On February 22, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and IASO Biotherapeutics (IASO Bio), reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for the investigational chimeric antigen receptor (CAR)-T cell therapy co-developed by Innovent and IASO (Innovent development code: IBI326, IASO development code: CT103A), for treatment of relapsed/refractory multiple myeloma (Press release, Innovent Biologics, FEB 22, 2021, https://www.prnewswire.com/news-releases/the-bcma-car-t-co-developed-by-innovent-and-iaso-was-granted-breakthrough-therapy-designation-by-the-nmpa-for-the-treatment-of-relapsedrefractory-multiple-myeloma-301232904.html [SID1234575400]). NMPA grants Breakthrough Therapy Designation to new medicines that are intended to treat serious conditions and where clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint. The BTD designation for IBI326 is based on the results observed in ongoing Phase 1/2 study for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) being conducted in China (ChiCTR1800018137).
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IBI326 is currently in a Phase 2 Pivotal trial for the treatment of adults with relapsed or refractory multiple myeloma (RRMM).
IBI326 is a fully-human anti-B-cell maturation antigen (BCMA) targeted CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully-human scFv, CD8a hinge and transmembrane, 4-1BB-mediated co-stimulation, and CD3ζ activation domains. Based on rigorous screening and comprehensive in vivo and in vitro evaluation, IBI326 CAR-T therapy is proven to have potent and rapid anti-myeloma activity and outstanding safety, efficacy, and persistence.
The clinical results of the RRMM trials presented at the 61st Annual Meeting of The American Society of Hematology (ASH) (Free ASH Whitepaper) held in 2019 highlighted the impressive safety profile, efficacy, and the durability of response of IBI326. It is important to note that the study also included 4 patients who had relapsed from a previous murine anti-BCMA CAR-T treatment. The overall response of these four patients showed that IBI326 can also be an effective treatment option for patients who have relapsed from an earlier CAR-T treatment. These clinical study results were published in the January 2021 issue of Blood titled: "A Phase 1 Study of a Novel Fully Human BCMA-targeting CAR (IBI326) in Patients with Relapsed/Refractory Multiple Myeloma."
Dr. Hui ZHOU, Vice President of Medical Science and Strategy Oncology of Innovent, stated: "The breakthrough therapy designation from NMPA indicated that IBI326 possesses great potential in treating relapsed or refractory multiple myeloma. We hope this product help more patients in the future."
"We are thrilled to have been granted this important designation from NMPA. This reinforces the importance and robustness of IBI326 as a new therapy option," said IASO Bio founder and CEO Jinhua Zhang. "We anticipate an expedited development and review in China, allowing more patients with relapsed or refractory multiple myeloma to benefit from this therapy at the earliest possible time."
About IBI326(BCMA CAR-T)
IBI326 is an innovative therapy co-developed by Innovent and IASO. Previous studies indicate patients with relapsed/refractory multiple myeloma (RRMM) who received high-dose BCMA-targeting CAR-T cells may achieve better remission but have worse adverse events. Moreover, once the disease progresses again, the re-infusion of CAR-T cells will be not effective. To solve this dilemma, IBI326 has been developed, a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3ζ activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, the construct of the BCMA CAR-T is potent and persistent.
About Multiple Myeloma
Multiple Myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For multiple myeloma patients, common first-line drug treatments include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. While treatment may result in remission, most patients will inevitably enter the relapsed or refractory stage as there’s currently no cure. As a result, there is a significant unmet need for patients with relapsed/refractory multiple myeloma.
About Breakthrough Therapy Designation
In recent years, in order to encourage innovation to address unmet clinical needs, China has established a rapid drug review and approval pathway. A Breakthrough Therapy Designation (BTD) is intended to facilitate and expedite development and review of an investigational drug to treat serious disease or condition when preliminary clinical evidence indicates that the drug has demonstrated substantial improvement over current therapies. The BTD will not only qualify a drug candidate to receive status for rapid review by the CDE, but also allow the sponsor to obtain timely advice and communications from the CDE to accelerate the approval and launch in order to address the unmet clinical needs of patients at an accelerated pace.