Biotex, Inc.

Novel Wearable Rotating Magnetic Field Therapy Device Targeting Treatment of Brain Cancers - Project Summary/abstract the Overall Goal of This Direct to Phase Ii Sbir Proposal Is to Accelerate the Translation to the Clinic and Commercialization of a Novel, Non-invasive Wearable Rotating Magnetic Field Therapy Device (oncomagnetic Device or Omtx) Targeting Treatment of Brain Cancers. the American Cancer Society (ACS) Estimates That There Will Be 25,400 New Cases of Brain and Other Central Nervous System (CNS) Cancers in 2024, With an Estimated 18,760 Deaths From These Diseases. Glioblastoma (GBM) Is One of the Most Aggressive Malignancies and the Most Common Brain Cancer, (representing 45.2% of All Brain and CNS Cancers) Occurring in ~3 of 100,000 People Per Year. Current Treatments (surgical Resection, Chemotherapy, Radiotherapy) Take a Heavy Toll on Patients, Often Causing Them to Quit Treatment Prematurely Due to Toxicity or Disease Progression. These Treatments Result in a Poor Quality of Life With High Rates of Recurrence and Modest Improvements in Survival Rates by Only 6-11 Months. Immunotherapies Such as Checkpoint Inhibitors, Peptide Vaccines, Dendritic Cell Vaccines, Chimeric Antigen Receptor (CAR) T Cells, and Oncolytic Virotherapy Have Recently Yielded Promising Results in Pre- Clinical and Clinical Studies, But They Are Still in the Experimental Stages. Thus, There Is a Great Unmet Need for a Novel, Less Toxic Therapeutic Approach to Improve Clinical Outcomes and Quality of Life for Brain Cancer Patients. the Oncomagnetic Device (OMTX) Is a Non-invasive, Wearable Device That Uses Spinning Oscillating Magnetic Fields (SOMFS) to Treat Brain Cancer Tumors. Omtx Generates Specially Devised Somf Patterns That Demonstrate Strong, Selective Anti-cancer Effects in Patient-derived GBM Cells and Other Brain Cancers in Culture, Without Damaging Cultured Normal Astrocytes and Neurons. Omtx Addresses the Whole Brain Volume, a Requirement for Effectiveness Against Invasive Infiltrating Tumors Like GBM. It Does Not Require Patients to Shave Their Head, Exhibits Low Toxicity, and Only Requires 4-6 Hours of Treatment Per Day. Preliminary Efficacy Has Already Been Demonstrated in Mice, and Omtx Has Been Used Under Fda’s Expanded Access Program in 10 Patients Who Had Failed All Other Therapies. Continued Efforts Will Build on These Results to Optimize to a Commercial-ready Design, Complete Required Design Controls and Validation Activities, and Perform a GLP Safety Study, Supporting Ide Approval for Future Clinical Studies Intended to Support Fda Premarket Approval. We Expect the End Result of This Effort Will Greatly Enhance Treatment and Quality of Life for Patients Impacted by Brain Cancers.