Insivio advances a 7-program in-house pipeline across oncology and rare disease — every candidate designed by agentic AI, protected by patent filings, and built for pharma out-licensing.
Insivio builds IP-protected preclinical candidates using our proprietary AI platform, then advances them toward out-licensing or co-development with pharma and biotech partners who can take programs through clinical development.
Every program begins with our agentic AI platform — target validation, virtual screening, ADMET profiling, and IP landscape analysis run in parallel before any synthesis investment is made.
Freedom-to-operate analysis and patent filing strategy are built into each program from the outset. Candidates advance only after IP position is established and documented.
Programs are designed for defined regulatory pathways. Where indications qualify, we pursue Orphan Drug Designation with the FDA and EMA COMP in parallel, before IND filing.
All programs computationally complete through Lead Optimization. Stages shown are the three in silico discovery phases. In vitro / in vivo / IND-enabling work is the proposed pharma partner validation gate.
| Program | Therapeutic Area | Modality | In Silico Stages | Orphan |
|---|---|---|---|---|
|
INSV-3001
Uro-Oncology
|
Bladder Ca |
Small Molecule |
01 · TARGET ID
Target ID / Validation
✓ Complete
02 · H2L
Hit-to-Lead
✓ Complete
03 · LEAD OPT
Lead Optimization
✓ 108/108 physics · clean
|
✓ FDA & EMA |
|
INSV-4601
Uro-Oncology
|
Urology Ca |
Small Molecule |
01 · TARGET ID
Target ID / Validation
✓ Complete
02 · H2L
Hit-to-Lead
✓ Complete
03 · LEAD OPT
Lead Optimization
✓ 91.7% physics · clinical-anchor confirmed
|
✓ FDA & EMA |
|
INSV-2001
Uro-Oncology
|
Prostate Ca |
Small Molecule |
01 · TARGET ID
Target ID / Validation
✓ Complete
02 · H2L
Hit-to-Lead
✓ Complete
03 · LEAD OPT
Lead Optimization
⚠ Dossier closed · pre-CRO flags
|
✓ FDA & EMA |
|
INSV-5001
Haemato-Oncology
|
AML |
Small Molecule |
01 · TARGET ID
Target ID / Validation
✓ Complete
02 · H2L
Hit-to-Lead
✓ Complete
03 · LEAD OPT
Lead Optimization
⚠ Dossier closed · pre-CRO flags
|
✓ FDA & EMA |
|
INSV-4501
Urology
|
Male LUTS |
Small Molecule |
01 · TARGET ID
Target ID / Validation
✓ Complete
02 · H2L
Hit-to-Lead
✓ Complete
03 · LEAD OPT
Lead Optimization
✓ V4 physics gate complete · platform-calibrated
|
Under assessment |
|
INSV-RNAi-006-007
Cardiovascular
|
Hypertension |
RNAi · SORT-LNP |
01 · TARGET VAL
Target Validation
✓ Complete
02 · SEQ DESIGN
Sequence Design
✓ Locked · seed-region screened
03 · DELIVERY
Delivery Specification
✓ SORT-LNP confirmed
|
✓ FDA & EMA |
|
INSV-RNAi-008
Cardiovascular
|
CV |
RNAi · SORT-LNP |
01 · TARGET VAL
Target Validation
✓ Complete
02 · SEQ DESIGN
Sequence Design
✓ Complete
03 · DELIVERY
Delivery Specification
→ In progress
|
✓ FDA & EMA |
Five of Insivio’s seven active programs target indications with fewer than 200,000 affected patients in the United States, qualifying for FDA Orphan Drug Designation (21 U.S.C. § 360bb) and EMA Committee for Orphan Medicinal Products (COMP) designation. Insivio policy is to file both FDA and EMA orphan applications in parallel, before or concurrent with IND submission. Orphan designation provides 7-year US market exclusivity (10 years EU), clinical trial tax credits, and fee waivers on IND and NDA filings.
Insivio’s programs are developed with out-licensing and co-development as the intended exit. Each program is documented to support pharma due diligence: ADMET profiles, IP filings, competitive landscape analysis, regulatory pathway assessment, and a clear route to IND-enabling studies.
We welcome early-stage conversations with business development teams at specialty pharma, rare disease-focused biotechs, and larger organizations with relevant therapeutic area presence.
Initial conversation — NDA/CDA execution
Program overview — data package review
Scientific due diligence
Term sheet & deal structure
Definitive agreement & close
For detailed program information, data packages, or partnership discussions — contact our business development team. Investor materials are available on request.