Breakthrough Phase II Study in Platinum-Resistant Ovarian Cancer Set for
February 11, 2026
Rondes de santé : Un médicament expérimental double la survie des patientes atteintes d’un cancer de l’ovaire
February 13, 2026Overall survival benefit with elenagen plus gemcitabine in platinum-resistant ovarian cancer
Key study findings
- Significant Overall Survival Benefit: Patients receiving elenagen plus chemotherapy lived significantly longer than those receiving chemotherapy alone.
- Median Overall Survival Doubled: Median overall survival increased from approximately 13 months to more than 25 months.
- Reduced Risk of Death: Treatment with elenagen reduced mortality risk by nearly 60%.
- Favourable Safety Profile: No increase in treatment-related toxicity was observed.
- Long-Term Responders: Several patients survived years beyond expected survival for this disease setting.
According to Sergei Krasny, MD, Ph.D., Sc. D., co-author of the study. “ What makes these results remarkable is not only the magnitude of the survival benefit, but that it was achieved without added toxicity and without specific biomarker. This suggests a fundamentally different therapeutic approach - one that supports the body’s biology rather than simply intensifying chemotherapy.”Dr. Gabriel Levin, gynaecologic oncologist at the McGill University Health Centre, and Director of Oncology at CureLab Oncology Inc. will present new clinical findings at the 27th Congress of the European Society of Gynaecological Oncology (ESGO 2026) in Copenhagen, highlighting a promising therapeutic advance for women with platinum-resistant ovarian cancer (PROC).
The oral presentation, titled 'Randomised Phase II Study of P62/Sqstm1-Encoding Plasmid (elenagen) In Combination With Gemcitabine for Platinum-Resistant Ovarian Cancer (Abstract 274)', details results from a randomised Phase II clinical trial evaluating the DNA-based therapy elenagen (p62/SQSTM1-encoding plasmid) in combination with gemcitabine.
Dr. Levin’s presentation is scheduled for Feb 27.
ESGO 2026 will convene more than 3,000 clinicians, researchers, and industry leaders from around the world to share late-breaking research, new guidelines, and innovations aimed at improving outcomes in gynaecologic cancers.
Dr. Levin’s oral presentation is centred around a recently published paper in the International Journal of Gynaecological Cancer, evaluated elenagen in women with platinum-resistant ovarian cancer and elevated CA-125 - among the highest-risk and poorest-prognosis patient populations.
Elenagen, developed by CureLab Oncology, Inc. , is a plasmid DNA therapy encoding the protein p62/SQSTM1 and was administered as a once-weekly intramuscular injection alongside standard gemcitabine chemotherapy.
Insights from unplanned treatment interruption
Longer exposure to elenagen strongly correlated with longer survival following treatment discontinuation, particularly within the first 12 months.
As a result, the overall survival benefit reported is considered a conservative, “lower-bound” estimate.
Future U.S. and EU trials will provide Elenagen for up to 24 months, based on data suggesting extended treatment maximises benefit.
How elenagen works
Elenagen acts by reducing chronic inflammation and reshaping the tumour microenvironment, enabling greater infiltration of immune cells while limiting tumour immune suppression and spread of metastasis.
Also, cancer cells’ reliance on p62/SQSTM1 appears to make overabundantly produced p62 a unique cancer-specific immune target which Elenagen trains immunity to attack.
Dr. Alexander Shneider, CEO of CureLab Oncology, inventor of elenagen, and senior author of the paper.
“What initially started as a cancer vaccine, now evolved in a comprehensive adjuvant filling the gaps of current anti-cancer therapies. Following serendipitous discoveries, we made elenagen to evolve from a simple anti-cancer vaccine to a novel class of therapy against cancers, diseases of chronic inflammation, and potentially even ageing”
Looking ahead
Due to geopolitical circumstances affecting drug supply, all patients in this ex-U.S. trial were required to stop elenagen simultaneously, despite treatment durations ranging from less than one month to more than 30 months.
This unexpected interruption yielded important insights.
It demonstrated that post-treatment effect is proportional to duration of the treatment, although the extent of the additional treatment reduces between 12th and 24th months.
Thus, in the future trials, protocols will assume elenagen application of up to 2 years.
CureLab Oncology is preparing Phase II/III clinical trials in the U.S. and EU, with protocols developed in collaboration with the Gynaecologic Oncology Group (GOG) Foundation.
In addition to platinum-resistant ovarian cancer, the company plans FDA-guided trials in aggressive forms of breast cancer.
Future studies will formally assess quality of life, a potential differentiator for therapies targeting chronic inflammation.
Ovarian cancer remains one of the most lethal cancers affecting women.
Approximately 1 in 80 women will develop the disease during her lifetime.
Each year, over 12,000 women die of the disease in the U.S., and over 200,000 worldwide.
While many women initially respond to chemotherapy, the cancer recurs in the majority of cases.
Effectively, all women with recurrent cancer eventually develop platinum-resistant ovarian cancer.
At this point, treatment options are extremely limited, response rates are low, and average survival is often measured in months, frequently accompanied by significant side effects.
Among these patients, those with elevated CA-125 levels have the poorest prognosis.
