The Boston-based CureLab Oncology team, in collaboration with their research partners at N.N. Alexandrov National Cancer Center and Minsk City Oncology Center (both located in Belarus), just published a really encouraging study:
CureLab's novel DNA vaccine Elenagen, in combination with a proven chemotherapy, demonstrated promising clinical results against one of the deadliest forms of cancer — triple-negative ovarian cancer.
- In a preprint paper published on MedRxiv, a team of scientists at CureLab Oncology and their international collaborators demonstrated a clear clinical benefit of a new biological agent against the deadliest form of ovarian cancer.
- The published results were derived from a clinical study that evaluated the safety and efficacy of Elenagen, a novel anticancer therapeutic (plasmid DNA encoding p62/SQSTM1 protein), as an adjuvant to platinum-based chemotherapy, gemcitabine, in patients with advanced platinum-resistant ovarian cancer.
- Their hypothesis: could injecting p62-encoding DNA into a muscle elicit a specific immune response against overly abundant p62, thereby selectively eliminating cancer cells? In other words, emulating a classic vaccine mechanism of action.
- 40 platinum-resistant ovarian cancer patients were randomly divided into two groups. One group received a standard gemcitabine regimen while the other received a combination of the same gemcitabine treatment coupled with weekly injections of Elenagen.?
- No serious adverse events (SAEs) due to Elenagen were reported. Note: SAEs have often been observed during immune oncology studies, which sets Elenagen apart. In addition to safety, the study used the standard primary endpoint of progression-free survival (PFS) — the duration of time between the moment when a patient is enrolled in a study and the moment of relapse of a primary tumor and/or metastatic lesions, as confirmed by radiographic scans.
- The average PFS for the gemcitabine-treated group was just 2.8 months, while the group receiving the chemotherapy supplemented with Elenagen demonstrated a PFS of 7.2 months, a statistically significant increase.?
- Importantly, 9 out of 20 patients receiving Elenagen did not demonstrate any disease progression, with a longest recorded observation of 24 months. At the same time, all patients receiving solely the chemotherapy experienced disease progression within less than one year.