Innovent Biologics and IASO Bio Present Updated Clinical Data of BCMA CAR-T (IBI326/CT103A) for Relapsed/Refractory Multiple Myeloma at ASH Annual Meeting

SUZHOU, China, Dec. 10, 2019 /PRNewswire/ -- Innovent Biologics (HKEX stock code: 01801), a biopharmaceutical company committed to the research, development, manufacturing, and commercialization of innovative drugs for the treatment of major diseases such as cancer, autoimmune disorders, and metabolic diseases, announced today that it jointly presented an oral report with Nanjing IASO Biotherapeutics Co., Ltd. (IASO Bio) at the 61st American Society of Hematology (ASH) Annual Meeting. The presentation featured the latest clinical data (Abstract #582) on the fully human BCMA CAR-T therapy (Innovent's development code: IBI326; IASO Bio's development code: CT103A) co-developed by the two companies for the treatment of relapsed/refractory multiple myeloma. The title of the presentation was "Efficacy and Safety of Fully Human BCMA CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma." The conference was held in Orlando, Florida, from December 7 to 10, 2019.

An investigator-initiated trial (IIT) conducted at Tongji Hospital, affiliated with Tongji Medical College of Huazhong University of Science and Technology, demonstrated the safety, efficacy, and durability of response for the IBI326 product. Among the 17 evaluable patients in the completed classic Phase I dose-escalation trial involving 18 cases, the objective response rate (ORR) reached 100%. Furthermore, 70.6% of patients achieved complete response (sCR/CR), and 88.2% attained very good partial response (VGPR) or better. Cytokine release syndrome (CRS) occurred in 17 out of 18 patients (Grade 1–2: 72.2% [13 cases]; Grade 3: 16.7% [3 cases]; Grade 4: 5.6% [1 case]), but was overall manageable with no neurotoxicity observed. Even in the lowest dose group (1*10⁶cells/kg), IBI326 maintained a 100% overall response rate (ORR), with 78% of patients achieving very good partial response (VGPR) or better. The study also included four patients who had relapsed after prior treatment with murine-derived anti-BCMA CAR-T therapy; their overall outcomes suggest that IBI326 can provide an effective therapeutic option for patients who relapse after murine-derived CAR-T therapy.

Dr. Zhou Hui, Vice President of Medical Science and Strategic Oncology at Innovent Bio, stated, “The presentations at ASCO, EHA, and ASH this year mark the exciting achievements that Innovent Bio and IASO Bio have attained in the field of cell therapy over the past year. We are delighted to observe the high response rates among patients receiving this treatment, as well as the prolonged duration of response. We look forward to our Phase II clinical trials, scheduled for early next year, bringing hope for a cure to more patients.”

On September 10, 2019, the Investigational New Drug (IND) application for the Phase Ib/II combined protocol of IBI326 received implicit approval from the National Medical Products Administration (NMPA), with the Phase II clinical trial expected to commence in early 2020.Start. 

# On Recurrence/Refractory Multiple Myeloma

MultipleMultiple myeloma is a fatal hematologic malignancy. Due to bone marrow infiltration and the production of abnormal immunoglobulins, it causes clinical complications such as anemia, renal failure, infection, fractures, and hypercalcemia. It is one of the most common hematologic malignancies, second only to non-Hodgkin lymphoma, with a global annual incidence rate of 2 per 100,000.

For patients with newly diagnosed multiple myeloma, common first-line therapeutic agents include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. For the majority of patients, standard first-line therapy can stabilize the disease for 3 to 5 years; however, a small subset of patients exhibits primary resistance at initial treatment, resulting in ineffective disease control. Relapsed patients are defined as those whose disease recurs after achieving complete remission following treatment. Refractory patients include those with primary resistance, as well as those who fail to achieve remission after standard first-line therapy or experience disease progression within 60 days after achieving only minimal remission. For the majority of initially treatment-responsive patients, relapse and refractoriness will inevitably occur after a 3- to 5-year period of disease stability. For this patient population, the overall response rate to existing second-line therapies is approximately 40% to 70%, with short durations of response.

AboutIBI326 （BCMA CAR-T）

IBI326 is an innovative CAR-T cell therapy product jointly developed by Innovent Bio and IASO Bio. Previous studies have shown that patients with relapsed/refractory multiple myeloma (R/R MM) who receive high-dose BCMA-targeted CAR-T cell therapy may achieve better remission, but experience more severe adverse events. Furthermore, reinfusion of CAR-T cells is ineffective once the disease progresses again. The development of IBI326PromisingOvercoming this challengeIt uses a lentiviral vector to transduce autologous T cells. The CAR comprises a fully human scFv, a CD8α hinge and transmembrane domain, a 4-1BB co-stimulatory domain, and a CD3ζ activation domain. Based on rigorous screening and comprehensive in vitro and in vivo functional evaluations, the IBI326 CAR-T product demonstrates potent and rapid efficacy, along with outstanding durability of response.

About Innovent Bio

“Rooted in Trust, Realized through Action.” Innovent Bio’s vision and goal is to develop high-quality biologics that are affordable for the general public. Founded in 2011, Innovent Bio is dedicated to the development, manufacturing, and commercialization of innovative medicines for the treatment of major diseases, including cancer, autoimmune disorders, and metabolic diseases. On October 31, 2018, Innovent Biologics (Suzhou) Co., Ltd. was listed on the Main Board of The Stock Exchange of Hong Kong Limited, with stock code: 01801.

Since its establishment, the company has stood out among numerous biopharmaceutical companies by leveraging innovative achievements and an internationalized operational model. It has built a product pipeline comprising 21 new drug candidates, covering multiple therapeutic areas including oncology, autoimmune diseases, and metabolic disorders. Among these, four candidates were selected for the National “Major New Drug Development” Special Project, 16 have entered clinical studies, five have advanced to Phase III clinical trials, and marketing applications for three monoclonal antibody products have been accepted by the National Medical Products Administration (NMPA), all of which have been included in the priority review program. One product (Sintilimab Injection, brand name: Tyvyt^®, English trademark: Tyvyt^®) received marketing approval from the National Medical Products Administration, with its first approved indication being relapsed/refractory classical Hodgkin lymphoma, and in November 2019, it became the only PD-1 inhibitor included in the updated National Reimbursement Drug List.

Innovent Bio has assembled a world-class team of experts in the development and industrialization of high-end biologics, including numerous overseas-returning specialists, and has established strategic collaborations with international pharmaceutical companies such as Eli Lilly and Company, Adimab, Incyte, and Hanmi Pharmaceutical. Innovent Bio is committed to working collaboratively to advance the development of China’s biopharmaceutical industry, thereby improving medication accessibility for the public and fulfilling people’s aspirations for better health and well-being. For more details, please visit the company website:www.innoventbio.com。   

About IASO Bio

IASO Bio is a clinical-stage biotechnology company dedicated to the development of innovative cancer therapies, founded in March 2017 by scientists,Executive, Biopharmaceutical CompanyCo-founded with senior investors, we are dedicated to developing innovative cell therapies that truly address clinical challenges through continuous clinical research. With over 10 development pipeline products, we focus on autologous and universal CAR-T products for hematologic malignancies. All product candidates utilize fully human scFv sequences. We have a distinctive portfolio in solid tumors, featuring TCR-like CAR-T cell therapy products for indications such as virus-induced gastric cancer and nasopharyngeal carcinoma. Possessing>2*10¹¹ofIndependent Intellectual PropertyQuan QuanrenSource phage display library. In addition to supporting the development of CAR-T and antibody drug pipelines, its unique panning technology can also screen for antibodies with extremely high difficulty that can recognize intracellular antigens. The company's proprietary plasmid virus large-scale production technology platform can meet the needs of IND applications and clinical research. For more details, please visit the company website:www.iasobio.com。

For more information, please contact：

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

Investors:
Email:ir@innoventbio.com
Tel: +86 512-69566088