"CDX-1127 has exceeded our expectations thus far in this ongoing Phase 1 dose-escalation study," said Thomas Davis, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics. "Our primary goal was to establish a favorable safety profile, a challenge that other agonist antibodies in this class have not been able to meet. To date, CDX-1127 has demonstrated minimal toxicity and, importantly, no evidence of worrisome overlap with toxicities seen with other immunotherapies--a critical hurdle for combination therapy. We were also very pleased to see clear evidence of biologic and anti-cancer activity in a heavily pretreated patient population. While future data from the expansion cohorts will be important to understanding single-agent activity, we are confident based on the dose-escalation data we have seen to date that we are well positioned to initiate combination studies of CDX-1127, with a particular interest in immune modulators."
"A 28 year old female with Stage IV Hodgkin lymphoma achieved a complete
response, including complete resolution of B symptoms (drenching sweats,
pruritus and weight loss)--an important marker of disease activity in
Hodgkin disease, after three cycles of CDX-1127 (0.3 mg/kg). The patient
remains in remission at 8.6+ months. During treatment, the area of
measurable lesions first increased and then regressed. This pattern is
consistent with the current perception of an immune mediated response.
The patient was heavily pretreated, including high dose chemotherapy with
autologous marrow transplantation, and most recently had progressed after
less than one month on Adcetris(TM) plus chemotherapy. "