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Veterinary 

Immuno-Oncology

Ongoing individual treatment regimens consistently demonstrate antitumor activity utilizing CPMV (MIE-201) alone or in combination with standard therapies against naturally occurring cancers in canine companion animals. Data to date demonstrate similar effects as those observed in preclinical tumor models evaluating CPMV. We believe these ongoing canine oncology studies provide valuable proof of concept data regarding the consistency of MIE-201's immune stimulation and antitumor effects across species. Additionally, insights into dosing amount and frequency, combined with immune modulating details available from biopsies of treated animals could help to inform and support the design of human clinical trials currently in planning stages. We are also investigating and evaluating regulatory requirements regarding the approval of canine oncology therapeutics which may provide a separate and expedited path toward the commercialization of our technology.

Canine oncology data summary

​​Activity in multiple tumor types​
  • Melanoma​
  • Mammary​
  • Sarcoma​
  • Ameloblastoma​
  • Mast cell​
  • Others​
​​
Treatment regimens​
  • Intratumoral single agent CPMV​
  • Combination with radiation
  • Combination with hyperthermia​
  • Combination with chemotherapies​
Observations​​
  • Single agent anti-tumor activity​​
  • Combination treatment activity​​
  • Increased anti-tumor immune cell infiltrate in tumors​​
  • Systemic anti-tumor responses (abscopal effect observed)

Parallel canine program to expedite clinical development

Companion animal field studies​
​
  • Prior experience has demonstrated MIE-201 activity in canine tumors​
  • Naturally occurring tumors​
  • Size and growth rates similar to human tumors​
  • Immune response consistent with humans​
  • Can be quickly operationalized to generate data in 2021​
  • Rapid recruitment of subjects​
  • 10% of the cost of human clinical trials
Provides multiple benefits​
​
  • Expedited generation of data equivalent to humans​
  • Longer treatment duration can yield important immune activation kinetics ​
  • Enhanced number of biopsies and timepoints​
  • PK/PD in naturally occurring tumors ​
  • Further inform dosing strategy​
  • Frequency; duration (prime and boost)​
  • Data to support potential indications​
  • Neoadjuvant​
  • Combinations with SOC

Canine companion animal study data

MIE-201 plus radiation demonstrates complete responses
in canines with oral melanoma 
Study design

Observations

•All MIE-201 treated animals were tumor free, either alive or died of unrelated causes

•Significant increase in immune cell infiltration of tumors receiving radiation + MIE-201

Hoopes P.J., Wagner R.J.,Duval K., Kang K., Gladstone D.J., Moodie K.L., Crary-Burney M., Ariaspulido H., Veliz F.A., Steinmetz N.F., Fiering S.N. (2018) Treatment of canine oral melanoma with nanotechnology-based immunotherapy and radiation. Mol Pharm., 15, 3717-3722. PMID: 29613803, PMCID: PMC6296751.
Complete tumor resolution and durable response at 20 months in oral melanoma (12 yr old female beagle)
Planned dose escalation study in canine patients