On January 19, 2022 Case Western Reserve University and NeoIndicate LLC have signed an exclusive license agreement to commercialize an imaging agent discovered and developed at the School of Medicine that fluorescently tags tumor cells to guide neurosurgeons to a more precise and complete surgical removal of glioblastoma and other malignant brain tumors (Press release, Case Western Reserve University, JAN 19, 2022, View Source [SID1234605571]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In addition, NeoIndicate received a Technology Validation and Start-up Fund (TVSF) Phase 2 award from the State of Ohio to help accelerate the product to market. Specifically, state funding will be used to produce and test the tumor-imaging agent in preparation for a clinical trial.

"We developed a way for clinicians to specifically recognize tumors and created a platform of technologies for use in the detection, imaging and treatment of cancer," said Susann Brady-Kalnay, a professor in the Department of Molecular Biology and Microbiology at the Case Western Reserve School of Medicine, who discovered the biomarker and developed the imaging agents that detect it. She is also NeoIndicate’s founder and chief scientific officer.

Under terms of the agreement, Case Western Reserve, through its Technology Transfer Office (TTO), granted NeoIndicate an exclusive license to the intellectual property rights developed at the university for the imaging agents used to remove the brain tumors.

The technology, called NEO-001, relies on a unique tumor biomarker combined with a fluorescent tag to detect cancerous cells. The biomarker is present on many tumor types in cancer patients, including children, adolescents and young adults.

Andrew Sloan, professor and vice chair of neurosurgery and director of the Brain Tumor and Neuro-Oncology Center at the School of Medicine, as well as the Center for Translational Neuro-Oncology at University Hospitals (UH) Seidman Cancer Center, will conduct the clinical trials. "With advances in intraoperative microscopes, robotic surgical devices and fluorescent dyes, now is the time for tumor-targeted, next-generation fluorescent imaging agents to become standard of care," Sloan said.

"NEO-001 has the potential to transform how clinicians visualize tumors, and our platform of technologies will allow us to monitor treatment efficacy," said NeoIndicate CEO Ted Gastineau.

Gastineau said the company expects to begin patient clinical trials in 2023.

Glioblastoma
The incidence of glioblastoma, the most common brain cancer, is rising and its prognosis remains dismal, with a median survival of 12 to 15 months. Surgical removal of all or part of a tumor—known as resection—remains the first line of treatment, with additional radiation and temozolomide treatment leading to modest improvement in overall survival.

Treatment of brain tumor patients is expensive, often involving ineffective treatments and repeat biopsies. Removing the cancerous tumor tissue while preserving normal tissue in the brain is challenging. Better surgical resection of brain tumors doubles a patient’s survival rate.

However, surgeons can’t always determine the edges of the tumor. And high-grade brain tumors are often invasive, with small tentacle-like projections that extend from the main tumor mass and are invisible to the naked eye.

"It is these tumor cells that lead to greater than 90% recurrence in patients due to tumor cells left at the edge of the primary tumor," Sloan said. "Therefore, better visualization of invading tumor cells improves survival and is an important unmet clinical need."

How the technology works
NeoIndicate’s license gives the company access to a proprietary platform using a unique cell surface adhesion molecule biomarker present only on tumor cells. Brady-Kalnay’s lab developed a series of agents that recognize this unique tumor biomarker.

Using models of various tumor types, she discovered that the targeted agents:

label the main tumor mass within minutes;
bind tumors for hours;
and recognize invasive tumor cells that lead to recurrence.
This technology can be used to recognize cancer cells in applications ranging from diagnosis to imaging along the treatment spectrum, including pre-, during or post-surgery. The agents can also target various treatments to primary, invasive and metastatic tumors to "seek and destroy" cancer.

Additional support
Translational support for Brady-Kalnay’s lab to develop the technology came in part from: the National Institutes of Health, Case Comprehensive Cancer Center, the School of Medicine’s Council to Advance Human Health, Case-Coulter Translational Research Partnership, Ohio Third Frontier and the CWRU TTO.

"We are very excited to see this technology move closer to the patient," said TTO Executive Director Michael Haag. "The license and NeoIndicate’s award from the State of Ohio TVSF program helps to bring this technology one step closer to creating a meaningful impact."