Atlantic Health said Dec. 22 that it is treating the first patient in the Northeast using a new cell therapy to treat glioblastoma, an 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.
Glioblastoma, formerly known as glioblastoma multiforme, is a type of cancer that can result in death in fewer than six months without treatment. More than 13,000 Americans are diagnosed with it every year, according to my.clevelandclinic.org.
“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, 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 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 Corp., a Houston-based clinical-stage biotechnology company founded to address the critical and unmet medical need of late-stage and aggressive cancers.
“We are optimistic that DOC1021 could lead to meaningful improvements in survival and quality of life for patients facing this aggressive disease,” said Dr. Laura Aguilar, chief medical officer, Diakonos Oncology.
Neuro-oncologist Dr. Robert Aiken and neurosurgeon Dr. Yaron A. Moshel 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 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.”
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.
“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 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.”
