To be eligible, the proposed project must satisfy the following requirements (1-10): 

(1) The applicant must be ready to initiate work on the funded project within 45 days of approval Given the urgency of CIRM’s mission, all approved awardees must initiate work on the funded project within 45 days of approval and authorization for funding by the Application Review Subcommittee of CIRM’s governing board, the Independent Citizens’ Oversight Committee (“ICOC”). Because of the open and ongoing nature of this Program Announcement, investigators should only apply when their project has reached the stage where all eligibility criteria are met. CIRM reserves the right to refuse to consider an application that is submitted prior to the completion of all necessary prerequisites. 

(2) The applicant must propose a single clinical trial using a regenerative medicine-based therapy (stem cell-based or genetic therapy) CIRM will support the completion (as defined in the Award Information section on page 

3) of a single clinical trial per award to test the safety and/or efficacy of a therapeutic candidate as follows: 

ü A cell therapy where human stem or progenitor cells4 (collectively, “stem cells”) either compose the therapy or are used to manufacture the cell therapy. Minimally manipulated bone marrow, minimally manipulated cord blood or unmodified hematopoietic stem cells (HSCs), are eligible only if being developed as a novel method of addressing a rare or unmet need.

 ü A genetic therapy5 approach 

(i) that targets a human somatic cell for its therapeutic effect AND 

(ii) is intended to replace, regenerate, or repair the function of aged, diseased, damaged, or defective cells, tissues, and/or organs. 

ü A small molecule or biologic that acts on or is dependent on endogenous human stem cells for its therapeutic effect, that is dependent on targeting human cancer stem cells for its therapeutic effect, that modifies a stem cell therapy, OR where a human stem cell is necessary to manufacture the therapy (e.g., extracellular vesicles).

(3) The applicant must have regulatory approval to proceed with proposed trial 

All applicants must have an active IND for the proposed candidate in the proposed indication before applying (i.e., the IND has been filed with FDA for >30 days and has approval to proceed with the proposed clinical protocol). The applicant must provide communication from FDA indicating it is safe to proceed with the proposed clinical protocol if proposing a new trial under an open IND.

Phase 2 trial applicants must have Phase 1 safety data obtained with the proposed treatment in an appropriate indication unless agreement to proceed with the Phase 2 protocol is otherwise indicated by the FDA. 

Phase 3 trial applicants must have Phase 2 data for the proposed indication(s) and have completed the End-of-Phase 2 meeting or equivalent.

(4) The project team must include a project manager The project team must include a project manager with experience managing clinical development programs and able to devote at least 50 percent effort to the project. 

(5) The applicant must propose appropriate co-funding and demonstrate availability of funds CIRM will require co-funding from the for-profit applicant or for-profit Partner of the nonprofit applicant based on the total “Allowable Project Costs”. Non-profit applicants may provide co-funding, but it is only required when project costs are in excess of the maximum CIRM award amount. Allowable Project Costs are those costs permitted under CIRM policies and regulations and include direct, facilities, and indirect costs. The sum of CIRM funds requested plus the co-funding contribution by the applicant make up the total Allowable Project Costs. For-profit CLIN2 applicants must commit at least the percentage of total Allowable Project Costs shown below under “Minimum Percentage of the Total Allowable Project Costs the Applicant Must Provide” as the co-funding amount on the project. Only funds that will be spent concurrently with CIRM funds (i.e., no sooner than board approval and no later than completion of the final Operational Milestone) will qualify toward this co-funding requirement.

Description and documentation demonstrating the commitment of funds to cover the proposed co-funding amount must be provided at the time of application submission by the application deadline. The co-funding may come from any funding source arranged by the applicant but may not include “in-kind” or similar types of support. The applicant may propose to use cash-on-hand, committed funding and/or planned fundraising as sources of funds for the co-funding commitment but must demonstrate that it will have cash-on-hand at project start date to co-fund at least the first operational milestone disbursement. Applicants are advised to refer to the Solvency & Co-Funding Template in the Document Uploads Section of the Application for additional instructions and guidance on co-funding requirements. Alternatively, for-profit applicants and for-profit Partners of non-profit applicants may elect to fulfill all or a portion of the minimum co-funding requirement by agreeing to issue equity warrants to CIRM. Applicants electing the warrant-based co-funding requirement may request CIRM funding to cover the co-funding commitment up to the award limit. Applicants who elect the warrant-based co-funding requirement must sign the Warrant Term Sheet at application submission and must issue equity warrants at the award start date. Applicants are advised to contact bd@cirm.ca.gov for additional guidance and information on warrant-based co-funding.

Minimum Percentage of the Total Allowable Project Costs the Applicant Must Provide 

• For first in-human clinical trial studies with the therapeutic candidate in a specific disease indication and using a given route of administration 

o 30% for for-profit awardee or for-profit Partner of non-profit awardee 

o None for non-profit awardee 

• For succeeding clinical trial studies conducted after a first in human trial with the therapeutic candidate in a specific disease indication and using a given route of administration 

o 40% for for-profit and for-profit Partners of non-profit awardees 

(6) The applicant must adhere to requirements for clinical trial sites in California Applicant organizations located outside of California must have at least one clinical site in California. California applicant organizations are expected to have clinical trial sites in California and must provide justification for inclusion of any sites located outside the State. 

(7) For-profit organizations must demonstrate solvency For-profit organizations must provide documentation that shows cash on hand or funding from committed sources that will cover company expenses for 180 days from date of application submission. These funds must be distinct from, and in addition to, funds for meeting the co-funding requirement for the term of the project and funds for the applicant’s financial contingency plan. The determination of solvency will be made at CIRM’s sole discretion. 

(8) The CIRM applicant must be the IND sponsor The IND sponsor (i.e., the entity named as the sponsor on the IND) for the proposed therapeutic must be the CIRM applicant organization if an organization-sponsored IND or the CIRM PI if an investigator-sponsored IND. 

(9) The application must be accurate and complete All required components of the application must be completed and may not contain false or inaccurate information. 

(10) The applicant must be in “good standing” Applicants must certify that they are in good standing, as follows: 

• The applicant’s Chief Executive Officer, Chief Financial Officer, and Principal Investigator must not have been convicted of, or currently under investigation for, crimes involving fraud/misappropriation;

• The applicant must have accounting systems in place that are capable of tracking CIRM funds; and 

• The Principal Investigator or key personnel named in the application must not be currently under investigation for research misconduct by the applicant institution or a funding agency and must not be currently debarred by HHS Office of Research Integrity. 

• The applicant organization must describe any pending legal proceedings to which the organization (or any of its affiliates or subsidiaries) is a party or of which any of their products or property is the subject of the proceeding; 

• The applicant organization, including any of its affiliates or subsidiaries, must describe any governmental investigation, or any administrative or judicial proceeding arising under any Federal, State, or local provisions; 

• The applicant organization must describe any outstanding UCC, federal or state tax judgment lines; and 

• For-profit applicants must provide a certified copy of a Certificate of Good Standing dated within 60 days of the date of their CIRM application from the jurisdiction in which the for-profit applicant organization is incorporated.

Sponsor Institute/Organizations: California Institute for Regenerative Medicine (CIRM)

Sponsor Type:

Address: 601 Gateway Blvd, Suite 400 South San Francisco, CA 94080 Phone: (510) 340-9101 Email: info@cirm.ca.gov

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