Medicenna is a clinical stage, privately held, immuno-oncology company developing first-in-class, Interleukin-4 Empowered Cytokines™ (IL4-ECs) that specifically target the Interleukin-4 Receptor (IL4R). The IL4R is over-expressed by 20 different cancers, cancer stem cells and immunosuppressive cells of the tumor micro-environment (TME). Medicenna’s IL4-ECs have the potential to not only purge the tumor but also un-blind the immune system to cancer thereby altering the treatment paradigm for a large majority of cancer patients.
Our lead IL4-EC, MDNA55 has been studied in 3 clinical trials in 72 patients with recurrent glioblastoma (rGBM), a uniformly fatal form of brain cancer, in which it has shown compelling indications of superior efficacy to the current standard of care. MDNA55 has been granted both, Fast Track (FDA) and Orphan Drug Status (FDA and EMA).
The company is poised to commence a Phase 2b study with MDNA55 in 2015, then seek Breakthrough Therapy Designation, and file for Accelerated Approval for rGBM by 2018. Our approach to treat brain and other aggressive cancers received strong validation by a recent award of a $14.1M non-dilutive grant from the Cancer Prevention and Research Institute of Texas (CPRIT).
In the US alone, nearly 23,000 primary malignant tumors of the brain will be diagnosed and cause over 15,000 deaths. Additionally, up to 170,000 new cases of primary cancers originating in the lung, breast, colon and other organs metastasize to the brain. At metastasis, the median survival of untreated patients is 1-2 months and is extended to less then 9 months in patients treated with surgery, chemotherapy, and radiation. Analysis of over 300 brain tumor biopsies, from primary adult and pediatric brain tumors as well as adult metastatic brain tumors, consistently show that over 75% of brain cancer patients over-express the IL4R.
NeuroExact™ incorporates our proprietary IL4R targeted drug (MDNA55), an IL4R companion diagnostic, precision image-guided convection enhanced delivery (CED) and real-time monitoring of drug distribution to ensure that our personalized approach will benefit thousands of patients diagnosed with IL4R brain cancers every year.
Treatment with NeuroExact™ involves direct one-time intra-tumoral infusion of MDNA55 using CED in patients that have been diagnosed with IL4R positive brain tumors. Image guided CED provides intra-tumoral delivery with sub-millimeter precision and real-time monitoring ensures uniform distribution of MDNA55 into the brain tumor and its infiltrative edges. This personalized approach by-passes the blood brain barrier (BBB), avoids potential systemic side effects and reduces the risk of tumor recurrence – problems that have continued to plague this difficult to treat disease.
NeuroExact™ enables high and uniform drug exposure with only a single dose of MDNA55 during a minimally invasive surgical intervention. It does not require a material change in neurosurgical practice as it involves minor adaptation of established procedures such as image guided biopsies, stereotactic radiosurgery or deep brain stimulation.
In addition to brain cancers, the IL4R is a marker for highly aggressive forms of solid and blood tumors affecting more then a million new cancer patients every year. The IL4/IL4R bias is known to play a central role in the establishment of a robust immunosuppressive tumor micro-environment (TME), is expressed by cancer stem cells and is generally associated with poor survival outcomes. MDNA55 and Medicenna’s next generation fully human IL4-EC platform (MDNA56 and MDNA57) has the potential to mature into an important class of treatments addressing large unmet needs in oncology.
Our Target Centric approach is complemented by our Patient Centric approach in that, by selecting patient populations that have a biased IL-4/IL4R profile, our IL-4 Empowered Cytokines™ will have a higher probability of clinical, regulatory and re-imbursement success.
With a significantly de-risked lead clinical program validated by a $14M grant, ripe opportunities for MDNA55 first in rGBM and then in numerous CNS cancer indications, potential for Accelerated Approval, a mechanism of action that will be synergistic with immunotherapies, an experienced management team and solid IP, we believe that Medicenna provides compelling opportunities for growth, collaboration and substantial near-term value inflection.