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罗氏公司和Inovio制药Inovio的前列腺癌和乙肝免疫产品的合作   [复制链接]

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发表于 2013-9-10 18:06 |只看该作者 |倒序浏览 |打印
Roche and Inovio Pharmaceuticals partner on Inovio's prostate cancer and hepatitis B immunotherapy products

PR Newswire

BASEL, Switzerland and BLUE BELL, Pa., Sept. 10, 2013


BASEL, Switzerland and BLUE BELL, Pa., Sept. 10, 2013 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) and Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that they have entered into an exclusive worldwide license agreement to research, develop and commercialize Inovio's highly-optimized, multi-antigen DNA immunotherapies targeting prostate cancer and hepatitis B. The licensed compounds are currently in preclinical development and have generated robust T-cell responses in animal models.

Roche acquired an exclusive license for Inovio's DNA-based vaccines INO-5150 (targeting prostate cancer) and INO-1800 (targeting hepatitis B) as well as the use of Inovio's CELLECTRA® electroporation technology for delivery of the vaccines. Roche also obtained an option to license additional vaccine opportunities in connection with a collaborative research program in oncology.  Roche and Inovio will collaborate to further develop INO-5150 and INO-1800.

Under the terms of the agreement, Roche will make an upfront payment of USD $10 million to Inovio. Roche will also provide preclinical R&D support and payments for near-term regulatory milestones  as well as payments upon reaching certain development and commercial milestones potentially up to USD $412.5 million. Additional development milestone payments could also be made to Inovio if Roche pursues other indications with INO-5150 or INO-1800.  In addition, Inovio is entitled to receive up to double-digit tiered royalties on product sales.

Commenting on the deal, Hy Levitsky, Head of Cancer Immunology Experimental Medicine at Roche, said: "At Roche we are always interested in finding first-in-class and best-in-class therapies that may become the next generation treatments for patients with different types of cancer. INO-5150 will allow promising combination opportunities with the Roche portfolio, particularly with our emerging cancer immunotherapy molecules." Janet Hammond, Head of Infectious Diseases Discovery & Translational Area at Roche, added: "We are very excited to have this potentially very important and novel mechanism of action as part of our portfolio as we seek to address the significant unmet medical need in chronic hepatitis B infection."

"This partnership represents an important milestone in Inovio's growth and maturing product portfolio. Roche brings to our immunotherapy candidates its leadership position and track record for developing and marketing innovative first-in-class therapies," said Dr. J. Joseph Kim, Inovio's President and CEO. "Collaborating with the world's preeminent oncology development partner allows us to rapidly advance two of our promising near-clinical stage immunotherapy products from our product pipeline as we continue development of our phase II lead product, VGX-3100, for treatment of  HPV-related cancers and dysplasia."

About INO-5150 for Prostate Cancer
Inovio's dual-antigen synthetic DNA vaccine (INO-5150) targets prostate-specific membrane antigen (PSMA) and prostate-specific antigen (PSA). A study in monkeys showed that vaccination with INO-5150 generated strong and robust T-cell immune responses that were the highest generated by a PSA-based immunotherapy in animal studies and were similar to the immune responses generated by VGX-3100, Inovio's phase II-stage therapeutic HPV vaccine that generated best-in-class T-cell responses in a phase I study.

Inovio's SynCon® DNA vaccine for prostate cancer was designed with PSA and PSMA synthetic consensus immunogens based on human and macaque sequences, resulting in amino acid sequences that differ slightly from the native human protein. In humans, this novel approach is utilized to help the body's immune system recognize cancerous cells created in the body as 'foreign', overcoming the body's self-tolerance of these cells and mounting an immune response to clear them.

About INO-1800 for Hepatitis B
Inovio has reported preclinical data showing its hepatitis B vaccine (INO-1800) generated strong T-cell and antibody responses that led to the elimination of targeted liver cells in mice. These results indicate this DNA vaccine's potential to treat hepatitis B infection and prevent further development of the infection into liver cancer in humans.

In a preclinical study, researchers found the vaccine-specific T-cells exhibited a killing function, and could migrate to and stay in the liver and cause clearance of target cells without evidence of liver injury. This was the first study to provide evidence that intramuscular immunization can induce killer T-cells that can migrate to the liver and eliminate target cells.

To provide worldwide rights to Roche, Inovio has re-acquired its hepatitis B, Asian-country rights from Inovio's international affiliate.

Read more: http://www.digitaljournal.com/pr/1457624#ixzz2eTsDK2SD

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发表于 2013-9-10 18:07 |只看该作者
罗氏公司和Inovio制药Inovio的前列腺癌和乙肝免疫产品的合作伙伴

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瑞士的巴塞尔, BLUE BELL ,宾夕法尼亚州, 2013年9月10日


瑞士的巴塞尔, BLUE BELL ,宾夕法尼亚州9月10日, 2013 /美通社- PR Newswire / - 罗氏( SIX : RO , ROG ; OTCQX : RHHBY)和Inovio制药公司( NYSE MKT : INO )今天宣布,他们已经进入进入全球独家许可协议,以研究,开发和商业化Inovio的高度优化的,多抗原DNA免疫疗法针对前列腺癌和B型肝炎的许可化合物,目前处于临床前开发,并已在动物模型中产生强大的T细胞反应。

罗氏收购Inovio的基于DNA的疫苗INO - 5150 (针对前列腺癌)和INO- 1800 (针对B型肝炎)以及疫苗交付使用, Inovio的CELLECTRA的®电穿孔技术的独家授权。罗氏公司还获得了额外的疫苗与肿瘤的一个合作研究项目的机会选项许可。罗氏和Inovio将合作进一步发展INO- 5150和INO- 1800 。

根据该协议的条款,罗氏将Inovio 1000万美元的预付款。罗氏公司也将提供临床前研发支持和短期的监管里程碑,以及支付的款项可能高达USD 412500000美元后达到一定的发展和商业里程碑。其他发展里程碑付款,也可以Inovio ,如果罗氏奉行INO- 5150或INO- 1800与其他适应症。此外, Inovio有权获得高达双位数​​的分层产品销售的版税。

在谈到这笔交易时,HY Levitsky ,罗氏在癌症免疫学实验医学主管说: “在罗氏,我们总是有兴趣发现第一类和最佳的一流的治疗,可能成为新一代治疗患者的不同类型的癌症, INO - 5150将与罗氏组合允许有前途的组合的机会,特别是与新出现的癌症免疫治疗分子。 “珍妮特·哈蒙德,罗氏传染病的发现与转化区主管补充说:“我们很高兴能有这种可能非常重要和新颖的作用机制,为我们的投资组合的一部分,我们寻求解决重大的未满足的医疗需要在慢性肝炎病毒的感染。 “

Inovio的增长和成熟的产品组合,这种合作伙伴关系的一个重要里程碑。罗氏带给我们的免疫候选人的领导地位,并开发和营销创新的第一级治疗纪录,博士说:“ J.约瑟夫金, Inovio的总裁和首席执行官。 “与世界卓越肿瘤发展伙伴合作让我们来迅速推进我们的前途接近临床阶段免疫产品从我们的产品管道作为我们继续发展我们的二期铅产品, VGX - 3100 ,用于治疗HPV相关癌症发育不良。 “

关于前列腺癌INO- 5150
Inovio的双抗原合成的DNA疫苗( INO -5150 )针对前列腺特异性膜抗原( PSMA ) ,前列腺特异性抗原(PSA) 。在猴子的研究表明, INO - 5150接种疫苗产生强而稳健的T-细胞免疫的反应,是一个基于PSA免疫疗法在动物研究中所产生的最高的和类似的VGX - 3100 , Inovio的相II所产生的免疫响应阶段治疗HPV疫苗产生最佳的一流的I期研究中的T细胞反应。

Inovio的SynCon ® DNA疫苗对前列腺癌的设计PSA和PSMA免疫原基础上略有不同,从本地的人类蛋白质的氨基酸序列,导致人类和猕猴序列合成的共识。在人类中,这种新方法被用来帮助人体的免疫系统识别癌细胞在体内建立'外国' ,克服身体的自我容忍这些细胞和安装的免疫反应来清除它们。

关于INO- 1800 B型肝炎
Inovio报告的临床数据显示其乙肝疫苗( INO 1800 )产生了浓厚的T细胞和抗体反应,导致小鼠肝细胞有针对性的消除​​。这些结果表明,该DNA疫苗的潜在的治疗乙型肝炎感染和防止进一步发展成肝癌的感染在人类。

在临床前研究中,研究人员发现,疫苗的特异性T细胞具有杀伤功能,可以迁移到无肝损伤的证据留在肝脏,引起靶细胞的间隙。这是首次研究提供证据肌肉注射免疫诱导杀伤性T细胞可以迁移到肝脏和消除靶细胞。

Inovio要提供全球罗氏公司的权利,已重新获得其B型肝炎, Inovio的国际分支机构的亚洲国家的权利。

阅读更多: http://www.digitaljournal.com/pr/1457624 # ixzz2eTsDK2SD的

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发表于 2013-9-10 18:58 |只看该作者
“这是首次研究提供证据肌肉注射免疫诱导杀伤性T细胞可以迁移到肝脏和消除靶细胞”。

这是个什么药?是治疗性疫苗吗?

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发表于 2013-9-10 20:18 |只看该作者
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是治疗性DNA疫苗, 输送使用电穿孔(electroportion)

Highly Efficient Electroporation Delivery of SynCon® Vaccine Enables
Best-in-Class Immune Responses

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发表于 2013-9-10 21:13 |只看该作者
本帖最后由 诗意栖居 于 2013-9-10 21:16 编辑

关于INO-1800(治疗性乙肝疫苗)
        Inovio公司已发布HBV疫苗INO-1800的临床前试验数据。INO-1800能产生强力的T细胞和抗体响应,这些响应能杀灭大鼠被感染的肝细胞。这表明,这种DNA疫苗具有治疗HBV感染的潜力,并能阻断感染的进一步发展。
        在临床前试验中,该疫苗的特异性T细胞表现出杀灭病毒的功能,并可以运移到和停留在肝脏中,在不导致肝损伤的情况下,能够引起靶细胞的清除。这是首次证实肌内免疫能够激发具有免疫能力的T细胞进入肝脏并杀灭被感染的肝细胞。

(向本文提供者Stephen致敬!)
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发表于 2013-9-10 22:10 |只看该作者
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好消息!!!

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发表于 2013-9-10 23:00 |只看该作者
希望能得到一个好的结果。

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发表于 2013-9-10 23:01 |只看该作者
希望能得到一个好的结果。

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发表于 2013-9-11 17:01 |只看该作者
欢迎收看肝胆卫士大型生活服务类节目《乙肝勿扰》,我们的目标是:普度众友,收获幸福。
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发表于 2013-9-11 19:03 |只看该作者
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