IASO Biotheraputics Completes Enrollment of First Patient in CT120's Phase I/II Registrational Clinical Trial

SAN JOSE, Calif. and SHANGHAI and NANJING, China, Nov. 9, 2021 /PRNewswire/ -- IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative medicines, today announced that the company's in-house-developed fully human CD19/CD22 dual-targeted chimeric antigen receptor (CAR)-T cell therapy (CT120) has completed enrollment of the first patient in the phase I/II registrational clinical trial for the treatment of CD19/CD22-positive relapsed/refractory B-cell non-Hodgkin's lymphoma (r/r B-NHL). CT120 is the first fully human dual-targeted CAR-T cell therapy approved to enter the clinical stage. The clinical trial of CT120 in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) will also start soon.

The study is a phase I/II, multi-center clinical trial (registration number: CTR20212328). The phase I trial aims to evaluate the safety and tolerability of CT120 in patients with r/r B-NHL and to determine the maximum tolerated dose (MTD) of CT120 treatment and/or the recommended phase 2 dose (RP2D). The phase II trial aims to evaluate the efficacy of CT120 in the treatment of patients with B-NHL.

"This clinical trial greatly reduces the economic burden on patients, and makes it possible for them to benefit early from this innovative drug," said Professor Jianfeng Zhou at Tongji Hospital of Tongji Medical School of Huazhong University of Science and Technology, the principal investigator of the trial. "CT120 is the first dual-targeted CAR-T cell therapy to enter the clinical stage. Compared with available single-targeted CAR-T cell therapy, CT120 is expected to further reduce the risk of tumor recurrence clinically and prolong patient survival. In the exploratory clinical trial, CT120 has shown well-tolerated safety and good efficacy. Our hospital will take an ethics- and science-based approach to work with all partners to advance the trial so as to benefit more patients."

Dr. Wen (Maxwell) Wang, CEO of IASO Bio said, "On October 13th we received approval from the Human Genetic Resources Administration of China, on the 14th we signed a research agreement with Tongji Hospital, and on the 15^th we held the project kick-off meeting. After screening, the first patient was enrolled at the end of October. We'd like to sincerely thank Professor Zhou for working closely with our team throughout the process."

"CT120 is the first fully human dual-targeted CAR-T candidate, and a highly innovative product independently developed by IASO Bio. The IIT study showed that CT120 can benefit not only CAR-T-naïve patients with relapsed/refractory B-NHL or B-ALL, but also patients whose disease progressed during or after treatment with the murine single-targeted CD19 CAR-T cell therapy. The company still has a pipeline of competitive products that are expected to achieve IND milestones. We look forward to leveraging our world-leading platform IMARS to develop more innovative fully human products and deliver on our mission of 'making innovative treatment the backbone therapy to cure patients'," Dr. Wang noted.

About CT120

CT120 is an autologous dual-target CAR-T therapy. Its extracellular domain contains two fully human single-chain fragment variable (scFv) sequences that can specifically bind to CD19 and CD22, identifying tumor cells with CD19 and CD22 expressions, thereby reducing the tumor escape caused by the loss of target antigen. Adopting a fully human design, CT120 has low immunogenicity, reduces the ADA effect, and improves CAR-T cells' viability.

Compared to the intracellular costimulatory signal CD28, CT120's intracellular costimulatory signal 4-1BB and CD3ζ have lower neurotoxicity and improved viability of CAR-T cells, thus more durable efficacy. Upon binding with CD19/CD22 antigens on the tumor cells, CT120 eliminates targeted tumor cells through the release of granzyme and perforin while simultaneously releases cytokine to promote the proliferation of CAR-T cells, thus achieves its durable antitumor activity.

About Non-Hodgkin Lymphoma (NHL)

Lymphoma arises from immune cells. It may cause various organ damage and is commonly associated with a complicated pathological process. Lymphoma has two subtypes: Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). NHL accounts for around 90% of all lymphoma cases, and 85% of NHL cases are B-NHL, which has numerous subtypes, including diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and small lymphocytic lymphoma (CLL). According to a Frost & Sullivan report, there were approximately 92,800 new incidences of NHL in China in 2020 with a total patient population of 514,200 and is expected to reach 632,300 in 2025. NHL has a high mortality rate, with a five-year survival rate of just 37% in China. The National Cancer Institute reports that the rate of new cases of non-Hodgkin lymphoma was 19.6 per 100,000 men and women per year. The death rate was 5.4 per 100,000 men and women per year. Non-Hodgkin lymphoma represents 4.3% of all new cancer cases in the U.S.

About IASO Bio

IASO Bio is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases. Leveraging its proprietary fully human antibody discovery platform (IMARS), high-throughput CAR-T drug priority platform, and proprietary manufacturing processes, IASO Bio is developing a rich clinical-stage pipeline of multiple autologous and allogeneic CAR-T and biologics product candidates. This includes a diversified portfolio of 10 novel pipeline products, including IASO's leading asset, CT103A, an innovative anti-BCMA CAR-T cell therapy under pivotal study for relapsed/refractory (R/R) multiple myeloma (RRMM). CT103A received Breakthrough Therapeutic Designation by China's National Medical Products Administration (NMPA) in February 2021. In addition, the company's in-house developed fully human CD19/CD22 dual-targeted chimeric antigen receptor (CAR)-T cell therapy has entered phase I/II registrational clinical trial for the treatment of CD19/CD22-positive relapsed/refractory B-cell non-Hodgkin's lymphoma (r/r B-NHL). It has also received IND clearance from NMPA for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). For more information on IASO Bio, please visit www.iasobio.com and or LinkedIn.

SOURCE IASO Biotherapeutics