Iaso Bio and Innovent Announce Oral Presentation of Updated Clinical Data on FUCASU® (Equecabtagene Autoleucel) in Relapsed/Refractory Multiple Myeloma at ASH 2023

Nanjing, Shanghai, and San Jose, California, USADecember 12, 2023PR Newswire -- IASO Bio, a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative cell therapies, and Innovent Biologics (HKEX: 01801), a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative drugs for oncology, autoimmune diseases, metabolic disorders, ophthalmology, and other major disease areas, jointly announced that the characteristics and efficacy findings of patients with sustained minimal residual disease (MRD)-negative multiple myeloma treated with fully human BCMA-targeted autologous chimeric antigen receptor T-cell (CAR-T) therapy using Ixcellen injection were presented as an oral report at the 65th American Society of Hematology (ASH) Annual Meeting in 2023.

Report TitleCharacteristics and Efficacy Outcomes of Patients with Sustained Minimal Residual Disease-Negative Multiple Myeloma Following Treatment with Idecabtagene Vicleucel Injection (CT103A) in the FUMANBA-1 Study
Report Time:Monday, December 11, 2023, 11:30 AM (San Diego Time)
Report Number：761
Reporter:Associate Professor Wang Jue from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

This selected study is a post-hoc analysis of the FUMANBA-1 study (ClinicalTrials.gov Identifier: NCT05066646). The FUMANBA-1 study is a Phase Ib/II, single-arm, multicenter trial designed to evaluate the efficacy and safety of the fully human BCMA-targeted CAR-T cell therapy, Icaritin-cel Injection (IASO Bio’s development code CT103A, Innovent’s development code IBI326, English name Equecabtagene Autoleucel, equ-cel), in patients with relapsed or refractory multiple myeloma (RRMM) who have received three or more prior lines of therapy.

As of December 31, 2022, with a median follow-up time of 18.07 months, deep and sustained responses were observed in 103 evaluable patients. Among the 103 evaluable patients, the overall response rate (ORR) was 96.1%, and the stringent complete response/complete response (sCR/CR) rate was 77.7%. In 91 subjects without prior CAR-T treatment history, the ORR reached 98.9%, with an sCR/CR rate of 82.4%, and the 12-month progression-free survival (PFS) rate was 85.5%.

Minimal Residual Disease (MRD) in the General PopulationMRD negativity rate was 94.2%, and the MRD negativity rate for patients achieving CR or higher was 100%. The median time to reach MRD negativity was 15 days. 80.8% of patients remained MRD-negative 12 months after infusion.。In addition,Iaso-cel Injection can persist in the body for a relatively long period.The median duration was up to 307.5 days. At 12 months post-infusion, 50% of the patients had a vector copy number (VCN) above the detection limit, and at 24 months, 40% of the patients still showed persistent detectable VCN.。

Based on descriptive analysis, 94.2% of patients treated with IASO Bio's Cilta-cel Injection achieved MRD negativity, regardless of whether they had high-risk cytogenetic abnormalities, extramedullary disease, prior lines of therapy, or performance status. This indicates that the killing effect of Cilta-cel Injection as a cellular immunotherapy on myeloma cells is not influenced by these factors.

In the FUMANBA-1 study, in 10^-5MRD test results for 90 evaluable patients with relapsed/refractory multiple myeloma who had no prior CAR-T treatment history showed：

The principal investigator of this clinical study,Professor Luogui Qiu from the Blood Disease Hospital of the Chinese Academy of Medical Sciences and Professor Chunrong Li from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, stated:"Studies have shown that MRD is a biomarker affecting the long-term survival of RRMM patients."MaintainMRD negativity is the essential path to improving prognosis and extending PFS for RRMM patients. Iasobio's Icarus injection overcomes two pain points of maintaining MRD negativity in traditional therapies: first, it increases the proportion of patients maintaining MRD negativity for 12 months from about 10% to 80%; second, with only a single infusion, sustainable MRD negativity can be achieved.Traditional MRD-negative maintenance therapy requires continuous medication, and discontinuation poses a risk of recurrence. However, continued treatment pressure may induce drug-resistant clones to progress to even higher-risk stages. Long-term medication and complex treatments not only increase direct treatment costs but also significantly impact patients' quality of life due to adverse effects from prolonged treatment, constituting indirect treatment costs and adding to the financial burden on patients and their families. With its remarkable long-term persistence in the body, IASO Bio's injectable drug Equecabtagene Autoleucel (generic name) can provide durable and deep remission for RRMM patients who have failed multiple lines of treatment, offering hope of a cure to more patients.

About IASO Bio

IASO Bio is a biopharmaceutical company dedicated to the research, production, and sales of innovative cell-based drugs. With a focus on developing cellular therapies and antibody drugs for hematological malignancies as its innovative foundation, the company has expanded into autoimmune diseases, possessing comprehensive capabilities across the entire process from early discovery, clinical development, regulatory submission, to commercial-scale production.

The company currently has more than 10 innovative drug candidates at various stages of development, including Ixazomib Injection (trade name: Fokusux).^®) has been approved for marketing by the National Medical Products Administration (NMPA) and has received FDA approval for registration clinical trials in the United States, for the treatment of relapsed/refractory multiple myeloma.

IASO Bio, with its strong management team, innovative product pipeline, proprietary GMP manufacturing, and robust clinical development capabilities, aims to provide transformative and curative innovative therapies, bringing hope of a cure to patients in China and around the world.

For more information, please visit the company's official website:www.iasobio.comOr LinkedIn account:www.linkedin.com/company/iasobiotherapeutics。

About Innovent Biologics

"Start with trust, achieve through action." Developing high-quality biologics that are affordable for the general public is the mission and goal of Innovent Biologics. Founded in 2011, Innovent Biologics is committed to the research, production, and sales of innovative drugs in major disease areas such as oncology, autoimmune diseases, metabolic disorders, and ophthalmology, allowing our work to benefit more lives. The company has received approval for 10 products to be marketed, including Sintilimab Injection (Tyvyt).^®), Bevacizumab Injection (Da You Tong^®），Adalimumab Injection (Sulixin)^®），Rituximab Injection (Dabohua)^®), Pemigatinib Tablets (Dabotan^®), Olverembatinib Tablets (Nelaroc^®), Ramucirumab Injection (Ciranze^®), Selpercatinib Capsules (Ruituo^®），Icarus Bio's Ixazomifene Injection (Focuxin)^®）and Toripalimab Injection (Xinbiyue)^®). Currently, two varieties are under NMPA review, five new drug molecules have entered Phase III or pivotal clinical trials, and an additional 19 new drug candidates have entered clinical studies.

The company has reached 30 strategic partnerships with international collaborators such as Eli Lilly, Roche, Sanofi, Adimab, Incyte, and MD Anderson Cancer Center. While continuously innovating in drug research and pursuing its own growth, Innovent Biologics adheres to the development philosophy of economic construction centered on the people. Over the years, it has always held a benevolent scientific belief, upheld the principle of "patient-centeredness," cared for patients and their families, and actively fulfilled social responsibilities. The company has successively initiated and participated in multiple public welfare drug assistance programs, enabling more and more patients to benefit from advancements in life sciences and afford high-quality biopharmaceuticals. As of October 2023, Innovent Biologics' patient assistance programs have benefited over 170,000 ordinary patients, with a total drug donation value of 3.4 billion RMB. Innovent Biologics hopes to work together with everyone to enhance the development level of China's biopharmaceutical industry to meet the public's need for accessible medicines and their aspirations for health and well-being.

For more details, please visit the company website:www.innoventbio.comOr company LinkedIn accountwww.linkedin.com/company/innovent-biologics/。

For more information, please contact:

IASO Bio

Media:pr@iasobio.com    
Investor:ir@iasobio.com
Phone: 025-58287610

Innovent Biologics

Media:
Email:pr@innoventbio.com
Tel: +86 512-69566088

Investor:
Email:ir@innoventbio.com
Phone: +86 512-69566088