PRINCETON, N.J., May 6, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc.(Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that it has appointed Thomas W. Hare as Vice President, Clinical Operations. Mr. Hare brings to Advaxis more than 28 years of experience in the biopharmaceutical and contract research organization industries overseeing the management of global commercial and clinical operations, data management, outsourcing and medical writing groups.
In his role as Vice President, Clinical Operations, Mr. Hare will report to Advaxis's Executive Vice President, Chief Medical Officer, David J. Mauro, MD, Ph.D., and will oversee clinical operations for the Company's multiple Lm-LLO cancer immunotherapy clinical programs. Since the beginning of 2015, Advaxis has initiated three new clinical trials, including the combination study involving ADXS-PSA and Merck's PD-1 checkpoint inhibitor KEYTRUDA® (pembrolizumab). In addition, the Company expects to initiate five additional clinical trials by the end of year to evaluate its Lm-LLO immunotherapy platform. This includes a Phase 3 clinical study of ADXS-HPV for the treatment of high-risk, locally advanced cervical cancer and combination studies involving ADXS-HPV and MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, and Incyte's investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360).
"Adding an individual of Thomas's expertise as our Vice President, Clinical Operations comes at a pivotal moment for Advaxis as we continue to advance several clinical programs during 2015, including the initiation of five new clinical trials," said Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "Thomas brings a wealth of experience overseeing the design, conduct and management of resources for clinical trials. His expertise will be essential as we look to expand our clinical development program, while ensuring we remain on budget and on track. Additionally, and equally significant, Thomas's prior operational experience with Incyte, should prove synergistic as we progress our combination studies with Incyte, as well as with Merck, and MedImmune."
Most recently, Mr. Hare served as Vice President, Drug Development Operations for Incyte Corporation. He joined Incyte Corporation in January 2004 and in his role Mr. Hare was responsible for the strategic growth and development of a team, which planned, implemented and managed Phase 1 through Phase III multinational clinical trials in cancer immunotherapy and cancer inflammation clinical trials.
Prior to Incyte, Mr. Hare was Director of Operations at PRA International (now PRA Health Sciences), where he was responsible for forecasting of project revenue, costs and resources, performing financial analysis to insure contract compliance, and developing metrics to measure quality, and managing a team responsible for the on-time and in-budget completion of Phase I through Phase III clinical trials. Previous to PRA International, Mr. Hare served as Vice President, Clinical Operations Division for Premier Research and as Clinical Manager/Senior Clinical Scientist for Bristol Myers-Squibb. Mr. Hare holds a Master of Science, Exercising Physiology and Biomechanics from the University of Delaware.
In connection with his appointment, Mr. Hare received a one-time inducement award of 85,000 restricted shares, of which 21,250 (25%) are fully vested as of the grant date. The remaining shares vest annually over a three-year period. The Company approved the award as an inducement material to Mr. Hare 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 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; 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.
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