Survivin recombinant overlapping peptide (ROP) vaccine in advanced solid tumours: a first-in-human, multicentre,...

Area of Science:

• Oncology
• Immunology
• Vaccine Development

Background:

• Survivin, a highly expressed cancer antigen, has low immunogenicity.
• OVM-200 is a novel survivin recombinant overlapping peptide (ROP) vaccine designed to elicit immune responses.
• This Phase 1a trial is the first human study of the ROP technology platform.

Purpose of the Study:

• Evaluate the safety and tolerability of OVM-200 in patients with non-small cell lung, ovarian, and prostate cancer.
• Determine the optimal dose for OVM-200 in Phase 1b trials.
• Assess the immunogenicity and preliminary anti-tumour activity of OVM-200.

Main Methods:

• A multicentre, open-label, dose-escalation Phase 1a trial (OVM-200-100).
• Twelve patients received three subcutaneous doses of OVM-200 at escalating doses (250-2000 μg).
• Primary endpoint: safety and tolerability; Secondary endpoints: immunogenicity and tumour response (RECIST).

Main Results:

• OVM-200 was well tolerated with no serious adverse drug reactions or dose-limiting toxicities.
• The 2000 μg dose showed the highest median anti-survivin IgG titre (1:327,680) and T-cell response (1282 SFU/million).
• Disease stabilization was observed in 50% of patients (100% in the 2000 μg group).

Conclusions:

• OVM-200 is a safe and well-tolerated therapeutic vaccine candidate.
• OVM-200 induces robust humoral and cellular immune responses against survivin.
• Preliminary disease stabilization supports further evaluation in Phase 1b trials.