CASI Pharmaceuticals Announces Submission Of Clinical Trial Application (IND) To Conduct Phase 1 Study For Anti-38 Monoclonal Antibody Program

CASI Pharmaceuticals, Inc., a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announced that it submitted a Clinical Trial Application (CTA) (IND) with the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) for CID-103, its novel anti-CD38 monoclonal antibody for the treatment of multiple myeloma and other hematological malignancies.

Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer, commented, "Submitting this CTA is an important step in the clinical development of this promising therapy in our hematology oncology franchise. CID-103 demonstrated encouraging efficacy in preclinical models and we believe it has the potential to be best in class and can offer meaningful clinical benefits over the standard of care for patients with CD38 malignancies, including multiple myeloma." 

Alexander Zukiwski, M.D., CASI's Chief Medical Officer commented, "We look forward to launching our study for this novel biological entity as a potential treatment for patients with hematological malignancies.  We will continue to monitor the COVID-19 related circumstances in the UK and are working on administrative activities in support of this trial.  Based on the current environment and timetable of our clinical sites, we are targeting the study initiation in late 2020 or early 2021."

About CID-103 (Anti-CD38 Mab)

CID-103 (f/k/a TSK011010) is a novel anti-CD38 monoclonal antibody program. CASI licensed the global rights to CID-103, from Tusk Therapeutics, Ltd in April 2019. Preclinical data demonstrate CID-103 possesses enhanced activity against a broad array of malignancies expressing CD38, and potentially enhance safety and efficacy benefits when compared to other CD38 monoclonal antibodies. CASI maintains exclusive global rights to CID-103.

About CASI Pharmaceuticals

CASI Pharmaceuticals is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, with a product portfolio that includes approved and investigational assets.  In August 2019, the Company launched its first commercial product, EVOMELA® (Melphalan for Injection), in China that is approved for use as a conditioning treatment prior to stem cell transplantation in the multiple myeloma setting.  The Company's other core hematology/oncology assets in its  pipeline include (i) an autologous CD19 CAR-T investigative product (CNCT19) being developed as a treatment for patients with B-ALL and B-NHL; (ii) CID-103, an anti-CD38 monoclonal antibody being developed for the treatment of patients with multiple myeloma; and (iii) ZEVALIN® (Ibritumomab Tiuxetan), a CD20-directed radiotherapeutic antibody that is approved in the U.S. to treat patients with NHL, and being developed for China.  The Company's oncology assets also include China rights to (i) octreotide long acting injectable (LAI) microsphere formulation indicated for the treatment of certain symptoms associated with particular neuroendocrine cancers and acromegaly, and (ii) a novel formulation of thiotepa, which has multiple indications and a long history of established use in the hematology/oncology setting, both of which are being developed for import registration and market approval in China.