Validation

&

Team

Science & External Research

The science behind Nerofe has been independently validated in peer-reviewed international journals — not a theoretical idea, but a documented molecular mechanism with remarkable pre-clinical results and registered clinical trials at leading US institutions.

Mechanism of Action

Nerofe (dTCApFs) is a peptide derivative of Tumor Cell Apoptosis Factor (TCApF). It enters cells via the T1/ST2 receptor, triggers endoplasmic-reticulum (ER) stress and loss of Golgi function, and activates apoptosis through caspases 8, 9 and 3 alongside JNK and p38 MAPK — combining anti-angiogenesis, immune activation and inhibition of tumor-cell proliferation.

AML mouse models: halted cancer development and complete elimination of metastatic colonies from bone marrow and spleen
Phase I in solid tumors: found safe and potentially efficacious.
T1/ST2 is overexpressed in mtKRAS tumors — the basis for the Nerofe + Doxorubicin combination that turns immunosuppressive tumors into immunostimulatory ones.
Registered clinical trials: NCT04365179 (AML/MDS · Sylvester, Miami) · NCT05661201 (KRAS · Georgetown).

Sources: Oncotarget · PubMed/PMC (NIH) · ClinicalTrials.gov · ASCO/JCO 2023 · immunesk.com

Independent Scientific Publications

Oncotarget (2023, 2025)

Molecular & Clinical Oncology — Spandidos

J. Exp. Ther. Oncology (JETO)

PubMed / PMC — NIH

US Patent — metastatic cancer compositions

Synapse / PatSnap — pipeline & patents

External Validation & Partnerships

Real science validated by the world’s best: partnerships with Harvard, Georgetown and the University of Miami, J&J JLABS membership, $4.2M in non-dilutive grants, and founder publications in Cell and Science.

J&J JLABS Member

Harvard / MGH

Georgetown University

FDA Orphan Drug (AML) · 7-yr exclusivity

Sylvester (U. Miami)

$4.2M Grants — Israel Chief Scientist (4)

Memorial Sloan Kettering (MSKCC)

Published in Cell & Science

University Collaborations

What the Institutions Publish

ISK’s collaborations are not claims — they are publicly documented on the universities’ own sites and trial registries, with named principal investigators.

University of Miami · Sylvester Comprehensive Cancer Center

The NEROFE AML/MDS trial is publicly listed on the Sylvester / University of Miami Health site.
Open-label Phase 1b, 3+3 design, to determine the Recommended Phase II Dose (RP2D).
Principal Investigator: Dr. Justin Watts.
IV NEROFE three times weekly on alternate days · population: relapsed/refractory AML with no life-prolonging alternative · enrollment opened June 18, 2020 (NCT04365179).

Sources: University of Miami Health (Sylvester) · ClinicalTrials.gov (NCT04365179)

Harvard

Massachusetts General Hospital (MGH)

Pre-clinical research collaboration in neurodegenerative disease, based on ISK’s peptide platform.
Proprietary basis: ISK US patents for a “survival-promoting/immunomodulatory” peptide for brain damage, neurodegenerative and inflammatory disorders (US 7,528,112 · US 8,716,223).

Sources: USPTO (US 7,528,112 · US 8,716,223) · ISK pipeline

Georgetown University

Lombardi Comprehensive Cancer Center

Phase I trial of NEROFE + doxorubicin in KRAS-mutant / ST2-positive tumors, ~24 participants.
Principal Investigator: Dr. Benjamin Weinberg (Georgetown University Medical Center / Lombardi).
Investigator team includes Joshua Reuss, Stephen V. Liu, Aiwu Ruth He, Chul Kim, Marcus Noel, Geoffrey Gibney — alongside ISK’s Uziel Sandler and Yoram Devary.
Presented at ASCO 2023 (Journal of Clinical Oncology) · NCT05661201.

Sources: ASCO / Journal of Clinical Oncology 2023 · ClinicalTrials.gov (NCT05661201