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Magnetic Insight seeks to introduce a ground breaking imaging technology addressing today's clinical and translational research challenges called magnetic particle imaging. 

Magnetic Particle Imaging (MPI) is a new imaging technology unique from any other technology on the market. It is a functional imaging modality similar to PET, SPECT and optical where real time biological events can be monitored verses anatomical imaging such as computed tomography (CT) or magnetic resonance imaging (MRI). MPI offers the ability to target biomarkers, cell tracking and real-time blood flow and vascular architecture all with direct quantitation. Harnessing the magnetic properties of iron oxide (rust) nanoparticles, visualization and quantitation is specific, direct and unobstructed by tissue depth at exquisite sensitivity and with elegant resolution

Company Background

Modulation Therapeutics is an early discovery and research startup company, which has been spun out of the Moffitt Cancer Center as part of their initiative to commercialize the research being conducted at the research facility. Modulation is dedicated to the development of novel peptidomimetic drugs for multiple myeloma (MM) and other cancers that home to bone. The company is currently focused on development of its lead candidate, MTI-101, a novel drug with a first-in-class mechanism of action.

Technology Overview 

MTI-101 is a cyclic peptidomimetic  that binds  CD44 and induces an agonistic signal leading to toxic increases in the levels of intracellular Ca2+ that trigger cell necrosis in MM cells. Recent evidence indicates that metastatic tumors rewire their Ca2+ circuitry. We propose that rewiring of Ca2+ signaling renders tumor cells vulnerable to Ca2+ overload. The in vivo efficacy of Modulation’s lead compound, MTI-101, has been demonstrated as a single agent and in combination with the proteasome inhibitor bortezomib using two independent MM in vivo models that considers the tumor microenvironment.  Importantly, MTI-101 shows increased activity in primary MM specimens obtained from patients who have relapsed on therapy; a finding that has been used to develop predictive biomarkers to be further explored in early phase clinical trials.

Intellectual Property

Modulation Therapeutics has licensed MTI-101 and several analogs from the Moffitt Cancer Center. The composition of matter and use patent was filed in 2012. Additional filed patents include coverage of analogs, combination strategies as well as biomarkers of response.

Market Potential

Multiple Myeloma is a disease that initially responds to therapy. However, inevitably all patients will relapse with disease that is refractory to standard of care agents. Thus novel treatment strategies are required to improve patient outcome. The market for MM is very large, and with improved diagnosis/detection combined with an aging population, is projected to exceed $10 billion worldwide by 2018.

Competitive Advantage

There are no drugs on the market or in development that would provide direct competition to Modulation’s lead candidate, MTI-101.

• MTI-101 induces necrotic cell death in myeloma cells and thus does not require the apoptotic machinery to induce cell death.
• Inhibits osteoclast formation and function and augments differentiation of osteoblasts using in vitro cultures and demonstrates decreased myeloma induced lytic bone lesions in vivo. MTI-101 uniquely targets the both the tumor and the bone marrow niche.
• Shows increased ex-vivo activity in specimens obtained from patients relapsing on therapy.

The crucial unmet need in myeloma is for drugs effective in patients that have relapsed on existing therapies. Modulation Therapeutics is well positioned to develop MTI-101 for the treatment of drug refractory myeloma.

Financial Overview

Modulation is an early-stage, pre-clinical research organization and has not generated any company revenues to date, nor have they developed any revenue projects beyond understanding the potential size of the market opportunity.

The company has raised over $1.7 million to date through a combination of research grants, foundation investments, and local commercialization debt.

Commercialization Strategy

Modulation is looking to raise $3 million to build and fund the infrastructure and partnerships required to plan, manage, execute, and document the IND-enabling studies to include the IND application and approval process. Modulation expects to complete the IND approval process within 18 months of receiving the required funding. Currently, Modulation has been able to advance the development of MT-101 through initial PK studies.

Pipeline Products

The initial focus for Modulation is on MTI-101 for the treatment of MM. Additional indications currently being validated are EGFR driven lung cancer, metastatic prostate and breast cancer. Targeting antibody conjugation strategies are in development and the patent has been filed for this strategy. Moreover a peptoid-peptide library is currently in development for covering additional chemical space surrounding MTI-101.

Management Team

• Co-founder and CSO Lori Hazlehurst, PhD is an expert in defining strategies to target the tumor microenvironment and is the co-inventor of multiple patents, including MTI-101.
• Director of Synthetic Chemistry Mark McLaughlin, PhD is an experienced synthetic organic and peptide chemist with more than 100 publications, is a co-inventor of MTI-101, and a senior member of the Moffitt Cancer Center.
• Board Member William Dalton, MD, PhD is the current CEO of M2GEN and former CEO of the Moffitt Cancer Center.
• Board Member Anne Cress, PhD is a professor of Cellular & Molecular Medicine at the University of Arizona, and Deputy Dean of Research.