2025 Alzheimer's Drug Development

FUNDING MEMO

Title: 2025 Alzheimer's Drug Development - LOI

Funding Agency: Alzheimer's Drug Discovery Foundation

External Deadline(s):

02/03/2025 02:00 PM PST (LOI)
04/07/2025 02:00 PM PDT (Full Proposal)

Cognizant Office: Office of Sponsored Research/Office of Foundation Relations

Description:

The Alzheimer's Drug Discovery Foundation (ADDF) Drug Development RFP supports investigational new drug (IND)-enabling studies (or the international equivalent) and early-phase clinical trials that test promising pharmacological interventions and devices for Alzheimer's disease (AD) and related dementias. Both disease-modifying and symptomatic agents will be considered.

Note: This opportunity has two review cycles in 2025. Deadlines are as follows:

LOI: 2/3/2025; Full Proposal: 4/7/2025
LOI: 9/15/2025; Full Proposal: 11/17/2025

Frequency: Typically offered multiple times per year

Total Award: $5,000,000

Up to $5,000,000 based on stage and scope of research. For studies requiring additional support, co-funding from other funding agencies or investors is encouraged.
- ADDF funding may be provided for approved personnel costs, supplies (e.g., consumables, chemicals, animals), small non-durable equipment up to $2,500, consultants, and patient costs related to clinical trials.
- ADDF funding is not provided for indirect costs/overhead, capital equipment, equipment service contracts, publication costs, or travel (unless travel is pre-approved under special circumstances).
Payment structure will be negotiated and based on milestone achievements and recruitment.

Indirect Costs: Not Allowed

Caltech’s minimum overhead rate is based on the award’s annual gross funding. Please refer to the FY25 Annual Rate Memo for applicable minimum overhead requirements. Applicants must work within their division to account for the required overhead via an approved MORA form.

Duration: Varies

Multi-year funding is available.

Discipline(s): Biology and Biological Engineering; Chemistry and Chemical Engineering; Engineering and Applied Science

Eligibility: Research Faculty, Tenure-Track Faculty, Tenured Faculty

Applicants may be researchers or clinicians working in academia or biotechnology companies based in the U.S. and worldwide.
- Caltech researchers other than tenure-track faculty will need to obtain approval from the Division Chair and Vice Provost for Research prior to submitting an application.
Industry partnerships are strongly encouraged.
Note: Funding is provided through mission-related investments that require return on investment based upon scientific and/or business milestones (see Research Strategy for more information).
- When working with academic institutions, ADDF typically asks for a share of any commercial returns that may arise from the funded research. If you have any questions or concerns, please reach out to OTTCP.

Research Areas of Interest:

Please review the RFP guidelines for additional information.
This RFP supports:
- Early-stage human clinical trials including:
  - Phase 0 micro- or sub-therapeutic-dosing studies;
  - Phase 1 trials in healthy subjects or patients;
  - Biomarker-based proof-of-concept studies (generally phase 1b or phase 2a trials) designed to assess target engagement and downstream pharmacologic effects.
- IND (or international equivalent) – enabling studies including:
  - Non-GLP and GLP pharmacology and toxicology studies, pre-formulation, and GMP manufacture of API and/or drug product required for regulatory packages. Funding is available for preparation of traditional and exploratory IND (or international equivalent) applications;
  - Long-term toxicology studies to enable longer-term dosing in phase 2 trials;
  - GMP manufacturing and testing of API and/or drug product required to move into phase 2 or phase 3 trials.
Type of therapy: Novel, repurposed and repositioned drugs, as well as natural products and devices will be considered. Therapeutic modalities of interest include small molecules, peptides, antibodies, gene therapies, antisense oligonucleotides, and stem cells. A detailed landscape analysis to compare competition related to the mode or mechanism of action is strongly encouraged.
Drug mechanisms or modes of action: Novel drug mechanisms and modes of action related to the biology of aging and other emerging therapeutic areas for dementia are considered high priority. These include, but are not limited to:
- Epigenetics;
- Inflammation;
- Mitochondrial & metabolic function;
- Neuroprotection;
- Proteostasis;
- Synaptic activity and neurotransmitters;
- Vascular function;
- Other mechanisms and modes of action related to the biology of aging (e.g. senescent cells);
- Other novel mechanisms or modes of action that are supported by compelling evidence demonstrating a rational biological connection to the disease process.

Research Exclusions:

This funding opportunity prioritizes diverse drug mechanisms and modes of action related to the biology of aging and other emerging therapeutic areas for dementia. For this reason, amyloid targeted approaches and cholinesterase inhibitor proposals will not be considered for this RFP.
Type of Therapy: Non-pharmacologic interventions, such as diet, meditation, and exercise, will not be considered.

Post-Award Obligations:

TBD

Recent Caltech Recipients:

None

Guidelines & Other Information:

Guidelines and Deadlines: https://www.alzdiscovery.org/research-and-grants/funding-opportunities/drug-development-rfp

Application Instructions (All Grants): https://www.alzdiscovery.org/research-and-grants/funding-opportunities/application-instructions

ADDF Funding Policies: https://www.alzdiscovery.org/research-and-grants/funding-opportunities/policies

ADDF Research Strategy: https://www.alzdiscovery.org/research-and-grants/our-research-strategy

Scientific Review Board: https://www.alzdiscovery.org/about-addf/board-scientific

Funded Projects (All Grants): https://www.alzdiscovery.org/research-and-grants/portfolio

Submissions and awards for this grant program will be processed through the Office of Sponsored Research (OSR). However, please notify the Office of Foundation Relations (OFR) if you anticipate making a submission, have any questions, or would like a content review of your proposal. OFR is available to help ensure that Caltech’s proposals are competitive and can assist with proposal development and advise you on the routing of your paperwork. Interested researchers should work with their division grant manager to prepare the budget, the MORA form, and the Division Approval Form (DAF).

Opportunity ID: 2129