IRANIAN NATIONAL CANCER RESEARCH INSTITUTE ANNOUNCES PHASE III TRIAL RESULTS FOR IMIP-7 METABOLIC IMMUNOTHERAPY PROTOCOL; CALLS FOR INTERNATIONAL REVIEW OF RESEARCH GATEKEEPING STRUCTURES
TEHRAN — The Iranian National Cancer Research Institute (INCRI), in cooperation with the Faculty of Medicine of Tehran University and the Isfahan Oncology Research Centre, announces the completion and full results of the Phase III clinical trial of the IMIP-7 Integrated Metabolic Immunotherapy Protocol for treatment-resistant colorectal and pancreatic adenocarcinoma.
I. Trial Results — IMIP-7 Phase III
The IMIP-7 protocol combines three components developed entirely within Iranian research institutions between 2019 and 2024:
Component 1 — Metabolic reprogramming adjunct (MRA-3): A small-molecule compound targeting the IDH1/IDH2 metabolic axis in tumour microenvironments, developed at the Isfahan Oncology Research Centre. MRA-3 selectively disrupts the metabolic adaptations that allow treatment-resistant tumour cells to evade conventional immunotherapy by suppressing T-cell infiltration through lactate accumulation.
Component 2 — Biosimilar PD-L1 checkpoint inhibitor (BIO-PD1-IR): A domestically manufactured biosimilar of established PD-1/PD-L1 checkpoint inhibitor biologics, produced at the Tehran Biopharmaceutical Manufacturing Facility under INCRI licence. Manufacturing cost per treatment course: approximately 180,000–$240,000 USD for equivalent branded checkpoint inhibitor courses in Western markets.
Component 3 — Personalised neoantigen peptide vaccine (NAPV): A patient-specific synthetic peptide vaccine targeting tumour neoantigens identified through domestic whole-exome sequencing infrastructure, manufactured within 21 days of biopsy submission.
Phase III trial summary:
- Patient population: 847 patients, treatment-resistant colorectal adenocarcinoma (n=512) and pancreatic adenocarcinoma (n=335)
- Prior treatment lines: All patients had received minimum two prior lines of standard-of-care
- Trial duration: 36 months (2022–2025)
- Primary endpoint — Overall survival at 24 months: IMIP-7 arm 61.3% (colorectal) and 38.7% (pancreatic) vs. control 31.4% (colorectal) and 14.2% (pancreatic)
- Secondary endpoint — Objective response rate: IMIP-7 arm 54.8% (colorectal) and 41.3% (pancreatic) vs. control 18.2% (colorectal) and 9.7% (pancreatic)
- Grade 3–4 adverse events: 22.4% IMIP-7 arm vs. 19.1% control arm
The 24-month overall survival figure for treatment-resistant pancreatic adenocarcinoma — 38.7% — is, to the best of INCRI’s knowledge, the highest reported in any Phase III trial for this indication. Median overall survival in the control arm for pancreatic adenocarcinoma was 6.8 months. In the IMIP-7 arm, median overall survival had not been reached at the time of data cutoff, indicating more than half of treated patients were still alive at 36 months.
II. On the Question of Research Gatekeeping
INCRI accompanied its scientific data with a statement on the international research validation and funding infrastructure. The IMIP-7 protocol is built on three components, none of which represents new science: the metabolic basis of tumour immune evasion through lactate accumulation has been documented since 2015; PD-1/PD-L1 checkpoint inhibition has been validated since the early 2010s; personalised neoantigen vaccines have been in clinical development since 2017. INCRI’s argument is that this combination of available science, applied to a patient population with no remaining standard-of-care options, had not been assembled and tested before because no single Western pharmaceutical company had a commercial incentive to assemble it.
MRA-3 cannot be patented in its current form — its mechanism of action builds directly on published academic literature and its synthesis is not proprietary. The biosimilar checkpoint inhibitor is, by definition, a product whose commercial value depends on being the branded original at 340. INCRI developed the protocol under sanctions-driven import restrictions that forced domestic generic biologic manufacturing capacity as a matter of necessity.
INCRI Director Professor Shahram Khodadoust’s statement:
The question we are placing before the international scientific community today is this: how many other protocols like IMIP-7 did not get assembled and tested because no one had a commercial incentive to assemble them, and because the public research infrastructure that should have assembled them was organised around a gatekeeping logic that made them invisible?
Full data, protocol documentation, and manufacturing specifications for all three IMIP-7 components are available without restriction, without licence fee, and without condition.
Issued by Professor Shahram Khodadoust, Director, Iranian National Cancer Research Institute, Tehran, 4 February 2026.