Elenagen (p62 DNA Vaccine) / CureLab Oncology - LARVOL DELTA

RANDOMIZED PHASE II STUDY OF P62/SQSTM1-ENCODING PLASMID (ELENAGEN) IN COMBINATION WITH GEMCITABINE FOR PLATINUM-RESISTANT OVARIAN CANCER (ESGO 2026) - No abstract available

Clinical • Combination therapy • P2 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • SQSTM1

Elenagen, a p62/SQSTM1-encoding plasmid, improves overall survival in patients with platinum-resistant ovarian cancer: a phase II trial. (PubMed, Int J Gynecol Cancer) - P2 | "The addition of Elenagen to gemcitabine prolonged overall survival in patients with platinum-resistant ovarian cancer without increasing toxicity."

Journal • P2 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • MUC16 • SQSTM1

Randomized Controlled Trial of Elenagen (Plasmid Encoding p62/SQSTM1) Plus Gemcitabine Versus Placebo Plus Gemcitabine in Patients With Platinum-Resistant Ovarian Cancer (SGO 2026) - No abstract available

Clinical • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • SQSTM1

Commentary: Clinical efficacy of plasmid encoding p62/SQSTM1 (Elenagen) in combination with gemcitabine in patients with platinum-resistant ovarian cancer: a randomized controlled trial. (PubMed, Front Oncol) - No abstract available

Journal • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • SQSTM1

Efficacy of P62-expressing plasmid in treatment of canine osteoarthritis pain: a pilot study. (PubMed, Front Vet Sci) - "In this pilot study Elenagen demonstrated efficacy in treatment of OA pain in dogs without side effects. The study has some limitations: small animal number, lack of long-term follow-up, and the outcome is limited to only one parameter, CBPI. Also in future studies the mechanism of anti-OA effect of p62 plasmid should be addressed."

Journal • Immunology • Inflammation • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Clinical efficacy of plasmid encoding p62/SQSTM1 (Elenagen) in combination with gemcitabine in patients with platinum-resistant ovarian cancer: a randomized controlled trial. (PubMed, Front Oncol) - P2 | "The addition of ELENAGEN to gemcitabine is effective in patients with platinum-resistant ovarian cancer, including those with a worse prognosis. https://www.clinicaltrials.gov/study/NCT05979298, identifier NCT05979298, 2023-08-07."

Combination therapy • Journal • Oncology • Ovarian Cancer • Solid Tumor • SQSTM1

Novel DNA vaccine Elenagen, in combination with a proven chemotherapy, demonstrates promising clinical results against one of the deadliest forms of ovarian cancer (PRNewswire) - P2 | N=40 | NCT05979298 | Sponsor: CureLab Oncology | "As in other published reports, the average PFS for gemcitabine-treated group was just 2.8 months. However, 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 only the chemotherapy had disease progression within less than one year....Encouraged by these ex-US results, CureLab Oncology has submitted its pre-IND package to the FDA. The company plans to expand the study in the USA as Phase II/III study. The principal investigator for the study will be Prof. Bhavana Pothuri, MD of NYU. The same combination of Elenagen with gemcitabine will be explored."

FDA event • P2 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

CLINICAL EFFICACY OF PLASMID ENCODING P62/SQSTM1 (ELENAGEN) IN COMBINATION WITH GEMCITABINE IN PATIENTS WITH PLATINUM-RESISTANT OVARIAN CANCER (medRxiv) - P2 | N=40 | NCT05979298 | Sponsor: CureLab Oncology | "To data cut-off, the median follow-up was 13.8 months. There were no SAE -related to ELENAGEN treatment. The median progression-free survival (PFS) was 2.8 and 7.2 mo in Chemo and ELENAGEN arms respectively (p Log-Rank = 0.03). Noteworthy, at the time of cut-off, 9 patients (45%) in Elenagen arm did not progress with the longest PFS recorded so far is 24 months. Subgroup analysis of patients in both arms demonstrated high efficacy of Elenagen in the patients with worse prognosis: high pretreatment levels of CA125, progression after only one line of chemotherapy, and peritoneal effusion."

P2 data • Preprint • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Efficacy of Plasmid Elenagen in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: CureLab Oncology

Combination therapy • New P2 trial • Oncology • Ovarian Cancer • Solid Tumor

CureLab Receives $3M from Prominent Biotech Investor Dr. John Ballantyne (PRNewswire) - "The co-founder of Aldevron, Dr. John Ballantyne, has invested $3M in CureLab Oncology and CureLab Veterinary. The two sister companies have developed an anti-cancer and anti-inflammatory drug that was contract-manufactured by Aldevron at the time Dr. Ballantyne served there as chief scientific officer. The investment positions both companies to attain the R&D milestones needed to secure additional rounds of funding....The funds will enable CureLab Oncology to ramp up toward FDA-monitored clinical trials for triple-negative breast cancer and platinum-resistant ovarian cancer in 2023."

Financing • Breast Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer