Clinical Development

A platform proven in the clinic, now advancing in breast cancer

Over 250 patients dosed across five cancer types. A safety and imaging dataset built over years of intraoperative study. Blaze is applying that foundation to its most compelling surgical opportunity.

Breast Cancer · Lead Program

Breast-conserving surgery: seeing the margin clearly

One in eight women will be diagnosed with breast cancer during their lifetime.1 Among those diagnosed, 60 to 70 percent will undergo breast-conserving surgery, an approach that aims to remove the malignancy while preserving the breast.2 Despite advances in surgical technique, obtaining clear margins remains a persistent challenge: reoperation rates due to positive margins range from 20 to 40 percent for ductal carcinoma in situ (DCIS) and 9 to 21 percent for invasive breast cancer.2 For younger women aged 18 to 44 with DCIS, the reoperation rate reaches 40 percent, with 18 percent ultimately converting to mastectomy.2 Reoperations increase treatment costs by 24 percent and complication risk by 54 percent.2 There is currently no widely adopted standard for real-time intraoperative margin visualization.

Blaze is positioned to address this directly. Administered before surgery, tozuleristide accumulates selectively in tumor tissue. In the operating room, tozuleristide-based fluorescence imaging renders that accumulation visible in real time, giving the surgeon a clear signal at the margin before the specimen is closed.

Blaze is advancing an Investigator Sponsored Trial in breast cancer as the foundation of a broader Phase 2 program, with plans to engage the FDA on a full development pathway.

Phase 2 Investigator Sponsored Trial Margin Assessment Breast-Conserving Surgery
1 in 8
Women will be diagnosed with breast cancer during their lifetime1
150K+
Breast-conserving surgeries performed in the United States each year
20–40%
Reoperation rate for DCIS due to positive margins; 9–21% for invasive breast cancer2
+54%
Higher complication risk when re-excision is required; reoperations also increase treatment costs by 24%2
1 American Cancer Society. Breast Cancer Facts & Figures, 2024.
2 Kim Y, et al. Ann Surg Oncol (2024) 31:3649–3660.
Brain Cancer · Clinical Foundation

Where the platform was proven

Blaze's most extensive clinical experience was built in brain cancer, spanning both pediatric and adult patients. These studies demonstrated that tozuleristide can be safely administered and imaged intraoperatively using CANVAS®, generating a robust dataset that informs the platform's ongoing development.

The pediatric brain cancer program holds FDA Fast Track Designation. Blaze is in active dialogue with the FDA regarding next steps. The adult brain cancer data complements the pediatric dataset and further validates the platform across tumor types and surgical settings.

This body of work established the safety profile, dosing, and imaging parameters that now underpin the breast cancer program.

Pediatric Brain Cancer Adult Brain Cancer FDA Fast Track Designation Ongoing FDA Dialogue
160+
Patients across the Phase 2/3 pivotal study (118 enrolled) and the completed Cedars-Sinai investigator sponsored trial (43 treated)
FDA Fast Track
Designation for pediatric CNS tumors. Ongoing dialogue with FDA on development path.
Pediatric + Adult
Safety and imaging data spanning both pediatric CNS tumors and adult glioma patients.

Program History

A decade of clinical evidence across cancer surgery

Safety & First Imaging
Investigator Sponsored Trials
Pivotal Program
Skin Cancer

First-in-human use. Safety and tolerability established across a broad dose range.

Head & Neck Cancer

University of Washington. Feasibility of intraoperative fluorescence in oral cavity tumor resection demonstrated.

Adult Brain Cancer

Intraoperative glioma fluorescence confirmed. Imaging dose defined for future studies.

Pediatric Brain Cancer

Phase 1 dose escalation in pediatric CNS tumors. Established the recommended dose for the pivotal program.

Adult CNS & Schwannoma

Cedars-Sinai Medical Center. Phase 2 Expanded real-world imaging study in adult brain and skull base tumors.

Pediatric Brain Cancer

Phase 2/3 randomized study completed. Robust safety dataset generated. Intraoperative imaging with CANVAS® validated.

Current Lead Program
Breast Cancer · Clinical Foundation

First fluorescence signal demonstrated in breast cancer tissue. Study enrolled primarily breast cancer patients, with a small number of lung and colorectal cases. Established the imaging rationale for the current program.

Breast Cancer · Phase 2

Investigator Sponsored Trial targeting breast-conserving surgery with positive margins. FDA development program in planning.

250+
Patients dosed clinically
5
Cancer types studied
FDA
Fast Track: pediatric CNS
Phase 2
Breast cancer program
Breast cancer patient
Why It Matters

Behind every statistic is a patient

For each patient who undergoes breast-conserving surgery, the goal is simple: one operation, clear margins, and the best possible outcome. Yet for too many patients, a positive margin means a return to the operating room: an additional surgery, additional recovery time, and additional risk.

Fluorescence-guided surgery with tozuleristide is designed to give surgeons the real-time information they need to complete a more thorough resection during the initial procedure, with the goal of reducing the burden that reoperations place on patients and the healthcare system.

Expanded Access

Blaze Bioscience's development resources are focused on development of tozuleristide, our investigational product. Blaze Bioscience does not have an active Expanded Access Program at this time and is not accepting or considering requests for expanded access use. Should we develop an Expanded Access Program in the future, this policy will be updated.

Interested in collaborating?

Blaze welcomes inquiries from clinical investigators, surgical oncologists, and potential partners interested in the tozuleristide development program.

Contact Us Technology