drugset / Press release

Innovent and IASO Bio Present New Data of FUCASO® (Equecabtagene Autoleucel) for Multiple Myeloma Patients in Oral Presentation at ASH 2023

2023-12-12 · Innovent Biologics (Suzhou) Co. Ltd. · original innoventbio.com ↗

ROCKVILLE, U.S. and SUZHOU, China, Dec 12, 2023 — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and IASO Biotherapeutics (“IASO Bio”), a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, today announced the latest analysis results from the FUMANBA-1 study of Equecabtagene Autoleucel for the treatment of multiple myeloma in an oral presentation at the 65th American Society of Hematology (ASH) Annual Meeting. The presentation highlights the characteristics and efficacy of fully human BCMA-targeting CAR-T (Equecabtagene Autoleucel) on multiple myeloma patients who had sustained minimal residual disease (MRD) negativity after receiving treatment. Oral Presentation Overview Presentation Title: Efficacy Outcomes and Characteristics of Patients with Multiple Myeloma (MM) Who Achieved Sustained Minimal Residual Disease Negativity after Treatment with Equecabtagene Autoleucel (Eque-cel, CT103A) in FUMANBA-1 Session Date and Time: Monday, December 11, 2023, 11:30 AM (San Diego) Publication Number: 761 Presenter: Dr. Jue Liu, Associate Professor, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology The presentation is based on a post-hoc analysis of the FUMANBA-1 study. The FUMANBA-1 Study (Registration No.: NCT05066646) is a Phase Ib/II, single-arm, multicenter study to assess the efficacy and safety of the investigational drug Equecabtagene Autoleucel (Innovent R&D code: IBI326, IASO R&D code: CT103A), a fully human CAR-T cell therapy, in patients with relapsed and refractory multiple myeloma (RRMM) who have received 3 or more lines of treatment. As of December 31, 2022, with a median follow-up of 18.07 months, deep and sustained responses were observed in 103 evaluable patients. Among these patients, the overall response rate (ORR) was 96.1%, and the stringent complete response/complete response (sCR/CR) rate was 77.7%. Among subjects without prior CAR-T therapy, the ORR reached 98.9%, the sCR/CR rate reached 82.4%, and the 12-month progression-free survival (PFS) rate was 85.5%. Minimal residual disease (MRD) negativity rate is 94.2% in the total evaluable patients, and all patients who achieved CR or above were MRD negative. The median time to achieve MRD negativity was 15 days, with 80.8% of patients remaining MRD negative at 12 months post infusion. In addition, Equecabtagene Autoleucel could persist in the body for an extended period of time, the median duration was 307.5 days. 12 months after infusion, 50% of patients had a vector copy number (VCN) above the lower limit of detection, and 24 months after infusion, VCN could still be detected in 40% of the patients. Based on the descriptive analysis, patients receiving eque-cel achieved MRD negativity irrespective of cytogenetics status, extramedullary disease status,number of prior lines of therapy,and performance status. It suggests that eque-cel as immune cell therapy showed strong killing effect to myeloma cells without being affected by these factors. In the FUMANBA-1 study, 90 RRMM patients without prior CAR-T therapy were evaluable for MRD test at 10-5 level. The results showed: (1) An important prognostic factor for progression-free survival (PFS) in patients with RRMM treated with Equecabtagene Autoleucel is sustained MRD negativity: When comparing the PFS of patients in different MRD negative duration groups, those in the ≥ 6 months and ≥ 12 months group was significantly better than those in the < 6 months group. This was particularly true for those in the ≥ 12 months MRD negative duration group. (2) There is a correlation between the persistence of CAR-T cells and sustainability of MRD negativity after infusion of Equecabtagene Autoleucel: Overall, there is a positive correlation between the two. This was particularly evident in subgroup analysis. The triple-class exposure subgroup, the previous autologous transplantation treatment history subgroup, the high-risk cytogenetic abnormality subgroup, etc., showed a moderate to strong positive correlation between the persistence of CAR-T cells (VCN persistence) after infusion of Equecabtagene Autoleucel and the duration of MRD negativity. The correlation may become more significant in the future with longer term follow-up data, which could further reveal the positive correlation between long-term survival of CAR-T cells and the long-term maintenance of MRD negativity. Professor Lu-gui Qiu, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, and Professor Chunrui Li, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, stated: "Studies have shown MRD is a biomarker that affects the long-term survival of RRMM patients. It’s necessary to maintaining MRD negativity to improve the prognosis of RRMM patients and extend PFS. Equecabtagene Autoleucel has overcome two difficulties faced by traditional therapies in maintaining MRD negativity. First, it has increased the proportion of patients with MRD-negative persistence past 12 months from less than 10% to 80%. Second, only one-time infusion is needed to achieve sustainable MRD negativity. Traditional therapies require continuous medication to maintain MRD negativity, and once medication is stopped, patients face the risk of relapse. On the other hand, Patients who do not stop the medication will be facing the potential risk of inducing drug-resistant clones. Long-term medication and complex therapies increase direct treatment costs, seriously affect patients’ quality of life. Whereas the adverse effects caused by long term treatment also increase indirect costs to patients and their families. With its outstanding long-term persistence in the body, Equecabtagene Autoleucel can achieve lasting and deep remission in RRMM patients who have failed multiple lines of treatment. We expect that it will give more patients the hope of a cure." About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to discover and develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to discovering and developing, manufacturing and commercializing high-quality innovative medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, and ophthalmology diseases to enhance the quality of the patients' lives. Innovent has 10 products in the market, including TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), Olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules ), FUCASO® (Equecabtagene Autoleucel Injection) and SINTBILO® (Tafolecimab Injection).Additionally, we have 2 assets are under NMPA NDA review, 5 assets are in Phase III or pivotal clinical trials, and 19 more molecules in early clinical stage. Innovent has also entered into more than 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. We strive to work with many collaborators to help advance the biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. Note: TYVYT® (sintilimab injection) is not an approved product in the United States. BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States. TYVYT® (sintilimab injection, Innovent) BYVASDA® (bevacizumab biosimilar injection, Innovent) HALPRYZA® (rituximab biosimilar injection, Innovent) SULINNO® (adalimumab biosimilar injection, Innovent) Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan. CYRAMZA® (ramucirumab, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. About IASO Bio IASO Bio is a biopharmaceutical company engaged in the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercial production. The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of RR MM. Leveraging its strong management team, innovative product pipeline, GMP production, as well as integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world. For more information, please visit http://www.iasobio.com or www.linkedin.com/company/iasobiotherapeutics. Innovent’s Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics, Inc. (“Innovent” or “Company”), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. Contact: Innovent Biologics Media: [email protected] +86 512-6956 6088 Investors: [email protected] +86 512-6956 6088 IASO Bio Media: [email protected] Investors: [email protected]

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