Immune System Key
First-in-class biologic agents to treat cancer. Nerofe turns immune-suppressed tumors into immune-active ones — flipping the body’s own defenses against the cancer, without chemo-style toxicity.
A clinical-stage biotech pioneering first-in-class biologic agents to treat cancer
- Nerofe is a first-in-class drug that flips immune-suppressed tumors into immune-active ones — turning the body’s own defenses against the cancer, without chemo-style toxicity.
- Validated in multiple preclinical studies and two independent human trials; measurable responses in late-stage AML and solid-tumor biopsies.
- ISK is now raising $18M to take Nerofe to Phase 2b trials — unlocking the next growth inflection point and securing a path to a $1B+ exit.
A once-in-a-lifetime opportunity to back a genuinely novel oncology company with strong clinical proof in heavily pretreated patients, and a pathway to one FDA approval across multiple cancers.
~40% of people will be diagnosed with cancer in their lifetime
The treatment still hasn't caught up.
Source: American Cancer Society — 1 in 2 men, 1 in 3 women will be diagnosed with cancer in their lifetime.
Chemotherapy
Standard of care since 1960
Poisons every dividing cell — cancer and healthy ones (hair, gut lining, bone marrow).
Severe toxicity; 50% of patients can't tolerate the needed dose.
Immunotherapy
Activates your immune system to fight cancer
Removes a brake on existing T-cells so they can attack cancer — but only works if immune cells are already at the tumor.
Effective for 10–15% of patients (can't help in cold tumors where immune cells are not present).
Targeted therapy
Tailored to specific cancer mutations
Custom-made antibodies designed to find one specific marker on cancer cells.
Each drug works for one mutation only, resistance develops in months.
ISK is pioneering a paradigm shift in therapeutics development
ISK is the first to target the ST2 receptor in clinical trials for cancer.
ST2 is a receptor over-expressed by a large subset of cancer cells across many tumor types, helping to suppress the immune response.
For decades, ST2 has been studied for asthma & heart disease, but no approved cancer drug has ever targeted it — until now.
Our novel peptide Nerofe binds the ST2 receptor to directly kill cancer cells while reactivating anti-tumor immunity — all while meeting robust efficacy and safety standards.
Introducing Nerofe: a first-in-class therapeutic for solid and liquid tumors
First-in-class ST2 inhibitor
Nerofe is a stabilized 14-amino-acid peptide derived from Tumor-Cell Apoptosis Factor (TCApF), a hormone naturally produced in the human thymus.
Direct immune activation
Nerofe activates anti-cancer immune response through binding to the ST2 receptor on innate immune cells and CD8 T-cells.
Tumor-agnostic potential
Robust preclinical data demonstrates efficacy across a broad range of tumors — AML, breast, glioblastoma, mCRC, pancreatic cancer, neuroblastoma, lung and prostate.
Born from a proprietary platform
Nerofe is the first of 20+ novel hormones identified by a proteogenomic engine (physics + AI) that mines the 95% of the human genome inaccessible to conventional drug discovery.
Note: the proteogenomic engine platform beyond Nerofe is not part of this offering.
A novel mechanism of action to destroy cancer cells
Nerofe enters the tumor cells through the ST2 receptor.
Nerofe reaches the Golgi Apparatus and induces its destruction.
Due to the destruction of the Golgi, proteins accumulate in the ER leading to ER stress and activation of the ER stress repair mechanism.
The ER stress repair mechanism is inhibited by Nerofe's downregulation of sXBP1.
Cell death is caused by unrepaired ER stress.
The first to change genetic characteristics of tumor cells — it causes the shut down of expression of IL10 and induction of IL2 gene and protien
Achieves downregulation of KRAS, reducing the most common cancer-driving mutation directly inside tumor cells
Favorable safety profile, with zero dose-limiting toxicities in early studies
$32B+ market opportunity, unlocked by a single FDA approval
All listed cancers express ST2 — allowing ISK to pursue one approval covering every ST2+ tumor instead of applying cancer-by-cancer (Keytruda / MSI-H and larotrectinib / NTRK+ as precedents).
Notes: Approval timelines assume successful Phase 2b readouts.
Sources: Mordor Intelligence, DelveInsight, Grand View Research, IHealthcareAnalyst, Coherent Market Insights, Clinical Trials Arena (2025 data); figures reflect addressable annual global drug market.
Built on decades of scientific research, validated by leading US institutions
Clinical studies led by senior oncologists from Georgetown University & Miami Medical Center; Northwell (NYC) and UPMC (PA) have expressed interest in joining upcoming trials.
Two investigator-initiated trial collaborations advancing with Memorial Sloan Kettering.
Currently advancing a strategic collaboration with Harvard Medical School on a new Alzheimer's therapy, expanding the platform's therapeutic applications beyond oncology.
Partner institutions have waived most clinical-trial fees.
Data that keeps pointing the same direction
Independent mouse studies and two ongoing investigator-initiated human trials, in AML and KRAS-mutated solid tumors, are converging on the same signal.
Nerofe effectively reverses AML tumors in mice
Effect of Nerofe on U937 tumors in nude mice
- 15 million U937 cells were inoculated SC in nude mice (7 mice per group).
- Mice entered the trial after tumor reached volume of 100mm³.
- Control group treated with 5% mannitol; low dose Nerofe — X mg/Kg of Nerofe three times weekly; high dose Nerofe — 3*X mg/Kg of Nerofe three times weekly (experiment repeated twice).
The only drug candidate currently able to completely eliminate AML cancer cells from the bone marrow
Nerofe (TCBAF) has definitively shown the ability to clear AML cells from bone marrow and blood — earning FDA Orphan Drug Designation in 2011 and putting Nerofe into the Phase 1b/2a trial now running at Miami. (Source: Sandler, 2010)
AML Phase 1b/2a is delivering: cancer patients alive a year past their 8-week prognosis
Interim data from the ongoing Phase 1b/2a with University of Miami — single-agent clinical activity in heavily pre-treated R/R and TP53-mutant AML patients. Trial ongoing; CR/PR/PD definitions relate to FDA definitions in blast reduction. (Watts LOS, interim, May 2025)
Nerofe’s efficacy and antitumor activity independently reproduced in KRAS-mutated, ST2-positive solid tumors
Tumor volume over 35 days at full therapeutic dose (3x weekly).
Early results from KRAS Phase 1b/2a trial show every immune biomarker flipping in the cancer-fighting direction
Interim data from ongoing Phase 1b/2a w/Georgetwon university: full immune biomarker flip + early tumor shrinkage in heavily pre-treated KRAS-mutated solid tumor patients. Complete genetic reprogramming of the tumor from immunosuppressive to immunostimulatory after a single weekly treatment.
Tumor volume over 35 days at full therapeutic dose (3x weekly).
Tumor shrinkage already observed in some Georgetown patients — at sub-therapeutic dose.
Full-dose escalation is expected to deliver similar tumor regression as in the mice study.
Our innovation is defensible
Layered patent protection and regulatory exclusivity extend potential commercial protection out to 2045.
Composition of matter US Patent (granted Dec ‘11) covers the Nerofe parent compound (TCApF), new composition of matter patent granted 2024 protects through 2044
Regulatory exclusivity — Orphan Drug Designation for AML (FDA, 2011) grants 7 years of US market exclusivity post-approval.
Methods of use & pharmaceutical compositions patent granted across 17 jurisdictions (including US, EU, Japan, China, Israel, Australia); protects through ~2037
New D-amino-acid peptide formulation family — provisional applications filed, extending potential commercial protection to ~2045.
Our team is world-class: deep experience in science, biotech & pharma
Uziel Sandler
PhD | CEO
- Architect of ISK's proprietary platform that reads the full 100% of the human genome — the engine that discovered Nerofe
- PhD in Theoretical Physics; founder of the "Fuzzy Dynamics" discipline applied to immune-cell modelling
- Author of 3 Springer-published books and 80+ peer-reviewed articles
Marc Lippman
MD | Prof., Georgetown University Medical Center
- Professor of Oncology at Georgetown; previously Chairman of Medicine at University of Miami and Chair at University of Michigan
- Sat on the Board of Directors of Seagen — acquired by Pfizer for $43B in 2023
- Previously Senior Investigator at the National Cancer Institute; Editor-in-Chief, Breast Cancer Research and Treatment
Yoram Devary
PhD | Chairman & CTO
- Inventor of Nerofe and all ISK patents; PhD in Biotechnology from UC San Diego
- Raised $20M to date and established two Phase 1b/2a investigator-initiated trials in the US
- Published in Cell and Science; secured 9 research grants from the Israel Cancer Society
Our clinical advisory board is comprised from distinguished scientists and oncology experts
Moshe Mittelman
MD | Clinical Professor at Tel Aviv University
- Former Chairman of Medicine, Tel Aviv Sourasky Medical Center; Professor of Medicine and Hematology, Tel Aviv University Medical School
- President of the Israel Society of Hematology and Blood Transfusion
- World expert in AML/MM, has run many clinical trials in Hematology
Joseph Rosenblatt
MD | University of Miami Health System
- Chief of Hematology at the University of Miami's Sylvester Comprehensive Cancer Center
- Has served on scientific advisory panels for Merck, Seattle Genetics, and Kite
- PI on grants from NIH, US Dept of Defense, American Cancer Society, and Leukemia & Lymphoma Society
Shane Gad
PhD | Regulatory Affairs Advisor
- Principal of Gad Consulting Services; 600+ clients across pharma and medical devices
- Filed 139 INDs plus NDA, BLA, and 510(k) submissions across 46 years in drug and device development
- Past president of the American College of Toxicology; authored and edited 53 books and 387+ papers
Ira Kalfus
MD | CMO
- Contributed to two FDA approvals: Cinryze® (Lev Pharmaceuticals, acquired by ViroPharma/Shire for $600M+) and Talicia® (RedHill Biopharma)
- CMO at Aclipse, Attune, and Thar; now CMO at LifeSci Venture Partners
- 40+ years in drug development; co-founder of EvoDenovo
Guy Wagner
Advisory Board Member
- CMC expert with 20+ years across drug development, licensing and quality assurance
- Expertise in GMP and GLP quality systems for development, preclinical studies, manufacturing and QP release
- Consultant in Devices, Cosmetics and Dietary Supplements
Nerofe is recognized by world-class professionals and industry leaders as a breakthrough innovation
“There is a signal here worth discovering. Nerofe is a novel class of agent that induces apoptosis of leukemic blasts but appears to also function as an immune-targeted therapy at a genomic level. We had 1 notable patient with R/R CMML-2 where blasts were reduced to less than 5%. Two other R/R AML patients with an initial life expectancy of 8 weeks stayed on trial for over a year. I strongly believe that this novel compound needs to be further explored.”
“We have treated 12 patients… Changes in the tumor immune microenvironment highlight potential synergy with immune checkpoint blockade. We are optimistic that combining NEROFE and doxorubicin with an anti-PD1 monoclonal antibody will lead to durable clinical responses. We are in active discussions with pharmaceutical companies to start an investigator-initiated clinical trial of NEROFE, doxorubicin, & anti-PD1 antibody.”
“Nerofe is a very novel peptide with mechanisms of action different from any other molecules I'm aware of in the Alzheimer's field. Its preclinical data to date suggest high potential in AD and related neurodegenerative diseases. Nerofe is near the top of our list of candidates we would like to investigate.”
20 years of compounding scientific, regulatory & clinical milestones; now ready to scale with Phase 2 trials
ISK founded
FDA Orphan Drug Designation
Clinical trial at Miami University opens (AML)
Clinical trial at Georgetown University opens (solid tumors)
Clinical trial with Memorial Sloan Kettering in discussion (breast, GI cancers)
Phase 2b launch — co-development with NASDAQ-listed pharma under discussion
IPO option opens on Phase 2b readout; FDA pre-IND meeting; Pathway to FDA approval covering every ST2+ tumor
FDA Approval
Raising $18M to fund Phase 2b trials and accelerate the path to exit
We’ve been extremely efficient with capital to date
- $20M capital raised to date to get to Phase 2b (vs. $100M+ raised by comparable companies)
- Extremely low burn rate (>$35k monthly)
$18M funding round unlocks Phase 2b progress
- Drug manufacturing for clinical trials
- Phase 2b AML / MDS preparation and trial support
- Phase 2b ST2+ mtKRAS solid tumor trial
Investor opportunity
- Revolutionary oncology opportunity with a clear pathway to a $1B+ exit
- Attractive valuation point on a company already at the same clinical stage as biotechs valued in the hundreds of millions
Note: minimum investment at $100k.
Nerofe is already helping patients who had exhausted every standard option.
Join us on the journey to scale this impact to millions globally.
17-year-old teenager with brain cancer, treated with everything available in the US for two years — no response.
First-ever measurable response came on Nerofe — confirmed on MRI.
Three wheelchair-bound patients with aggressive cancer at the start of treatment.
After 12 months on Nerofe at Rabin Medical Center, the patients can walk again.
Stage IV cancer patient discharged to palliative care in Zurich to die.
After 5 months of Nerofe, PET-CT showed clear tumor reduction.
It’s what your investment unlocks — a fighting chance for patients who were told there was none.
The proteo-genomic engine behind Nerofe
A proprietary model, powered by physics and AI, reads 100% of the human, plant & animal genome to find functional molecules nobody knew existed. Novel sequences are publicly searchable in NCBI / NCI databases.
The next drug candidates in the pipeline
2% of the platform’s capacity already gave ISK more candidates than the lab can validate — spanning breast cancer, cardio / metabolic and regenerative diseases. Each molecule in the catalogue is a potential standalone drug program –across multiple therapeutic areas.
Every current cancer treatment is a trade-off between breadth and selectivity
Nerofe is the only approach positioned in the top-right: broad, cross-indication reach with tumor-cell selectivity, because it targets a receptor rather than a single mutation.
Dramatic improvement on current treatment options provided by iSK
| Chemotherapy | Immunotherapy | Targeted therapy | Nerofe | |
|---|---|---|---|---|
| Tumor kill mechanism | Cytotoxic (broad) | Indirect (T cells) | Direct (G12C only) | Direct + immune activation |
| Patient response rate | ~50% w/ toxicity | ~20–30% | ~36% (NSCLC G12C+) | Early trials show response rates equal or above chemo |
| Damages healthy cells | Yes — severe | Sometimes (autoimmune) | Limited | No — ST2 tumor-selective |
| Cold tumor response | Yes (kills both) | Often no | N/A | Yes — flips cold to hot |
| Patients eligible | Most | ~30% biomarker+ | ~13% NSCLC, ~3% CRC | Most — any ST2+ tumor |
Phase 1b/2 readouts in novel-mechanism oncology routinely unlock $1B+ exits
Recent biotech transactions across oncology and adjacent rare disease — novel mechanism, biomarker-driven, single-asset focus.
| Target | Acquirer · date | Stage at deal | Value | Relevance to ISK |
|---|---|---|---|---|
 | BMS · Oct 2023 | FDA-approved (Krazati / adagrasib, KRAS G12C NSCLC) | Up to $5.8B | Biomarker-defined oncology · similar TAM logic |
 | BMS · Jun 2022 | Phase 2 (repotrectinib, breakthrough designation) | $4.1B | Phase 2 biomarker-driven NSCLC (ROS1/NTRK) |
 | BMS · Dec 2023 | Phase 3 enrolling (RYZ101, GEP-NETs) | $4.1B | Novel oncology platform (radioligand) |
 | AstraZeneca · Mar 2024 | Phase 2 (FPI-2265, PSMA prostate radioconjugate) | Up to $2.4B | Phase 2 novel-mechanism oncology |
 | Sanofi · Jan 2024 | Phase 2 (INBRX-101, rare disease — AATD) | Up to $2.2B | Single-asset, mid-stage exit mechanics |
 | Pfizer · Aug 2021 | Phase 1b/2 (CD47-SIRPα, hematologic malignancies) | $2.26B | Early clinical · novel IO mechanism |
 | Genmab · Apr 2024 | Phase 1/2 (rina-S, FRα ADC for ovarian + solid tumors) | $1.8B | Phase 1/2 novel ADC platform |
 | AstraZeneca · Dec 2023 | Phase 1/2 (GC012F, BCMA/CD19 dual CAR-T) | Up to $1.2B | Phase 1/2 novel cell-therapy platform |
ISK: first-in-class immunotherapy platform targeting unmet oncology needs
On the mission to save millions of cancer patients around the world.