Innovent and IASO Bio Announce the NMPA Approval of FUCASO®, the First Fully-human BCMA CAR-T Therapy, for the Treatment of Relapsed or Refractory Multiple Myeloma

ROCKVILLE, Md. and SUZHOU, China, July 2, 2023 /PRNewswire/ -- 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 Biotechnology ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products,  announce  that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for FUCASO® (Equecabtagene Autoleucel, co-developed and co-commercialized by Innovent and IASO Bio, Innovent R&D code: IBI326, IASO Bio R&D code: CT103A), the first fully-human BCMA-directed chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

FUCASO^® (Equecabtagene Autoleucel) is a BCMA-directed CAR T cell therapy, using lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully-human scFv, CD8a hinge and transmembrane, and 4-1BB-mediated co-stimulation and CD3ζ activation domains. Based on rigorous selection and screening of the molecular structures, and comprehensive in vivo and in vitro evaluation, FUCASO^® has demonstrated rapid and potent efficacy as well as prolonged persistency in RRMM patients, providing higher and deeper responses and long-term clinical benefit. 

The NDA approval was based on the results from the FUMANBA-1 clinical study (CTR20192510, NCT05066646), a multi-center Phase I/II registrational clinical trial conducted in China to evaluate the efficacy of Equecabtagene Autoleucel in patients with RRMM. In June 2023, updated data from this ongoing study was presented as a poster presentation (Abstract Number: 8025) at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO), in which Equecabtagene Autoleucel demonstrated remarkable efficacy and favorable safety profiles.

A total of 103 subjects received a dose of 1.0×10⁶ CAR-T cells/kg, with a median follow-up time of 13.8 (0.4, 27.2) months.

• Among the 101 evaluable patients, the overall response rate (ORR) was 96%, and the stringent complete response/ complete response (sCR/CR) rate was 74.3%. Median time to response (mTTR) was only 16 days, and the 12-month PFS rate was 78.8%. 95% of the patients achieved minimal residual disease (MRD) negativity, and all sCR/CR patients achieved MRD negativity. Of the 12 patients with prior CAR-T therapy, 9 achieved CR, and 5 achieved sCR (including 4 patients that sustained sCR for over 18 months post-infusion). In 89 patients without prior CAR-T therapy, 78.7% reached sCR/CR.
• Of the 103 patients, only one experienced grade ≥3 cytokine release syndrome (CRS), and 2 experienced grade 1-2 immune effector cell-associated neurotoxicity syndrome (ICANS). All patients with CRS or ICANS recovered after the treatment.
• Equecabtagene Autoleucel was still detectable in 50% and 40% respectively of the patients who completed 12-month and 24-month follow-ups after infusion. Only 19.4% of the patients were anti-drug antibody (ADA)-positive after Equecabtagene Autoleucel infusion.

The Principal Investigators of FUMANBA-1 study, Prof. Lugui Qiu, MD, Chinese Academy of Medical Science Hematology Hospital, and Prof. Chunrui Li, MD, PhD, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology: "There's a significant unmet clinical need for the treatment of multiple myeloma (MM) in China. As a fully-human BCMA CAR-T therapy, FUCASO® has demonstrated remarkable efficacy, with evidence of deep and durable response for high-quality survival for MM patients. We believe that FUCASO's® approval will offers clinicians a novel breakthrough option benefiting patients with later-line RRMM."

Dr. Hui Zhou, Senior Vice President of Innovent Biologics, stated, "Multiple myeloma is a common hematology malignant disease with high incidence rate, and relapse and refractory are almost inevitable after current treatments. There's an urgent unmet need of a treatment with well-tolerated and long persistence for RRMM patients in China. FUCASO®, as an innovative fully-human BCMA-directed T cell therapy, has demonstrated robust and long-lasting efficacy and outstanding safety in long-term follow-up data from the registrational clinical study, which underscores its potential to be a pioneering treatment option for patients with RRMM. We are very pleased with the approval of FUCASO® and hope it could benefit RRMM patients as the first approved BCMA CAR-T therapy in China."

Ms. Jinhua Zhang, Chairman and Chief Executive Officer of IASO Bio, stated, "We are excited that FUCASO® was approved as a new drug, which is a significant milestone for our team. FUCASO® is not only IASO Bio's first commercialized product but is also the world's first commercially available fully-human CAR-T therapy. Furthermore, FUCASO® is the first self-developed and independently manufactured CAR-T cell therapy in China as well as China's first approved BCMA CAR-T product and first approved cell therapy for the treatment of MM in China. The NMPA's NDA approval of FUCASO® will help us in achieving our strategic goal of bringing groundbreaking treatment options, as well as new hope for a potential cure, to MM patients in need."

About Multiple Myeloma (MM)
Multiple Myeloma (MM) is a blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For MM 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 or refractory multiple myeloma. According to Frost & Sullivan, new MM cases in China rose from 20,100 in 2018 to 22,400 in 2022 and are expected to increase to 25,700 by 2027.

About FUCASO® (Equecabtagene Autoleucel)
FUCASO® (Equecabtagene Autoleucel) is an innovative fully-human anti- BCMA 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, and 4-1BB-mediated co-stimulation and CD3ζ activation domains. Based on rigorous selection and screening of the molecular structures, and comprehensive in vivo and in vitro evaluation, FUCASO® has demonstrated rapid and potent efficacy as well as prolonged persistency in RRMM patients. FUCASO® (Equecabtagene Autoleucel) is approved by China's NMPA for the treatment of RRMM. Innovent and IASO Bio are responsible for joint development and commercialization of FUCASO® (Equecabtagene Autoleucel) for the treatment of RRMM in mainland China.

Furthermore, Equecabtagene Autoleucel received Orphan Drug Designation (ODD) designation from the U.S. Food and Drug Administration (FDA) for the treatment of RRMM and obtained the U.S. FDA IND approval. Equecabtagene Autoleucel also received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations in February 2023 from the FDA. In addition to multiple myeloma, the NMPA has accepted another IND application for the new extended indication of Neuromyelitis Optica Spectrum Disorder (NMOSD).

About Innovent 
Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 35 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 9 approved products on the market. These include: TYVYT® (sintilimab injection), BYVASDA® (bevacizumab injection), SULINNO® (adalimumab injection), HALPRYZA® (rituximab injection), Pemazyre® (pemigatinib oral inhibitor), olverembatinib(BCR ABL TKI), Cyramza® (ramucirumab), Retsevmo® (selpercatinib) and FUCASO® (Equecabtagene Autoleucel). An additional 2 assets are under NMPA NDA review, 6 assets are in Phase III or pivotal clinical trials, and 18 more molecules are in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives.

Disclaimer: Innovent does not recommend any off-label usage.

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.

Retsevmo® (selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

About IASO Biotechnology
IASO Bio is a clinical stage biopharmaceutical company engaged in discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. Leveraging its proprietary fully human antibody discovery platform (IMARS), high-throughput chimeric antigen receptor T-cell (CAR-T) drug screening platform, and proprietary manufacturing processes, IASO Bio is developing a rich clinical-stage pipeline of multiple autologous and allogeneic CAR-T and biologics product candidates. This pipeline includes a portfolio of over 10 novel products, including FUCASO® (Equecabtagene Autoleucel). 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 R/R MM. IASO also received Breakthrough Therapy Designation (BTD) from the NMPA in February 2021 and Orphan Drug Designation (ODD) from the FDA in February 2022, Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations from the FDA in February 2023. In addition to multiple myeloma, NMPA has approved IND application of FUCASO® for the new expanded indication of Neuromyelitis Optica Spectrum Disorder (NMOSD).

Additionally, the company's in-house developed fully human CD19/CD22 dual-targeted CAR-T cell therapy received two IND clearances for treating relapsed/refractory B-cell non-Hodgkin's lymphoma (r/r B-NHL) and relapsed/refractory acute B-lymphoblastic leukemia (r/r B-ALL). It is currently in Phase I clinical trial for r/r B-NHL. It was also granted ODD for treatment of acute lymphoblastic leukemia by the FDA in October 2021. And the fully human monoclonal antibody targeting human CD19, IASO-782 Injection, received both FDA and NMPA IND approvals in June 2023 for use in U.S. and China clinical trials for Autoimmune hematological disorders, including primary immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA).

Leveraging its strong management team, innovative product pipeline, 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, visitwww.iasobio.com or www.linkedin.com/company/iasobiotherapeutics.

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