Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced recently that the enrollment for Phase I study of the CDX-1140 has been launched for patients with advanced solid tumors. The CDX-1140 is a human antibody targeted to CD40, an activator of the immune response commonly found on various cells including the dendritic cells, macrophages, and B cells, and on many cancer cells.
Tibor keler, Ph.D., Executive Vice President and Chief Scientific Officer at Celldex Therapeutics stated that the CD40 is an essential target for immunotherapy since it plays a very critical role in activation of the innate and adaptive immune responses. But in most circumstances, the balancing systemic dosing and safety have proven to be indefinable for CD40 activating therapeutics.
The CDX-1140 element is an exclusive, potent CD40 that the company believes it has the potential to balance the systemic doses for tumor penetration with acceptable safety measures. Celldex intends to characterize the CDX-1140 in Phase I of the study and thereafter advance to a greater length by combining the study with other anti-tumor agents.
The Phase I study is expected to enroll about 105 patients who have recurrent, advanced or metastatic cancers and the study is designed to establish the maximum tolerated dose and to recommend the particular dose(s) for further examination in the future studies. The participants in the study will obtain CDX-1140 at different dose levels ranging from 0.01 mg/kg to 30 mg/kg once for a period of four weeks up to until the condition ceases or is intolerable.
Further studies will be determined by the results from the Phase I study and will focus on evaluating the tolerability and biologic impacts of the CDX-1140 dose(s) used in specific tumor types. Furthermore, further studies will include the analysis of the safety and tolerability of the CDX-1140 in various patients.
The potent CD40 antibodies have clearly shown some encouraging results in the previous studies but the CD40 activation has shown some systemic toxicity which has limited their dosing.