Geneos Therapeutics Launches Phase 2 Trial for Personalized Cancer Immunotherapy

PHILADELPHIA, Oct. 21, 2026 /CourierPR/ -- Geneos Therapeutics, a clinical stage biotherapeutics company focused on developing neoantigen-based personalized immunotherapy for cancer, has initiated a Phase 2 randomized clinical trial, named IMPACT31, to evaluate the efficacy of its personalized DNA immunotherapy for patients with high-risk hepatocellular carcinoma (HCC) following surgical resection with curative intent. The trial, registered as NCT07722741, is a multi-center global study with a planned enrollment of 90 patients.

The IMPACT31 trial aims to compare the efficacy of Geneos' personalized DNA vaccine, GNOS-PV02, with the current standard of care, which involves active surveillance. This approach seeks to train the patient's immune system to target unique genetic mutations (neoantigens) found only in their specific tumor cells, potentially offering a new strategy to reduce recurrence and improve long-term outcomes for high-risk HCC patients.

Dr. Rosenberg, who has held leadership roles at major pharmaceutical companies including Boehringer Ingelheim, Bristol Myers Squibb, Bayer Healthcare, and Pfizer, brings a wealth of expertise to the team. She most recently served as Head of the Oncology Franchise for Linical, a mid-sized, global, Contract Research Organization.

The personalized DNA immunotherapy for cancer (PIC) developed by Geneos uses DNA plasmids that encode up to 40 tumor neoantigens on a single DNA plasmid. A patient's tumor is sequenced to identify the neoantigens used to develop a personalized DNA cancer vaccine. Treatment with PICs trains the patient's immune cells to produce cancer-targeting CD4 and CD8 T cells that destroy the cancer cells. The platform is cancer-agnostic, supporting seamless expansion into other cancers beyond HCC and glioblastoma.

The IMPACT31 trial will enroll patients at clinical sites in the United States and countries in the Asia-Pacific region.

The Phase 2b trial (ClinicalTrials.gov identifier: NCT07722741) is a multi-center, open-label, two-arm randomized controlled study that evaluates the personalized DNA vaccine versus active surveillance, the current standard of care, in patients with high-risk HCC post tumor resection. The trial design of PIC monotherapy versus active surveillance in the adjuvant setting will both leverage and highlight PIC's patient-specific mechanism of action for treating patients with cold, low tumor mutational burden cancers.