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Oligonucleotide Toxicity (OligoTox) Open Data Challenge is sponsored by Department of Health and Human Services - National Institutes of Health. Background Oligonucleotides (“oligos”) are an emerging class of therapeutics most commonly used in the treatment of rare genetic diseases.
As used here, the term “oligos” refers to short (typically 15-30 nucleotides in length) nucleic acids intended to be used as therapeutics to treat human diseases by modulating gene expression. Typically, oligo therapeutics contain chemical modifications in the phosphodiester backbone or sugar moiety to limit degradation by cellular nucleases. Examples of therapeutic oligos include anti-sense oligos (ASOs), siRNAs, and microRNA mimics.
To date, there are 17 FDA-approved oligo therapeutics, and many more in clinical development, to treat rare genetic diseases, infectious diseases, and cancer. As with any new molecular entity used as a therapeutic, the consideration of toxicity is a critical requirement in assessing safety.
Toxicity in oligo therapeutics may be sequence-dependent (e.g., hybridization to nucleic acids other than the intended target) or sequence-independent (e.g., binding to cellular proteins) and are primarily assessed through expensive and time-consuming animal studies.
Notably, both the FDA ( FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs ) and NIH ( NIH to prioritize human-based research technologies | National Institutes of Health ) are focusing on new approach methodologies that can reduce animal testing in preclinical safety studies through practices such as use of in vitro human-based systems, in silico/computational modeling, and other innovative platforms that can collectively evaluate immunogenicity, toxicity, and pharmacodynamics in humans and improve the predictive relevance of preclinical drug testing.
One possible strategy for assessing the toxicity of oligo therapeutics would be the use of in vitro human-based systems, including microphysiological systems (i.e., tissue chips, organs-on-a-chip) and 3-dimensional human organoids. NIH has already inves
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Or search similar grants →According to the current listing, eligibility includes: To be eligible to win a prize under this Challenge, a Participant (whether an individual, group of individuals, or entity) — a. Shall have registered to participate in the Challenge under the rules promulgated by the National Institutes of Health (NIH) as published in this announcement; b. Shall have complied with all the requirements set forth in this announcement; c. In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States. However, non-U.S. citizens and non-permanent residents can participate as a member of a team that otherwise satisfies the eligibility criteria. Non-U.S. citizens and non-permanent residents are not eligible to win a monetary prize (in whole or in part). Their participation as part of a winning team, if applicable, may be recognized when the results are announced. d. Shall not be a federal entity or federal employee acting within the scope of their employment; e. Shall not be an employee of the Department of Health and Human Services (HHS, or any other component of HHS) acting in their personal capacity; f. Who is employed by a federal agency or entity other than HHS (or any component of HHS), should consult with an agency ethics official to determine whether the federal ethics rules will limit or prohibit the acceptance of a prize under this Challenge; g. Shall not be a judge of the Challenge, or any other party involved with the design, production, execution, or distribution of the Challenge or the immediate family of such a party (i.e., spouse, parent, step-parent, child, or step-child). h. Shall be 18 years of age or older at the time of submission. Confirm the full requirements in the official notice before applying.
The current listing shows $500,000. Verify award ceilings, matching requirements, and allowable costs in the official notice.
Applications for Oligonucleotide Toxicity (OligoTox) Open Data Challenge are due January 1, 2027. Build your timeline backwards from this date to cover registrations, approvals, and final submission checks.
Yes — Oligonucleotide Toxicity (OligoTox) Open Data Challenge is offered by Department of Health and Human Services - National Institutes of Health and this listing comes from Challenge.gov, an official U.S. federal source. Federal applications generally require registrations (for example SAM.gov or an agency submission portal), so allow extra lead time.
Start from the official opportunity page linked in this listing — it carries the sponsor's submission instructions.
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