In a Wave of Innovation Coming Out of China, One Nanjing Biotech Firm Stands Out at the 2019 ASCO and EHA Annual Meetings

Advancing CAR-T related treatments in the fight against cancer, IASO Biotherapeutics (IASO Bio) was one of the top biotechnology innovators unveiling their potential best-in-class therapy back-to-back at two of the most prestigious clinical meetings in the worlds of hematology and oncology, the American Society of Clinical Oncology (ASCO) Annual Meeting 2019 in Chicago, Illinois, May 31 - June 4, and the 24^th Congress of the European Hematological Association (EHA), June 13 - 16. In an IIT study conducted by Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, IASO Bio presented compelling results for safety, efficacy and persistence of a therapy that may also provide patients, having relapsed from a prior CAR-T, an option for CAR-T retreatment.

These notable meetings feature the efforts of the brightest minds driving innovation in hematology and cancer research from around the globe. With a combined international attendance of more than 50,000, this year's meetings focused heavily on the field of immunotherapy, presenting the latest trends and approaches in immuno-oncology, including adaptive cell therapies, immune checkpoint inhibitors, CAR-T therapies and more.

It was on this global stage that IASO Bio debuted the initial clinical results of CT103A, an anti-BCMA CAR-T for the treatment of multiple myeloma developed in conjunction with Innovent Biologics (Innovent) (HKEX: 01801), a world-class pharmaceutical company that develops and commercializes high-quality medicines. At both conferences, they presented their data providing impressive results for efficacy, persistence and safety.

CT103A is an innovative therapy developed by IASO Bio and Innovent. Previous studies indicate patients with relapsed/refractory multiple myeloma (R/RMM) 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.

For newly treated patients with multiple myeloma, the 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 patients who have a reoccurrence after complete remission of the disease. Refractory patients are patients with primary drug resistance or the patients who have finished with first-line treatment and do not achieve remission, or the patients whose disease progresses within 60 days after achieving minimal response. The majority of patients with effective treatment 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.

As of the data cutoff date of May 22, 2019, the objective response rate (ORR) was 100% (CR-64%, VGPR-36%) with strong persistence and high expansion of the CAR-T in-vivo. All patients (100%) experienced CRS. The onset of CRS occurred within 2 to 5 days (median - 2.6) and resolved within 14 days. Mostly grade 1 and 2, at the low and medium dosage levels, CRS was routinely managed with Tocilizumab and steroids. Interestingly, the 12-patient study included 4 patients having previously relapsed from a prior CAR-T therapy, a murine anti-BCMA CAR-T.

"Relapsed/refractory multiple myeloma (R/RMM) is associated with a poor prognosis," said Dr. Chunrui Li of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology. "Many who receive CAR-T treatments have had their disease come back, and with a non-human scFv, re-treatment may not be an option due to immunogenicity. With a fully-human BCMA scFv, CT103A provides an effective option for these patients. This data suggests they should not be excluded from the benefit of future trials."

Multiple myeloma is a malignant hematologic cancer with abnormal proliferation of clonal plasma cells, which has no medical cure so far. In many countries, myeloma is the second most common blood cancer. The American Cancer Society estimates that in the United States (U.S.), about 32,110 new cases will be diagnosed this year. In Europe, more than 48,200 people were diagnosed with multiple myeloma in 2018. Among them, 40% of patients are diagnosed with moderate or high-risk multiple myeloma, and their median survival is less than five years.

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