Using Nanotechnology to Change Cancer Care

Using Nanotechnology to Change Cancer Care MarylandTechnologyDay 28 February 2013

The Promise of Cancer Nanomedicines Deliver potent an6-‐cancer agents directly to the site of disease Reduced or no toxicity Improved eﬃcacy Ø Ø Treat cancer as a medical disease ﬁrst Dose intravenously prior to surgery Limited biodistribu6on due to leaky tumor blood vessels Reduce tumor burden by tumor-‐targeted nanomedicines Reduce or eliminate sophis6cated surgical procedures Improve pa6ent outcome Ø Ø Ø Ø Ø Treat cancer as a chronic medical disease Treat periodically to destroy nascent tumor neovasculature Suppress metasta6c disease 2 Ø Ø

Design of Aurimune (CYT-‐6091): Waterabsorbedby PEG-THIOLshields nanoparticlefrom immunedetection 3

Safe, Targeted Delivery: Size MaGers Too Large for Toxic Side Eﬀects. Aurimune is small enough to safely travel through healthy blood vessels, but too large to pass through blood vessel walls into healthy 6ssues and organs, resul6ng in reduced toxicity. Small Enough to Exit Tumor Vessels. All solid tumors are fueled by new, “leaky” blood vessels that have gaps in their walls. When Aurimune reaches these “leaky” vessels, the nanopar6cles are small enough to pass through these walls into their target, the tumor. Due to its engineered nanometer size and targeted capabiliJes, Aurimune is able to reduce toxicity and increase eﬃcacy. 4

Clinical Grade Aurimune Current produc6on capacity scaled 10-‐fold from Phase I to Phase II Process is robust, reproducible and cost eﬀec6ve Solved manufacturing challenge for a nanomedicine 3-‐year shelf life as a freeze dried product Ø Ø Ø 5

Aurimune Phase I Trial: Clinical ObservaJons Safe, systemic delivery. Delivered 1.2 mg of TNF with no dose limi6ng toxicity ØNo Hypotension, the dose-‐limi6ng toxicity associated with TNF use in man ØNo Serious Adverse Events that were unexpected and related to treatment Tumor targeted. Drug accumula6on at tumor sites ØGold par6cles seen in tumors but few if any in healthy 6ssues 6

Electron Micrographs* of a PaJent’s Biopsies Pa6ent diagnosed with inoperable breast cancer Ø Pa6ent had no prior treatment; samples taken 24h aYer treatment Ø Drug accumulated in tumor, not in healthy breast 6ssue HealthyBreast Tumor *Magnification=20,000x 7

Monteﬁore’s Commitment to Nanomedicine 8

The Pipeline: Leveraging PlaWorm’s Flexibility PlaWorm allows for mulJple cancer treatments for mulJple cancer indicaJons 9

Blueprint of Gold-‐Based, Drug-‐Rescue Nanomedicine PEG-‐THIOL TNF: A targeted VDA AstraZeneca Proprietary Drug 10

CytImmune Summary Aurimune will transform current “medieval” approaches to cancer treatment Aurimune plus chemotherapies aims to signiﬁcantly improve responses rates Aurimune is not another “me too” drug; it’s a quantum leap forward in cancer care Aurimune is the ﬁrst-‐in-‐a-‐family of nanomedicines CytImmune will create a pipeline of cancer nanomedicines CytImmune’s technology will change the way we treat cancer 11

Using Nanotechnology to Change Cancer Care