Celsion will acquire EGEN in an up-to-$44 million deal that expands the buyer’s oncology pipeline with a Phase Ib drug candidate and multiple platform technologies.
Celsion will add to its cancer-fighting arsenal EGEN’s DNA-based immunotherapy candidate EGEN-001 for localized treatment of cancer. Designed using the company’s TheraPlas™ platform technology for delivery of DNA and mRNA, EGEN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system designed to enable cell transfection followed by persistent, local secretion of the IL-12 protein.
The mechanism of action and method of administration of EGEN-001 are designed to address the poor pharmacokinetics and serious toxicities associated with recombinant proteins such as IL-12, among the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation.
EGEN-001 is in an ongoing Phase Ib trial in combination with PEGylated doxorubicin in patient with platinum-resistant ovarian cancer. The combined company plans to initiate a Phase I study in glioblastoma multiforme (brain cancer) following promising preclinical activity in that indication. Also planned is a Phase II combination trial that would include EGEN-001, after the compound showed positive safety and encouraging Phase I results as monotherapy in patients with peritoneally metastasized ovarian cancer.
TheraPlas is one of three EGEN platforms that Celsion is acquiring with the company. The other two platforms are:
- TheraSilence™, focused on delivering synthetically generated small inhibitory RNAs (siRNAs), microRNAs, and microRNA mimics, and related molecules that can regulate protein expression by exploiting endogenous cell mechanisms. TheraSilence has generated its first drug candidate, EGEN-RNA-002, now in preclinical development.
- RNA Amplification and Secretion Technology (RAST™), designed to enable cells to express and secrete RNA (microRNA, mRNA, shRNA, aptamers). EGEN said it has secured broad intellectual property rights to RAST and is evaluating new opportunities for therapeutic and life science products that can be based on the platform.
Celsion said the deal was designed to complement its lead development candidate the Phase III-ready experimental drug ThermoDox®, a heat-activated liposomal encapsulation of doxorubicin. The technology is designed to allow for delivery of high concentrations of doxorubicin in a region to which localized heat has been applied, such as via radiofrequency ablation (RFA).
ThermoDox is now advancing in a double-blind, placebo-controlled, 550-patient global Phase III trial (the OPTIMA Study) in primary liver cancer, and is in an ongoing Phase II study in recurrent chest wall breast cancer. The FDA recently cleared ThermoDox for a 550-patient Phase III trial assessing its effect on primary liver cancer in combination with RFA.
“This transaction offers an immediately well-defined strategic fit, bringing together discovery and preclinical expertise with clinical and operational excellence, ground-breaking technologies with high-value clinical assets, to form a company whose synergy provides substantially more than its parts,” Michael H. Tardugno, Celsion's president and CEO, said in a statement.
Celsion agreed to pay $14 million upfront—$10.6 million in common stock representing some 16.4% of its outstanding shares, the remainder in cash—plus up to $30.4 million in payments based on clinical development and licensing milestones.
The boards of Celsion and EGEN have approved the deal, which is expected to close later this month, subject to customary closing conditions.
Celsion and EGEN said the combined company is expected to retain all EGEN employees and will be headquartered in Lawrenceville, NJ. However, discovery and preclinical operations will be based at EGEN's current, leased facilities in Huntsville, AL, where Celsion also plans to consolidate all of its analytical service and laboratory functions.