Mount Sinai Hospital, NYC: $100,000 for a fully personalized immunotherapy approach to GBM through Dr. Adilia Hormigo.
Press Release (5/12/2020):
FOR IMMEDIATE RELEASE
Brain Cancer Groups to Fund Pilot Trial of Individualized Approach to Immunotherapy
National Brain Tumor Society and StacheStrong team up to fund clinical testing of a personalized therapeutic vaccine for pediatric and adult high-grade glioma patients
BOSTON, MA (5/12/2020) — National Brain Tumor Society (NBTS), a leader in brain tumor patient advocacy, research, information and support, and StacheStrong, a nonprofit dedicated to raising funds and awareness for brain cancer research, have announced a $100,000 research grant to Adilia Hormigo, MD, PhD, Director of the Neuro-Oncology Program at The Tisch Cancer Institute at Mount Sinai in New York City, New York. The grant will help fund a pilot clinical trial at Mount Sinai, led by Dr. Hormigo, evaluating a personalized approach to immunotherapy in both adults and children with high-grade glioma brain tumors.
“Dr. Hormigo’s forthcoming trial presented a compelling funding opportunity for the National Brain Tumor Society’s Defeat Brain Tumors program, which directs philanthropic support to treatment-focused research projects that offer a clear path forward to clinical drug development efforts,” said Kirk Tanner, Ph.D., Chief Scientific Officer, National Brain Tumor Society. “Capitalizing on the fact that every patient’s high-grade glioma tumor is unique in its molecular signature, Dr. Hormigo wants to develop a truly personalized vaccine that will be specifically tailored for each and every patient. Though this pilot study will be small, it is an important step necessary to demonstrate the potential validity of this approach.”
Anticipating an initial enrollment six patients, the trial will evaluate the safety, efficacy, and feasibility of delivering a therapeutic vaccine to patients made up of their own dendritic cells (isolated from blood samples), loaded with individualized multiple neoantigens made from synthetic peptides created in the laboratory and based on the specific alterations found in a patient’s tumor tissue. Previously, Dr. Hormigo has initiated ongoing pilot studies for glioblastoma patients of both a personalized multi-peptide therapeutic vaccine, as well as a dendritic cell vaccine, which have demonstrated encouraging early results. In the new NBTS-StacheStrong funded study, Dr. Hormigo plans to combine these two earlier approaches. These vaccines will be tested alone and in combination with immune checkpoint inhibiting drugs.
“This grant is important to StacheStrong for a multitude of reasons,” said Colin Gerner, President and Co-Founder of StacheStrong. “From a medical standpoint, we believe Dr. Hormigo’s approach has strong promise for drug development. From a personal standpoint, Dr. Hormigo treated my brother, GJ, for 25 months and is the definition of a patient-centric neuro-oncologist. Knowing that GJ’s battle has directly resulted in this partnership to fund a promising trial is everything to us.”
Dendritic cells (DCs) are a special type of cell that boosts immune responses by presenting antigens to T-cells. T-cells recognize an antigen as ‘foreign’ and initiate an immune response. Dr. Hormigo’s study will generate neoantigens — newly formed antigens that arise as a result of a tumor mutation — that are actually synthetic peptides based on a molecular analysis of each individual patient’s own tumor. Loaded onto the patients’ own DCs, these synthetic peptides will help the new vaccine teach T-cells to mount an immune response against a tumor. Because immune checkpoint inhibitors can help increase the number of T-cells available in the tumor’s neighborhood, or microenvironment, it is anticipated that combining these treatments will generate a more effective immune assault on patients’ tumors.
“I am pleased to receive this funding for my research that aims to reverse the immunosuppression of the tumor microenvironment of glioblastoma (GBM),” said Dr. Hormigo. “With this strategy, we hope to successfully treat glioblastoma patients and change the fate of their disease.”
High-grade gliomas consist of tumors classified as World Health Organization (WHO) grade III and IV glioma. Gliomas account for approximately 25% of all primary brain tumors, and 80% of all primary malignant brain tumors (brain cancer). A majority of gliomas are high-grade gliomas, including glioblastoma, anaplastic astrocytoma, and diffuse intrinsic pontine glioma (DIPG). These tumors have especially poor survival rates, representing a major unmet medical need. The most common high-grade glioma (and, indeed, most common malignant brain tumor), glioblastoma, has a five-year relative survival rate of only six percent. And the survival rate for DIPG patients is less than one percent.
GBM AGILE: $500,000 for the world’s first global adaptive clinical trial platform for GBM in partnership with NBTS.
Press Release (5/12/2020):
FOR IMMEDIATE RELEASE
New Funding & Partnership Bolsters Support for First Global Adaptive Clinical Trial Platform for Brain Cancer Patients
With new partnership agreement and philanthropic support, National Brain Tumor Society and StacheStrong make an additional investment into innovative GBM AGILE clinical trial
National Brain Tumor Society (NBTS), the largest nonprofit dedicated to the brain tumor community in the United States, today announced a second round of funding for the GBM AGILE clinical trial. Together with the nonprofit glioblastoma (GBM) advocacy group, StacheStrong, and additional major gift support, NBTS is investing $500,000 to assist in the operationalization and launch of GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), the world’s first global “adaptive” clinical trial for brain cancer.
Following a previous investment of $750,000 in GBM AGILE announced in January, NBTS’s total support for this novel approach to GBM clinical trials and drug development now totals $1.25 million.
“We strongly believe that new approaches are desperately needed to advance more, safe and effective treatments for glioblastoma patients,” said David Arons, Chief Executive Officer, National Brain Tumor Society. “Glioblastoma is one of the most stubborn and challenging cancers there is and, to date, efforts to improve patient survival have largely been unsuccessful. It is our hope that GBM AGILE will be a critical vehicle for transforming the clinical realities of this devastating disease, and that with our support and that of committed and energetic new partners like our friends at StacheStrong, we will soon begin to realize its many benefits to the brain cancer field.”
Brothers Colin and GJ Gerner formed StacheStrong in 2018 to raise funds and awareness for brain cancer research following GJ’s glioblastoma diagnosis in 2017. Growing mustaches and living “StacheStrong” became the Gerner brother’s motto and rallying cry to celebrate GJ’s tenacity and strength.
“Being in a position to not only provide hope for families and patients diagnosed with GBM, but also be a catalyst for change by collaborating with NBTS to help launch GBM AGILE is something I’m truly passionate about,” said Colin Gerner, President and Founder of StacheStrong. “I dream of a day where someone diagnosed with GBM doesn’t have to go through what I’ve seen my brother, GJ, endure.”
GBM AGILE is sponsored by the Global Coalition for Adaptive Research (GCAR), a nonprofit organization comprised of some of the world’s foremost clinical, translational, and basic science investigators. National Brain Tumor Society, National Foundation for Cancer Research (NFCR), and now Stachestrong are working together with GCAR as GBM AGILE prepares to begin enrolling patients.
“We are determined, as partners, to launch GBM AGILE and make a difference for brain tumor patients,” said Faramarz Yousefzadeh, Chairman of the GCAR Board of Directors, who lost his wife to brain cancer and has provided his own personal financial support for the GBM AGILE trial. “We welcome StacheStrong to an ever-growing list of supporters for GBM AGILE and thank the Gerners and NBTS for the encouragement and critical resources they are providing to prepare for the opening this historic trial. With the best minds in glioblastoma research and treatment, as well as the passion of the patient advocacy community behind us, we can maximize the potential of GBM AGILE to deliver improved outcomes for those diagnosed with glioblastoma.”
GBM AGILE was first conceived in 2015 by an international group of more than 130 clinicians, researchers, biostatisticians, imagers, pathologists, patient advocates, and leaders from government and industry. The trial is designed as a learning system to more efficiently and rapidly identify effective therapies for GBM patients. GBM AGILE’s innovative model enables multiple drugs (and combinations of drugs) to be screened simultaneously and over time. Drugs that show initial evidence of benefit to patients will seamlessly transition to a confirmatory stage designed to support registration approval. Drugs that are underperforming are dropped. The intent is to lower the cost, time, and number of patients required to evaluate potential new effective therapies for patients with GBM.
In late 2018, GCAR announced a partnership with Bayer Oncology to use the company’s drug regorafenib as the first therapy arm entering the GBM AGILE platform, which will begin during the first half of 2019. Ultimately, the trial will include multiple arms at clinical sites starting in the United States and Canada, and expanding into Europe, Asia, and Australia in the near future.
Visit http://www.gcaresearch.org/gbm-agile for more about GBM AGILE.