Pipeline
Asset Portfolio — 5 Assets
Five novel-gene-based assets — from cancer to neurodegenerative disease — all derived from the same unique discovery platform.
Nerofe
A novel peptide hormone from a novel gene we discovered. It activates the first anti-cancer-specific nuclear immunotherapy by overexpressing its ST2 receptor in cancer cells. Now in two Phase 1b US trials (University of Miami, FL and Georgetown, Washington D.C. — both IITs) with exciting results. Further collaborations are opening (MSKCC, Northwell Health) for breast cancer, GI-tract tumors, GBM and meningioma.
4 Brain Peptide Hormones
In collaboration with Prof. Steven Arnold of MGH, Boston, four novel peptide hormones were discovered in the human brain, statistically strongly related to ALS, Parkinson's, Alzheimer's and dementia. One strongly regulates activated glial cells and is ready to begin Phase 2 with AD/PD patients.
TMH
A novel gene we discovered (named TMH) responsible for testosterone manufacture in the human testis. The hormone is heavily expressed in prostate-cancer cells of Gleason 8–9 patients — resistant to anti-hormonal therapy, where castration does not truly help. ISK is developing a monoclonal antibody (mAb) to block TMH activity.
AI Genome
A deterministic AI genomic technology for reading any genome and discovering new peptide-hormone genes, receptors and enzymes — the engine behind all of ISK's discoveries.
APC1
A novel peptide hormone from a novel gene we discovered. It strongly increases HER2-receptor expression in triple-negative breast-cancer (TNBC) cells, transforming them into HER2+ cells that respond to anti-HER2 therapy; it also induces ESR-alpha1, making them sensitive to Tamoxifen. Very close to a Phase 1 trial. The same effect is anticipated in gastric and esophageal cancer cells.
Clinical Pipeline
Nerofe™ is not a single drug — it is a platform. From its AML lead to KRAS-mutant solid tumors, breast cancer and neurodegenerative disease, the same breakthrough mechanism spans five indications, each a growth opportunity in its own right.
Competitive Differentiation
Verified Clinical Evidence
The clinical data are not marketing claims — they are documented in peer-reviewed journals and public trial registries. Here is the essence, with sources.
🧪 Phase I — Solid Tumors (published results)
17 patients · doses 6–96 mg/m² · zero DLTs up to 96 mg/m² · MTD not reached.
Biomarkers: decreased angiogenic factors (12–48 mg/m²), increased anti-cancer cytokines, and induction of the ER-stress marker GRP78/BiP.
Patients whose tumors were T1/ST2-positive responded better.
Source: Molecular and Clinical Oncology (Spandidos) — first-in-human trial of dTCApFs
🧬 KRAS Trial — Georgetown (NCT05661201)
Lombardi Comprehensive Cancer Center, Georgetown University.
3+3 design · weekly Nerofe 288 mg/m² + low-dose doxorubicin 8 mg/m².
Eligibility: advanced solid tumors, KRAS-mutant and ST2-positive (IHC).
Enrollment to the first dose level began Q1 2023; presented at ASCO 2023.
Sources: ClinicalTrials.gov (NCT05661201) · ASCO / Journal of Clinical Oncology 2023
BRIDGES B2B
