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news.Celldex Therapeutics, an integrated biopharmaceutical company, has announced initial results from multi-center Phase I clinical trials of its cancer vaccine candidate, CDX-1307, combined with GM-CSF. These data provide the basis for the ongoing assessment of CDX-1307 combined with more potent adjuvants with data expected in the first half of 2009.
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The Phase I studies are open-label, dose-escalating clinical trials in patients with incurable breast, bladder, pancreatic, or colorectal cancer, all tumors that can express hCG Beta.
The studies evaluated the safety and immunogenicity of multiple dosing of CDX-1307 alone and in combination with GM-CSF at multiple dose levels. In one dose escalation scheme 25 patients have received CDX-1307 by local intradermal injection at up to 2.5mg, and in the other Phase I study 25 patients have received CDX-1307 systemically via intravenous injection at higher doses of up to 30mg.
According to the company, CDX-1307 has been well tolerated at all doses and via both routes of administration without any dose limiting toxicity. The most frequent treatment related toxicities were mild flu-like symptoms and mild local reactions associated with the intradermal injections. The hCG Beta was shown to be localized in antigen presenting cells of the skin in post-treatment biopsies following intradermal administration of CDX-1307.
Even in the absence of potent adjuvants, humoral immune responses were seen in approximately half of patients at the higher dose levels despite circulating hCG Beta antigen, with reduction or clearance of hCG Beta in some patients. Enhancement of CD8 T-cell responses after vaccination was also seen in some patients. Despite advanced disease in the majority of patients, two patients experienced stable disease for at least six months and a minor response was seen in a patient with pancreatic cancer.
Based on the safety and immunogenicity seen in the dose escalation studies, Celldex is now evaluating CDX-1307 in combination with the experimental toll-like receptor (TLRs) agonists that the company recently accessed (poly-ICLC, a TLR 3 agonist, and resiquimod, a TLR 7/8 agonist) and expects results by mid-2009. Celldex then expects to initiate a Phase II clinical trial of CDX-1307 in combination with selected TLR agonists in the second half of 2009.
Anthony Marucci, president and CEO of Celldex Therapeutics, said: “The CDX-1307 data define the feasibility and tolerability of Celldex’s novel antibody-targeting platform for cancer vaccines, allowing the flexibility to add novel adjuvant combinations such TLR agonists. This will enable the company to uniquely advance its broad immunotherapy portfolio across a range of disease indications.”