Key Dates

NOT-CA-21-069 - Notice of Intent to Publish a Funding Opportunity Announcement for Coordinating Center for Canine Cancer Immunotherapy Network (K9CIN; U24 Clinical Trial Not Allowed)

National Cancer Institute (NCI)

The purpose of this Notice is to announce the NCI's intention to issue a Funding Opportunity Announcement (FOA) that invites applications for Canine Cancer Immunotherapy Network (K9CIN). Canine patients with spontaneous tumors closely mimic human conditions and physiology for preclinical immunotherapy research. The network of laboratories and canine clinical trial sites created through this FOA will support canine clinical studies using immunotherapeutic agents and novel drug combinations together with laboratory correlative studies that seek to characterize and understand the cellular and molecular mechanisms that determine anti-tumor responses (or non-responses) in pet dogs with spontaneous tumors. An essential goal of these studies will be to determine whether or not canine cancer is a close model of human malignant disease, and if so, whether immunotherapy alone or in combination with other modalities in canine models will inform the design of therapies in humans.

This Notice is being provided to allow potential applicants sufficient time to develop a responsive grant application. The FOA is expected to be published in July 2021 with an expected application due date in October 2021. Details of a planned pre-application webinar will be announced in the Guide after the publication of the FOA.
The FOA will utilize the U01 (Research Project-Cooperative Agreements) mechanism to support a network of laboratories and canine clinical trial sites. Within the network, awardees are expected to share therapeutic agents, specimens, and laboratory and clinical protocols in order to standardize and validate the data generated. A companion U24 funding opportunity will support a coordinating center that will aid in the development, standardization, harmonization, and conduct of the clinical and laboratory studies, as well as data management and statistical support across the funded U01 sites.

Collectively, data generated through the funding announcement will assess the suitability of canine models to study single and combination immunomodulating agents, ideally with molecularly targeted drugs, chemotherapy, or radiation, for the purpose of translating the canine findings to human studies.

The K9CIN will conduct immunotherapy clinical trials in pet dogs with spontaneous tumors and perform laboratory correlative studies associated with the clinical trials. The FOA will support a clinical trial or trials and correlative studies. The U24 coordinating center (companion funding opportunity) will work with intramural and extramural NCI staff to develop and manage a steering committee for oversight of network activities.

U01 applications must include convincing preliminary data to support a clinical trial or trials and correlative studies. The clinical trial or trials must include therapeutic modulation of the tumor microenvironment (TME) or must elicit direct immune-mediated destruction of cancer. Priority attributes include:

• Combinations of immunotherapy/TME-modulating therapy with radiation therapy or other therapies (targeted therapies, chemotherapies or other immunotherapies)
• Adoptive immune cell therapies such as CAR T-cell therapies or NK cell therapies
• Studies including longitudinal biopsies, tumor DNA sequencing and transcriptomics, and biomarker development in pet dogs treated with immunotherapeutic agents

Grants may propose a focused immunotherapy clinical trial or a series of pilot clinical trials followed by a second stage, a larger focused clinical trial. Participation in the network will allow cross-recruitment of canine patients, sharing of clinical trial designs and data, and harmonization of clinical and correlative data to accelerate the progress of individual and collaborating U01s.

Applications are not being solicited at this time. 

Please direct all inquiries to:

Connie Sommers, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7187
Email: [email protected]

Anju Singh, B.V.Sc, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7603
Email: [email protected]