PRINCETON, N.J., Feb. 13, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that it has appointed Mayo Pujols as Vice President, Manufacturing. Mr. Pujols brings to Advaxis more than 22 years of experience in global commercial and clinical manufacturing, technology transfer, and product development strategy.
In his role as Vice President, Manufacturing, Mr. Pujols will oversee production for the Company's multiple immunotherapy programs, which utilize bioengineered live attenuated bacteria, Listeria monocytogenes (Lm), to actively suppress key components in the tumor microenvironment. Advaxis expects to initiate four new clinical trials in 2015 involving its Lm-LLO immunotherapy platform, including combination studies involving ADXS-PSA and Merck's PD-1 checkpoint inhibitor KEYTRUDA® (pembrolizumab) and ADXS-HPV and MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736.
"The addition of Mayo as our Vice President, Manufacturing comes at an critical juncture for Advaxis as we expect to rapidly advance several programs during the course of 2015, including the initiation of four new clinical trials," said Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "Mayo's expertise will be essential as we look to increase the scale and efficiency of our manufacturing capabilities, while upholding the highest level of quality control. Additionally, and equally significant, Mayo's prior operational experience with Merck and MedImmune, should prove synergistic as we progress our respective checkpoint inhibitor combination studies with each company."
Most recently, Mr. Pujols served as Executive Director, Technical Operations for Merck, Sharp & Dohme (MSD), the UK subsidiary of Merck & Co., Inc. As Executive Director, Technical Operations, Mr. Pujols led a team responsible for technical support and global supply of reliable, compliant, and cost competitive biologics, vaccines, and pharmaceuticals. Highlighting his success at MSD, Mr. Pujols was instrumental in spearheading partnerships with several key stakeholders and executing strategies that ensured the realization of opportunities, business continuity, innovation, and financial results. Mr. Pujols also spent nine years with Merck & Co. at the beginning of his professional career.
Prior to MSD, Mr. Pujols spent seven years at MedImmune where he held positions of increasing responsibility, most recently serving as Director Clinical Manufacturing Operations, Research & Development. In this position, Mr. Pujols managed a team of development scientists and engineers responsible for scale-up, tech transfer, and manufacture of pipeline biopharmaceuticals for global clinical trials. Previous to MedImmune, Mr. Pujols served as Manager, Global Technical Operations for Schering-Plough prior to its merger with Merck.
Mr. Pujols holds a Bachelor of Engineering, Chemical Engineering from Stevens Institute of Technology and a Master of Science, Chemical Engineering from Columbia University.
In connection with his appointment, Mr. Pujols received a one-time inducement award of 75,000 restricted shares, of which 25,000 (33%) are fully vested as of the grant date. The remaining shares vest annually over a two-year period. The Company approved the award as an inducement material to Mr. Pujols entering into employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4).
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 pediatric 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; the safety and efficacy of Advaxis's proprietary immunotherapies, ADXS-HPV and ADXS-PSA; and initiation of clinical trials in 2015 involving our Lm-LLO immunotherapy platform . 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.
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