Recent FDA Designation Puts Promising Engineered Cellular Therapy that Reduces Complications of Lymphoma Treatment on Accelerated Path to Market Approval

Newswise — HACKENSACK, NJ – In November 2020, the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation for a promising engineered cellular therapy called AB-205. AB-205 acts promptly to repair injured vascular niches of organs to prevent or reduce severe toxicities in patients who have Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL) undergoing high dose chemotherapy and autologous stem cell transplantation.

AB-205 represents a new approach to repairing damaged organs and tissues and consists of proprietary universal human-engineered cord endothelial (E-CEL®)cells.  This novel approach was based on groundbreaking research started in 2005 by Jason Butler, Ph.D., a research scientist at Hackensack Meridian’s Center for Discovery and Innovation (CDI). 

“The CDI is at the forefront of pioneering research that translates to improved care and quality of life for patients at Hackensack University Medical Center, and around the world,” said Robert C. Garrett, FACHE, CEO, Hackensack Meridian Health

AB-205’s RMAT designation is based on the drug’s Phase 1b/2 clinical trial results.

 The John Theurer Cancer Center (JTCC) at Hackensack University Medical Center participated in the in the Phase 2 AB-205 trial that led to the RMAT designation. Two JTCC patients were enrolled in the study. 

“At Hackensack University Medical Center, our patients have access to some of the most promising, groundbreaking clinical trials that are advancing the field of cancer care,” said Ihor S. Sawczuk, M.D., FACS, northern market regional president at Hackensack Meridian Health and the chief research officer of the network. “AB-205 is a perfect example of how our researchers are helping to bring treatments from the lab to the clinic for the benefit of our patients.” 

According to a press release from Angiocrine Bioscience Inc., the clinical-stage biotechnology company that is developing the drug, the RMAT designation is an important step in accelerating the development of AB-205 toward its first market approval. 

“The FDA RMAT designation is awarded to regenerative medicine therapies that have the potential to address serious unmet medical needs and provides AB-205 the opportunity for an accelerated review with the FDA,” said Scott Rowley, M.D., of the Stem Cell Transplantation and Cellular Therapy Program, at Hackensack University Medical Center’s John Theurer Cancer Center and principal investigator on the AB-205 trial. “Only a small number of novel products  receive this designation each year.” 

AB-205 , is is administered intravenously on the same day that the patient’s own blood stem cells are infused, after a week of high-dose chemotherapy and radiation to eradicate cancer cells.  By repairing vascular niches in healthy organs, AB-205 cells aid in the restoration of the body’s natural ability to heal itself following myelosuppressive therapies including chemotherapy and radiation. Examples of vascular niches, which have significant  restorative capabilities, include the bone marrow and the gastrointestinal (GI) tract. 

“The GI tract replenishes its lining approximately every 7 days and can be very sensitive to chemotherapy,” said Dr. Rowley. 

When the vascular niche in the GI tract is injured by chemotherapy, it can result in nausea, vomiting and diarrhea. Harmful bacteria may also escape from the gut and cause serious infections such as endotoxemia, bacteremia, or sepsis. These complications are known as severe regimen-related toxicities (SRRT). 

High-dose chemotherapy and stem cell transplantation are the standard therapy for patients with aggressive systemic HL and NHL. However, SRRT can occur in up to 50 percent of people with lymphoma who receive the standard treatment, with increased frequency and severity of SRRT occurring in older people. AB-205 helps repair vascular niches by restoring the natural process of tissue renewal, preventing or reducing SRRT.

“With AB-205, patients have fewer side effects from cancer treatment, they are discharged more quickly, and have a better quality of life,” said Dr. Rowley. “The product has so far shown to be very safe.” 

Hackensack University Medical Center also plans to participate in Angiocrine’s planned Phase 3 clinical trial for AB-205, which is expected to begin in 2021. 

Dr. Rowley and Dr. Butler are also looking forward to applying this research to other cancers — particularly multiple myeloma (MM) through Hackensack University Medical Center’s robust MM program.

“This could be a very major advancement for patients with MM as well as lymphoma,” said Dr. Rowley. 

Dr. Butler is also looking for ways to use these types of cells to repair the cardiovascular system. 

“Cardiovascular disease is the biggest killer of people around the world,” said Dr. Butler. “This would be very helpful for patients with co-morbidities that attack the cardiovascular system, such as diabetes.” 

“Our CDI researchers and clinical teams are continually building on research successes and finding new ways to apply scientific advancements to improve public health,” said Mark D. Sparta, FACHE, president and chief hospital executive, Hackensack University Medical Center. 

About John Theurer Cancer Center at Hackensack University Medical Center

John Theurer Cancer Center at Hackensack University Medical Center is New Jersey’s largest and most comprehensive center dedicated to the diagnosis, treatment, management, research, screenings, and preventive care as well as survivorship of patients with all types of cancers. The 15 specialized divisions covering the complete spectrum of cancer care have developed a close-knit team of medical, research, nursing, and support staff with specialized expertise that translates into more advanced, focused care for all patients. Each year, more people in the New Jersey/New York metropolitan area turn to John Theurer Cancer Center for cancer care than to any other facility in New Jersey. John Theurer Cancer Center, part of Georgetown Lombardi Comprehensive Cancer Center, an NCI designated comprehensive cancer center. Housed within a 775-bed not-for-profit teaching, tertiary care, and research hospital, John Theurer Cancer Center provides state-of-the-art technological advances, compassionate care, research innovations, medical expertise, and a full range of aftercare services that distinguish John Theurer Cancer Center from other facilities. For additional information, please visit www.jtcancercenter.org.

 

About Hackensack Meridian Health Hackensack University Medical Center

Hackensack Meridian Health Hackensack University Medical Center, a 781-bed nonprofit teaching and research hospital located in Bergen County, NJ, is the largest provider of inpatient and outpatient services in the state. Founded in 1888 as the county’s first hospital, it is now part of the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care, which is comprised of 35,000 team members and more than 7,000 physicians. Hackensack University Medical Center is ranked #2 in New Jersey and #59 in the country in 2019-20 Best Hospital rankings and is ranked high-performing in the U.S. in colon cancer surgery, lung cancer surgery, COPD, heart failure, heart bypass surgery, aortic valve surgery, abdominal aortic aneurysm repair, knee replacement and hip replacement. Out of 4,500 hospitals evaluated, Hackensack is one of only 57 that received a top rating in all nine procedures and conditions. Hackensack University Medical Center is one of only five major academic medical centers in the nation to receive Healthgrades America’s 50 Best Hospitals Award for five or more years in a row. Becker’s Hospital Review Green Guide’s list of Top 10 Green Hospitals in the U.S. Hackensack University Medical Center is the Hometown Hospital of the New York Giants and the New York Red Bulls and is Official Medical Services Provider to THE NORTHERN TRUST PGA Golf Tournament. It remains committed to its community through fundraising and community events especially the Tackle Kids Cancer Campaign providing much needed research at the Children’s Cancer Institute housed at the Joseph M. Sanzari Children’s Hospital. To learn more, visit www.HackensackUMC.org.

 

ABOUT HACKENSACK MERIDIAN HEALTH

Hackensack Meridian Health is a leading not-for-profit health care organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care.

Hackensack Meridian Health comprises 17 hospitals from Bergen to Ocean counties, which includes three academic medical centers – Hackensack University Medical Center in Hackensack, Jersey Shore University Medical Center in Neptune, JFK Medical Center in Edison; two children’s hospitals – Joseph M. Sanzari Children’s Hospital in Hackensack, K. Hovnanian Children’s Hospital in Neptune; nine community hospitals – Bayshore Medical Center in Holmdel, Mountainside Medical Center in Montclair, Ocean Medical Center in Brick, Palisades Medical Center in North Bergen, Pascack Valley Medical Center in Westwood, Raritan Bay Medical Center in Old Bridge, Raritan Bay Medical Center in Perth Amboy, Riverview Medical Center in Red Bank, and Southern Ocean Medical Center in Manahawkin; a behavioral health hospital – Carrier Clinic in Belle Mead; and two rehabilitation hospitals – JFK Johnson Rehabilitation Institute in Edison and Shore Rehabilitation Institute in Brick. 

Additionally, the network has more than 500 patient care locations throughout the state which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, fitness and wellness centers, rehabilitation centers, urgent care centers and physician practice locations. Hackensack Meridian Health has more than 36,000 team members, and 7,000 physicians and is a distinguished leader in health care philanthropy, committed to the health and well-being of the communities it serves. 

The network’s notable distinctions include having four of its hospitals are among the top hospitals in New Jersey for 2020-21, according to . Additionally, the health system has more top-ranked hospitals than any system in New Jersey. Children’s Health is again ranked a top provider of pediatric health care in the United States and earned top 50 rankings in the annual U.S. News’ 2020-21 Best Children’s Hospitals report.   Other honors include consistently achieving Magnet® recognition for nursing excellence from the American Nurses Credentialing Center and being named to Becker’s Healthcare’s “150 Top Places to Work in Healthcare/2019” list. 

The Hackensack Meridian School of Medicine, the first private medical school in New Jersey in more than 50 years, welcomed its first class of students in 2018 to its On3 campus in Nutley and Clifton. The Hackensack Meridian Center for Discovery and Innovation (CDI), housed in a fully renovated state-of-the-art facility, seeks to translate current innovations in science to improve clinical outcomes for patients with cancer, infectious diseases and other life-threatening and disabling conditions.  Additionally, the network partnered with Memorial Sloan Kettering Cancer Center to find more cures for cancer faster while ensuring that patients have access to the highest quality, most individualized cancer care when and where they need it. 

Hackensack Meridian Health is a member of AllSpire Health Partners, an interstate consortium of leading health systems, to focus on the sharing of best practices in clinical care and achieving efficiencies. 

To learn more, visit www.hackensackmeridianhealth.org

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