MSK新型T细胞疗法获FDA突破性药物认证
认证网 (2015/3/3 13:10:42) 浏览:269 评论:0
2015年3月3日讯 /生物谷BIOON/-- 骨髓移植是治疗白血病等重大疾病的重要疗法之一。然而这种疗法经常会导致一些异源物质如病毒侵入机体。最近美国的纪念斯隆凯特林肿瘤研发中心宣布，FDA已经授予其开发的新型T细胞疗法突破性疗法认证。这种新型T细胞疗法有望极大程度改善这一现状。
据了解，这一疗法是由纪念斯隆凯特林肿瘤研发中心和Atara医药公司共同开发的，主要用于治疗骨髓移植时造成的EBV（一种人类疱疹病毒）感染以及由此引发的肿瘤。研究人员首先在体外培育来自第三方的健康T细胞，并对其表面抗原进行修饰。这些修饰后的T细胞能够在患者体内特异性的识别并清除这些有EBV表达的肿瘤细胞。目前这一疗法正处于临床二期研究阶段。此次FDA的突破性药物认证无疑将大大加速这一疗法的开发进度。
此外，这一疗法也是纪念斯隆凯特林肿瘤研发中心众多产学结合项目的一个。作为美国著名的生物医药研究中心，纪念斯隆凯特林肿瘤研发中心建立了一套成果转化的完整渠道。此前，该中心就与著名的免疫疗法巨头Juno公司建立了研发合作关系。而此次T细胞疗法合作的另一方Atara公司则是于今年九月份加入到这一研究项目中的。Atara公司主要致力于抗体药物等免疫疗法的开发。去年十月份，Atara公司刚刚完成一笔总额5500万美元的IPO。（生物谷Bioon.com）
详细英文报道：
Memorial Sloan Kettering Cancer Center picked up the FDA's coveted breakthrough-therapy designation for a promising T cell therapy, working with partner Atara Biotherapeutics ($ATRA) to get it on the market for patients with complications tied to bone marrow transplants.
The treatment, dubbed EBV-CTL, uses off-the-shelf cytotoxic T lymphocytes to attack cancer cells associated with Epstein-Barr virus (EBV), which often crop up in patients who have just received new bone marrow. MSK developed the therapy by harvesting healthy T cells from third-party donors and exposing them to certain antigens, creating souped-up cells that can home in on EBV-expressing tumors and kill them. The center is currently running a Phase II trial with the therapy.
The breakthrough tag guarantees MSK and Atara greater access to FDA experts during the development process and a speedy review if and when they submit the treatment. And it brings the partners "one step closer to our ultimate goal of making EBV-CTL available to all patients with EBV-LPD, a serious and life threatening condition with limited treatment options," MSK Pediatrics Chairman Richard O'Reilly said in a statement.
Atara got involved in the program in September, signing a deal in which it traded an undisclosed amount of cash and stock to MSK in exchange for exclusive options on three T cell projects. Beyond MSK's work in EBV, the biotech has optioned a Phase II cytomegalovirus program and a Phase I effort targeting Wilms tumor 1.
The deal closely followed Atara's $55 million IPO, executed in October, and expanded the biotech's pipeline beyond its core competency of molecularly targeted treatments. Outside of its MSK-partnered projects, Atara is working on the Phase II PINTA 745, a peptide-antibody combo that inhibits myostatin in order to fight protein energy wasting; STM 434, a Phase I oncology therapy that inhibits activin to kill off ovarian cancer and other solid tumors; and NINA 842, a preclinical myostatin-targeting antibody designed to combat cancer-related weight loss.
For MSK, the agreement is one of its many industry tie-ups, headlined by a novel deal with Juno Therapeutics ($JUNO) in which the center is eligible for escalating payments as the high-profile biotech's share price moves upward.
据了解，这一疗法是由纪念斯隆凯特林肿瘤研发中心和Atara医药公司共同开发的，主要用于治疗骨髓移植时造成的EBV（一种人类疱疹病毒）感染以及由此引发的肿瘤。研究人员首先在体外培育来自第三方的健康T细胞，并对其表面抗原进行修饰。这些修饰后的T细胞能够在患者体内特异性的识别并清除这些有EBV表达的肿瘤细胞。目前这一疗法正处于临床二期研究阶段。此次FDA的突破性药物认证无疑将大大加速这一疗法的开发进度。
此外，这一疗法也是纪念斯隆凯特林肿瘤研发中心众多产学结合项目的一个。作为美国著名的生物医药研究中心，纪念斯隆凯特林肿瘤研发中心建立了一套成果转化的完整渠道。此前，该中心就与著名的免疫疗法巨头Juno公司建立了研发合作关系。而此次T细胞疗法合作的另一方Atara公司则是于今年九月份加入到这一研究项目中的。Atara公司主要致力于抗体药物等免疫疗法的开发。去年十月份，Atara公司刚刚完成一笔总额5500万美元的IPO。（生物谷Bioon.com）
详细英文报道：
Memorial Sloan Kettering Cancer Center picked up the FDA's coveted breakthrough-therapy designation for a promising T cell therapy, working with partner Atara Biotherapeutics ($ATRA) to get it on the market for patients with complications tied to bone marrow transplants.
The treatment, dubbed EBV-CTL, uses off-the-shelf cytotoxic T lymphocytes to attack cancer cells associated with Epstein-Barr virus (EBV), which often crop up in patients who have just received new bone marrow. MSK developed the therapy by harvesting healthy T cells from third-party donors and exposing them to certain antigens, creating souped-up cells that can home in on EBV-expressing tumors and kill them. The center is currently running a Phase II trial with the therapy.
The breakthrough tag guarantees MSK and Atara greater access to FDA experts during the development process and a speedy review if and when they submit the treatment. And it brings the partners "one step closer to our ultimate goal of making EBV-CTL available to all patients with EBV-LPD, a serious and life threatening condition with limited treatment options," MSK Pediatrics Chairman Richard O'Reilly said in a statement.
Atara got involved in the program in September, signing a deal in which it traded an undisclosed amount of cash and stock to MSK in exchange for exclusive options on three T cell projects. Beyond MSK's work in EBV, the biotech has optioned a Phase II cytomegalovirus program and a Phase I effort targeting Wilms tumor 1.
The deal closely followed Atara's $55 million IPO, executed in October, and expanded the biotech's pipeline beyond its core competency of molecularly targeted treatments. Outside of its MSK-partnered projects, Atara is working on the Phase II PINTA 745, a peptide-antibody combo that inhibits myostatin in order to fight protein energy wasting; STM 434, a Phase I oncology therapy that inhibits activin to kill off ovarian cancer and other solid tumors; and NINA 842, a preclinical myostatin-targeting antibody designed to combat cancer-related weight loss.
For MSK, the agreement is one of its many industry tie-ups, headlined by a novel deal with Juno Therapeutics ($JUNO) in which the center is eligible for escalating payments as the high-profile biotech's share price moves upward.
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