of ADXS-HPV, as a monotherapy, has demonstrated improvements in overall survival in women with recurrent cervical cancer. We believe the combination of immunotherapies may hold significant promise for the treatment of this difficult-to-treat disease."
Under the terms of the agreement, Advaxis and Incyte will collaborate on a non-exclusive basis to evaluate the combination of ADXS-HPV with epacadostat for the treatment of cervical cancer. The companies will collaboratively conduct and fund the study, which is expected to begin later this year. Results from the study will be used to determine whether further clinical development of this combination is warranted. Further details of the agreement were not disclosed.
"We believe immune-targeted combination therapy represents a promising new approach in oncology," said Rich Levy, MD, Chief Drug Development and Medical Officer at Incyte. "This clinical trial collaboration is a further illustration of our desire to investigate the therapeutic value of our IDO1 inhibitor in multiple tumor types as rapidly as possible."
About cervical cancer
There are 500,000 new cases of cervical cancer caused by HPV worldwide every year, according to the WHO Human Papillomavirus and Related Cancers in the World Summary Report 2010. Current preventative vaccines cannot protect the 20 million women who are already infected with HPV; and of the high risk oncogenic strains, only HPV 16 and 18 are present in these vaccines. Challenges with acceptance, accessibility, and compliance have resulted in only about a third of young women being fully vaccinated in the United States and even less in other countries around the world. HPV is associated with 20-50% of oral squamous cell carcinomas.
ADXS-HPV is Advaxis's lead immunotherapy product candidate for the treatment of HPV-associated cancers. It is currently under investigation in three HPV-associated cancers: invasive cervical cancer, head and neck cancer, and anal cancer. In cervical cancer, a recently completed Phase 2 study of ADXS-HPV demonstrated apparent prolonged survival and tumor responses including complete responses, and a manageable safety profile when given alone or in combination with chemotherapy supporting further development of the Immunotherapy. Clinical trials in head and neck cancer and in anal cancer are ongoing. Advaxis has received Orphan Drug Designation from the US Food and Drug Administration for ADXS-HPV to treat invasive cervical cancer, HPV-associated head and neck cancer, and for anal cancer.
About epacadostat (INCB24360)
Indoleamine 2,3-dioxygenase 1 (IDO1) is an immunosuppressive enzyme that has been shown to induce regulatory T cell generation and activation, and allow tumors to escape immune surveillance. Epacadostat is an orally bioavailable small molecule inhibitor of IDO1 that has nanomolar potency in both biochemical and cellular assays and has demonstrated potent activity in enhancing T lymphocyte, dendritic cell and natural killer cell responses in vitro, with a high degree of selectivity. Epacadostat has shown proof-of-concept clinical data in patients with unresectable or metastatic melanoma in combination with the CTLA-4 inhibitor ipilimumab, and is currently in four proof-of-concept clinical trials with PD-1 and PD-L1 immune checkpoint inhibitors in a variety of cancer types.
About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm-LLO platform technology. The Lm-LLO technology, using bioengineered live attenuated Listeria monocytogenes bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs), that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm-LLO immunotherapy, ADXS-HPV, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The FDA has granted Advaxis orphan drug designation for each of these three indications. The Company plans to initiate a registrational clinical program for cervical cancer in 2015 and has established licensing partners in India and Asia for commercialization in those regions. Advaxis entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, for a Phase 1/2 immunotherapy study to evaluate the safety and efficacy of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis's ADXS-HPV as a treatment for patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck cancer.
Advaxis's second Lm-LLO immunotherapy candidate in clinical testing will be ADXS-PSA, which is being developed to address prostate cancer. Advaxis entered into a clinical trial collaboration agreement with Merck & Co., Inc. ("Merck"), known as MSD outside the United States and Canada, through its subsidiaries, to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck's PD-1 checkpoint inhibitor KEYTRUDA® (pembrolizumab). The planned clinical trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a Phase 1/2 study of patients with previously treated metastatic, castration-resistant prostate cancer.
Advaxis is also developing Lm-LLO immunotherapy ADXS-HER2, to target the HER2 receptor expressing cancers. HER2 is expressed in certain solid-tumor cancers, including bone cancer (or osteosarcoma), breast cancer, esophageal, gastric cancer, and others. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal-health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for pet therapeutics.
For more information about our cancer immunotherapies please visit www.advaxis.com.
Forward-Looking Statements (Advaxis)
This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis's ability to develop the next generation of cancer immunotherapies; the safety and efficacy of Advaxis's proprietary immunotherapy, ADXS-HPV; whether Advaxis immunotherapies can redirect the powerful immune response all human beings have to the bacterium to cancers. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis's SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2013, which is available athttp://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made 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.
KEYTRUDA is a registered trademark of Merck & Co., Inc.
CONTACT: Company: Advaxis, Inc. Greg Mayes, Executive Vice President and COO [email protected] 609.452.9813 ext. 102 Media Contact: Tiberend Strategic Advisors, Inc. Amy S. Wheeler [email protected] 646.362.5750