Updated Phase 1/2 Clinical Data of Equecabtagene Autoleucel (IBI326/CT103A), a Fully Human Anti-BCMA CAR-T Therapy, Demonstrates Deep and Durable Responses in Relapsed/Refractory Multiple Myeloma Patients at EHA 2022

San Francisco, USA and Suzhou, ChinaJune 13, 2022PR Newswire -- Innovent Bio (HKEX stock code: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs in major disease areas such as oncology, autoimmune diseases, metabolic disorders, and ophthalmology, and IASO Bio, an innovative clinical-stage biopharmaceutical company focused on the development and industrialization of cell therapies and antibody drugs, jointly announced that the latest Phase 1/2 registrational clinical study results of their jointly developed fully human autologous B-cell maturation antigen (BMCA) chimeric antigen receptor autologous T-cell (CAR-T) therapy (Equecabtagene Autoleucel Injection, Innovent Bio's R&D code: IBI326, IASO Bio's R&D code: CT103A) were presented in an oral presentation at the 27th Annual Meeting of the European Hematology Association (EHA) in 2022 (Abstract Number: S187).

Abstract Title:Updated Data on the Safety and Efficacy of Fully Human B-Cell Maturation Antigen-Specific CAR-T Cells (CT103A) in Phase 1/2 Clinical Trials for Relapsed/Refractory Multiple Myeloma Patients
Abstract Number:EHA-S187
Meeting Topic:Relapsed/Refractory Multiple Myeloma: BCMA-Targeted Therapy
Meeting Time:June 12, 2022 (Sunday) 11:30-12:45 CEST
Meeting Location:Vienna, Austria (Online + Offline)
Reporter:Professor Chunrui Li from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Report Format:Oral Report

This report includes more comprehensive safety and efficacy results of IASO Bio's Icarus injection in a longer follow-up period with more participants, as well as pharmacokinetic, pharmacodynamic, and immunogenicity data. The research results show that the Icarus injection demonstrates excellent safety and efficacy in the human body, with long-lasting persistence in vivo, and is expected to become a breakthrough treatment for patients with relapsed or refractory multiple myeloma.

This oral presentation showcased updated clinical data from 14 clinical research centers participating in the Phase 1/2 registrational clinical study (ChiCTR1800018137, NCT05066646) of Ixcellen Injection for the treatment of relapsed/refractory multiple myeloma (R/R MM). As of January 21, 2022, a total of 79 subjects received the Phase 2 recommended dose (RP2D) of 1.0×106 CAR-T cells/kg. The median follow-up time was 9.0 months (range: 1.2 to 19.6 months), with a median of 5 prior lines of therapy (range: 3–23). Among the participants, 34.2% (27/79) had high-risk cytogenetic abnormalities, 12.7% (10/79) had extramedullary plasmacytomas, and notably, 15.2% (12/79) had previously been treated with non-fully human BCMA CAR-T therapy.

Idecabtagene Vicleucel Injection Demonstrates Excellent and Controllable Safety:Among 79 subjects, 94.9% (75/79) experienced cytokine release syndrome (CRS), all of which were grade 1-2 CRS, with no grade 3 or higher CRS. The median onset time of CRS was day 6.0 post-infusion, and the median duration of CRS was 5.0 days. Only 2.5% (2/79) of subjects developed immune effector cell-associated neurotoxicity syndrome (ICANS), including one case each of grade 1 and grade 2. All subjects' CRS and ICANS were resolved.

Idecabtagene Vicleucel Injection Demonstrates Excellent and Durable Efficacy:Among 79 subjects, the objective response rate (ORR) was 94.9% (75/79), with 89.9% (71/79) achieving very good partial response (≥VGPR). The complete response rate (CR)/stringent complete response rate (sCR) was 68.4% (54/79). IASO Bio's Iciclen Cell Injection also demonstrated favorable efficacy in subjects with extramedullary multiple myeloma. Among 10 subjects with extramedullary multiple myeloma, the ORR was 100% (10/10), and CR/sCR was 90.0% (9/10). Additionally, 92.4% (73/79) of subjects achieved MRD negativity, with all CR/sCR subjects reaching MRD negativity. The median duration of MRD negativity has not yet been reached.

Equecab Injection for Previously TreatedSubjects who relapsed after CAR-T treatment still showed good efficacy:The ORR of 12 subjects previously treated with CAR-T was 75.0% (9/12), with 41.7% (5/12) achieving CR/sCR.

Idecabtagene Vicleucel Injection Demonstrates Robust Expansion and Persistent Durability In Vivo:The median peak time of CAR copy numbers in peripheral blood was 12 days. Among evaluable subjects at 6 months and 12 months post-infusion, 62.3% (38/61) and 53.3% (8/15), respectively, still had detectable CAR-T cell persistence. Following the infusion of Idecabtagene Vicleucel Injection, free BCMA in peripheral blood rapidly decreased and remained below the limit of detection for an extended period.

Idecabtagene Vicleucel Injection has low immunogenicity:After the infusion of Icarus injection, 16.5% (13/79) of the subjects tested positive for ADA. Among them, 1.3% (1/79) of the subjects tested positive for ADA before the infusion of CT103A, and 2.5% (2/79) of the subjects tested positive for ADA within 3 months after the infusion.

Professor Chunrui Li from Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyCAR-T therapy is a novel precision targeted therapy with very promising therapeutic prospects. In our previous studies, the injectable Icaselisib has demonstrated excellent efficacy and safety. Its CAR structure contains fully human single-chain variable fragments (scFvs), which can bypass potential host anti-CAR immunogenicity while retaining anti-tumor activity. At this year's EHA conference, we updated the report on the efficacy and safety of Icaselisib in R/R MM patients with longer follow-up periods. Compared to the 7.0-month median follow-up data reported at the 2021 ASH conference, where CR/sCR was 58.2%, with the median follow-up extended to 9.0 months, CR/sCR deepened to 68.4%, demonstrating the sustained and deepening efficacy of Icaselisib. We are also pleased to see that Icaselisib continues to show positive efficacy in patients who relapsed after prior CAR-T treatment, which is of great significance for the treatment of R/R MM and represents a potential breakthrough direction for future research.

About Multiple Myeloma (MM）

Multiple Myeloma (MM) is one of the most common blood cancers and is a malignant disease characterized by the clonal proliferation of abnormal plasma cells. For newly diagnosed multiple myeloma patients, commonly used first-line treatment drugs include proteasome inhibitors, immunomodulatory agents, and alkylating agents. While the majority of patients achieve disease stability for 3-5 years with first-line treatment, a small number exhibit primary resistance at initial treatment, resulting in uncontrolled disease progression. Most initially responsive patients will inevitably enter a relapsed or refractory phase after a period of disease stability. Therefore, there remains an unmet need for patients with relapsed/refractory multiple myeloma. In the United States, MM accounts for nearly 2% of all cancer cases and over 2% of cancer-related deaths.

According to the Frost & Sullivan report: The number of newly diagnosed cases of MM in China increased from 18,900 in 2016 to 21,100 in 2020, and is expected to grow to 24,500 by 2025. The prevalence of MM in China increased from 69,800 in 2016 to 113,800 in 2020, and is projected to reach 182,200 by 2025. In the United States, the number of newly diagnosed MM cases rose from 30,300 in 2016 to 32,300 in 2020, and is anticipated to increase to 37,800 by 2025. The number of MM patients in the U.S. grew from 132,200 in 2016 to 144,900 in 2020, and is expected to rise to 162,300 by 2025.

About Idecabtagene Vicleucel Injection (IBI326/ CT103A）

Equecabtagene Autoleucel Injection is an innovative candidate product jointly developed by Innovent Bio and IASO Bio. This candidate product is a CAR-T cell therapy targeting B-cell maturation antigen (BCMA), utilizing lentivirus as a gene vector to transfect autologous T cells. The CAR comprises a fully human scFv, CD8a hinge and transmembrane domain, 4-1BB co-stimulatory domain, and CD3ζ activation domain. Based on stringent screening and comprehensive in vivo and in vitro functional evaluations, Equecabtagene Autoleucel Injection demonstrates potent and rapid efficacy, with remarkable persistence in vivo.

In February 2021 and February 2022, Ixalontin injection was granted the "Breakthrough Therapy Designation (BTD)" by the NMPA and the "Orphan Drug Designation (ODD)" by the FDA, respectively, for the treatment of relapsed/refractory multiple myeloma. In June 2022, the new drug application for Ixalontin injection for the treatment of relapsed/refractory multiple myeloma was officially accepted by the National Medical Products Administration.

In addition to multiple myeloma, the NMPA has officially accepted the clinical trial application (IND) for the new extended indication of antibody-mediated neuromyelitis optica spectrum disorder (NMOSD) for the drug Idecabtagene Vicleucel Injection.

About Innovent Bio

"Start with trust, achieve through action." Developing high-quality biologics that are affordable for the general public is the ideal and goal of Innovent Bio. Founded in 2011, Innovent Bio is committed to the development, production, and sales of innovative drugs in major disease areas such as oncology, autoimmune diseases, metabolic disorders, and ophthalmology. On October 31, 2018, INNOVENT BIOLOGICS(SUZHOU)CO LTD was listed on the Main Board of the Hong Kong Stock Exchange, stock code: 01801.

Since its establishment, the company has stood out among numerous biopharmaceutical companies with its innovative achievements and internationalized operating model. It has built a product chain comprising 32 new drug varieties, covering multiple disease areas such as oncology, autoimmune diseases, metabolism, and ophthalmology. Among these, seven varieties have been selected for the national "Major New Drug Creation" project. The company already has seven products (Sintilimab Injection, trade name: Tyvyt).^®，English trademark: TYVYT^®; Bevacizumab biosimilar, brand name: BYVASDA^®，English trademark: BYVASDA^®; Adalimumab biosimilar, brand name: SULINXIN^®, English trademark: SULINNO^®; Rituximab biosimilar, brand name: Dabohua^®, English trademark: HALPRYZA^®; Pemigatinib Tablets, Trade Name: Dabotan^®, English trademark: PEMAZYRE^®; Olverembatinib, Trade Name: Naxit^®;Product Name: Cilraize^®，English trademark: CYRAMZA^®) have been approved for marketing, 2 varieties are under NMPA review, 4 varieties have entered Phase III or pivotal clinical trials, and another 19 products have entered clinical trials.

Innovent Bio has assembled a team of top-tier biopharmaceutical development and industrialization professionals with international advanced standards, including numerous returned overseas experts. It has also established strategic partnerships with international collaborators such as Eli Lilly and Company (USA), Adimab, Incyte, MD Anderson Cancer Center, and Hanmi Pharmaceutical (South Korea). Innovent Bio hopes to work together with everyone to enhance the development level of China’s biopharmaceutical industry, in order to meet the public's access to medicines and their aspirations for life and health.

For more details, please visit the company website:www.innoventbio.comOr the company's LinkedIn account: Innovent Biologics.

About IASO Bio

IASO Bio is an innovative biopharmaceutical company focused on the development and industrialization of cell therapies and antibody drugs. Building its innovation on the development of hematological tumor cell-based drugs and antibody drugs, the company has expanded into solid tumors and autoimmune diseases. It possesses a complete, full-process platform capability from early discovery, regulatory submission, clinical development, to commercial production, along with multiple technology platforms including a fully human antibody discovery platform, high-throughput CAR-T drug optimization platform, universal CAR technology platform, manufacturing technology platform, and clinical translational research platform.

The company currently has 10 drug candidates in different stages of development. The most advanced candidate, Ixazomib Injection (NDA), has been officially accepted by the National Medical Products Administration (NMPA) for marketing approval, and was previously designated as a "Breakthrough Therapy" by the NMPA and granted "Orphan Drug Designation (ODD)" by the FDA. In addition to multiple myeloma, the clinical trial application (IND) for the expanded indication of Ixazomib Injection for antibody-mediated neuromyelitis optica spectrum disorder (NMOSD) has also been officially accepted by the NMPA. CT120, an innovative candidate independently developed by the company (a fully human CD19/CD22 dual-target CAR-T cell injection), has entered the clinical research stage for indications including CD19/CD22-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) and relapsed/refractory acute B lymphoblastic leukemia (B-ALL), and has received "Orphan Drug Designation (ODD)" from the FDA.

With a highly-executive management team, a rich product pipeline, and unique innovative R&D and business models, IASO Bio is committed to becoming an influential innovator in the pharmaceutical industry. By advancing truly innovative drugs that address clinical pain points and possess market competitiveness from clinical trials to the marketplace, the company aims to pave new treatment pathways for patients and bring them renewed hope. For more information, please visit the company website: www.iasobio.com or the company’s LinkedIn account.www.linkedin.com/company/iasobiotherapeutics。

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