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PASADENA, Calif.--(BUSINESS WIRE)--Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and other serious diseases, announced it will regain exclusive worldwide rights to plamotamab, a CD20 x CD3 bispecific T-cell engager, which Xencor advanced through Phase 1 clinical development in hematologic cancers.
加利福尼亚州帕萨迪纳市(商业新闻短讯)--Xencor,Inc.(纳斯达克:XNCR),一家临床阶段的生物制药公司,开发用于治疗癌症和其他严重疾病的工程抗体,宣布将重新获得plamotamab的全球独家权利,plamotamab是一种CD20 x CD3双特异性T细胞接受者,Xencor在血液癌症的第一阶段临床开发中取得了进展。
In 2021, Xencor entered a collaboration and license agreement with Janssen Biotech, Inc. to develop and commercialize plamotamab and novel B-cell targeting bispecific antibodies designed to conditionally activate T cells through the CD28 co-stimulatory receptor. Xencor completed enrollment in a Phase 1 study of plamotamab in late 2023..
2021年,Xencor与Janssen Biotech,Inc.签订了合作和许可协议,以开发和商业化plamotamab和新型B细胞靶向双特异性抗体,旨在通过CD28共刺激受体有条件地激活T细胞。Xencor于2023年末完成了plamotamab的第一阶段研究。。
Xencor has been notified that Janssen will terminate its rights to plamotamab under the collaboration and license agreement. Janssen has retained its rights to develop and commercialize B-cell targeting CD28 bispecific antibodies, including JNJ-9401 (PSMA x CD28) and JNJ-1493 (CD20 x CD28).
Xencor已被通知,Janssen将根据合作和许可协议终止其对plamotamab的权利。Janssen保留了开发和商业化B细胞靶向CD28双特异性抗体的权利,包括JNJ-9401(PSMA x CD28)和JNJ-1493(CD20 x CD28)。
“Plamotamab is a Phase 2 ready, subcutaneously administered immune-cell directed cytotoxic antibody, and we will review its potential for addressing unmet medical needs,” said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. “Xencor’s CD28 platform remains the subject of two collaborations with Janssen.
Xencor总裁兼首席执行官Bassil Dahiyat博士说:“Plamotamab是一种2期就绪的皮下免疫细胞定向细胞毒性抗体,我们将审查其解决未满足医疗需求的潜力。”。“Xencor的CD28平台仍然是与杨森进行两次合作的主题。
JNJ-9401 and JNJ-1493 are clinical-stage CD28-targeting bispecific antibodies that J&J is currently developing in prostate cancer and B-cell malignancies, respectively, and both entered clinical development during the fourth quarter of 2023.”.
JNJ-9401和JNJ-1493是针对双特异性抗体的临床阶段CD28,J&J目前分别在前列腺癌和B细胞恶性肿瘤中发展,并且都在2023年第四季度进入临床开发。”。
Under Xencor’s two collaboration agreements with Janssen, Xencor and Janssen conducted joint research activities to discover XmAb® bispecific antibodies against CD28 and select targets, with Janssen maintaining exclusive worldwide rights to develop and commercialize licensed products identified from the research activities.
根据Xencor与Janssen的两项合作协议,Xencor和Janssen进行了联合研究活动,以发现针对CD28的XmAb®双特异性抗体并选择目标,Janssen拥有开发和商业化研究活动中确定的许可产品的全球独家权利。
Janssen has advanced JNJ-9401and JNJ-1493 into Phase 1 clinical studies.1,2.
Janssen将JNJ-9401和JNJ-1493推进了1期临床研究[1,2]。
Xencor is eligible to receive additional development, regulatory and sales-based milestone payments, and tiered royalties on approved products in the high-single to low-double digit percent range of net sales. Upon clinical proof-of-concept for each program, Xencor has the right to opt-in to fund 20% of development costs (JNJ-9401) or 15% of development costs (JNJ-1493 or other B-cell targeting bispecifics) and to perform up to 30% of detailing efforts in the United States.
Xencor有资格获得额外的开发、监管和基于销售的里程碑付款,以及批准产品的分层版税,净销售额的百分比范围从高单位数到低双位数。在每个项目的临床概念验证后,Xencor有权选择资助20%的开发成本(JNJ-9401)或15%的开发成本(JNJ-1493或其他B细胞靶向双特异性药物),并在美国执行高达30%的详细工作。
If Xencor exercises these rights, the Company would then be eligible to receive tiered royalties in the low-double digit to mid-teen percent range..
如果Xencor行使这些权利,那么该公司将有资格获得低两位数至中青少年百分比的分层版税。。
References
参考文献
ClinicalTrials.gov Identifier NCT06095089. “A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer.”
ClinicalTrials.gov标识符NCT06095089。“JNJ-87189401联合JNJ-78278343治疗晚期前列腺癌的研究。”
ClinicalTrials.gov Identifier NCT06139406. “A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer.”
ClinicalTrials.gov标识符NCT06139406。“一项针对B细胞非霍奇金淋巴瘤(NHLs)参与者的JNJ-87801493联合T细胞参与者的研究。”
About Plamotamab
关于Plamotamab
Plamotamab is an investigational XmAb® bispecific antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3). Engagement of CD3 by plamotamab activates T cells for highly potent and targeted killing of CD20-expressing cells.
Plamotamab是一种研究性XmAb®双特异性抗体,包含CD20结合结构域和细胞毒性T细胞结合结构域(CD3)。plamotamab参与CD3激活T细胞,以高效和靶向杀死表达CD20的细胞。
Data presented from a Phase 1 clinical study of plamotamab in patients with B-cell malignancies indicated intravenously administered plamotamab was generally well tolerated and demonstrated encouraging clinical activity.
来自B细胞恶性肿瘤患者的plamotamab 1期临床研究的数据表明,静脉注射plamotamab通常耐受性良好,并显示出令人鼓舞的临床活性。
About Xencor
关于Xencor
Xencor is a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of patients with cancer and other serious diseases. More than 20 candidates engineered with Xencor's XmAb® technology are in clinical development, and three XmAb medicines are marketed by partners.
Xencor是一家临床阶段的生物制药公司,开发用于治疗癌症和其他严重疾病患者的工程抗体。使用Xencor的XmAb®技术设计的20多种候选药物正在临床开发中,三种XmAb药物由合作伙伴销售。
Xencor's XmAb engineering technology enables small changes to a proteins structure that result in new mechanisms of therapeutic action. For more information, please visit www.xencor.com..
Xencor的XmAb工程技术使蛋白质结构发生微小变化,从而产生新的治疗作用机制。有关更多信息,请访问www.xencor.com。。
Forward-Looking Statements
前瞻性声明
Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by the use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” and similar terms, or by express or implied discussions relating to Xencor’s business, including, but not limited to, statements regarding the future evaluation of any product, potential future milestone and royalty payments, the quotations from Xencor's president and chief executive officer, and other statements that are not purely statements of historical fact.
本新闻稿中的某些声明可能构成适用证券法含义内的前瞻性声明。前瞻性陈述包括不纯粹是历史事实陈述的陈述,通常可以通过使用“潜在”、“可以”、“将要”、“计划”、“可能”、“可能”、“会”、“期望”、“预期”、“寻求”、“展望”、“相信”、“承诺”、“调查”等词语来识别,也可以通过与Xencor业务相关的明示或暗示讨论来识别,包括但不限于关于任何产品的未来评估、潜在的未来里程碑和版税支付、Xencor总裁和首席执行官的报价以及其他不纯粹是历史事实陈述的陈述。
Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results.
此类声明是根据Xencor管理层目前的信念、期望和假设做出的,并受到重大已知和未知风险、不确定性和其他因素的影响,这些因素可能导致实际结果、绩效或成就以及事件发生的时间与此类声明所暗示的时间有重大差异,因此这些声明不应被视为对未来绩效或结果的保证。
Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks, including the ability of publicly disclosed preliminary clinical trial data to support continued clinical development and regulatory approval for specific treatments, in each case as described in Xencor's public securities filings.
此类风险包括但不限于与发现、开发、制造和商业化安全有效的人类治疗药物过程相关的风险和其他风险,包括公开披露的初步临床试验数据支持持续临床开发和特定治疗的监管批准的能力,在每种情况下,如Xencor的公共证券文件所述。
For a discussion of these and other factors, please refer to Xencor's ann.
有关这些因素和其他因素的讨论,请参阅Xencor的ann。