First of all, Celldex is becoming widely known. There was already one article today on CLDX (Motley Fool). Undoubtedly, a lot of people will be talking and researching Celldex this weekend. Second, Celldex has 9+ drug candidates that are owned 100% by Celldex. Also, look what is coming soon.
The three-year, randomized, placebo-controlled, Phase I trial, known as DCVax-001, will enroll 45 healthy HIV-uninfected volunteers in New York City. Investigators will evaluate both the safety and immunogenicity of the vaccine candidate administered at three different doses, along with a fixed dose of an experimental adjuvant called Poly ICLC (Hiltonol) that was designed to activate innate immune responses. The volunteers will receive three subcutaneous vaccinations of either the vaccine candidate or placebo over 12 weeks, and will then be monitored for 12 months.
Researchers at Rockefeller have been working with Celldex Therapeutics, a biotechnology company headquartered in Massachusetts, on the development of the candidate vaccine. Celldex previously developed a vaccine candidate with a mAb fused to DEC-205 to target a tumor-associated antigen known as NY-ESO-1, but this is the first time an AIDS vaccine candidate has been constructed using this technology.
Estimated Enrollment: 45
Study Start Date: May 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Principal Investigator: Sarah Schlesinger, MD The Rockefeller University
Looks what’s coming at AACR!
Characterization of the response of human T cells to an agonist human anti-CD27 mAb
Monday, Apr 08, 2013, 1:00 PM - 5:00 PM
Karuna Sundarapandiyan, Laura Vitale, Biwei Zhao, Thomas O'Neill, Henry Marsh, Venky Ramakrishna, Tibor Keler. Celldex Therapeutics, Inc., Phillipsburg, NJ
APC targeting and maturation in the clinic
Tuesday, Apr 09, 2013, 11:05 AM -11:25 AM
Thomas A. Davis. Celldex Therapeutics, Clarksville, M.D.
The commercial potential of a cancer therapy not only depends on its efficacy and safety profile but also how many different cancers it can be used to treat. Huge amounts of money and time are spent developing cancer drugs, and if one is able to treat multiple indications due to its design, the return on investment could be substantial. The current king of multiple indications is Genentech's Avastin (bevacizumab), a single therapy that is used to treat multiple cancers. This anti-VEGF antibody is approved to treat four different cancers including colorectal, lung, renal, and brain along with off-label uses such as wet AMD and breast cancer. Sales of this blockbuster drug are expected to peak at $7.5 billion worldwide. Herceptin (trastuzumab), an anti-HER2/neu antibody also from Genentech, is approved for both breast and gastric cancers and has peak sales forecasts of about $6 billion worldwide.
Celldex Therapeutics' (CLDX) lead product, rindopepimut, which targets EGFRvIII is currently in a Phase III trial in patients with newly diagnosed GBM and a Phase II trial in patients with recurrent GBM. EGFRvIII is expressed in about one third of GBM patients but also reported in lung, breast, ovarian, and prostate cancers. Rindopepimut was partnered with Pfizer earlier, but the rights were returned to Celldex for unspecified reasons. Celldex's deep pipeline includes another product, CDX-1401, in a Phase I/II trial for several cancers. CDX-1401 is an antibody targeting dendritic cells linked to the TAA, NY-ESO-1. This TAA is widely expressed on several tumors: approximately a quarter of all lung, prostate, melanoma, bladder, esophageal, and ovarian cancers.