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DxVx计划与OVM-200达成协议,并在亚洲进行临床试验

DxVx, plans to make a license-in agreement of OVM-200 and conduct clinical trials in Asia

PR Newswire 等信源发布 2023-11-24 22:00

可切换为仅中文


- Final stage in licensing OVM-200 from Oxford Vacmedix in the UK- DxVx plans to proceed its own clinical trials in Asia, including Korea and China

-从英国牛津Vacmedix获得OVM-200许可的最后阶段-DxVx计划在亚洲进行自己的临床试验,包括韩国和中国

SEOUL, South Korea, Nov. 24, 2023 /PRNewswire/ -- DxVx announces today that it will conduct its own clinical trials of OVM-200, an anti-cancer vaccine from Oxford Vacmedix(OVM) by license-in agreement and develop further with its own new drug development knowledge. Currently, the vaccine has completed a Phase 1a clinical trial in the first half of this year and is expected to start a Phase 1b trial soon..

韩国首尔,2023年11月24日/PRNewswire/--DxVx今天宣布,它将通过许可协议对牛津Vacmedix(OVM)的抗癌疫苗OVM-200进行自己的临床试验,并进一步发展拥有自己的新药开发知识。目前,该疫苗已于今年上半年完成1a期临床试验,预计即将开始1b期试验。。

OVM-200 has achieved successful results in a Phase 1a clinical trial and a new publication in Advanced Therapeutics comprehensively reviews the rationale and preclinical results for OVM-200 both alone and in combination. A Phase 1b clinical trials are under discussion to be conducted in the UK by OVM and in Asia, including Korea and China, by Dx&Vx..

OVM-200在1a期临床试验中取得了成功,Advanced Therapeutics的新出版物全面回顾了OVM-200单独或联合使用的基本原理和临床前结果。OVM正在英国进行1b期临床试验,Dx&Vx将在亚洲(包括韩国和中国)进行1b期临床试验。。

OVM-200 is a therapeutic vaccine that enters the body and kills cancer cells. Over time, even if new cancer cells arise, immune cells remember and eliminate the cancer cells.

OVM-200是一种进入人体并杀死癌细胞的治疗性疫苗。随着时间的推移,即使出现新的癌细胞,免疫细胞也会记住并消除癌细胞。

In particular, the ROP (Recombinant Overlapping Peptide) technology used in OVM-200 cancer vaccines significantly enhances immunity and vaccine efficacy. In addition, the targeting of survivin(anti-apoptotic protein), which is closely related to cancers, and the fact that DxVx has a large number of experts with rich experience in the new drug development and commercialization are also considered to be differentiators..

特别地,OVM-200癌症疫苗中使用的ROP(重组重叠肽)技术显着增强免疫和疫苗功效。此外,与癌症密切相关的survivin(抗凋亡蛋白)的靶向以及DxVx在新药开发和商业化方面拥有丰富经验的大量专家也被认为是差异化的。。

OVM-200 is highly safe as it is a peptide vaccine. Vaccines based on mRNA or viral particles are not immune to the safety concerns highlighted by the COVID-19 pandemic. On the other hand, vaccines based on recombinant proteins have significant advantages in terms of stability, as their safety has been proven over a long period of time..

OVM-200是一种高度安全的肽疫苗。基于mRNA或病毒颗粒的疫苗对COVID-19大流行突出的安全性问题不具备免疫力。另一方面,基于重组蛋白的疫苗在稳定性方面具有显着的优势,因为它们的安全性已经在很长一段时间内得到证实。。

In addition, the method of selecting and targeting a single antigenic peptide only works for a limited number of HLAs(human leukocyte antigen), an identifier that helps the immune system distinguish itself from foreign substances, but in the case of peptide complexes, it is expected to increase treatment efficacy because it is likely to act on more diverse HLAs (about 30 types)..

此外,选择和靶向单一抗原肽的方法仅适用于有限数量的HLA(人白细胞抗原),这是一种帮助免疫系统区别于外来物质的标识符,但在肽复合物的情况下,它预计会提高治疗效果,因为它可能作用于更多样化的HLA(约30种类型)。。

Furthermore, OVM's Recombinant Overlapping Peptides (ROP) platform technology has superior production and cost advantages over existing peptide complex technology, which produces and mixes multiple peptides. The ROP platform technology is a peptide complex technology that produces one long overlapping peptide, which is cleaved into individual peptides by human enzymes in vivo.

此外,OVM的重组重叠肽(ROP)平台技术与现有的肽复合物技术相比具有优越的生产和成本优势,后者可生产和混合多种肽。ROP平台技术是一种肽复合技术,可产生一个长重叠肽,该肽在体内被人体酶切割成单个肽。

It is therefore expected to have advantages in terms of CMC, production process, cost, etc..

因此,预计在CMC,生产工艺,成本等方面具有优势。。

DX&VX believes that if adequate data is collected showing that OVM-200 improves the prognosis of chemotherapy patients and prevents relapse, it will be also possible to develop a vaccine for cancer prevention.

DX&VX认为,如果收集到足够的数据显示OVM-200可改善化疗患者的预后并防止复发,那么开发预防癌症的疫苗也是可能的。

Safety is paramount when it comes to preventive vaccines. Even a little toxicity is unacceptable in terms of safety, because it is a preventive vaccine to be given to healthy people who have not yet been diagnosed. OVM-200 is a traditional recombinant protein vaccine and has a very high likelihood of success because it is a type of vaccine that has a long history of clinical safety..

在预防性疫苗方面,安全性至关重要。就安全性而言,即使是一点毒性也是不可接受的,因为它是一种预防性疫苗,可用于尚未确诊的健康人群。OVM-200是一种传统的重组蛋白疫苗,成功的可能性非常高,因为它是一种具有悠久临床安全历史的疫苗。。

A DxVx official said that they plan to complete the license-in process soon and proceed with Phase 1b and Phase 2 clinical trials in major Asian countries (Korea, China and considering India in the future). They will try to launch it through an accelerated approval that will allow patients to benefit early from effective drugs before all clinical trials are completed around 2027.

DxVx的一位官员表示,他们计划尽快完成许可证,并在亚洲主要国家(韩国,中国和未来考虑印度)进行1b期和2期临床试验。他们将尝试通过加速批准,使患者能够在2027年左右完成所有临床试验之前从有效药物中早期受益。

Of course, they are also considering collaborations with global Big Pharma if necessary in the future..

当然,如果将来有必要,他们也在考虑与全球大型制药公司合作。。

Dx&Vx is currently in the process of agreeing the licensing terms with OVM and coordinating the final details.

Dx&Vx目前正在与OVM达成许可条款并协调最终细节。

Meanwhile, OVM is a spin-off company from Oxford University in the UK, and Dx&Vx is the largest shareholder with a 43% stake.

与此同时,OVM是英国牛津大学的分拆公司,Dx&Vx是第一大股东,股权43%。

SOURCE Dx&Vx

源Dx和Vx