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

Innovative CAR-T therapy shows impressive safety, efficacy and persistence with an objective response rate (ORR) of 100%.

NANJING, China–(BUSINESS WIRE)–IASO Biotherapeutics (IASO Bio), a clinical-stage biotechnology company advancing the development of innovative therapies for cancer, had the latest clinical data presented on their potential best-in-class therapy at the “Efficacy and Safety of Fully Human BCMA Targeting CAR T Cell Therapy in Relapsed Refractory Multiple Myeloma” session during the prestigious 61^st Annual American Society of Hematology (ASH) Meeting & Exposition, December 7-10 in Orlando, FL (Abstract #582).

In an IIT study conducted by Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, the oral presentation highlighted the impressive safety, efficacy and persistence of CT103A, an anti-BCMA CAR-T for the treatment of Relapsed/Refractory Multiple Myeloma. With 17 of the 18 patients evaluable, the objective response rate (ORR) was 100%. 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), CT103A 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.

In addition, 4 patients participating in the study had relapsed from a prior murine CAR-T infusion. Their response, and the overall performance, suggests that CT103A may also provide patients, having relapsed from a prior CAR-T, a potential first-line treatment option

“Having presented at ASCO and EHA earlier this year, our presence at ASH marks the end of a very exciting year for IASO BIO. We are very happy to see the prolonged patient response to this therapy and look forward to starting our phase II clinical trial early in the new year,” said Hu Guang, Ph.D., Director of R&D at IASO BIO. “By applying highly innovative science in our pre-clinical programs, we believe our pipeline has potential to bring us closer to addressing critical unmet needs, not just for patients, but for the healthcare professionals that treat them.”

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 of 2/100,000 persons, it is one of the most commonly diagnosed blood cancers, second only to non-Hodgkin lymphoma.

This past September CT103A received IND approval for Ib/II chimeric protocol by the National Medical Products Association (NMPA), and phase II clinical trials are expected to begin in early 2020.

About Relapsed/Refractory Multiple Myeloma

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 CT103A

CT103A is an innovative therapy co-developed by IASO BIO and Innovent. 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 is not effective. To solve this dilemma, CT103A 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 CT103A CAR-T is potent and persistent.

About IASO Bio

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（>2×10¹¹）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. www.iasobio.com.

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, autoimmunity 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 up a robust pipeline of 20 innovative assets in the fields of oncology, ophthalmology, autoimmunity, and cardiovascular diseases. Fourteen assets have entered into clinical development, four have entered Phase 3 clinical trials, three monoclonal antibodies have their New Drug Application (NDA) under review and two of them have been granted with priority review status, and one, Tyvyt® (sintilimab injection), is now approved for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL).

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.

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