Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and IASO Biotherapeutics (IASO Bio), jointly announce that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for the investigational chimeric antigen receptor (CAR)-T cell therapy co-developed by Innovent and IASO, for treatment of relapsed/refractory multiple myeloma. NMPA grants Breakthrough Therapy Designation to new medicines that are intended to treat serious conditions and where clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint. The BTD designation for IBI326 is based on the results observed in ongoing Phase 1/2 study for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) being conducted in China (ChiCTR1800018137).

IBI326 is currently in a Phase 2 Pivotal trial for the treatment of adults with relapsed or refractory multiple myeloma (RRMM).

IBI326 is a fully-human anti-B-cell maturation antigen (BCMA) targeted 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, 4-1BB-mediated co-stimulation, and CD3ζ activation domains. Based on rigorous screening and comprehensive in vivo and in vitro evaluation, IBI326 CAR-T therapy is proven to have potent and rapid anti-myeloma activity and outstanding safety, efficacy, and persistence.

The clinical results of the RRMM trials presented at the 61st Annual Meeting of The American Society of Hematology (ASH) held in 2019 highlighted the impressive safety profile, efficacy, and the durability of response of IBI326. It is important to note that the study also included 4 patients who had relapsed from a previous murine anti-BCMA CAR-T treatment. The overall response of these four patients showed that IBI326 can also be an effective treatment option for patients who have relapsed from an earlier CAR-T treatment. These clinical study results were published in the January 2021 issue of Blood titled: "A Phase 1 Study of a Novel Fully Human BCMA-targeting CAR (IBI326) in Patients with Relapsed/Refractory Multiple Myeloma." 

Dr. Hui ZHOU, Vice President of Medical Science and Strategy Oncology of Innovent, stated: "The breakthrough therapy designation from NMPA indicated that IBI326 possesses great potential in treating relapsed or refractory multiple myeloma. We hope this product help more patients in the future."

"We are thrilled to have been granted this important designation from NMPA. This reinforces the importance and robustness of IBI326 as a new therapy option," said IASO Bio founder and CEO Jinhua Zhang. "We anticipate an expedited development and review in China, allowing more patients with relapsed or refractory multiple myeloma to benefit from this therapy at the earliest possible time."

About IBI326(BCMA CAR-T)

IBI326 is an innovative therapy co-developed by Innovent and IASO. 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 CD3ζ 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.

About Multiple Myeloma

Multiple Myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For multiple myeloma 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/refractory multiple myeloma.

About Breakthrough Therapy Designation 

In recent years, in order to encourage innovation to address unmet clinical needs, China has established a rapid drug review and approval pathway. A Breakthrough Therapy Designation (BTD) is intended to facilitate and expedite development and review of an investigational drug to treat serious disease or condition when preliminary clinical evidence indicates that the drug has demonstrated substantial improvement over current therapies. The BTD will not only qualify a drug candidate to receive status for rapid review by the CDE, but also allow the sponsor to obtain timely advice and communications from the CDE to accelerate the approval and launch in order to address the unmet clinical needs of patients at an accelerated pace.

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, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong, S.A.R., China 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 23 valuable assets in the fields of cancer, metabolic, autoimmune diseases and other major therapeutic areas, with 4 products - TYVYT? (sintilimab injection), BYVASDA? (bevacizumab biosimilar injection), SULINNO? (adalimumab biosimilar injection) and HALPRYZA? (rituximab biosimilar injection) - officially approved for marketing in China, four assets in Phase 3 or pivotal clinical trials, and additional 15 molecules in clinical trials. TYVYT? was included in the National Reimbursement Drug List (NRDL) in 2019 as the historically first PD-1 inhibitor entering in NRDL and the only PD-1 included in the list in that year.

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

About IASO Biotherapeutics

IASO Biotherapeutics is an innovative, clinical stage biotechnology company focused on discovering, developing, and manufacturing innovative medicines for cancer and autoimmune diseases. Established in 2017, IASO has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. Based in China and the U.S, the company has expanded rapidly and now has a global team of approximately 360 employees.

With the development of cell therapies and biologics against hematological tumor as the cornerstone of innovation, IASO is expanding into the fields of solid tumors and autoimmune diseases. Currently, the company has an innovative pipeline of more than ten assets in different stages.

With a strong executive management team, rich product lines, unique innovative R&D and business model, IASO is committed to provide innovative and effective therapies to patients in China and around the world. IASO aims to become a trusted "Partner of Choice" for global biopharmaceutical companies seeking to advance their platform and assets in the China market and build long-term strategic relationships for global innovative first-in-class and best-in-class drug development.