The ALSF Bio-Therapeutics Impact Award provides substantial funding to support investigator-initiated clinical trials using biologic therapies—including but not limited to immunotherapy (cell therapies), gene therapy, and small molecules—for the treatment of childhood cancers. This grant category was created specifically to accelerate the development of clinical trials for promising biologic approaches in pediatric oncology. ALSF, which holds the NCI peer-reviewed funder designation, emphasizes that potential for major scientific and clinical impact in pediatric oncology, along with a well-defined plan and timeline for trial enrollment, are critical components of a successful application. Applications are submitted directly as full proposals (no prior LOI required) through ProposalCentral and are reviewed by an independent panel of experts in accordance with the NIH-recognized peer-review process. Finalist virtual presentations are scheduled for September 2026, with award notification in October 2026 and a projected start date of November 2026.
Eligibility Criteria:
- Applicant institutions must be based in the United States or Canada; applicants need not be U.S. citizens. Funds must be granted to nonprofit institutions or organizations.
- Applicants must hold an MD, PhD, or MD/PhD (or equivalent) and be appointed at the Assistant Professor level or higher.
- The study team must have completed pre-clinical studies informing the trial and must hold an approved IND (Investigational New Drug application).
- Applicants must demonstrate a track record of implementing biologics clinical trials, documented by publication of a prior investigator-initiated clinical trial as lead PI or as a member of a study committee.
- Applicants working within a consortium are eligible; however, industry-sponsored clinical trials and clinical trials conducted through cooperative groups with existing per-patient reimbursement mechanisms are not eligible.
Funding Details:
- Total award: Up to $1,800,000 USD in direct costs over 3 years ($600,000 maximum per year).
- Indirect costs are not allowed. ALSF adheres to the NIH Salary Cap.
- Allowable costs include clinical trial expenses (per-patient reimbursement, IRB costs, drug distribution, cell therapy production, required assays), trial-embedded correlative studies (up to 15% of total budget), personnel fringe, travel, supplies, and small equipment.
- Non-renewable; one no-cost extension (max 12 months) may be requested with the final report.
Deadline:
- Full application due: June 9, 2026, 8:00 PM ET (via ProposalCentral).
- Finalist virtual presentations: September 2026.
- Award notification: October 2026; projected start: November 2026.
Where to Go for Further Information:
- 2026 Application Guidelines (PDF).
- ALSF Applicants Page (forms, templates, policies).
- Contact: Audrey Gorton, Grant Associate — A.Gorton@AlexsLemonade.org