Results of Fully-human BCMA CAR-T for the Treatment of Relapsed/Refractory Multiple Myeloma Co-developed by Innovent and IASO BIO Presented at the 2019 ASH Annual Meeting

SUZHOU, China, Dec. 10, 2019 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, today announced that the latest clinical data of Fully-human BCMA CAR-T, a potential best-in-class cell therapy co-developed with IASO Biotherapeutics (IASO BIO) (Innovent:IBI326, IASO BIO: CT103A), has been presented in an oral session at the prestigious 61^st Annual American Society of Hematology (ASH) Meeting & Exposition convened in Orlando, FL, from 7 December 2019 to 10 December 2019 [Abstract #582]. The oral presentation title is "Efficacy and Safety of Fully Human BCMA Targeting CAR T Cell Therapy in Relapsed Refractory Multiple Myeloma".

The oral presentation highlighted the impressive safety, efficacy and persistence of an IIT study of anti-BCMA CAR-T for the treatment of Relapsed/Refractory Multiple Myeloma conducted by Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology. With 17 of the 18 patients evaluable, the objective response rate (ORR) was 100% in the study. In addition, 70.6% of patients achieved a best response of stringent complete or complete response (sCR/CR), and 88.2% achieved a best response of very good partial response (VGPR) or better. CRS occurred in 17 of 18 patients (Grade 1&2- 72.2% (13), Grade 3- 16.7% (3), Grade 4- 5.6% (1)), but was generally manageable with no neurotoxicity. At the lowest dose (1 x10⁶ cells/kg), IBI326 still maintained 100% ORR, with 78% of these patients achieving a best response of very good partial response (VGPR) or better. As well, toxicity was manageable with 88% of these patients experiencing grade 2 CRS or less.

Furthermore, 4 patients participating in the study had relapsed from a prior murine CAR-T infusion. Their response and the overall performance indicate that IBI326 may also can provide a potential first-line treatment option for patients who have relapsed from prior CAR-T infusions.

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, said: "It is a fruitful year for us, as the clinical progress of BCMA CAR-T has also been presented at ASCO and EHA earlier this year before ASH. We are very happy to see the prolonged patient remission to this therapy and look forward to starting our phase II clinical trials by early next year. Hope more patients suffering from multiple myeloma could benefit from that."

The Ib/II chimeric protocol of IBI326 has been granted IND approval by the National Medical Products Administration (NMPA), and the phase II clinical trials are about to be initiated by early next year.

About Relapsed/Refractory Multiple Myeloma

Multiple Myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems and bone fractures. With a global annual incidence rate at 2/100,000, it is one of the most commonly diagnosed blood cancers, second only to non-Hodgkin lymphoma.

For newly treated patients with multiple myeloma, common first-line treatment drugs include proteasome inhibitors, immunoregulatory drugs and alkane agents. For most patients, the commonly used first-line treatment can stabilize the patient's condition for 3-5 years, but a small number of patients show primary drug resistance at the time of initial treatment, and the disease cannot be effectively controlled. Relapse patients are those who have a reoccurrence after complete remission of the disease. Refractory patients are those with primary drug resistance or those who have finished first-line treatment and do not achieve remission, or patients whose disease progress within 60 days after achieving minimal response. With effective treatment, the majority of patients will inevitably enter the stage of relapse and refractory after 3-5 years of disease stabilization. For these patients, the overall effective rate of existing second-line treatment is about 40% to 70%, with short remission time.

About IBI326 (BCMA CAR-T)

IBI326 is an innovative therapy co-developed by Innovent and IASO BIO. 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 CD3z 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 Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop 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 oncology, autoimmune, metabolic 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 it was founded, Innovent has developed a fully-integrated 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 21 innovative assets in the fields of oncology, autoimmune, metabolic diseases and other major therapeutic areas. Sixteen have entered into clinical development, five have entered Phase III clinical trials, three monoclonal antibodies have their New Drug Application ("NDA") under review and three of them have been granted with priority review status, and one, Tyvyt^® (sintilimab injection), has been approved for r/r cHL and is the only PD-1 inhibitor that has been included in the NRDL in November 2019.

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, Hanmi and other international pharmaceutical companies. 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. For more information, please visit: www.innoventbio.com.

About Nanjing IASO Biotherapeutics

Founded in March 2017, IASO BIO is a clinical stage biotechnology company advancing the development of innovative cell therapies for cancer. The company is dedicated to curing cancer using autologous/allogenic T cell therapies to enhance the immune system's ability to recognize and eradicate cancer cells. IASO BIO is developing over 10 high-potential, high-end biopharmaceutical products, targeting hematological and solid tumors. Additional development efforts include unique TCR-like CAR-T cell therapy products for indications such as gastric cancer, nasopharyngeal carcinoma and viral infection related solid tumors.

IASO BIO has broad capability including; a proprietary phage display library (2x10¹¹) supporting the development of CAR-T products, antibody drugs and intracellular targets, a screening system using high-throughput CAR-T analysis techniques and large scale data mining to obtain best-in-class CAR-T candidates, in-house plasmid, lentivirus and CAR-T production technology platforms meeting the requirements of IND submissions and clinical research. For more information, please visit: www.iasobio.com.

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SOURCE Innovent Biologics, Inc.

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