Celldex Therapeutics (CLDX) Receives U.S. Patent Supporting CDX-1127

July 10, 2013 7:45 AM EDT
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Celldex Therapeutics, Inc. (Nasdaq: CLDX) announced today that the United States Patent and Trademark Office (USPTO) has issued US Patent No: 8,481,029 entitled "Human immune therapies using a CD27 agonist alone or in combination with other immune modulators" which broadly supports the Company's product candidate CDX-1127. CD27, a signaling molecule expressed on T lymphocytes, can be effectively manipulated with activating antibodies to induce potent anti-tumor responses and, due to the restricted expression and regulation of CD27, may result in less toxicity—overcoming a key barrier that other targets in this class have faced. CDX-1127 is a fully human monoclonal antibody (mAb) that targets CD27 and is currently in Phase 1 clinical development for the treatment of solid tumors and hematologic malignancies.

The patent is assigned to the University of Southampton and Celldex has an exclusive license to this patent based on the execution of an exclusive licensing agreement with the University of Southampton to develop human antibodies to CD27 in November 2008. The patent includes 18 claims covering various methods of treating cancer using agonistic anti-human CD27 antibodies and relates, among other things, directly to Celldex's CD27 antibody program and therapeutic uses of Celldex's antibody CDX-1127.

"We continue to make excellent progress advancing CDX-1127 and securing this key piece of intellectual property is an important achievement as we expand our clinical program in solid tumors and complete dose-escalation studies in hematologic malignancies," said Tibor Keler, Senior Vice President and Chief Scientific Officer of Celldex Therapeutics. "This patent also directly speaks to the importance of the innovative work of Professor Martin Glennie and his team at the University of Southampton in targeting members of the TNF receptor superfamily—which we believe is resulting in rapid translation of exciting immunostimulatory antibodies into the clinic."

At the 2013 American Association of Cancer Research Annual Meeting, in vitro human data were presented that demonstrated that CDX-1127 elicits potent activation of T cells by inducing their proliferation and release of important immune modulating cytokines. Most importantly, the data demonstrated that this activation is highly regulated, which limits safety concerns related to non-specific stimulation of the immune system that similar candidates in this class have faced. These finding have continued to be supported by the favorable safety profile seen to date in our ongoing multi-dose Phase 1 human clinical trial. In the solid tumor arm, dose escalation has been completed and CDX-1127 was determined to be well tolerated, including at the highest dose level. The Company recently initiated the expansion part of the study with cohorts in metastatic melanoma and renal cell carcinoma. The hematologic tumor arm continues to enroll patients in the dose escalation portion of the study and expects to move into expansion cohorts by year-end.

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