Canine Cancer Immunotherapy Network (K9CIN; U01 Clinical Trial Not Allowed)

The goal of this RFA is to continue to support canine cancer immunotherapy clinical trials as indicators of safe and effective cancer treatments in humans. Pet dog patients develop cancer spontaneously and the courses of disease and treatment responses are similar to those in humans. Canine clinical trial results are translatable to humans. The assessment of responses to immunotherapy in immune-intact animals with existing cancers, such as pet dog patients, is the only way to preclinically take into account all facets of the immune response to cancer and to therapies. Ethically, pet dogs can benefit from the clinical trials by receiving cutting-edge therapies supported by the NIH, while providing important data informative to human disease. The network supported by this U01 RFA will consist of five U01 awards. One U01 will serve as a multifunctional Network Coordinating Center that will not only facilitate coordination across the Canine Cancer Immunotherapy Network (K9CIN) but will also perform limited research to support the network. Four U01 recipients will conduct canine clinical trials using immunotherapeutic agents alone or in combination with other treatment modalities. Through this reissue Notice of Funding Opportunity, the National Cancer Institute intends to continue to support canine immunotherapeutic development as the field continues to grow, in part because of NIH funding. In the last five years, canine immunotherapeutics such as immune checkpoint inhibitors have become available as have canine analytics, development of which were partially supported by NCI. The goal is to maintain the momentum for further development of canine analytics and therapeutics and the ability to evaluate novel and repurposed drugs, treatment combinations, and treatment dosing and sequencing in pet dogs in a timely fashion. This NOFO consolidates the prior U01 (RFA-CA-21-050) and U24 (RFA-CA-21-051) funding opportunities to streamline the application process for continued support to K9CIN. Applicants have the option of submitting either for the Network Coordinating Center with limited research focus or for conducting canine cancer immunotherapy clinical trials and correlative studies. These important canine cancer-related activities will provide a valuable opportunity for NIH support to benefit humans and dogs, at both ends of the leash.

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions).

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; 2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; 2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...

The major elements in evaluating applications include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the...