Why the World Needs UbiVac’s Cancer Vaccine
Checkpoint Inhibitors Alone Aren’t Enough
Checkpoint inhibitors have transformed cancer therapy, yet most patients still do not benefit. Non-responders often lack activated T cells infiltrating their tumors (PMID: 31318407), meaning there is no immune response to "unleash" with anti–PD-1 or CTLA-4 blockade. Administering checkpoint inhibitors in the absence of tumor-reactive T cells is like stepping on the gas with no engine.
UbiVac’s Solution: Prime the Immune System First
UbiVac’s investigational product, DPV-001, is designed to address this gap by activating and recruiting tumor-specific T cells. In a first-in-human trial conducted with Providence Cancer Institute and Incyte, UbiVac reported at AACR 2023 that every treated patient exhibited increased infiltration of activated T cells into their tumors following DPV-001 vaccination.
By week 2, DPV-001 induced activation of T cells in peripheral blood, and by week 8, T cells within the tumor expressed CD39, CD103, interferon-γ, and granzyme B—markers of functional, tumor-killing capacity. Notably, these activated T cells also expressed LAG-3, indicating early checkpoint exhaustion and providing a rationale for next-generation combination strategies.
Key 2024 Clinical Findings
At the SITC 2024 annual meeting, UbiVac presented immune monitoring and response data from its combination trial in patients with recurrent/metastatic Head and Neck Squamous Cell Carcinoma (HNSCC):
Combination immunotherapy with DPV-001:
Tripled the objective response rate (ORR) vs. anti–PD-1 alone
Tripled progression-free survival (PFS)
Tripled the rate of complete responses (CRs)
Additionally, immune profiling revealed that DPV-001 induced T cells capable of recognizing and responding to multiple solid tumor types, including:
Head and neck squamous cell carcinoma (HNSCC)
Non–small cell lung cancer (NSCLC, adenocarcinoma)
Melanoma
Renal cell carcinoma
These findings suggest DPV-001 elicits cross-tumor immunity targeting shared tumor antigens and broadens the potential scope of cancer types where DPV-001 may be effective.
AAI 2025: First Vaccine-Induced TCR to Dark Matter Antigen
At the AAI 2025 meeting, UbiVac and collaborators presented a landmark finding:
A patient vaccinated with DPV-001 developed a T cell receptor (TCR) specific to a Dark Genome–derived antigen expressed by their tumor.
This TCR was functionally active and tumor-destructive, without apparent toxicity to normal tissues.
The patient remains alive and disease-free >10 years post-treatment.
This is the first documented vaccine-induced TCR response to a Dark Matter antigen, offering powerful validation of UbiVac’s antigen discovery platform and the clinical potential of targeting non-canonical cancer antigens.
Pipeline Innovation: Tailored Combination Immunotherapy
Based on these data, UbiVac is looking for a partner to expand the current combination strategy to test:
DPV-001 + anti–PD-1 + anti–LAG-3
This rational combination directly addresses the immune exhaustion seen post-vaccination and is designed to sustain tumor-killing T cell activity. This precision-guided evolution of immunotherapy aims to increase patient responses and, ultimately, long-term cures.
Neoadjuvant Applications in Early-Stage Breast Cancer
UbiVac also holds FDA authorization to begin a neoadjuvant clinical trial combining DPV-001 with chemotherapy in locally advanced breast cancer. Chemotherapy reduces tumor burden pre-surgery; UbiVac aims to improve this effect and potentially eliminate residual disease by:
Activating tumor-reactive immunity
Promoting immunologic memory
Increasing rates of pathologic complete response
The same neoadjuvant protocol is being launched in China through a strategic partnership with CanWell Pharma, which has licensed DPV-001 for development in HNSCC, NSCLC, and breast cancer. UbiVac retains manufacturing rights and royalties, accelerating global expansion.
Cancer’s Hidden Targets: UbiVac’s Dark Matter Advantage
A major strength of DPV-001 lies in its enrichment for over 300 tumor-associated and Dark Genome–derived antigens, many of which are unrecognized by the immune system during thymic development and not found in normal tissues.
Conclusion: A New Era of Cancer Immunotherapy
UbiVac is pioneering a new model: cancer vaccines that prime, expand, and guide immune responses—turning cold tumors hot and making checkpoint inhibitors work better. With encouraging early clinical results, groundbreaking antigen discoveries, and global partnerships in place, UbiVac is well-positioned to reshape the treatment of both early and advanced cancers.