Geneos Therapeutics Initiates IMPACT31 Phase 2 Randomized Clinical Trial Evaluating Neoantigen-Targeted Personalized DNA Immunotherapy for Cancer

• The study evaluates patients with liver cancer at high risk of recurrence following surgical resection
• Julie Rosenberg, MD, appointed to leadership team as Chief Medical Officer

PHILADELPHIA, Oct. 21, 2026 /PRNewswire/ -- Geneos Therapeutics, a clinical stage biotherapeutics company focused on the development of neoantigen-based personalized immunotherapy for cancer (PIC), today announced the initiation of its Phase 2 randomized clinical trial (NCT07722741) in patients with high-risk hepatocellular carcinoma (HCC, liver cancer) who have undergone resection with curative intent.  The IMPACT31 trial is a multi-center global trial with a planned enrollment of 90 patients.  PICs are targeted treatments that train a patient's immune system to attack unique genetic mutations (neoantigens) found only in their specific tumor cells while sparing healthy tissue. The trial evaluates the efficacy of Geneos' PIC (GNOS-PV02), compared to the current standard of care (active surveillance) in high-risk patients following surgery.

Additionally, the company announced the appointment of Julie Rosenberg, MD, as Chief Medical Officer. Dr. Rosenberg has more than two decades of leadership and drug development experience in the biopharmaceutical industry.

"We are thrilled to welcome Julie to our leadership team to drive the IMPACT31 trial and advance the development of Geneos' tumor-agnostic immunotherapy platform and clinical pipeline. 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," said Niranjan Sardesei, Ph.D., President & CEO of Geneos. "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. We are excited to bring the possibility of long-term clinical benefit to high-risk HCC patients in this randomized controlled trial."

Dr. Rosenberg completed her pediatric residency and hematology/oncology training at Baylor College of Medicine and has held leadership roles at major pharmaceutical companies – Boehringer Ingelheim, Bristol Myers Squibb, Bayer Healthcare and Pfizer. She most recently served as Head of the Oncology Franchise for Linical, a mid-sized, global, Contract Research Organization. Dr. Rosenberg joins Geneos at a pivotal stage, bringing her deep leadership and executive experience related to trial design, clinical development pathways, pharmacovigilance, medical strategy, operational efficiencies, regulatory submissions, and more.

"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."

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

"Initiating the IMPACT31 trial is an important milestone in our effort to improve outcomes for patients with HCC," said Mark Yarchoan, MD, Professor of Medicine at Johns Hopkins University, and Clinical Investigator on the IMPACT31 trial. "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. IMPACT31 builds on encouraging safety and preliminary efficacy data from a prior Phase 1/2 trial in patients with advanced HCC, published in Nature Medicine in 2024, as well as recent successes 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."

About personalized DNA immunotherapy for cancer (PIC)

PICs are patient-specific treatments based on 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. PICs mechanism of action is cancer agnostic, and the platform supports seamless expansion into other cancers beyond HCC and glioblastoma.

About GT-31 Phase 2b Randomized Controlled Trial

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.

About Geneos Therapeutics

Geneos Therapeutics is a Phase 2 clinical-stage biotherapeutics company developing personalized immunotherapies for cancer (PICs). The company's approach uses its proprietary DNA-based GT-EPIC™ platform to target neoantigens (abnormal mutations produced by cancer cells) from individual patient tumors to develop novel and uniquely personalized DNA immunotherapies for cancer. For more information, please visit www.geneostx.com.

This press release contains certain forward-looking statements relating to our business, including our plans regarding the development of neoantigen-based personalized immunotherapies for cancer, our expectations regarding our research and development programs, including the planned expansion and conduct of clinical trials. Actual events or results may differ from the expectations set forth herein. There can be no assurance that any product candidate in Geneos' pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and Geneos undertakes no obligation to update or revise these statements, except as may be required by law.

Media Contact:
Jennifer Williams
Cook Williams Communications, Inc.
[email protected]

SOURCE Geneos Therapeutics, Inc.