ADXS-HPV Combined with Anti-OX40 or Anti-GITR Antibodies Demonstrates Tumor Growth Inhibition and Prolonged Survival in a Preclinical Study
ADXS-HER2 in Combination with Palliative Radiation Delays Tumor Progression, Prolongs Overall Survival and Maintains Limb Function in Preliminary Data from a Clinical Study in Canine Osteosarcoma
ADXS-HPV in Combination with Anti-PD-L1 Antibody Prolongs Survival without Added Toxicities in a Preclinical Study
Advaxis to Host AACR 2015 Research Reception on April 21, 2015 at 6:30 p.m., EDT
PRINCETON, N.J., April 21, 2015 (GLOBE NEWSWIRE) — Advaxis, Inc. (ADXS), a cancer immunotherapy company, today announced the data of one clinical and two preclinical studies highlighting the survival outcomes and anti-tumor effects of its proprietary Lm-LLO cancer immunotherapy technology at the American Association for Cancer Research (AACR) Annual Meeting 2015, held April 18 — 22 in Philadelphia, Pennsylvania.
On Tuesday, April 21, Samir Khleif, M.D., Director of the State of Georgia Cancer Center, Georgia Regents University Cancer Center (GRU), presented on a preclinical study evaluating the therapeutic potential of ADXS-HPV in combination with anti-OX40 and anti-GITR antibodies (Poster Board #13; Abstract #LB-229). The data demonstrated that the combination of therapies led to significant inhibition of tumor growth and prolonged survival in tumor bearing mice. Complete regression of established tumors occurred in 40% and 60% of animals treated with ADXS-HPV in combination with anti-OX40 and anti-GITR antibodies, respectively.
On Monday, April 20, Nicola J. Mason, BVetMed, Ph.D., DACVIM, Assistant Professor of Medicine, University of Pennsylvania’s School of Veterinary Medicine, presented preliminary data from an ongoing Phase 1 clinical study of 10 companion dogs with osteosarcoma (Poster Board #7; Abstract #LB-113). The data suggests that ADXS-HER2 in combination with palliative radiation delayed tumor progression and prolonged overall survival in pet dogs with spontaneous osteosarcoma that were not candidates for primary tumor removal (amputation). Repeat doses of ADXS-HER2 were well tolerated with no systemic or cardiac toxicity. Additionally, the combination treatment was found to maintain or improve limb function and quality of life over the study period. Five of the treated dogs remain alive, with a median survival, to date, of all 10 study dogs reported at 285 days, which compares favorably to historical median survival time of 136 days in dogs treated with palliative radiation only.
Poonam Molli, Ph.D., Senior Scientist, Advaxis, Inc., also presented on Monday, April 20, on a preclinical study evaluating the therapeutic potential of ADXS-HPV in combination with anti-PD-L1 antibody in mice (Poster Board #25 Abstract #2513). The data indicated that co-administration of ADXS-HPV with anti-PD-L1 antibody demonstrated an improved ability to control tumor growth compared with anti-PD-L1 antibody therapy alone. The combination was well tolerated with no added toxicities.
Daniel J. O’Connor, Chief Executive Officer of Advaxis, stated, “The studies presented at AACR showcase the diverse range of Advaxis’s novel immunotherapies and the abundance of potential that our Lm-LLO technology platform enables in combination with complimentary technologies, including anti-PD-L1 immune checkpoint inhibitors and anti-OX40 and anti-GITR antibodies. Advaxis believes that it is at the forefront of innovation in the immunotherapy space, and the data presented at AACR suggest that our Lm-LLO technology platform offers significant opportunity to address a number of cancer needs and indications.”
Robert Petit, Ph.D., Chief Scientific Officer of Advaxis, stated, “Dr. Mkrtichyan and Dr. Khleif’s data on the combination of agnostic co-stimulatory antibodies OX40 and GITR with our Lm-LLO immunotherapy reflects the potential for promising improvements in survival in this model. We believe these findings may be directly translatable to clinical investigations in patients. The Phase 1 safety and efficacy data with ADXS-HER2 in canine osteosarcoma supports and informs our clinical development program for ADXS-HER2 in HER2 expressing cancers, such as osteosarcoma, breast, gastric and esophageal cancers. It is the first clinical demonstration of the preclinical synergy between hypofractionated radiation therapy and Advaxis Lm-LLO immunotherapy. These data also support further development of a potential treatment option for osteosarcoma in dogs that does not include amputation or chemotherapy. Lastly, Advaxis’s preclinical research with ADXS-HPV in combination with anti-PD-L1 antibodies highlights the potential that we foresee in our combination studies with MedImmune’s MEDI4736.”
The three poster presentations are available on Advaxis’s corporate website:http://www.advaxis.com/technology/scientific-presentations.
Additionally the posters will be showcased during Advaxis’s Research Reception at the AACR Annual Meeting 2015 being held at The Ritz-Carlton, Philadelphia, at 6:30 p.m., EDT. Details about the event and registration information are available via Advaxis’s corporate website:http://www.advaxis.com.
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(R) (pembrolizumab). The ongoing clinical trial is designed to 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 osteosarcoma, breast cancer, esophageal, and gastric cancer. 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.
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; and the safety and efficacy of Advaxis’s proprietary immunotherapy, ADXS-HPV. 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, 2014, which is available at http://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.