New Therapy Offers Hope for Patients with Advanced Cancer

Rampart Health’s first-in-class salvage immunotherapy achieves systemic tumor regression in patients unresponsive to conventional treatment

ORLANDO, FL, UNITED STATES, September 16, 2025 /EINPresswire.com/ -- Rampart Health today announced the publication of results from its first-in-human, single-arm Phase 2 clinical trial (Abscopal 5001; NCT04713371) of Multiplex IntraTumoral Immunotherapy (MITI™) in the prestigious peer-reviewed journal Cancers. Results will also be presented at the International Cancer Conference (ICC 25) in London, UK, on September 18.

The MITI approach, designed as a salvage therapy for patients with metastatic cancer who have failed conventional treatment, integrates cryoablation with localized intratumoral delivery of a unique multiplexed immunotherapy cocktail (RPT-01-5001: low-dose pembrolizumab, ipilimumab, and cyclophosphamide) followed by GM-CSF. Unlike systemic immunotherapy, MITI is delivered directly into tumors, creating a personalized, in situ cancer vaccine that minimizes systemic toxicity while triggering a coordinated systemic immune attack.

Key Findings from the Published Study:
• Disease Control: Achieved in 77% of patients (1 complete response, 4 partial responses, 5 stable disease).
• Abscopal Effect: Regression of untreated metastases in 31% of patients, including biopsy-confirmed complete resolution of lung and liver metastases in bladder cancer patient and complete lung metastasis regression in sarcoma patient.
• Durability: Median overall survival was 20.9 months and median progression-free survival was 5.4 months.
• Safety: MITI was safe and well tolerated. 69% experienced only mild (Grade 1–2) side effects; 15% had transient Grade 3 complications. No Grade 4–5 events occurred.
• Broad Utility: Responses were observed across diverse cancers including prostate, sarcoma, bladder, colon, breast, kidney, cervical, tongue, and chordoma.

“These findings establish MITI as a fundamentally new paradigm in intratumoral immunotherapy,” said David G. Bostwick, MD, MBA, CEO of Rampart Health. “For patients who have exhausted conventional options, MITI offers a safe, outpatient salvage treatment with unprecedented abscopal responses and broad applicability across tumor types. By integrating multiple complementary immune activation pathways, we are creating a personalized, in situ cancer vaccine with the potential to transform the treatment of metastatic cancer.”

MITI distinguishes itself from other intratumoral approaches by simultaneously triggering four anti-cancer mechanisms with its multiplex design: (1) cryoablation releases the full complement of intact patient-specific tumor antigens, (2) intratumoral PD-1 and CTLA-4 blockade unmasks and unleashes T-cell activity, (3) low-dose cyclophosphamide reduces regulatory T-cell suppression, and (4) GM-CSF mobilizes effector immune cells. Together, these mechanisms consistently trigger systemic immune activation and abscopal tumor regressions rarely seen with systemic therapies alone.

David Granger Bostwick
Rampart Health
+1 804-677-8527
email us here

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