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HOUSTON & SEATTLE--(BUSINESS WIRE)--Indapta Therapeutics, Inc., a privately held biotechnology company developing IDP-023, a natural killer (NK) cell therapy for the treatment of cancer, today announced that the company has initiated treatment of the first patients in its Phase 1 trial in multiple myeloma and Non-Hodgkin’s lymphoma.
休斯顿和西雅图--(商业新闻短讯)--Indapta Therapeutics,Inc.,一家私营生物技术公司,开发用于治疗癌症的自然杀伤(NK)细胞疗法IDP-023,今天宣布,该公司已开始治疗多发性骨髓瘤和非霍奇金淋巴瘤的第一阶段试验中的首批患者。
The patients were treated at the University of Texas MD Anderson Cancer Center and NEXT Oncology, Virginia..
这些患者在德克萨斯大学MD安德森癌症中心和弗吉尼亚州下一肿瘤中心接受治疗。。
The first patient received a single dose of IDP-023. The second patient has received the first of three planned doses of IDP-023. Subsequent cohorts of patients will receive three doses of IDP-023 with or without interleukin-2. Once safety of multiple doses in combination with interleukin-2 has been established, cohorts of patients with lymphoma and multiple myeloma will receive treatment with IDP-023 in combination with the monoclonal antibodies rituximab and daratumumab, respectively..
第一名患者接受了单剂量的IDP-023。第二名患者已接受三剂计划剂量的IDP-023中的第一剂。随后的患者队列将接受三剂IDP-023,有或没有白细胞介素-2。一旦确定了多剂量联合白细胞介素-2的安全性,淋巴瘤和多发性骨髓瘤患者队列将分别接受IDP-023联合单克隆抗体利妥昔单抗和达拉木单抗的治疗。。
“We are excited to transition to a clinical stage company,” said Dr. Mark Frohlich, CEO of Indapta. “Based on the encouraging clinical activity of NK cells demonstrated by others and the superior activity of IDP-023 compared to conventional NK cells in preclinical models, we are looking forward to evaluating the safety and clinical activity of IDP-023 in this Phase 1 trial.”.
Indapta首席执行官Mark Frohlich博士表示:“我们很高兴能过渡到临床阶段的公司。”。“基于其他人证明的NK细胞令人鼓舞的临床活性以及IDP-023在临床前模型中与常规NK细胞相比的优越活性,我们期待着在本阶段1试验中评估IDP-023的安全性和临床活性。”。
Indapta also announced that it has successfully manufactured sufficient IDP-023 to supply the Phase 1 clinical trial through the second half of 2024. “We are very pleased with the high yields we are achieving in our GMP production runs,” added Frohlich. “The recent improvements in our manufacturing process together with additional planned process changes should position us well for a competitive cost of goods by the time of product launch.”.
Indapta还宣布,它已经成功生产了足够的IDP-023,以在2024年下半年提供1期临床试验。“我们对GMP生产运行中取得的高产量感到非常满意,”Frohlich补充道。“最近我们制造流程的改进以及计划中的其他流程更改,将使我们在产品发布时拥有具有竞争力的商品成本。”。
Indapta’s Differentiated G-NK Cell Therapy
Indapta的分化G-NK细胞疗法
Indapta’s universal, allogeneic NK cell therapy platform consists of a potent subset of naturally occurring NK cells, known as “G minus” NK cells, or “g-NK” that markedly improve the cancer killing power of monoclonal antibody (mAb) therapy, without the need for genetically engineering the cells. G-NK cells arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV).
Indapta的通用同种异体NK细胞治疗平台由天然存在的NK细胞的有效子集组成,称为“G减”NK细胞或“G-NK”,可显着提高单克隆抗体(mAb)治疗的抗癌能力,而无需对细胞进行基因工程。G-NK细胞是由暴露于巨细胞病毒(CMV)引起的表观遗传变化引起的。
To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors with increased numbers of g-NK cells. Indapta’s off-the-shelf g-NK cell therapy is further differentiated from other NK cell therapies in that it is a cryopreserved product with low variability..
为了产生IDP-023,Indapta优先从健康供体扩增g-NK细胞,增加g-NK细胞数量。Indapta的现成g-NK细胞疗法与其他NK细胞疗法有进一步的区别,因为它是一种低变异性的冷冻保存产品。。
Indapta’s g-NK are capable of releasing dramatically more immune activating cytokines and cancer-killing compounds than conventional NK cells. In preclinical studies, IDP-023 has demonstrated more potent and durable antitumor activity when combined with cancer targeting monoclonal antibodies as compared to conventional NK cells.
与传统的NK细胞相比,Indapta的g-NK能够释放出更多的免疫激活细胞因子和抗癌化合物。在临床前研究中,与常规NK细胞相比,IDP-023与靶向癌症的单克隆抗体联合使用时表现出更有效和持久的抗肿瘤活性。
(Bigley et al., Blood Advances 2020, https://doi.org/10.1182/bloodadvances.2020002440).
(Bigley等人,《血液进展2020》,https://doi.org/10.1182/bloodadvances.2020002440)。
About Indapta Therapeutics
关于Indapta Therapeutics
Indapta Therapeutics, Inc. is a biotechnology company focused on developing and commercializing IDP-023, its proprietary allogeneic cell therapy to treat multiple types of hematologic cancers and solid tumors. The company is working to bring this off-the-shelf cell therapy to patients to address the limitations of currently available autologous cell therapies.
Indapta Therapeutics,Inc.是一家专注于开发和商业化IDP-023的生物技术公司,IDP-023是其专有的同种异体细胞疗法,用于治疗多种类型的血液癌症和实体瘤。该公司正在努力将这种现成的细胞疗法带给患者,以解决目前可用的自体细胞疗法的局限性。
For more information, please visit www.indapta.com..
欲了解更多信息,请访问www.indapta.com。。