A lead program in radiation induced severe oral mucositis.
Nearly 90,000 patients a year face an untreatable toxicity.
Severe oral mucositis is the most consequential acute toxicity of head and neck cancer radiation therapy — and there is no FDA-approved drug to prevent it.
*Patient figures based on US, UK, EU markets
What severe oral mucositis does
Oral mucositis is the breakdown of the oral mucosa under the cumulative effect of fractionated radiation. In its severe (Grade 3 or 4) form it produces ulceration across the mouth and throat that makes eating, swallowing and speaking difficult or impossible — during the most intensive phase of cancer treatment.
Patients with severe mucositis can be left unable to eat, swallow, or speak normally during the most intensive weeks of cancer treatment.
“Only moans escape my lips. I cannot eat or speak.”
— Anita Hart Balter, “Stomatitis,” NEJM, 1990. Read the published poem →
Missed Treatment Days
Treatment breaks let tumors regrow about 3 times faster, and each missed day of radiation cuts tumor control by about 1%.
~$18,000
Incremental cost of treating the side effect
Zero
FDA-approved drugs to prevent RI-SOM
Why Vepoloxamer fits
Radiation generates membrane-damaging reactive oxygen species in epithelial cells; the cells lose integrity; an inflammatory cascade follows. Vepoloxamer, administered before a radiation fraction, is kinetically positioned to act at the moment membrane damage begins.
Mechanistically Aligned
Direct DNA damage accounts for only about a third of the injury to basal epithelial cells in mucositis. The rest is downstream — reactive oxygen species, lipid peroxidation of the cell membrane, and breakdown of the epithelial barrier. Vepoloxamer reseals those damaged membranes. It does not shield cells from radiation itself, and it does not interfere with the DNA-level effects that drive tumor killing.
Scheduled Insult, Scheduled Drug
The radiation schedule means the timing of the cellular damage is known. Vepoloxamer can be given before the initial damage, making it immediately available to begin the repair of non-targeted cells.
Internal Research
In internal preclinical research, Vepoloxamer was shown to minimize damage to non-targeted regions of irradiated lung tissue, with additional experiments demonstrating no tumor protection when Vepoloxamer was added to irradiated tumors — the profile of a clinically useful radioprotectant: healthy tissue shielded, tumor not.
The RI-SOM development plan
A focused Phase 1b/2a trial in head and neck cancer patients receiving curative-intent radiation, leveraging an existing regulatory package, established drug substance, and AI-driven approaches to protocol design and execution.
Trial Architecture
A focused Phase 1b/2a design incorporating an interim analysis, to inform a data-driven go/no-go decision before committing full enrollment.
Endpoint Strategy
Quantifiable, FDA-recognized mucositis endpoints aligned to current regulatory thinking.
Acceleration Levers
Approximately 75% of the language in a complete prior IND package is reusable. Drug substance is in hand. AI-native company, including IND drafting, protocol reviews, and business operations. Recognized KOLs engaged on protocol design.
Why it fits
- A severe burn keeps growing after the injury. The zone of stasis — injured but still-perfused tissue at the wound margin — progresses to necrosis over 24 to 72 hours, and no approved drug intervenes in that window.
- Vepoloxamer partitions selectively into damaged cell membranes and not intact ones, making it mechanistically matched to exactly this problem. A 2024 PRISMA-compliant systematic review of 33 preclinical studies concluded that P188 is beneficial across thermal and electrical burn injury models and warrants clinical investigation.1
1. Mutore KT, Koduri R, Alatrash N, Nomellini V. Shock 2024;62(4):461–469. PMID 39178216.
The Burns Development Plan
- Vepoloxamer is being supplied under a material transfer agreement to an academic burn research program for preclinical evaluation.
- Burns is our proof of concept for the platform: a lesion that is anatomically bounded, externally visible, and reads out in days rather than months. Establish that early membrane stabilization preserves tissue there, and the same clock governs stroke, traumatic brain injury, hemorrhagic shock, and limb ischemia.