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

P1, N=104, Active, not recruiting, Guangzhou Lupeng Pharmaceutical Company LTD. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024

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.

P1, N=114, Recruiting, Fujian Akeylink Biotechnology Co., Ltd. | Trial completion date: Jul 2023 --> Mar 2024 | Trial primary completion date: Feb 2023 --> Dec 2023

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.

This makes the management of HDV a challenge for physicians. In this review, we look at the background, diagnosis and treatment of HDV, informed by our hospital data, to set out the optimal management of HDV; we also explore novel treatment options for this disease.

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.

Recently, a wave of new investigational therapies has come under evaluation, including bulevirtide, lonafarnib, pegylated interferon lambda (PEG-IFNλ), and REP-2139 creating new excitement in HDV. These clinical benefits may include reducing the risk of progression to cirrhosis, hepatic decompensation, hepatocellular carcinoma, liver transplantation, and mortality. However, the optimal way to measure success in HDV clinical trials remains unknown and will continue to evolve.

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.

Taken together, we present new genetic/epigenetic evidence that links chronic HBV infection to B-cell lymphomagenesis, and HBV-associated FL is likely to have a distinct cell-of-origin and represent as a separate subtype of FL. Targetable genetic/epigenetic alterations identified in tumors and their associated tumor microenvironment may provide potential novel therapeutic approaches for this subgroup of patients.

Guidelines suggest lamivudine prophylaxis in OBI/CLL pts treated with CIT... From the collected evidence, it seems reasonable to suggest that prophylactic treatment should be considered appropriate and started in pts who were previously treated with CIT. For the treatment naïve group, a clinical choice could be performed, knowing that reactivation could seldomly occur and be detected in time to promptly treat the pts, but prophylaxis is not mandatory for a favourable clinical course.

A plasma panel, including miR-340-3p and miR-451a that might suppress HBV replication by targeting ATF2, has the potential as biomarkers for HBV infection. In the setting of blood donations, this panel would be more practical to moderately differentiate OBI in HBsAg-negative donors.

Summarizing the results, HBV and HCV infection represent the most associated forms of viral hepatitis causing HCC. Further studies are warranted to further improve the prediction of high-risk patients and development of targeted therapeutics preventing the transition from hepatic inflammation-fibrosis to cancer.

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.

During induction phase, pts received rituximab biosimilar (Henliritux ® Shanghai Henlius Biotech) 375 mg/m 2 intravenous infusion on d1. Peg-IFN-α2b (Pegberon ® , Xiamen Amoytop Biotech) was given at a dose of 135ug, subcutaneously, on d1,8...Simultaneously, CHB pts orally treated with entecavir continuously... Rituximab biosimilar plus pegylated interferon α-2b provided favorable response in newly diagnosed advanced iBCL and was well tolerated. No hepatitis B virus reactivation was observed. Further investigation is warranted.

Semi-annual liver ultrasound and serum alpha-fetoprotein testing favor early detection of that cancer and should be carried out in all patients with chronic HBV infection, regardless of the presence of advanced fibrosis or cirrhosis. Currently, nucleoside/nucleotide analogues that have a high barrier to resistance are the first-line therapies.

Multivariate analysis and the prognostic nomograms revealed that tumor NEIL3 level may serve as a promising prognostic indicator for OS and DFS in HCC patients. Our findings suggested that NEIL3 might be a potential prognosis assessment marker and therapeutic target for HCC patients.

The long-term prognosis of well-defined ICs was similar to that of general population controls. In addition, the ICs had a high HBsAg clearance rate and low phase transition rate.

Switching to TAF monotherapy for patients with decompensated hepatitis B cirrhosis due to poor response to NAs therapy/LLV, is effective regarding both CVR and the liver function benefits. TAF has good renal safety for the treatment of decompensated hepatitis B cirrhosis.

Discontinuation of antiviral treatment in CHB children and adolescents can result in relapse in one third of the patients . Relapse is more often seen in those with HBeAg positivity and if >22.5 months time is taken for HBV DNA to become undetectable on antivirals. Discontinuation of antivirals along with retreatment with sequential therapy is feasible and safe in children .

ETV combined with IFN-α therapy is superior to ETV monotherapy in reducing the risk of HCC and EHCs for patients with CHB. People who can tolerate and benefit from IFN-α therapy could consider combination therapy.

In conclusion, ANXA2 expression in HCC tissues could predict postoperative OS. However, the predictive value was limited in patients with specific clinical conditions.

Therefore, a therapeutic DNA vaccine was designed, expressing both HBV core and polymerase proteins, and was sequence optimized to ensure high protein expression and secretion. Although the vaccine, administered intramuscularly via electroporation, had no effect on plasma viral parameters in a mouse model of persistent HBV infection, it did induce robust HBV-specific immune responses in healthy and adeno-associated hepatitis B virus (AAV-HBV) infected mice as well as in healthy non-human primates.

The characteristics of those with severe outcomes were consistent with those of overall CHB, although there was a 2-3 times higher prevalence of diabetes in those with severe outcomes. Identifying characteristics that are more prevalent in those with severe outcomes can help inform screening and management of CHB.