IIT Research Institute (IITRI) buyer-window signal capture

Evidence

• NIAID SBIR Fast-Track award 1R44AI197364-01 started August 1, 2026 to fund pre-clinical IND-enabling studies for recombinant eCD4-Ig ahead of a first-in-human Phase 1 trial.
• The award abstract states that Phase II of the grant is a definitive GLP toxicology study in macaques covering toxicokinetics, anti-drug antibodies, clinical pathology and histopathology.
• An earlier NIAID Phase I award, 1R43AI191927-01 (May 9 to October 31, 2025), funded the tissue cross-reactivity and immunotoxicity assays required for the IND and a pre-IND meeting with the FDA for the same molecule.
• The target product profile is a long-acting recombinant protein dosed quarterly by subcutaneous injection.

Practical opening

“Emmune's NIAID Fast-Track award started August 1, 2026 to fund IND-enabling studies for eCD4-Ig ahead of a Phase 1 trial. The award says Phase II of the grant is a definitive GLP toxicology study in macaques. So the GLP macaque study is written into the grant as the next step. We could price that macaque GLP protocol now.”

Claim boundaryDo not claim Emmune has no laboratory quoted or that the Phase II segment is funded; the abstract commits to the study, not to a vendor or a budget.

A Fast-Track application normally carries a budgetary quote from a laboratory, so a quoted incumbent may exist even though none is public.

Decision ownerMichael D. Alpert, PhD, President & Co-founder · malpert@emmune.bio (catch-all domain, MillionVerifier catch-all, second opinion pending, Google host, 2026-09-05) · LinkedIn: https://www.linkedin.com/in/michael-alpert-88094234/

Evidence

• NCI SBIR Phase I award 1R43CA310454-01A1 started August 13, 2026 ($400,000, twelve months) and its Aim 2 explores the toxicity of CB-101 in mice and determines the maximum tolerated dose.
• The abstract states that successful execution will enable XTOP to initiate IND-enabling mouse and cynomolgus monkey toxicology studies and antibody CMC development in a follow-up Phase II SBIR proposal.
• Massachusetts Biomedical Initiatives lists XTOP Biotherapeutics LLC as an immuno-oncology company that joined its Worcester incubator in 2025.

Practical opening

“XTOP's NCI Phase I award started August 13, 2026 and funds a mouse toxicity and maximum tolerated dose study. The abstract says the follow-on Phase II will initiate IND-enabling mouse and cynomolgus monkey toxicology studies. So the cynomolgus study is already in the next budget and the mouse study is funded. We could give Xiaoyan a budgetary quote for the cynomolgus study.”

Claim boundaryDo not claim the cynomolgus study is funded or that XTOP has budget beyond the $400,000 Phase I.

The cynomolgus package depends on a Phase II award or private money that does not exist yet; $400,000 is the only disclosed capital.

Decision ownerXiaoyan Li, Founder and contact principal investigator on the NCI award · xli@xtopbio.com (catch-all domain, MillionVerifier catch-all, second opinion pending, Google host, 2026-09-05) · LinkedIn: https://www.linkedin.com/in/xiaoyan-li-69238a57/

Evidence

• Decoy's quarterly report filed August 12, 2026 restates the plan to file an IND application with the FDA, or the European equivalent CTA, during the first half of 2027.
• The annual report says the pan-coronavirus program is supported through IND-enabling studies by grants from the Gates Foundation and Blue Knight Program totaling $6.5 million.
• At June 30, 2026 Decoy held $8.3 million of cash, cash equivalents and restricted cash, about $2.7 million of it restricted to the Gates grant, with going-concern language in the filing.
• The product is self-administered as an intranasal spray, with dry-powder nasal formulations also in development.

Practical opening

“Decoy's August 12, 2026 quarterly report restates an IND or CTA filing in the first half of 2027. Decoy's annual report says Gates Foundation and Blue Knight grants totaling $6.5 million support the program through IND-enabling studies. That suggests the nasal GLP package gets placed in the next two quarters, our inference. We could scope the intranasal GLP program with Barbara before the year ends.”

Claim boundaryDo not claim a species, a start date, or that Decoy has chosen a US IND over a European CTA; the filings state the plan and the money, not the study.

No filing names the non-rodent species; the only in vivo model disclosed is the Syrian hamster, so the second species is an inference from the route.

Decision ownerBarbara Hibner, PhD, Chief Scientific Officer, Co-Founder · bhibner@decoytx.com (catch-all domain, MillionVerifier catch-all, second opinion pending, Google host, 2026-09-05) · LinkedIn: https://www.linkedin.com/in/barb-hibner-1bb1b73/

Evidence

• BreezeBio announced the close of $60 million in Series B financing on February 25, 2026 to advance its first internal therapeutic programs toward the clinic.
• The financing release states the company is advancing BRZ-101 into IND-enabling studies and that BRZ-101 was well tolerated in mice and non-human primates.
• A May 26, 2026 release restates that BRZ-101 is advancing into IND-enabling studies for type 1 diabetes.

Practical opening

“BreezeBio closed $60 million of Series B financing on February 25, 2026. The release says BreezeBio is advancing BRZ-101 into IND-enabling studies and that it was tolerated in mice and non-human primates. That suggests the IND-enabling package, likely with a primate arm, is being scoped now, our inference. We could put an NHP repeat-dose and biodistribution design in front of Ryan.”

Claim boundaryDo not claim BreezeBio has started GLP studies, chosen a species, or that the Genentech agreement excludes BRZ-101; the releases say advancing into IND-enabling, nothing more.

A multi-year Genentech collaboration and licensing agreement continues on the platform, and public sources do not say whether it covers BRZ-101.

Decision ownerKunwoo (Ryan) Lee, PhD, Chief Executive Officer · klee@breezebio.com (MillionVerifier ok, Google host, checked 2026-09-05)

Evidence

• The Michael J. Fox Foundation awarded Shape a research grant, announced July 29, 2026, to support preclinical studies of SHP-201 toward an IND submission.
• The release states the team will conduct IND-enabling pharmacology, pharmacokinetic, biodistribution, and toxicology studies of SHP-201 across a range of doses ahead of a planned IND submission.
• Shape's October 2025 ESGCT data release says SHP-201, delivered intravenously to non-human primates, caused a significant reduction of functional SNCA across the NHP brain.

Practical opening

“The Michael J. Fox Foundation granted Shape money on July 29, 2026 for SHP-201's preclinical studies toward an IND. The release says the team will conduct IND-enabling pharmacology, pharmacokinetic, biodistribution, and toxicology studies of SHP-201. So the toxicology and biodistribution package for a primate-characterized AAV is funded and still ahead. We could sketch the NHP GLP and biodistribution design with Adrian.”

Claim boundaryDo not claim the grant amount, that Shape has no laboratory, or that the GLP species is primate; the release names the study types, not the vendor, the money, or the species.

A May 2025 statement that the company was conducting IND-enabling studies means a dose-range-finding laboratory may already exist.

Decision ownerAdrian Briggs, PhD, Chief Technology Officer · adrian@shapetx.com (MillionVerifier ok, Google host, checked 2026-09-05) · LinkedIn: https://www.linkedin.com/in/adrian-w-briggs-1a348737/

Evidence

• Ceramedix announced on August 11, 2026 that NIAID awarded it a contract worth up to $4.5 million (75N93026C00007) to advance its lead GI-ARS therapeutic toward an IND submission.
• The company's August 11, 2026 release says the contract funds continued nonclinical in vivo studies and CMC development and supports the submission of an IND application.
• Ceramedix's consultants page lists Janice A. Lansita, PhD, DABT as Preclinical Safety and Toxicology Consultant alongside radiation research consultant Thomas J. MacVittie, PhD.

Practical opening

“Ceramedix announced on August 11, 2026 a NIAID contract worth up to $4.5 million toward an IND for its GI-ARS antibody. Ceramedix says the contract funds nonclinical in vivo studies and the IND submission. That suggests the GLP package is being scoped for bid now, species unstated. We could ask Galina which species the package needs before bids close.”

Claim boundaryDo not claim a species, a GLP study, or an open RFP; the sources show a funded path to IND and a consultant, and the company has never bought in vivo work from a commercial laboratory.

No source names the toxicology species; a mouse-model history and an antibody with universal target biology could allow a rodent-heavy design.

Decision ownerGalina Vid, PhD, Vice President, Operations · galina@ceramedix.com (MillionVerifier ok, Outlook host, checked 2026-09-05) · LinkedIn: https://www.linkedin.com/in/galinavid/ · Also: Charles L. Dimmler III, Executive Chairman, chuck.dimmler@ceramedix.com (MillionVerifier ok, Outlook host, 2026-09-05)