May 05, 2025
UbiVac’s DPV-001 induces Development of 1st in-patient generated TCR to Non-Small Cell Lung Cancer’s “Dark Matter” – Targets cancer without apparent toxicity.
Targeting Cancer’s Dark Genome: First Vaccine-Induced TCR Against Dark Matter Antigen
UbiVac’s lead clinical-stage immunotherapy, DPV-001, was first evaluated as adjuvant therapy for non-small cell lung cancer in an NCI-funded trial. At AAI 2025, UbiVac presented a landmark finding from that study:
1. A Dark Matter antigen—derived from the non-coding, or “dark,” genome—was identified in the patient’s tumor.
2. DPV-001 contained this specific dark matter antigen and induced, in the patient, a tumor-destructive T cell receptor (TCR) against it.
3. The TCR response occurred without adverse events, suggesting selectivity for cancer cells and sparing of normal tissue.
4. The patient remains alive and disease-free 10 years post-treatment.
UbiVac believes this represents the first documented case of a vaccine-induced TCR targeting a Dark Genome-derived Dark Matter antigen—offering compelling evidence of both cancer specificity and safety.
March 19, 2025
Cancer’s “Dark Matter” represents a spectrum of previously unknown proteins that have recently been identified as antigens expressed on the surface of cancer cells but not on normal cells or the thymus. Some of these dark matter proteins appear to be responsible for cancer’s malignant properties, making them valuable targets for an anti-cancer immune response. UbiVac believes DPV-001 is the first cancer immunotherapy to include cancer’s dark matter in a form that can induce a destructive anti-cancer immune response and established its therapeutic efficacy in more than a decade’ worth of preclinical studies.
November 7-10, 2024
“The still maturing median PFS we are seeing of over 9 months for PD-1 naive 1L r/m HNSCC, compares favorably with the 3.2 month median PFS reported for Keytruda monotherapy in the KN-048 study”— Rom S. Leidner, MD.
UbiVac is Pioneering the World's 1st Dark Matter Cancer Immunotherapy
UbiVac's DPV-001 Dark Matter combo Immunotherapy triples response rate and progression-free survival (PFS) over PD-1 alone for patients with r/m head and neck cancer. Data were presented at the Society for Immunotherapy of Cancer Annual Meeting November 7-10, 2024, in Houston, TX.
ASCO 2024 Dark Matter Interview with Dr. Bernard Fox American Society of Clinical Oncology, Dark Matter Interview, ASCO. June 1, 2024
An Off-the-Shelf Multivalent Vaccine Containing Cancer’s Dark Matter, DPV-001, Combined with PD-1 +/- GITR in Head & Neck Cancer: Safety, Efficacy, and Immunodynamics from the Phase 1 GITRVax Trial. These data will be presented by Rom S. Leidner, M.D., during the First-in-Human Phase I Clinical Trials Session 1 on April 8 (No. CT112, Poster Section 48, 1:30 to 5pm), at the American Association for Cancer Research Annual Meeting held 5-10 April in San Diego, CA. https://www.einpresswire.com/article/701519390/dpv-001-vaccine-containing-cancer-s-dark-matter-yields-2-to-3-fold-increased-response-rate-for-head-and-neck-cancer