PSA targeted vaccine(Etubics Corp.)(PSA targeted vaccine(Etubics Corp.)) - 药物靶点：KLK3_在研适应症：前列腺癌_专利_临床

概要

基本信息

药物类型

重组载体疫苗、预防性疫苗

别名

Adenoviral PSA vaccine、hAd5-PSA、PSA targeted vaccine

+ [4]

靶点

KLK3

作用机制

KLK3调节剂(前列腺特异性抗原调节剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

National Cancer Institute

最高研发阶段临床1期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

1

项与 PSA targeted vaccine(Etubics Corp.) 相关的临床试验

NCT03481816 / Completed临床1期IIT

Treatment of Patients With Castration Resistant Prostate Cancer Using a Multi-Targeted Recombinant Ad5 PSA/MUC1/Brachyury Based Immunotherapy Vaccines

Background:
Metastatic castration resistant prostate cancer (mCRPC) keeps growing even when the amount of testosterone in the body is reduced to very low levels. mCRPC is incurable. Researchers want to develop vaccines to teach the immune system to target and kill cancer cells. They want to test three of these vaccines (ETBX-071, ETBX-061, and ETBX-051) against mCRPC.
Objective:
To test the safety of combination ETBX-071, ETBX-061, and ETBX-051 and to study their effects on the immune system.
Eligibility:
People ages 18 and older with mCRPC that has not responded to standard therapies
Design:
Participants will be screened with:
Medical history
Physical exam
Blood, urine, and heart tests
Computed tomography (CT) or magnetic resonance imaging (MRI) scans
Bone scan
Participants will get the vaccines as shots under the skin every 3 weeks for 3 doses. They may then have the shots every 8 weeks for up to 1 year.
Participants will keep a diary to record any symptoms from the vaccines.
Participants will have blood tests each time they get the vaccines. They will also have scans and other tests to measure the effect the vaccines have on their tumors.
Participants will have a visit within 28 days after their last treatment. This includes a physical exam and blood and urine tests.
Participants will then be contacted by phone every 3 months for the first year, every 6 months for the next 2 years, and every 12 months for another 2 years.
Participants will be asked to join a long-term follow up study.

开始日期2018-07-24

申办/合作机构

National Cancer Institute

100 项与 PSA targeted vaccine(Etubics Corp.) 相关的临床结果

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100 项与 PSA targeted vaccine(Etubics Corp.) 相关的转化医学

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100 项与 PSA targeted vaccine(Etubics Corp.) 相关的专利（医药）

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29

项与 PSA targeted vaccine(Etubics Corp.) 相关的文献（医药）

2023-11-01·Research and practice in thrombosis and haemostasis

Vaccine-induced immune thrombotic thrombocytopenia post COVID-19 booster vaccination in Brazil: a case series

Article

作者: Melo de Amorim Filho, Luiz ; Ferreira, Diogenes Seraphim ; Bise Viegas, Anna Paula ; Xavier, Janaína Reis ; Júlio, Liliam Cristiana ; Jenifer da Silva Araújo Cunha, Juliana ; Takey, Paulo Roberto Gomes ; Ferreira, Rosane ; Morgenstern, Georgia Karina ; Marques de Figueiredo, Risoleide ; Bertollo Gomes Porto, Victor ; Greffe, Nadja ; Pietrowski Bertuol, Ana Paula ; Garcez, Tatiana ; Lima Frizzera, Renata Loss ; Palm, Cláudia Weingaertner ; Abreu, Debora Lima ; Nunes, Gabriele Tantos ; Mattos de Carvalho, Isis ; Lignani, Letícia Kegele ; Zago, Luzia ; Pereira, Tainá dos Santos ; Burger, Marion ; Fernandes, Eder Gatti ; Mendes-de-Almeida, Daniela P. ; Genuino de Souza, Thaina ; Rodrigues, Juliana Vassalo ; Vitiello Teixeira, Gabriellen ; Kamoi, Tsukiyo Obu ; Filho, Rubens Costa ; Furtado, Barbara Emoingt ; Sousa Maia, Maria de Lourdes de ; Nascimento Costa, Nathalya Macedo ; Castro, Thalita da Matta de ; Freire, Claudio Renato ; Saraiva Pedro, Renata ; Mouta Nunes de Oliveira, Patrícia

Background:

The emergence of new variants of SARS-CoV-2 has led to the administration of different booster vaccines to mitigate COVID-19. Vaccines with adenoviral vectors have been rarely associated with vaccine-induced immune thrombotic thrombocytopenia (VITT).

Objectives:

This study aimed to describe 15 cases of VITT after the third and fourth doses of the COVID-19 vaccine in Brazil.

Methods:

Cases were reported after all kinds of anti-SARS-CoV-2 booster vaccinations between October 17, 2021, and September 4, 2022.

Results:

Of the 26 suspected cases, 15 cases of VITT were analyzed. Of these, 10 were classified as definite VITT, 2 as probable, 1 as possible, and 2 as unlikely. The estimated frequency of definite, probable, or possible VITT was 0.33 cases per million. Cases were assigned to ChAdOx1 (13 cases), Ad26.COV2.S (1 case), and BNT162b2 (1 case). None of the patients received an adenoviral vaccine as a primary vaccination. The average age of participants was 34 years, and symptoms usually appeared 8 days after vaccination. Headache was the most common symptom, and cerebral veins were the most affected thrombotic site. The overall mortality risk was 53%. Anti-platelet factor 4 enzyme-linked immunosorbent assay serology was positive in 11 out of 15 patients (73.3%), negative in 2 (13.3%), and missing in 2 (13.3%).

Conclusion:

The study confirms that VITT is linked to the first exposure to adenoviral vector vaccines. Since January 2023, Brazil has recommended preferably COVID-19 messenger RNA vaccines for individuals aged 18 to 39 years. We suggest that, in the current disease scenario, COVID-19 adenovirus vaccines should not be the first choice for individuals aged <50 years who have not received a previous dose of this type of vaccine.

2020-11-01·Journal of stomatology, oral and maxillofacial surgery4区 · 医学

Bone regeneration and mineralisation was promoted during distraction osteogenesis by human periostin gene in rabbit mandibular model

4区 · 医学

Article

作者: Huang, H ; Peng, H ; Chen, J ; Jiang, X ; Chen, Y

OBJECTIVE:

To study the effect of periostin gene on bone regeneration and mineralisation during distraction osteogenesis (DO) in a rabbit mandibular model.

SUBJECTS AND METHODS:

A total of 54 New Zealand white rabbits underwent mandibular lengthening and were divided into group A and group B (n=27, each). At the end of the distraction, adenoviruses containing human POSTN/enhanced green fluorescent protein (Ad5-POSTN/EGFP) viruses or Ad5-POSTN viruses were injected into the distraction gaps in the group B or A, respectively. On the 4th and 8th week after distraction, eight samples, randomly selected from each group, were subjected to CT scanning and dual energy X-ray absorptiometry detection. All animals from each group were sacrificed for micro-CT, histology, and three-point bend testing eight weeks after DO.

RESULTS:

The CT images showed that callus in the distraction gap of group B was significantly better than that of group A. On the 4th and 8th weeks, the bone mineral densities (BMD) of the bone tissue in the distraction gap of the group B were 0.163±0.011g/cm² and 0.239±0.024g/cm², respectively, while the bone mineral contents (BMC) was 0.099±0.011g and 0.205±0.018g, respectively, which were significantly higher compared with group A. Histological sections showed that the trabecular bone in the distraction gap of group B was more coarse. On the basis of micro-CT images and micro-architecture parameters show that the microstructure of the distraction gap of the group B had more mature characteristics. The biomechanical strength of the distracted gap in the group B was 234.30±30.48N, which was 1.28 times higher than that in the group A (P=0.003).

CONCLUSION:

Local transduction with human periostin gene would promote osteogenesis and mineralisation in a rabbit mandibular DO model. Periostin might be considered for clinical use if only there is a safe and effective administration method.

2015-03-02·The Journal of clinical investigation1区 · 医学

Antigen expression determines adenoviral vaccine potency independent of IFN and STING signaling

1区 · 医学

Article

作者: Geoffrey M. Lynn ; Alfredo Nicosia ; Antonella Folgori ; Stefano Colloca ; Ayako Yamamoto ; Daniel E. Zak ; Riccardo Cortese ; Lingshu Wang ; Kathrin Kastenmuller ; Mario Roederer ; Kylie M. Quinn ; Jason G.D. Gall ; Ross W.B. Lindsay ; Emma Gostick ; Robert A. Seder ; Brenna J. Hill ; David A. Price ; Andreia Costa ; Patricia A. Darrah ; Alan Aderem ; Cheng Cheng

Recombinant adenoviral vectors (rAds) are lead vaccine candidates for protection against a variety of pathogens, including Ebola, HIV, tuberculosis, and malaria, due to their ability to potently induce T cell immunity in humans. However, the ability to induce protective cellular immunity varies among rAds. Here, we assessed the mechanisms that control the potency of CD8 T cell responses in murine models following vaccination with human-, chimpanzee-, and simian-derived rAds encoding SIV-Gag antigen (Ag). After rAd vaccination, we quantified Ag expression and performed expression profiling of innate immune response genes in the draining lymph node. Human-derived rAd5 and chimpanzee-derived chAd3 were the most potent rAds and induced high and persistent Ag expression with low innate gene activation, while less potent rAds induced less Ag expression and robustly induced innate immunity genes that were primarily associated with IFN signaling. Abrogation of type I IFN or stimulator of IFN genes (STING) signaling increased Ag expression and accelerated CD8 T cell response kinetics but did not alter memory responses or protection. These findings reveal that the magnitude of rAd-induced memory CD8 T cell immune responses correlates with Ag expression but is independent of IFN and STING and provide criteria for optimizing protective CD8 T cell immunity with rAd vaccines.

100 项与 PSA targeted vaccine(Etubics Corp.) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
转移性去势抵抗性前列腺癌	临床1期	美国	National Cancer Institute	2018-07-24
前列腺癌	临床1期	-	Etubics Corp.	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03481816 (CTgov)	临床1期	去势抵抗性前列腺癌 \| 转移性去势抵抗性前列腺癌	18	ETBX-061; adenoviral MUC1 vaccine+ETBX-071; adenoviral PSA vaccine+ETBX-051; adenoviral brachyury vaccine (Arm 1/Dose De-Escalation)	窪鹹壓製積積夢遞蓋膚(廠膚淵製餘襯淵願餘範) = 積構築鬱鹹膚製淵鬱餘蓋鏇範壓壓範鑰願網鬱 (鏇憲淵窪齋膚壓願鬱襯, 窪衊鏇憲衊簾糧蓋窪壓 ~ 襯築顧襯鹹鹽願簾艱願) 更多	-	2020-12-22
NCT03481816 (CTgov)	临床1期	去势抵抗性前列腺癌 \| 转移性去势抵抗性前列腺癌	18	ETBX-061; adenoviral MUC1 vaccine+ETBX-071; adenoviral PSA vaccine+ETBX-051; adenoviral brachyury vaccine (Arm 2/Dose Expansion)	窪鹹壓製積積夢遞蓋膚(廠膚淵製餘襯淵願餘範) = 膚壓齋築顧鹽構壓觸築蓋鏇範壓壓範鑰願網鬱 (鏇憲淵窪齋膚壓願鬱襯, 網淵糧築餘範鹽簾顧顧 ~ 衊窪憲淵糧獵襯壓襯鑰) 更多	-	2020-12-22
NCT03481816 (ESMO2019)	临床1期	转移性去势抵抗性前列腺癌	12	Ad5 PSA/MUC-1/Brachyury Vaccine	觸蓋醖鑰簾醖顧簾夢鬱(餘築製鏇鏇鑰餘願積蓋) = 襯遞網艱積鏇鬱築網選壓齋蓋鹽鹹鏇選繭糧餘 (衊艱鏇鹹鏇壓餘壓夢範 )	-	2019-09-30