Celldex Therapeutics has reported positive results from its Phase I study of CDX-301 (recombinant human Flt3L; rhuFlt3L) conducted in healthy volunteers.

The positive data from the study conducted at Rockefeller University supports the commencement of a pilot study in hematopoietic stem cell transplantation.

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Celldex clinical science vice president Dr Michael Yellin said CDX-301 is well-tolerated and can effectively mobilise hematopoietic stem cell populations as a single agent in healthy volunteers.

"Based on the safety profile and the impressive increases observed for CD34+ stem cells and dendritic cells, we believe CDX-301 holds significant promise in both the allogeneic and autologous transplant setting, including the potential for combination with other molecules that could work in synergy with CDX-301 to further enhance the mobilisation of hematopoietic stem cell populations," Yellin said.

"The positive data from the study conducted at Rockefeller University supports the commencement of a pilot study in hematopoietic stem cell transplantation."

"Published pre-clinical Flt3L studies also suggest that CDX-301 could potentially improve engraftment and reduce the risk of graph versus host disease. This may be especially important for older patients and patients who are in poor health."

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The study enrolled 30 healthy volunteers across seven cohorts.

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Escalating doses of CDX-301301 (from 1mcg/kg to 75mcg/kg) as a five-day regimen was assessed in the first five cohorts, while CDX-301 (at 25mcg/kg) was evaluated in the final two cohorts as seven and 10-day regimens.

Short-term dosing of five days produced a median of 10-fold increases in CD34+ cells. On day 10 of dosing, more than a 100-fold increase in dendritic cells was observed in the peripheral blood.

Transient grade 1 lymphadenopathy was observed in six volunteers (all treated at the highest dose levels of 25mcg/kg and 75mcg/kg), while CDX-301 was well-tolerated.

Volunteers did not exhibit any anti-CDX-301 antibodies at any time from commencement to the end of study follow-up.