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275 Development of Generic Antibodies for the Treatment of Cancer

Number of anticipated awards: 3

(Fast-Track proposals will NOT be accepted. Phase II information is provided only for informational purposes to assist Phase I proposers with their long-term strategic planning.)

Budget (total costs): Phase I: $300,000;
Phase II: $2,500,000

(Note: It is strongly suggested that Proposals adhere to the above budget amounts. Proposals with budgets exceeding the above amounts may not be funded. Phase I project periods may last a maximum of 9 months.)

The deadline for receipt of all contract proposals submitted in response to this solicitation is: November 9, 2009.

Summary:
New biological agents for the treatment of cancer are steadily entering the market. These targeted biologics carry the hope of ushering in the next generation of cancer therapy. Yet, there are often toxicities associated with them and they are very expensive, costing more than $100,000 per year to administer. The overall goal of this SBIR contract topic is to support small businesses to develop generic and lower priced versions of therapeutic biologics for the treatment of cancer.

Project Goals:
The goal of the NCI SBIR program is to accelerate the development of products that benefit cancer patients. As such, the short-term goal of this project is to stimulate the development of biosimilars for cancer therapy, whereas its long-term objective is the enhancement of competition in the biologics arena in order to reduce the cost of therapy for this class of molecules. The long-term goal would be the commercialization of generic versions of therapeutic antibodies for the treatment of various cancers.

Phase I activities and expected deliverables:
  • Molecule selection (e.g. FAb).
  • Molecule optimization (e.g. binding studies using SPR, Biacore, Binding Assays, FACS).
  • Construction of the biologic (e.g. IgG) and its purification (CHO/other system).

Phase II activities and expected deliverables:
  • Functional studies in cells.
    • Identification of signal transduction pathways (e.g. AKT inhibition).
    • Determination of mode of action (e.g. apoptosis, proliferation, angiogenesis, migration).
  • Functional studies in animals- non-GLP.
    • PK studies, including PK assay development.
    • PD studies, including PD assay development.
    • Efficacy studies in mice or other appropriate species.
    • Determination of cross-reactivity of the biologic with its target from various species in order to identify relevant species for non GLP studies.
  • ADCC/CDC (for antibodies) assessment.
  • Non-GMP Manufacturing.
    • Clone Selection for Highest Expresser (e.g. using FPLC/ FACS/ELISA)
    • Potency assay development for manufacturing
    • Stability studies
  • Non-GLP studies.
    • Non-GLP Dose determination study in 2 relevant species (rodent and primate)
    • Immunogenicity assay development.
  • Toxicology.
    • GLP studies (tox/PK) in primates including GLP PK assay development and immunogenicity assessment.
    • GLP studies (tox/Pk) in rodents or non-primate.
    • GLP tissue cross reactivity in human and two relevant species.

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