An Open-Label, Phase 1/2 Study to Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of RG002 Injection (an mRNA Therapeutic Vaccine) in Subjects With Human Papillomavirus (HPV) 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3 (CIN2/3)

The purpose of this study is to to evaluate the safety, tolerability, immunogenicity, and efficacy of RG002 Injection in subjects with HPV16/18 associated Cervical Intraepithelial Neoplasia Grade 2 or 3(CIN2/3).

Start Date01 Mar 2024

Sponsor / Collaborator

RinuaGene Biotechnology Co., Ltd.

100 Clinical Results associated with RG-002(RinuaGene Biotechnology )

100 Translational Medicine associated with RG-002(RinuaGene Biotechnology )

100 Patents (Medical) associated with RG-002(RinuaGene Biotechnology )

Literatures (Medical) associated with RG-002(RinuaGene Biotechnology )

03 Jul 2024·Journal of Agricultural and Food Chemistry

Four-Dimensional Label-Free Quantitative Proteomics of Ginsenoside Rg₂ Ameliorated Scopolamine-Induced Memory Impairment in Mice through the Lysosomal Pathway

Article

Author: Song, Shixin ; Mi, Qianwen ; Bi, Yunfeng ; Wang, Heyu ; Yin, Pei ; Xiong, Boyu ; Yu, Lei ; Meng, Xingjian ; Yu, Xiaoran ; Xue, Tingfang

Alzheimer's disease (AD) is a neurodegenerative disease. Ginsenoside Rg₂ has shown potential in treating AD, but the underlying protein regulatory mechanisms associated with ginsenoside Rg₂ treatment for AD remain unclear. This study utilized scopolamine to induce memory impairment in mice, and proteomics methods were employed to investigate the potential molecular mechanism of ginsenoside Rg₂ in treating AD model mice. The Morris water maze, hematoxylin and eosin staining, and Nissl staining results indicated that ginsenoside Rg₂ enhanced cognitive ability and decreased neuronal damage in AD mice. Proteomics, western blot, and immunofluorescence results showed that ginsenoside Rg₂ primarily improved AD mice by downregulating the expression of LGMN, LAMP1, and PSAP proteins through the regulation of the lysosomal pathway. Transmission electron microscopy and network pharmacology prediction results showed a potential connection between the mechanism of ginsenoside Rg₂ treatment for AD mice and lysosomes. The comprehensive results indicated that ginsenoside Rg₂ may improve AD by downregulating LGMN, LAMP1, and PSAP through the regulation of the lysosomal pathway.

01 Mar 2024·Journal of Pharmaceutical and Biomedical Analysis

20(S)-Ginsenoside Rg2 amino acid derivatives for anti hemorrhagic shock: Synthesis, characterization and evaluation

Article

Author: Liu, Jiayin ; Dong, Qinghai ; Liu, Jihua ; An, Yang ; Xie, Hongliu ; Su, Jun ; Shi, Fei ; Lin, Fang

The purpose of this study is to screen a novel Rg₂ derivative for anti hemorrhagic shock. Eight Rg₂ amino acid ester derivatives were designed and synthesized, and their effects on hypoxia and shock were studied. Among them, the derivative 1 (D1) exhibited excellent anti hypoxia by promoting survival rate of H9c2 cells damaged by hypoxia. D1 improved physiological indicators of the rats in hemorrhagic shock, such as blood pressure, heart rate, lactate, acid-base balance, and alleviate oxidative stress and inflammatory damage. Its latent mechanisms were explored by a method of plasma metabolomics based on UPLC-QTOF-MS. As a result, a total of 16 biomarkers were identified involving 6 metabolic pathways. The results of this study contained that the derivative 1 could be considered as potent drug candidates for anti shock and deserved further research and development.

01 Jan 2023·Therapeutic Advances in Medical Oncology

Patient outcomes following a response biomarker-guided approach to treatment using 177Lu-PSMA-I&T in men with metastatic castrate-resistant prostate cancer (Re-SPECT)

Article

Author: John, Nikeith ; Pathmanandavel, Sarennya ; Pranavan, Ganes ; Gedye, Craig ; Crumbaker, Megan ; Poole, Aron ; Emmett, Louise ; Mallesara, Girish ; Hickey, Adam ; Joshua, Anthony M. ; Counter, William ; Hovey, Elizabeth ; Lee, Adrian ; Sharma, Shikha ; Stockler, Martin R. ; Nguyen, Andrew ; Agrawal, Shikha ; Ayers, Maria ; Eu, Peter ; Guminski, Alex

Background:177LuPSMA is an effective treatment in metastatic castrate-resistant prostate cancer with trials adopting a standardised dose interval. Adjusting treatment intervals utilising early response biomarkers may improve patient outcomes. Objective: This study evaluated progression-free survival (PFS) and overall survival (OS) based on treatment interval adjustment utilising 177LuPSMA 24-h SPECT/CT (177Lu-SPECT) and early prostate-specific antigen (PSA) response. Design: Retrospective analysis of a clinical 177Lu-PSMA-I&T treatment programme. Methods: In all, 125 men were treated with 6-weekly 177LuPSMA-I&T [median 3 cycles, interquartile range (IQR): 2–4], median dose 8.0 GBq [95% confidence interval (CI): 7.5–8.0]. Imaging screening involved 68GaPSMA-11 PET/diagnostic CT. 177Lu-SPECT/diagnostic CT was acquired following each therapy, and clinical assessments 3-weekly. Following dose 2 (week 6), a composite PSA and 177Lu-SPECT/CT imaging response [partial response (PR), stable disease (SD), and progressive disease (PD)] determined ongoing management. Response group (RG) 1 (marked reduction in PSA/imaging PR) break in treatment until subsequent PSA rise, then re-treatment. RG 2 (stable or reduced PSA and/or imaging SD) 6-weekly treatments until six doses, or no longer clinically benefitting. RG 3 (rise in PSA and/or imaging PD) recommended for an alternative treatment. Results: Overall PSA50% response rate (PSARR) was 60% (75/125), median PSA-PFS 6.1 months (95%CI: 5.5–6.7), and median OS 16.8 months (95%CI: 13.5–20.1). 35% (41/116) were classified as RG 1, 34% (39/116) RG 2, and 31% (36/116) RG 3. PSARRs by RG were 95% (38/41), 74% (29/39), and 8% (3/36); median PSA-PFS rates were 12.1 months (95%CI: 9.3–17.4), 6.1 months (95%CI: 5.8–9.0), and 2.6 months (95%CI: 1.6–3.1); and OS rates were 19.2 months (95%CI: 16.8–20.7), 13.2 months (95%CI: 12.0–18.8), and 11.2 months (95%CI: 8.7–15.6) for RG 1, 2, and 3, respectively. The median months of ‘treatment holiday’ for RG 1 was 6.1 months (IQR: 3.4–8.7). Nine men had received prior 177LuPSMA-617 and were retreated with 177LuPSMA-I&T, with a PSARR of 56% on re-treatment. Conclusion: Personalising dosing regimens using early response biomarkers with 177LuPSMA has the potential to achieve similar treatment responses to continuous dosing while allowing treatment breaks or intensification. Further evaluation of early response biomarker-guided treatment regimens in prospective trials is warranted. Plain Language Summary Lutetium-PSMA therapy is a new therapy for metastatic prostate cancer that is well tolerated and effective. However, not all men respond equally, with some responding very well and others progressing early. Personalising treatments require tools that can accurately measure treatment responses, preferably early in the treatment course, so adjustments to treatment can be made. Lutetium-PSMA can measure tumour sites after each therapy by taking whole body 3D images at 24 h using a small radiation wave from the treatment itself. This is called a SPECT scan. Previous work has shown that both prostate-specific antigen (PSA) response and changes in tumour volume on a SPECT scan can predict how patients will respond to treatment as early as dose 2. This study demonstrates that stratifying how men are treated based on the results of the 6-week SPECT scan and PSA response potentially allows a third of men to have break in treatment and that these men have both longer time to disease progression and OS. Men with an increase in tumour volume and increase in PSA early in treatment (6 weeks) had shorter time to disease progression and OS. Men with early biomarker disease progression were offered alternative treatments early in an attempt to allow the opportunity to allow a more effective potential therapy, if one was available. The study is an analysis of a clinical programme, and was not a prospective trial. As such, there are potential biases that could influence results. Hence, while the study is encouraging for the use of early response biomarkers to guide better treatment decisions, this must be validated in a well-designed clinical trial.

100 Deals associated with RG-002(RinuaGene Biotechnology )

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Indication	Highest Phase	Country/Location	Organization	Date
Cervical Intraepithelial Neoplasia	Phase 2	-	RinuaGene Biotechnology Co., Ltd.	01 Mar 2024
HPV16 Infection	Phase 2	-	RinuaGene Biotechnology Co., Ltd.	01 Mar 2024
human papilloma virus infection type 18	Phase 2	-	RinuaGene Biotechnology Co., Ltd.	01 Mar 2024
Neoplasms	IND Application	CN	RinuaGene Biotechnology Co., Ltd.	13 Sep 2024

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