Signals tracked for IIT Research Institute (IITRI)
The signal classes we read for IITRI, ordered by how close each sits to the moment a sponsor places its GLP toxicology package. Every program on the Accounts tab came out of one of these classes, and the class is named there.
How we rank a signal
Two questions decide a signal's value for a GLP tox laboratory: how close is it to the placement decision, and can the sponsor pay for a rodent plus non-rodent package. A federal award that names the GLP study and the species is close to the decision. A funding release that says 'preclinical' is far from it.
One signal is a lead. Two independent signals at the same program is a qualified window. An award that names the study plus a Phase II budget being written is the shape we lead with; a designation alone is a clock without a budget.
Timing matters more than volume. The dose-range-finding study is usually placed eighteen to twenty-four months before the IND and its laboratory tends to inherit the GLP program, so the window is the quarter the sponsor scopes that first study, not the quarter it announces the IND.
Closest to the placement
One to three quarters before the RFPPublic records in which the sponsor itself commits to a GLP toxicology study, names the species, or budgets the work, with a date attached.
GLP study named in a federal award
An NIH or BARDA award whose abstract or contract scope states the GLP toxicology study and the species. The sponsor has already written the scope of work a laboratory can price; the open question is who prices it.
From this screenEmmune: NIAID Fast-Track award started August 1, 2026 whose abstract says Phase II is 'a definitive GLP toxicology study in macaques', with the in vitro IND assays and pre-IND meeting funded by a 2025 award.
Phase II budget window
A Phase I SBIR in months three to nine, or one that has just expired, whose abstract puts IND-enabling toxicology in the Phase II. Budgetary quotes for that application are requested now, and a quoted laboratory is not yet a contracted one.
From this screenXTOP Biotherapeutics: NCI Phase I started August 13, 2026 with a funded mouse maximum-tolerated-dose study and a Phase II written to 'initiate IND-enabling mice and cynomolgus monkey toxicology studies'.
Toxicology consultant engaged
A sponsor announces a nonclinical or toxicology strategy consultant. At companies under sixty staff the consultant writes the RFP and picks the bid list, so the announcement dates the start of the placement process.
From this screenCeramedix: NIAID countermeasure contract started July 1, 2026 to carry an anti-ceramide antibody to IND, and a toxicology-strategy consultant engaged the same month.
Money that pays for the package
Two to four quartersDated commitments whose downstream is a GLP package. Slower than the first tier, and only as strong as the species and stage they state.
Countermeasure contracts with milestone lists
NIAID, BARDA and MTEC development contracts publish their milestones, so 'a GLP toxicology study' appears in the funder's own words. Read the species and who owns the drug before treating it as a program.
From this screenMicron Biomedical: NIAID contract announced July 27, 2026 with 'a GLP toxicology study' as a milestone, no species named, and the drug owned by a partner.
Foundation and translational grants naming IND-enabling work
Disease foundations and translational programs fund IND-enabling pharmacology, biodistribution and toxicology by name. The grant is often smaller than the package, so pair it with a financing or a second grant.
From this screenShape Therapeutics: Michael J. Fox Foundation grant announced July 29, 2026 to 'conduct IND-enabling pharmacology, pharmacokinetic, biodistribution, and toxicology studies' of an intravenous AAV already characterized in nonhuman primates.
First institutional round with IND-enabling in the use of proceeds
A seed or Series A whose release funds IND-enabling studies. Read the tense: 'planned' is a window, 'currently in IND-enabling studies' means the dose-range-finding laboratory is already in the chair.
From this screenFortitude Biomedicines: $13 million seed in January 2026 with IND-enabling work in the use of proceeds, and a pipeline page that already reads 'currently in IND-enabling studies'.
Regulatory clocks
Six to eighteen monthsDesignations and meetings that date a program's intent to file. Strong when paired with money; weak when the toxicology already sits in an academic lab.
Orphan and rare pediatric designations to preclinical programs
A designation granted while the program is still preclinical puts an IND on the sponsor's calendar. Check where the nonclinical work already lives before calling.
From this screenGalibra Neuroscience: orphan and rare pediatric designations for an AAV gene therapy in summer 2026, with the toxicity work funded through an NINDS award in the founder's own academic laboratory.
Pre-IND and INTERACT announcements
A pre-IND package is written with the incumbent consultant or laboratory. This class dates the next program, not the current one.
Confirming only
Never lead with theseFirst preclinical or toxicology hire
A live posting for a head of preclinical or nonclinical development confirms the seam and the systems. The hire brings vendors, so the window is the weeks while the seat is empty, and the posting never carries a program alone.
From this screenKernal Biologics: a Director of Preclinical Development role posted August 12, 2026 under an ARPA-H award, with no GLP or IND-enabling language in any company source.
Public-company filings
A 10-K or 10-Q that gives an IND date is a real clock that every laboratory reads. It earns a row only when the company is small, cash-constrained and no laboratory is named.
From this screenDecoy Therapeutics: an eleven-person public company whose filings put an IND or CTA in the first half of 2027 for an intranasal antiviral, with no laboratory named.
'IND-enabling studies underway' is the stop sign
Present-progressive language, a poster with a laboratory co-author, or a partnerships page naming GLP providers means the package is placed. These programs re-enter for the next molecule, not this one.
From this screenENCUE said in a June 2025 abstract that its Rett candidate had completed IND-enabling studies; Arisan Therapeutics names Frontage Laboratories and Battelle as collaborators.
What each program arrives with
- Sponsor and the award, filing or release that surfaced it, linked to the record with its date
- The species and study set the record implies, and why
- The program owner with title and a found work email, validation method and date included
- The line to open with and the claim to avoid, so outreach never says more than the record shows
- What to check first, so the account can be verified in two minutes
Programs whose window has not opened are timed and held, not sent. They re-enter the moment a dated record makes them useful.
Signal classes describe categories of public record and how often we read them. Per-program claims live on the Accounts tab with their sources.