press release

Atlantic Health treats first patient in Northeast for glioblastoma with new cellular immunotherapy in Phase 2 clinical trial

PR contact: Rob Seman

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Atlantic Health is one of 11 locations in the U.S. in trial sponsored by Diakonos Oncology.

MORRISTOWN & SUMMIT, NJ - DECEMBER 22, 2025 – Atlantic Health today announced that it is treating the first patient in the Northeast using a groundbreaking new cell therapy to treat glioblastoma (GBM), a highly aggressive primary brain tumor, as part of a Phase 2 clinical trial.

The initial patient at Atlantic Health is being treated collaboratively at Morristown Medical Center and Overlook Medical Center in Summit, by the Atlantic Medical Group neuro-oncology and Atlantic Brain and Spine neurosurgery teams.

“Through the Atlantic Center for Research, Atlantic Health is successfully translating scientific discoveries into innovative treatments, accelerating access to life-changing therapies and inspiring hope and healing in our communities,” said Saad Ehtisham, DHA, FACHE, president and CEO, Atlantic Health. “As a health system with community hospitals deeply embedded in our local neighborhoods, Atlantic Health is uniquely positioned to provide our patients and their families with complex, cutting-edge care close to home.”

The Phase 2 trial (ClinicalTrials.gov Identifier: NCT06805305) is evaluating the safety, tolerability, and efficacy of DOC1021, an investigational patient-derived double-loaded dendritic cell therapy, in combination with standard-of-care (SOC) treatment versus SOC alone in adult patients newly diagnosed with glioblastoma (IDH-wildtype), who have undergone maximal safe surgical resection. 

DOC1021 is a first-in-class, double-loaded autologous dendritic cell therapy. This immunotherapy is made with a patient's dendritic cells combined with mRNA and proteins prepared from freshly obtained patient tumor specimens. The study is sponsored by Diakonos Oncology.

Neuro-oncologist Robert Aiken, MD and neurosurgeon Yaron A. Moshel, MD PhD are co-investigators for the study at Atlantic Health. 

“Despite significant advances in neuro-oncology, glioblastoma remains the most common and most aggressive type of brain cancer, with typical survival of 14-20 months,” said Dr. Aiken. “The Diakonos dendritic cell therapy enhances a patient’s natural immune response, mimicking the way the body fights off viral infections to target and eliminate cancer cells. Beginning treatment for the first patient in the Northeast with this novel therapy is momentous and indicates substantial momentum behind the science. Atlantic Health is proud to help advance innovative and effective therapies for patients.”

“Patient-specific cell therapies like DOC1021 require careful clinical and scientific collaboration. It is critical to properly obtain fresh tissue specimens and the patient’s dendritic cells from their blood,” said Dr. Moshel. “That means this type of immunotherapy needs to be considered early in diagnosis and coordinated before surgery to meet the study’s technical requirements with precision. It is this type of coordination that is the cornerstone of everything we do here at Atlantic Health when it comes to brain tumor care.”

“We are optimistic that DOC1021 could lead to meaningful improvements in survival and quality of life for patients facing this aggressive disease," said Laura Aguilar, MD, PhD, Chief Medical Officer, Diakonos Oncology. "It’s exciting to work with Atlantic Health, which has demonstrated an enduring commitment to research, to evaluate DOC1021's potential to enhance the immune response and work alongside standard therapies.”

The primary outcome measure of this randomized clinical trial is overall survival (OS), with 1-, 2- and 3-year survival as secondary outcome measures, along with progression-free survival (PFS), frequency of adverse events, health-related quality of life, and neuro-cognitive function.

Eligibility criteria include presumed diagnosis of glioblastoma IDH-wt (as per the 2021 WHO Classification of CNS Tumors) deemed to be resectable and deemed to be a good candidate for post-operative standard of care temozolomide and radiation therapy. To learn more about study inclusion and exclusion criteria, contact Atlantic Health at (908) 522-5985 or Morgan.finlay@atlantichealth.org or visit ClinicalTrials.gov.

About Research at Atlantic Health

Atlantic Health is building healthier communities through groundbreaking research.

Advancing the science behind Atlantic Health’s award-winning network of care is the Atlantic Center for Research (ACR).

The ACR is the hub for cutting-edge, patient centered, translational and clinical research, with the potential to directly impact patient outcomes and shape the future of personalized care. The ACR research portfolio includes industry and federally sponsored clinical research in a range of medical conditions including cancer, heart disease and complex neurological conditions.

The ACR pairs extraordinary talent with vast resources. Leading physicians have access to a robust research infrastructure including state of the art laboratories and a biospecimen bank. Results are shared with the world through publication in national journals, conferences and through the ACR’s annual Research Symposium.

Learn more about the Atlantic Center for Research at www.atlantichealth.org.

About Atlantic Health

Atlantic Health is at the forefront of medicine, setting standards for quality health care in New Jersey, Pennsylvania and the New York metropolitan area. Powered by a workforce of 24,000 team members and more than 7,779 affiliated physicians dedicated to building healthier communities, Atlantic Health serves more than half of the state of New Jersey including 14 counties and 7.5 million people.

The not-for-profit system offers more than 550 sites of care, including its eight hospitals: Atlantic Health Morristown Medical Center in Morristown, NJ, Atlantic Health Overlook Medical Center in Summit, NJ, Atlantic Health Newton Medical Center in Newton, NJ, Atlantic Health Chilton Medical Center in Pompton Plains, NJ, Atlantic Health Hackettstown Medical Center in Hackettstown, NJ, Atlantic Health Goryeb Children’s Hospital in Morristown, NJ, Atlantic Rehabilitation Institute in Madison, NJ and Atlantic Health CentraState Medical Center in Freehold, NJ.

The system includes Atlantic Medical Group, part of a physician enterprise that makes up one of the largest multispecialty practices in New Jersey with more than 1,700 physicians and advance practice providers. Joined with Atlantic Accountable Care Organization and Optimus Healthcare Partners they form part of Atlantic Alliance, a Clinically Integrated Network of more than 2,500 health care providers throughout northern and central NJ.

Atlantic Health provides care for the full continuum of health care needs through 30 urgent care centers, Atlantic Visiting Nurse and Atlantic Health Virtual Visits. Facilitating the connection between these services on both land and air is the transportation fleet of Atlantic Mobile Health.

Founded by Atlantic Health, the Healthcare Transformation Consortium is a partnership of seven regional hospitals and health systems dedicated to improving access and affordability. Atlantic Health has a medical school affiliation with Thomas Jefferson University, is home to the regional campus of the Sidney Kimmel Medical College at Morristown and Overlook Medical Centers and is the official health care partner of the New York Jets.

About DOC1021

DOC1021(Dubodencel) is a first-in-class, double-loaded autologous dendritic cell therapy that uniquely combines tumor lysate and amplified tumor-derived mRNA. The immunotherapy is made with a patient's dendritic cells combined with mRNA and proteins prepared from freshly obtained patient tumor specimens.

The unique double loading approach, which mimics a viral infection, unlocks a synergistic and exponentially more powerful tumor killing TH1 response driven by dual protein and RNA antigen sourcing, and it allows targeting of the complete cancer antigen pool. Moreover, the approach does not require any genetic modification of the patient's immune cells for manufacturing, and does not require preconditioning of bone marrow or high dose IL-2 for administration. DOC1021 allows for a simple administration in the outpatient setting and broad reach via community cancer centers.

In addition to the recently opened Phase 2 GBM study, a clinical trial of Diakonos' DOC1021 is ongoing for the treatment of pancreatic cancer. Diakonos has received Fast Track designations from the FDA for both the GBM and pancreatic cancer programs, in October 2023 and May 2024, respectively. The company has also received Orphan Drug Designation for the GBM program in January 2024. A refractory melanoma Phase 1/2 study with DOC1021 will be initiated with the facilitation and support of the Cancer Prevention and Research Institute of Texas (CPRIT).

About Diakonos Oncology Corp.

Based in Houston, Diakonos Oncology Corp. is a clinical-stage biotechnology company dedicated to revolutionizing cancer immunotherapy with its proprietary double-loaded patient-derived dendritic cell therapeutic platform, focused on addressing the critical, unmet medical needs for treatment of late-state and aggressive cancers. For more information visit: https://www.diakonosoncology.com

Published: December 22, 2025

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