Geneos Therapeutics, a Philadelphia-based clinical-stage company developing personalized cancer immunotherapies, has begun a randomized trial of its investigational DNA-based treatment in patients with liver cancer. The company announced on October 21, 2026 the start of IMPACT31, a Phase 2 study in patients with high-risk hepatocellular carcinoma (HCC) who have had surgery to remove their tumors. Geneos also named Julie Rosenberg, MD, as its Chief Medical Officer.
“We are excited to bring the possibility of long-term clinical benefit to high-risk HCC patients in this randomized controlled trial,” said Niranjan Sardesei, Ph.D., President & CEO of Geneos.
Inside the IMPACT31 Trial
IMPACT31 (NCT07722741) is a multicenter, open-label study that plans to enroll 90 patients at sites in the U.S. and the Asia-Pacific region. It will compare Geneos’ personalized immunotherapy for cancer (PIC), GNOS-PV02, with active surveillance, the current standard of care after surgery for HCC.
Each PIC is built for an individual patient. Geneos sequences the patient’s tumor to find neoantigens, which are mutations found only in that patient’s cancer cells. It then encodes up to 40 of those neoantigens on a single DNA plasmid. The treatment is designed to train the immune system to produce CD4 and CD8 T cells that attack the cancer, while sparing healthy tissue, according to the company.
For Dr. Mark Yarchoan, Professor of Medicine at Johns Hopkins University and a clinical investigator on IMPACT31, the trial targets a clear gap:
“Most patients with HCC, particularly those with high-risk features at the time of surgery, experience disease recurrence following curative-intent resection, and there are currently no approved or effective therapies to prevent recurrence.”
Building on Earlier Data
IMPACT31 follows earlier Phase 1/2 studies of the Geneos platform. Sardesei says the company has reported clinical safety and efficacy in two cancers that typically respond poorly to immunotherapy:
“We have reported clinical safety and efficacy in our early Phase 1/2 trials, in two distinct cancers, by treating patients with advanced HCC who failed or were intolerant to first-line therapy and, also in the adjuvant setting in glioblastoma (brain cancer). These are two hard-to-treat, immune-excluded, cold cancers, which have historically proved unresponsive to immunotherapy.”
Results from the earlier Phase 1/2 trial in advanced HCC were published in Nature Medicine in 2024, according to Dr. Yarchoan. He also pointed to recent progress with personalized cancer vaccines in other tumor types.
“We are hopeful that this approach will offer a new strategy to reduce recurrence and improve long-term outcomes for patients with HCC,” Dr. Yarchoan said.
A New Chief Medical Officer
Dr. Rosenberg will lead the IMPACT31 trial and the broader clinical pipeline. She brings more than two decades of drug development experience.
“Her experience and well-developed network in clinical development within biopharma will be invaluable in the coming years as Geneos advances toward late-stage clinical development,” Sardesei said.
Dr. Rosenberg most recently served as Head of the Oncology Franchise at Linical, a global contract research organization (CRO). She previously held leadership roles at Boehringer Ingelheim, Bristol Myers Squibb, Bayer, and Pfizer. She completed her pediatric residency and hematology/oncology training at Baylor College of Medicine.
“The clinical data to date and the Geneos DNA vaccine platform are extremely compelling,” said Dr. Rosenberg. “I’m delighted to join Geneos at this critical time and value the opportunity to further augment the clinical programs with the hope of seeing truly differentiating data for hard-to-treat cancers.”
About Geneos Therapeutics
Geneos develops its personalized immunotherapies using its DNA-based GT-EPIC™ platform. Each treatment has three parts: the personalized DNA plasmid, a plasmid-encoded IL-12 (pIL12) adjuvant to boost the immune response, and the CELLECTRA® electroporation device, which helps cells take up the DNA. The treatment is injected into the skin of the patient’s arm. The company says the platform’s approach works independently of cancer type, and its clinical development so far has been in HCC and glioblastoma.
