Soligenix inked a definitive licensing deal with the University of Colorado (CU) for a novel vaccine thermostabilization technology the firm has been developing for use with its ricin toxin subunit vaccine candidate RiVax and a subunit vaccine for preventing anthrax. The new licensing deal with the university supersedes Soligenix’ previous option-to-license agreement and means the firm can now use the platform for the development of biodefense vaccines and all other potential vaccine indications.
The technology in question effectively fixes sensitive vaccine components in their native configuration. “The achievement of extended stability under elevated temperature would represent a significant step forward in vaccine technology,” states Robert N. Brey, Ph.D., Soligenix CEO. “Lack of long-term stability is a significant problem in vaccines for use in emergency situations and especially for vaccines used in the developing world where the cold storage chain is difficult to maintain. Further, this novel thermostability technology has the potential to allow us to expand our vaccine business into the development of countermeasures against other more common infectious diseases.”
Soligenix is focused on the development of therapeutics both for life-threatening conditions such as gastrointestinal graft-versus-host disease (GvHD), cancer, and biodefense vaccines for military and civilian applications. RiVax is currently in Phase I development. In September 2009 Soligenix received a $9.4 million grant from the National Institute of Allergy and Infectious Diseases (NIAID) to support development of the thermostable vaccine for RiVax and other rapidly acting vaccines. The firm consequently established a consortium of research expertise to develop the technology further, and inked its option-to-license deal with the University of Colorado. The RiVax candidate itself was originally developed at the University of Texas Southwestern Medical Center (UTSW). Soligenix and UTSW have collectively received approximately $15 million in overall grant funding from NIH for RiVax. The vaccine candidate was granted orphan drug designation by FDA earlier this month.
Soligenix’ biotherapeutics pipeline is headed by the Phase III-stage candidate orBec (beclomethasone dipropionate, BDP), which has been developed as a locally acting oral therapy for treating the gastrointestinal manifestations of acute GvHD. A confirmatory Phase III study with orBec is expected to complete during the second half of 2011. Meanwhile, Soligenix is collaborating with pharmaceutical and distribution partners around the world to provide orBec via named patient access programs to patients suffering from gastrointestinal GvHD. The drug is separately undergoing Phase II evaluation for the prevention of GvHD and Phase I testing for the treatment of chronic GvHD.
A timed-release form of oral beclomethasone dipropionate (designated SGX201) is separately being developed for the prevention of acute radiation enteritis in patients undergoing external radiation therapy for cancer. FDA has granted IND approval for a Phase I/II trial of the drug in this indication, and Soligenix has received a $500,000 SBIR grant from NIH to support the drug’s development for this indication.