Pharma Mag: Belrose Pharma Acquires Enzon’s Advanced Drug Formulation Technology and Clinical Assets
By: Sophia Ktori
New specialty pharma firm Belrose Pharma has acquired Enzon Pharmaceuticals’ PEGylation Linker Technology (Customized Linker Technology®) platform and associated product pipeline. Belrose is focused on the development of next generation injectable and sustained release drug therapies in patient disease populations with high unmet medical needs. The firm says acquisition of the Enzon IP and assets will enable it to accelerate the design of improved biologic and small molecule therapies with better treatment outcomes for patients with diseases including breast cancer and paediatric neuroblastoma, and orphan drug diseases such as hereditary angioedema (HAE). Several members of the core technical team that was formerly involved in Enzon’s research, development, and commercialization of the permanent and releasable Customized Linker Technology® have joined Belrose Pharma.
The acquisition gives Belrose both “traditional” permanent PEGylation and less well known releasable PEGylation technologies, in addition to compounds based on both technologies. Polyethylene glycol (PEG), when permanently linked to certain compounds, has a long track record of enabling high-value commercial products through sometimes dramatic improvements in in vivo circulation, toxicity, and efficacy. The lesser-known releasable PEGylation technique provides a different set of clinical benefits – including targeted release options without a corresponding reduction in potency, improved drug loading, pharmacokinetics, and efficacy, and a simplified and potentially shorter clinical path to market.
“This acquisition of Enzon’s permanent and releasable Customized Linker Technology® significantly strengthens our platform for accelerating the development of more patient-friendly and effective therapies in a range of specialty disease categories,” comments Belrose founder and CEO, Eric Gilbert. “We look forward to being a positive force for bringing new therapies and improved formulations of existing therapies to the global healthcare marketplace and to critically ill patient populations.”
Belrose says it plans to will leverage the value of the assets purchased from Enzon within its two key business areas: advancing development of internal clinical and pre-clinical compounds; and developing products for third party customers seeking to improve both early clinical and mid-lifecycle products using Customized Linker Technology®, where technologies such as nanoparticles and lipid formulations are less suitable.
Belrose will also continue development of two programs acquired from Enzon. The first program is PEG-SN38 (formerly EZN-2208), a Phase III-ready PEGylated conjugate of SN38 that demonstrates improved properties including parenteral delivery, increased solubility, higher exposure, more profound deoxyribonucleic acid (DNA) damage, inhibition of angiogenesis, and longer half-life when compared with native SN38. PEG-SN38 has already generated positive data in clinical trials for metastatic breast cancer and pediatric neuroblastoma. The second program is PEG-C1 esterase inhibitor (formerly EZN-3008), a preclinical PEGylated form of plasma-derived C1-esterase inhibitor (C1-INH). The firm says the product offers the improvement of weekly or bi-weekly subcutaneous or intravenous injections to HAE patients who currently need to be given twice-weekly infusions for prophylactic use.