LucaVax (tertomotide)

P2, N=67, Active, not recruiting, GemVax & Kael | Recruiting --> Active, not recruiting | Trial completion date: Jul 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Nov 2025

P2, N=78, Completed, GemVax & Kael | Recruiting --> Completed | Trial completion date: May 2024 --> Oct 2024 | Trial primary completion date: Dec 2023 --> Oct 2024

P1, N=56, Recruiting, GemVax & Kael | Not yet recruiting --> Recruiting

P1, N=56, Not yet recruiting, GemVax & Kael

GV1001 demonstrated protective effects against bone loss in OVX mice by upregulating osteogenic differentiation via the Pin1-mediated protein stabilization of Runx2 and Osterix. GV1001 could be a potential candidate with anabolic effects for the prevention and treatment of osteoporosis.

GV1001 also suppressed the accumulation of AD biomarkers in the brains of mice with periodontal disease. Overall, these findings suggest that GV1001 holds promise as a preventive agent in the development of atherosclerosis and AD-like conditions associated with periodontal disease.

P2, N=180, Active, not recruiting, GemVax & Kael | Trial primary completion date: Sep 2025 --> Apr 2025

P2, N=180, Active, not recruiting, GemVax & Kael | Recruiting --> Active, not recruiting | Trial completion date: Sep 2024 --> Mar 2026 | Trial primary completion date: Jul 2023 --> Sep 2025

P2, N=75, Recruiting, GemVax & Kael

The patients in this study experienced no additional toxicities other than the cytotoxic chemotherapy-associated side effects. GV1001 is a relatively safe anticancer vaccine for patients with heavily-treated breast cancer and can to improve the quality of life.

P2, N=75, Recruiting, GemVax & Kael | Phase classification: P2a --> P2

GV1001 plus gemcitabine/capecitabine improved OS and TTP compared to gemcitabine/capecitabine alone in eotaxin-high patients with advanced PDAC.

Consistent with the in vitro results, the recombinant oncolytic influenza virus significantly inhibited liver tumor growth in mice in vivo, in addition to inducing an anti-tumor immune response, including an increase in the number of CD4+ and CD8+ T lymphocytes and, in turn, improving survival. Our results suggest that oncolytic influenza virus carrying GV1001 is a promising immunotherapy in patients with HCC.

Total 148 patients were randomly assigned to the GV1001 (n=75) and control groups (n=73). The GV1001 group showed improved median OS (11.3 vs. 7.5 months, p=0.021) and TTP (7.3 vs.

As an application example, we estimate the survival function of the overall survival time of the KG4/2015 study, the phase 3 clinical trial of the efficacy of GV1001 as a treatment for pancreatic cancer...Applying the estimation method with dependent censoring, we obtain that the estimates of the median survival times are 339 days in the treatment group and 225.5 days in the control group. We also find that the estimated difference of the medians is 113.5 days, and the difference is statistically significant at the one-sided level with size 2.5.

In the present study, we synthetized a new peptide, DS-2, based on the telomerase vaccine GV1001, a 16-mer peptide...These data indicated that the inhibition of hTERT expression by DS-2 suppressed prostate cancer cell growth and induced anti-cancer immunity. Therefore, DS-2 might be used as a novel therapeutic drug for cancer immunotherapy by targeting hTERT in prostate cancer.

Furthermore, GV1001 suppresses the proliferation and invasion of non-small cell lung cancer cells, and the release of VEGF from the cells, suggesting the regulatory role of GV1001 in tumor-derived angiogenesis as well as cancer cell growth and progression. Collectively, our study reports the pharmacological potential of GV1001 in the regulation of angiogenesis, and warrants further evaluation and development of GV1001 as a promising therapeutic agent for a variety of angiogenesis-related diseases including cancer.

Cytotoxic chemotherapy and targeted agents (bevacizumab, cetuximab, or aflibercept) were allowed to be used at the discretion of the investigator. The baseline eotaxin level was not associated with any efficacy outcome. Although no clear GV1001-specific immune response was observed, the addition of GV1001 vaccination to chemotherapy was tolerable and associated with modest efficacy outcomes.

Overall, this study reveals an essential role of AR-YAP1 in the regulation of PCa cell migration, and provides evidence that GV1001 could be a novel GnRHR ligand to inhibit metastasis of PCa via the Gαs/cAMP pathway.

G/C/GV treatments significantly extend OS and TTP in advanced PDA than G/C, and specific safety-related issues had not been found . GV1001 should be considered as one of the options in PDA pts with high serum eotaxin levels.