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Study Shows Promise for Non-Small Cell Lung Cancer Patients Who Require New Treatment Options

June 1, 2020

Dr. Haigentz helps lead study of Advaxis’ new ADXS-503 immune therapy in conjunction with Keytruda® for non-small cell lung cancer 

Dr. Haigentz helps lead study of new type of treatment for non-small cell lung cancer

May 30, 2020 - Morristown, NJ – A new type of immunotherapy treatment for metastatic non-small cell lung cancer (NSCLC) is being tested by Missak Haigentz, Jr., MD,  medical director of hematology and oncology for Atlantic Health System. Early results appear promising in this phase 1/2 clinical trial of ADXS-503 being developed by Advaxis, Inc., a new type of cancer therapy which targets “hotspot” mutations that commonly occur in specific cancer types, both by itself and in combination with immunotherapy Keytruda® (pembrolizumab), which is commonly used to treat this type of lung cancer.

Dr. Haigentz and colleagues published early results of this study in conjunction with ASCO 2020, the world’s premier scientific meeting for clinical research in oncology.  Princeton-based Advaxis, ADXS-503’s manufacturer and the study’s sponsor, reported additional results following submission of the ASCO research summary.

Atlantic Health System’s Carol G. Simon Cancer Center at Morristown Medical Center and Overlook Medical Center are the only sites in New Jersey for this study.

“I find these results very encouraging, although they are early,” said Dr. Haigentz, who also serves as principal investigator for the Atlantic Health Cancer Consortium, the only New Jersey-based National Cancer Institute Community Oncology Research Program (NCORP).  “New treatments are urgently needed for this form of cancer.”

Advaxis reported 16-week results of the first patients dosed in Part B of this study, which is designed for NSCLC patients whose cancer has progressed despite treatment with pembrolizumab.  Among their findings were that the first two patients whose cancer had previously progressed while on pembrolizumab alone had tumors that stopped growing or were reduced in size while on the two-drug combination. One patient’s tumor had reduced by 25% after 16 weeks of combination therapy.  The second patient achieved a partial response with a nearly 60% reduction of the lung tumor burden. Responses to combination treatment of patients whose cancer had spread while on pembrolizumab immediately before starting the clinical trial suggest ADXS-503 may re-sensitize or enhance response to pembrolizumab.

Examination of biomarkers (molecular indicators of disease) showed activation of two types of immune system T cells, which are known to fight cancer cells, with new CD8+ T cells generated in all seven patients evaluated.  Both as a standalone treatment and in combination with pembrolizumab, ADXS-503 appeared safe and well tolerated with no toxicities at the dosage given.

Based on the latest data, the company has decided to expand the study.

“We are excited with the outcomes in these very early stages of the evaluation of the combination therapy ADXS-503 + pembrolizumab in patients failing pembrolizumab as a potential new therapeutic option for patients failing a checkpoint inhibitor,” said Andres A. Gutierrez , MD, PhD, chief medical officer & EVP, Advaxis, Inc.  “Based on our promising early results, we are planning to expand Part B to further characterize the potential clinical benefit in patients, as well as the opening of Part C, as a first-line therapy next month.”

ADXS-503 is part of Advaxis’ ADXS-HOT cancer immunotherapy program, which uses the company’s proprietary Lm technology (listeria monocytogenes bacteria) to target hotspot cellular mutations by mimicking infection and redirecting the immune system’s response against the cancer.  Pembrolizumab is an anti-PD-1 (anti-programmed death receptor-1) immunotherapy known as a checkpoint inhibitor.  These drugs inactivate “checkpoints” on certain immune cells in order to stimulate an immune response against the cancer.

About Atlantic Health System Cancer Care

Atlantic Health System Cancer Care offers an unparalleled network of cancer specialists and resources for more than 70,500 patients annually through its flagship Carol G. Simon Cancer Center at Morristown and Overlook medical centers, as well as its comprehensive oncology programs at Chilton, Hackettstown and Newton medical centers. With more than 250 cancer specialists and medical professionals, all five hospitals and Atlantic Medical Group have been recognized nationally for their role in advancing the fight against cancer.

Atlantic Health System Cancer Care is the lead affiliate of Atlantic Health Cancer Consortium (AHCC) - the only New Jersey-based National Cancer Institute (NCI) Community Oncology Research Program (NCORP).  The NCORP develops and implements NCI cancer prevention, screening, care delivery, and treatment studies with leading healthcare systems across the state.  Atlantic Health System Cancer Care is affiliated with the Translational Genomics Research Institute (TGen) of Phoenix, Arizona, and together they have created the Breakthrough Oncology Accelerator, a pioneering research and clinical collaboration designed to improve patient access to the most innovative and sophisticated therapies for cancer.

About Atlantic Health System

Atlantic Health System has a long-standing tradition of providing exceptional patient outcomes and experiences. Home to seven award-winning hospitals including Morristown Medical Center, the number one hospital in NJ according to U.S. News & World Report, Castle Connolly and Newsweek’s World’s Best Hospitals, the system has been ranked first in New Jersey in consumer preference by Monigle and first among health systems in New Jersey as a “best workplace” by both Modern Healthcare and Fortune Magazine.

Many of the system’s programs have received national accolades and designations, including Morristown Medical Center’s Cardiology and Heart Surgery program ranked among the top 30 in the nation by U.S. News and World Report; Morristown Medical Center’s Orthopedics program ranked among the top 35 in the nation by U.S. News and World Report and Atlantic Health System’s Cancer Care program, New Jersey’s first and only National Cancer Institute National Community Oncology Research Program. Additionally, Atlantic Health System Neuroscience at Overlook Medical Center, working with Atlantic Mobile Health, was the first in the nation to deploy and use portable Telestroke technology in ambulances for routine pre-hospital assessment of stroke patients.

Powered by a passionate workforce of 17,000 team members and 4,800 affiliated physicians dedicated to building healthier communities, Atlantic Health System serves more than half of the state of New Jersey, including 11 counties and 4.9 million people. The system provides care for the full continuum of health needs across a wide array of settings, including Atlantic Medical Group, one of the largest multi-specialty practices in New Jersey with more than 1,000 physicians and providers, 12 urgent care centers, Atlantic Rehabilitation Institute, Atlantic Visiting Nurse and Atlantic Anywhere’s Virtual Visits. Facilitating connections between these services on both land and air is the transportation fleet of Atlantic Mobile Health.

With a clear sense of purpose and an unparalleled culture, Atlantic Health System attracts top leaders in the field of health care, from CEO Brian Gragnolati, who was Chairman of the American Hospital Association in 2019, to the numerous team members who serve as leaders across national clinical associations and research entities.

About Advaxis, Inc.

Advaxis, Inc. a publicly-traded, clinical-stage biotechnology company (Nasdaq: ADXS) focused on the discovery, development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable T cells to eliminate tumors.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.