PDX PHARMACEUTICALS, INC. — Department of Health and Human Services SBIR Phase II: Over one million women worldwide are diagnosed with breast cancer each year. Roughly 20% o
PDX PHARMACEUTICALS, INC. — SBIR Phase II award from Department of Health and Human Services.
Phase II SBIR prototype / development signal
- Phase II is where Department of Health and Human Services funds deeper R&D after feasibility. Incumbents with Phase II history are serious competitors on adjacent topics.
- Use this award as past-performance context and to map customer organizations for STRATFI/TACFI-style transition planning.
- Obligated amount $1,000,000 is consistent with substantial Phase II-scale effort; compare to related awards from the same agency.
- Amount
- $1,000,000
- Agency
- Department of Health and Human Services · National Institutes of Health
- Program / Phase
- SBIR · Phase II
- NAICS
- —
- Place of performance
- OR
- Period
- —
Description
Over one million women worldwide are diagnosed with breast cancer each year. Roughly 20% of all breast cancers overexpress the human epidennal growth receptor 2 (HER2-positive subtype). HER2-targeted therapies, including Herceptin and lapatinib, account for 55% of the breast cancer therapy market in 2011 (or $5 billion annually). Response to HER2-targeted therapies typically average about one year due to developed resistance. This represents an area of unmet clinical need. HER2 over-expression has been clearly linked to aggressive and abnonnal tumor growth, rapid metastases, and drug resistance in this cancer subtype. siRNA for knocking down HER2 offers a new treatment modality to overcome drug resistance. We are developing a novel nanoparticle platform for therapeutic siRNA delivery. Novelty lies in the hybrid polymeric-inorganic nanoparticles that take full advantage of both classes of materials to overcome siRNA delivery barriers (e.g., poor bioavailability, poor cellular uptake, and off-target effects) and enable large-scale manufacturing of the nanocontruct. This Phase I portion will optimize the nanoparticle platforms to achieve >70% knockdown ofHER2 in three HER2-positive breast cancer cell lines, leading to programmed death of the cancer cells, while having no adverse effect on HER2-negative cells or nonnal cells. The most optimized nanoparticle platform will undergo further in vivo evaluation in Phase II SBIR project.