Following completion of the acquisition, Celsion's pipeline will include two clinical-stage candidates targeting various oncology indications, and three platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA/RNA therapies.
In addition to its Phase Ib DNA-based immunotherapy product candidate, Egen has three therapeutic platform technologies, including one for delivery of DNA and mRNA, one for synthetically-generated small inhibitory RNAs (siRNAs), and one for Cell Enabled Expression and Secretion of RNA.
The Phase Ib DNA-based immunotherapy product candidate is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system which enables cell transfection followed by persistent, local secretion of the IL-12 protein.
In addition, Egen has developed several classes of proprietary carriers that can efficiently deliver the siRNAs to the cytoplasm of many types of cells both in vitro and in vivo.
The acquired assets will build on Celsion's ThermoDox, which recently received clearance for a Phase III trial from the US FDA, and is a proprietary heat-activated liposomal encapsulation of doxorubicin.
The liposomal technology allows for the delivery of high concentrations of doxorubicin, a widely used anthracycline chemotherapy, in a region specifically targeted with the application of localized heat, such as in radiofrequency ablation (RFA). Celsion plans to conduct a 550 patient, Phase III pivotal study of ThermoDox in combination with RFA in primary liver cancer. ThermoDox is also being evaluated in an ongoing Phase II study in recurrent chest wall breast cancer.
Michael Tardugno, Celsion's President and CEO, said in a conference call on Tuesday that early results on ThermoDox revealed the treatment could extend survival for liver cancer patients by as many as two years.
Payment Details
The upfront payment consists of $10.6m in Celsion common stock, representing approximately 16.4% of Celsion's outstanding shares, and $3.4m in cash.
In addition to the upfront payment, a total of $30.4m in future milestone obligations are payable to Egen based on the successful completion of certain clinical development and licensing milestones. The acquisition is expected to close in June 2014, subject to customary closing conditions. The boards of directors of both Celsion and Egen have unanimously approved the transaction and no employees from either company are expected to be laid off.
The company will remain headquartered in Lawrenceville, New Jersey, Tardugno said.
He added: "As a combined Company, Celsion-Egen will be focused on the leading-edge of cancer treatment, with assets in directed chemotherapies, immunotherapies and DNA- or RNA-based therapies. With clinical programs in Phases III, II and I, and an extensive pipeline of pre-clinical product candidates, Celsion-Egen will be well positioned to deliver innovative new therapies to address areas of pressing unmet medical need in oncology."