Autophagosome vaccine (UbiVac)

DPV-001, first cancer vaccine derived from the human dark genome, shows improved survival in head and neck cancer and reveals more than 400 new antigen targets. We now know the dark genome encodes hundreds of novel cancer antigens. DPV-001 is the first therapy designed to leverage this biology, expanding the antigenic landscape that immunotherapy can target” — Dr. Bernard A. Fox, Co-Founder and Chief Executive Officer at UbiVac NATIONAL HARBOR, MD, UNITED STATES, November 10, 2025 / EINPresswire.com / -- UbiVac , https://www.ubivac.com/ a private, clinical-stage immuno-oncology and cancer target discovery company, announced new data at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting highlighting its first-in-class “Dark Matter” cancer vaccine, DPV-001. Summary: At SITC 2025, UbiVac unveiled data showing that DPV-001, the first dark genome–derived cancer immunotherapy in the clinic, improved two-year overall survival in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) when combined with checkpoint inhibitors. The company also detailed over 400 dark genome–derived antigens incorporated in the vaccine, underscoring its potential to broaden the antigenic landscape for cancer immunotherapy. Expanding the reach of Cancer Immunotherapy DPV-001 is built on UbiVac’s DRibble Platform Vaccine (DPV) technology and is designed to stimulate a broad, multi-antigen immune response against both conventional and dark genome–derived tumor antigens. The investigational vaccine is the first therapy known to target the “dark matter” of the cancer genome—regions once thought to be non-coding DNA but now known to produce tumor-specific proteins. “For decades, large portions of the genome were dismissed as ‘junk DNA,’” said Dr. Bernard A. Fox, Co-Founder and Chief Executive Officer at UbiVac. “We now know this dark genome encodes hundreds of novel cancer antigens. DPV-001 is the first therapy designed to leverage this biology, expanding the antigenic landscape that immunotherapy can target.” About DPV-001 Each dose of DPV-001 includes more than 400 noncanonical, shared ‘dark matter’ antigens and 300 overexpressed tumor antigens found across most solid cancers. The vaccine is designed to be: • Off-the-shelf, requiring no patient-specific manufacturing; and • HLA-independent, enabling broad use without tissue matching. The platform is being developed for combination use with checkpoint inhibitors across multiple tumor types, including lung, breast, prostate, brain/GBM, and colorectal cancers. Clinical Context Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer globally, with approximately 890,000 new cases and 450,000 deaths annually. UbiVac’s data suggest that combining DPV-001 with anti–PD-1 therapy could enhance survival outcomes in this population, independent of HPV status or prior checkpoint inhibitor exposure. About UbiVac UbiVac is a clinical-stage biotechnology company focused on immuno-oncology and cancer target discovery. The company develops multi-antigen immunotherapies designed to prevent tumor escape and improve response rates to checkpoint inhibitors. Its lead program, DPV-001, is advancing as the first-in-class “Dark Matter” cancer vaccine. For more information, visit www.ubivac.com . Bernard A. Fox UbiVac +1 971-413-7139 foxb@ubivac.com Visit us on social media: LinkedIn Bluesky YouTube X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

AI will accelerate discovery, but the breakthrough is off‑the‑shelf vaccines targeting shared Dark‑Genome drivers—paired with nextgen immunotherapy combinations This week marks a milestone for UbiVac: we’ve documented the 1st vaccine‑induced TCR to a Dark Genome cancer antigen & the patient is cancer‑free at 10 yrs suggesting it may be safe and effective.” — Bernard A. Fox, PhD, Founder & CEO PALO ALTO AND SAN JOSE, CA, UNITED STATES, May 8, 2025 / EINPresswire.com / -- At SynBioBeta, Bernard A. Fox, PhD—Founder and CEO of UbiVac —will join a distinguished panel on accelerating vaccine innovation through AI and synthetic biology, spotlighting UbiVac’s off the shelf, universal vaccines that target cancer’s Dark Genome “Dark Matter” antigens. He will also attend the Wilson Sonsini Life Sciences Investment Forum , where UbiVac seeks partners to advance its Dark Matter combination therapy that has tripled response rates in HNSCC. UbiVac's Disruptive Immunotherapy UbiVac’s proprietary DRibbles ® technology is a self adjuvanting microvesicle vaccine that packages >300 tumor associated and Dark Genome–derived antigens together with endogenous toll like receptor (TLR) and danger signal agonists. This “single shot toolbox” primes broad, durable immunity and helps tumors avoid immune escape, giving the platform plug and play versatility across solid cancers. In a Phase I combination immunotherapy trial, DRibbles tripled overall and complete response rates—early proof of its clinical power. DRibbles in the Clinic DPV-001, the lead DRibble platform vaccine is in the clinic for head and neck squamous cell carcinoma (HNSCC) and has been tested in small phase 1 and pilot studies for non-small cell lung, triple negative breast, and prostate cancers. These studies provided formulation, mechanism of action, and safety data. Blood samples from those studies are being used for dark matter target discovery. Because its antigen repertoire mirrors many shared targets across solid tumors, DPV-001 was specifically engineered to address high need indications such as pancreatic, ovarian, glioblastoma, and gastric cancers. Next generation programs for melanoma and thyroid cancer have been initiated. UbiVac aims to deliver "off-the-shelf" cancer vaccines that combine seamlessly with checkpoint inhibitors, cell therapies, or standard of care regimens—raising response rates and extending survival across multiple tumor types. About Cancer’s Dark Matter 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. The first description of the "in-patient" development of a T cell receptor (TCR) to a dark genome-derived dark matter antigen was presented earlier this week at the American Association of Immunologists annual meeting. About DPV-001 UbiVac’s DRibble Platform Vaccine (DPV) technology is a novel first-in-class cancer vaccine immunotherapy. DPV-001 was developed to be used as combination immunotherapy for most solid cancers, including cancers of the breast, lung, prostate, stomach, colon, pancreas, ovary, brain, and others. DPV-001 contains recently described non-canonical, non-mutated shared alternative neoantigens, also termed cancer’s “dark matter”, plus more than 300 antigens overexpressed by the average solid cancer. This allows DPV-001 to be available off-the-shelf without having to manufacture a patient specific vaccine. Additionally, DPV-001 can be administered without having to match a patients HLA tissue antigens. About UbiVac UbiVac is a privately held, Clinical Stage Immunotherapy & Cancer Target Discovery Company, with First-in-Human Combination Immunotherapies that Include Cancer’s Dark Matter - the Newly Discovered Non-Mutated Shared Alternative Cancer Neoantigens derived from the dark genome. DPV-001 is UbiVac’s lead agent and is a first-in-class platform technology that couples an off-the-shelf DC-targeted microvesicle containing cancer’s dark matter plus more than 300 cancer antigens for most adenocarcinomas and squamous cell cancers. DPV-001 also contains multiple TLR/NOD agonists and DAMPs that are effective at supporting anti-cancer immune responses. UbiVac believes that DPV-001 is highly complementary to current and developing immunotherapy, adoptive immunotherapy, chemotherapy and small molecule drug portfolios, and preliminary clinical data suggests it may be effective at increasing response rates in patients that have failed to respond to anti-PD-1/anti-PD-L1. UbiVac also has a pipeline of agents under development for the treatment of melanoma and thyroid cancer, and to prevent cancer in patients at high risk of developing disease. Bernard A. Fox UbiVac +1 971-413-7139 dr.fox@ubivac.com Visit us on social media: LinkedIn X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.