Late Breaking Abstract to Highlight Enhanced Anti-Tumor Efficacy of ADXS-HPV (ADXS11-001) in Combination with OX40 and GITR Co-Stimulatory Molecule Monoclonal Antibodies
Additional Late Breaking Abstract to Demonstrate Delay of Tumor Progression and Prolonged Overall Survival in Study of ADXS-HER2 in Combination with Radiation in Canine Osteosarcoma
Advaxis to Host AACR Research Reception on April 21, 2015 at 6:30 p.m., EDT
PRINCETON, N.J., March 18, 2015 (GLOBE NEWSWIRE) — Advaxis, Inc. (ADXS), a cancer immunotherapy company, today announced that three abstracts revealing new data for Advaxis’s proprietary Lm-LLO cancer immunotherapy platform have been selected for poster presentations at the 2015 American Association for Cancer Research (AACR) Annual Meeting, April 18 — 22, 2015, at the Pennsylvania Convention Center in Philadelphia, Pennsylvania.
The first poster, selected as a late breaking abstract, is entitled “Agnostic antibodies to co-stimulatory molecules, OX40 and GITR, significantly enhance the anti-tumor efficacy of Listeria monocytogenes (Lm-LLO)-based immunotherapy.” The poster will be presented by Samir Khleif, M.D., Director of the State of Georgia Cancer Center, Georgia Regents University Cancer Center (GRU), during the Late-Breaking Research: Immunology session, on Tuesday, April 21, 2015, from 1:00 PM — 5:00 PM E.T. (Section 26; Poster Board #13; Abstract #LB-229).
The second poster, also selected as a late-breaking abstract, is entitled “Recombinant HER2/Neu expressing Lm-LLO immunotherapy combined with radiation safely delays tumor progression and prolongs overall survival in a phase I clinical study in canine osteosarcoma.” The poster is scheduled to be presented by principal investigator Nicola J. Mason, B.Vet.Med., Ph.D., Assistant Professor of Medicine and Pathobiology at the University of Pennsylvania School of Veterinary Medicine, during the Late-Breaking Research: Clinical Research/Endocrinology session, on Monday, April 20, 2015, from 1:00 PM — 5:00 PM E.T. (Section 40; Poster Board #7; Abstract #LB-113).
The third poster, entitled, “Anti-tumor therapeutic effects in mice treated with Listeria monocytogenes (Lm-LLO) immunotherapy in combination with PD-L1,” highlights preclinical work demonstrating that ADXS-HPV (ADXS11-001) yields significantly better anti-tumor activity when combined with an anti-PD-L1 antibody, than the anti-PD-L1 antibody alone. The poster will be presented by Poonam Molli, Ph.D., Senior Scientist, Advaxis, Inc., during the Tumor Vaccines poster session, on Monday, April 20, 2015, from 1:00 PM — 5:00 PM E.T. (Section 26; Abstract #2513).
Advaxis also announced that the company will host an AACR Research Reception at The Ritz-Carlton, Philadelphia on April 21, 2015 at 6:30 p.m., EDT. Additional details about the event and registration information will be made 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 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, 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.