CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company that is focusing on developing and accelerating the launch of innovative therapeutics and pharmaceutical products in China, the U.S., and throughout the world, announces the signing of a license agreement for exclusive worldwide license and commercialization rights to an autologous anti-CD19 T-cell therapy product (CNCT19) from Juventas Cell Therapy Ltd., a China-based domestic company located in Tianjin City, China. Juventas will continue to develop CNCT19 with CASI's participation on the program's steering committee. CASI will be responsible for payment of certain future development milestones and sales royalties.
In connection with the license, CASI Pharmaceuticals (Wuxi) Co., Ltd., a joint venture in which CASI owns 80% of the registered capital, will invest RMB 80 million (approximately 11.6 million) in Juventas through a wholly owned Chinese subsidiary in lieu of the upfront payment for the license.
CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19-targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used biomarker in the CAR-T cell therapy clinical trials for hematological malignant diseases such as leukemia and lymphoma. Juventas has previously submitted two INDs to the NMPA for Acute Lymphoblastic Leukemia (ALL) and Non-Hodgkin Lymphoma (NHL) indications; approvals of which are expected in late 2019.
Larry Zhang, President of CASI (Beijing) Pharmaceuticals Co., Ltd., a wholly owned subsidiary of CASI, commented, "We are extremely excited by this partnership and are encouraged by the preliminary data which showed promising results that may offer the potential to be the best in class anti-CD19 CAR-T product for Non-Hodgkin lymphoma (NHL) and B-cell acute lymphoblastic leukemia (B-ALL). We are excited about our role to help drive innovation in this exciting therapeutic area and remain committed to providing a range of solutions to patients with hematological malignancies. We look forward to working with Juventas to advance the clinical development of this therapy and for CASI to begin commercial planning."
Alexander Zukiwski, M.D., CASI's Chief Medical Officer commented, "Juventas has made significant strides thus far with regulatory filings in two treatment areas, B-cell acute lymphoblastic leukemia (B-ALL) and Non-Hodgkin lymphoma (NHL), and have identified sites for both Phase 1 and Phase 2 studies in China. We look forward to reviewing the data from the Phase 1 and 2 studies once they are available."
About CASI Pharmaceuticals
CASI Pharmaceuticals is a U.S. biopharmaceutical company focused on developing and accelerating the launch of pharmaceutical products and innovative therapeutics in China, the U.S., and throughout the world. CASI's product pipeline features (i) an autologous anti-CD19 t-cell therapy product (CNCT19) being developed for the treatment of B-ALL and NHL; (ii) an anti-CD38 monoclonal antibody being developed for the treatment of multiple myeloma and other CD38 positive hematological cancers (CID-103); (iii) China rights to three U.S. Food and Drug Administration (FDA)-approved drugs (EVOMELA® (melphalan hydrochloride for injection) approved by China's National Medical Products Administration (NMPA) for marketing, ZEVALIN® (ibritumomab tiuxetan) and MARQIBO® (vincristine sulfate LIPOSOME injection) approved by NMPA for registration confirmatory trials in China; and (iv) a portfolio of FDA-approved and pending abbreviated new drug applications (ANDAs). CASI has offices in Rockville, Maryland and a wholly owned subsidiary in Beijing, China. More information on CASI is available at www.casipharmaceuticals.com.
About Juventas
Juventas Cell Therapy is a China-based domestic company located in Tianjin City, China engaged in cell therapy. The company's lead product, CNCT19, devolved from the CD19 CAR-T, was originally created at the Institute of Hematology, Chinese Academy of Medical Sciences, one of the top hematology centers in China. CD19 CAR-T is used to treat cancer patients with acute lymphoblastic leukemia and relapsed non-Hodgkin lymphoma. Through its commercial collaboration with CASI, Juventas intends to be the first domestic company to launch a CD19 CAR-T in China. Wei-Wu He Ph.D. is the chairman and a founding shareholder of Juventas. A committee of independent directors of CASI negotiated the terms of the investment and license agreements and recommended that the board of directors approve the transaction. Dr. He did not participate in the committee's deliberations or the board of directors' approval of the transaction.
