PRINCETON, N.J., May 21, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that it has appointed Fred J. Frullo as Vice President, Regulatory Affairs. With more than 20 years of experience in the biopharmaceutical industry, Mr. Frullo is well versed in the development of global regulatory strategies for the supervision, review and assembly of pharmaceutical product submission and coordination with global health authorities to obtain approvals.
As Vice President, Regulatory Affairs, Mr. Frullo will oversee regulatory submissions for the company's Lm-LLO cancer immunotherapy clinical programs, including ADXS-HPV, ADXS-PSA and ADXS-HER2, as well as combination studies involving complementary immunotherapy technologies. Mr. Frullo will lead the development and submission of all regulatory documents on behalf of Advaxis to the appropriate health agencies and coordinating joint submissions with Advaxis's strategic partners as warranted. In this role, Mr. Frullo will succeed Ms. Chris L. French, MBA, who will now lead the company's compliance program.
"Over the past 12 months, Advaxis has significantly expanded and accelerated its clinical development activities requiring an individual of Fred's expertise and experience to manage our regulatory processes," said David J. Mauro, Advaxis's Executive Vice President, Chief Medical Officer. "As Vice President, Regulatory Affairs, Fred will be responsible for leading Advaxis's global regulatory strategy and will be a primary liaison between the company and the global health authorities where we are conducting our clinical studies and working to bring our immunotherapy products to market."
Mr. Frullo was previously the Director, Global Regulatory Strategy at Bristol-Myers Squibb, where he was responsible for maintaining regulatory compliance for the oncology portfolio of marketed products and providing global regulatory strategy support for both Life Cycle Management Teams and Early Development Teams. Mr. Frullo's notable career in regulatory affairs is comprised of executive positions at several prominent pharmaceutical companies, including Pharmacia Corporation, McNeil Consumer Healthcare, and Johnson & Johnson. Mr. Frullo holds a Bachelor of Science, Biology from Ohio University.
In connection with his appointment, Mr. Frullo received a one-time inducement award of 75,000 restricted shares, of which 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. Frullo 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