On December 10, 2019 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, reported that the latest clinical data of Fully-human BCMA CAR-T, a potential best-in-class cell therapy co-developed with IASO Biotherapeutics (IASO BIO) (Innovent:IBI326, IASO BIO: CT103A), has been presented in an oral session at the prestigious 61st Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting & Exposition convened in Orlando, FL, from 7 December 2019 to 10 December 2019 [Abstract #582] (Press release, Innovent Biologics, DEC 10, 2019, View Source [SID1234552220]). The oral presentation title is "Efficacy and Safety of Fully Human BCMA Targeting CAR T Cell Therapy in Relapsed Refractory Multiple Myeloma".
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The oral presentation highlighted the impressive safety, efficacy and persistence of an IIT study of anti-BCMA CAR-T for the treatment of Relapsed/Refractory Multiple Myeloma conducted by Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology. With 17 of the 18 patients evaluable, the objective response rate (ORR) was 100% in the study. In addition, 70.6% of patients achieved a best response of stringent complete or complete response (sCR/CR), and 88.2% achieved a best response of very good partial response (VGPR) or better. CRS occurred in 17 of 18 patients (Grade 1&2- 72.2% (13), Grade 3- 16.7% (3), Grade 4- 5.6% (1)), but was generally manageable with no neurotoxicity. At the lowest dose (1 x106 cells/kg), IBI326 still maintained 100% ORR, with 78% of these patients achieving a best response of very good partial response (VGPR) or better. As well, toxicity was manageable with 88% of these patients experiencing grade 2 CRS or less.
Furthermore, 4 patients participating in the study had relapsed from a prior murine CAR-T infusion. Their response and the overall performance indicate that IBI326 may also can provide a potential first-line treatment option for patients who have relapsed from prior CAR-T infusions.
Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, said: "It is a fruitful year for us, as the clinical progress of BCMA CAR-T has also been presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) earlier this year before ASH (Free ASH Whitepaper). We are very happy to see the prolonged patient remission to this therapy and look forward to starting our phase II clinical trials by early next year. Hope more patients suffering from multiple myeloma could benefit from that."
The Ib/II chimeric protocol of IBI326 has been granted IND approval by the National Medical Products Administration (NMPA), and the phase II clinical trials are about to be initiated by early next year.
About Relapsed/Refractory Multiple Myeloma
Multiple Myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems and bone fractures. With a global annual incidence rate at 2/100,000, it is one of the most commonly diagnosed blood cancers, second only to non-Hodgkin lymphoma.
For newly treated patients with multiple myeloma, common first-line treatment drugs include proteasome inhibitors, immunoregulatory drugs and alkane agents. For most patients, the commonly used first-line treatment can stabilize the patient’s condition for 3-5 years, but a small number of patients show primary drug resistance at the time of initial treatment, and the disease cannot be effectively controlled. Relapse patients are those who have a reoccurrence after complete remission of the disease. Refractory patients are those with primary drug resistance or those who have finished first-line treatment and do not achieve remission, or patients whose disease progress within 60 days after achieving minimal response. With effective treatment, the majority of patients will inevitably enter the stage of relapse and refractory after 3-5 years of disease stabilization. For these patients, the overall effective rate of existing second-line treatment is about 40% to 70%, with short remission time.
About IBI326 (BCMA CAR-T)
IBI326 is an innovative therapy co-developed by Innovent and IASO BIO. 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 CD3z 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.