# Preclinical development and translation

> **NIH NIH U19** · SLOAN-KETTERING INST CAN RESEARCH · 2022 · $2,995,716

## Abstract

A fundamental pillar of future global pandemic preparedness strategy involves building a robust arsenal of direct 
acting antivirals targeting a broad range of mechanisms of action and viral families. By building such an arsenal, 
humanity will be better positioned to respond to future emerging viral threats of endemic or pandemic potential. 
As evidenced by the response to the COVI D-19 pandemic, it is clear that relying on existing therapeutics alone, 
antiviral or otherwise (the repurposing approach) is far from ideal. Although repurposing has yielded life-saving 
options for intervention (e.g. dexamethasone) it has also been plagued by inefficiencies and squandering of 
resources. By far the most promising COVI D-19 therapeutics have their origins in stalled or halted antiviral efforts 
executed mostly prior to the emergence of the current pandemic (Merck's Molnupiravir, Pfizer oral and i.v. M Pro 
inhibitors). Similar efforts are now proposed by ASAP, building on the lesson that any pandemic preparedness 
arsenal should be built from molecules progressed as far into the clinical cascade as possible. 
The aim of Project 6 is to take the three best novel chemical antiviral chemical series identified by the consortium 
and progress them towards "Phase I readiness" (IND filing stage or equivalent regulatory assessment). We will 
initiate preclinical profiling on the best molecules identified in Project 5, focus rapidly down to one preclinical 
candidate per series, and carry out all required toxicological tests and specific pharmaceutical manufacturing 
processes to enable first in human administration of the novel chemical entity. In addition to providing a set of 
IND-filed candidates at Phase I ready status, we will also fully disclose the process followed and data acquired 
for each. These data and processes can then act as a global pedagogical resource and case studies for the 
process of preclinical to Phase I translation. 
ASAP will work in an open-science model, with all molecules ideally developed free of patents and exclusivity, 
to ensure resulting therapies can be produced rapidly and without hindrance or excessive cost by manufacturers 
world-wide. The future commercial development and deployment processes for pandemic preparedness are 
opaque and are an ongoing topic of discussion at the highest level of global society. Driven by the primary goal 
of providing novel antivirals based on a policy of equitable affordable access, the ASAP Project 6 team will 
actively engage in and influence these discussions to ensure that the question of global access, and the 
requirements of potentially neglected patients is fully represented within these discussions.

## Key facts

- **NIH application ID:** 10513876
- **Project number:** 1U19AI171399-01
- **Recipient organization:** SLOAN-KETTERING INST CAN RESEARCH
- **Principal Investigator:** Annette Reingart von Delft
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $2,995,716
- **Award type:** 1
- **Project period:** 2022-05-16 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10513876

## Citation

> US National Institutes of Health, RePORTER application 10513876, Preclinical development and translation (1U19AI171399-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10513876. Licensed CC0.

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