The poster presentations featuring Advaxis immunotherapies at SITC 2015 include:
- Cohen et al., Phase I/II study of ADXS11-001 or MEDI4736 immunotherapies alone and in combination, in patients with recurrent/metastatic cervical or human papillomavirus (HPV)-positive head and neck cancer.
- Haas et al., Phase 1-2 study of ADXS31-142 alone and in combination with pembrolizumab in patients with previously treated metastatic castration-resistant prostate cancer (mCRPC): The KEYNOTE-046 trial.
- Ghamande et al., High-dose treatment with ADXS11-001, a Listeria monocytogenes (Lm)-listeriolysin O (LLO) immunotherapy, in women with cervical cancer.
The first poster will feature an ongoing Phase 1/2 clinical trial of Advaxis’s lead immunotherapy candidate axalimogene filolisbac (ADXS-HPV) in combination with MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), for the treatment of patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck cancer.
The second poster will feature an ongoing Phase 1/2 clinical trial (KEYNOTE-046) evaluating the combination of ADXS-PSA and Merck’s PD-1 checkpoint inhibitor KEYTRUDA®(pembrolizumab) in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC). The KEYNOTE-046 trial is the first-in-human study of ADXS-PSA and the second study initiated to evaluate the use of KEYTRUDA® in advanced prostate cancer.
Data from preclinical studies suggest that Advaxis’s Lm Technology™ immunotherapies in combination with a checkpoint inhibitor, such as durvalumab or KEYTRUDA®, may lead to an enhanced anti-tumor immune response. Results from these two studies will determine the future clinical development program for both combinations.
The third poster will include preliminary data from an ongoing Phase 1/2 clinical trial of axalimogene filolisbac at a high dose in patients with recurrent or refractory cervical cancer. Cervical cancer is the fourth most common cancer and the most common cause of mortality in women worldwide.
Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology™ immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s LmTechnology™.
ADXS-PSA is an Lm Technology™ immunotherapy under investigation for targeting the prostate-specific antigen (PSA) associated with prostate cancer. ADXS-PSA is in clinical development both as a monotherapy and in combination with immune checkpoint inhibitors for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
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 LmTechnology™, 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 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 Technology™ immunotherapy, axalimogene filolisbac, 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 axalimogene filolisbac orphan drug designation for each of these three clinical settings. Advaxis has two additional immunotherapy products, ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube andGoogle+.
This media statement 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, axalimogene filolisbac. 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.