Actimab-M: Phase 1

Candidate & Indication Development Stage
R & D Preclinical Phase 1 Phase 2 Phase 3
Actimab-M CD33 Multiple Myeloma
Relapsed or refractory patients age 18 and above
R & D Phase complete
Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started

Actimab-M is being studied in a Phase 1 clinical trial in patients who have progressing disease after 3 prior multiple myeloma treatment regimens or are refractory to QUAD (Caflizomib, Lenalidomide, Pomalidomide, Dexamethason).  This is an investigator initiated study sponsored by Baylor Research Institute.

The Phase 1 trial will estimate maximum tolerated dose (MTD), assess adverse events, measure response rates (objective response rate, complete response rate, stringent complete response rate, very good partial response rate and partial response rate) as well as progression free survival (PFS) and overall survival (OS).

CD33 is an antigen found on hematopoietic cells in certain blood cancers. It is commonly associated with myeloid malignancies including AML, but recent research has shown that CD33 can also be found on malignant cells of approximately 25%-35% of all multiple myeloma patients1.  Furthermore, the expression of this marker increases in relapsed and refractory myeloma.  In addition, it predicts for a very aggressive course of disease2. This makes CD33 a potential target for the treatment of this usually fatal disease. Although treatable, multiple myeloma is currently not considered curable and almost all patients eventually relapse or become refractory to available treatments as their condition progresses.

[1] Robillard, N., Wuilleme, S., Lode, L., Magrangeas, F., Minvielle, S., & Avet-Loiseau, H. CD33 is expressed on plasma cells of a significant number of myeloma patients, and may represent a therapeutic target. Leukemia, 19(11), 2005; 2021-2021.

[2] Sahara, N., Ohnishi, K., Ono, T., Sugimoto, Y., et al. Clinicopathological and prognostic characteristics of CD33‚Äźpositive multiple myeloma. European journal of haematology, 77(1), 2006; 14-18.