A Newly Published Paper Demonstrates That A Novel DNA-Based Therapy Called Elenagen Achieves Significant Reduction in Mortality and an Increase In Overall Survival in Platinum Resistant Ovarian Cancer | Newswise

A randomized Phase II trial reported in the International Journal of Gynecological Cancer found that adding the experimental DNA therapy Elenagen to standard chemotherapy significantly extended overall survival for women with platinum-resistant ovarian cancer (PROC) and elevated CA-125.

Elenagen, a plasmid encoding the protein p62/SQSTM1 developed by CureLab Oncology, was given once weekly by intramuscular injection alongside gemcitabine. The trial enrolled patients with PROC, a group that typically faces limited treatment options, low response rates and median survival measured in months.

Study results showed that median overall survival increased from about 13 months in the chemotherapy-alone arm to more than 25 months in the Elenagen-plus-chemotherapy arm. The addition of Elenagen was associated with an approximately 60 percent reduction in the risk of death. Investigators reported no increase in treatment-related toxicity with the combination, and several patients receiving Elenagen survived several years beyond typical expectations for this setting.

The trial took place outside the United States and was affected by a regional military-related supply interruption that caused all patients to stop receiving Elenagen at once. Treatment durations at the time of cessation ranged from about three weeks to more than 30 months. Investigators observed a strong correlation between longer Elenagen exposure and longer survival after treatment termination, most pronounced in the first 12 months and still evident at 18 months. Authors describe the reported survival benefit as a conservative estimate because it includes patients who received shorter-than-intended treatment.

Elenagen’s proposed mechanism of action includes reduction of chronic inflammation within the tumor microenvironment, increased tumor infiltration by immune cells, impairing metastatic spread and preventing tumor-driven immune suppression. The therapy also aims to elicit an immune response against p62, a protein found at high levels in some cancer cells.

“As a gynecologic oncologist, I see firsthand how devastating platinum-resistant ovarian cancer is for patients and their families,” said Dr. Gabriel Levin of McGill University Health Centre, a co-author of the study. “What makes these findings so meaningful is not only the improvement in survival but the fact that this was achieved without adding toxicity.”

Alexander Shneider, CEO of CureLab Oncology and senior author of the paper, said the team plans to offer Elenagen for up to 24 months in planned U.S. and EU trials, noting that available data suggest little additional benefit beyond that duration. He said future studies will also include quality-of-life endpoints to assess the therapy’s broader clinical impact.

CureLab is designing Phase II/III trials in the U.S. and EU in collaboration with the Gynecologic Oncology Group Foundation. The company also plans trials of Elenagen in aggressive forms of breast cancer.

Elenagen is an investigational plasmid DNA therapy encoding human p62/SQSTM1. In prior non-U.S. clinical studies it demonstrated a favorable safety profile and evidence of clinical benefit when combined with chemotherapy, along with effects consistent with reduced chronic inflammation and stimulation of anti-tumor immune responses.