GQ Bio Closes Collaboration Deal with Pacira BioSciences for Development of a Commercial-Scale Manufacturing Process for High-Capacity Adenoviral Vectors

GQ Bio Therapeutics GmbH today announced that it has closed a collaboration deal with Pacira BioSciences, Inc. for the development of a manufacturing process for its High-Capacity Adenoviral vector (HCAd) gene therapy product candidate, PCRX-201, which was originally developed by GQ Bio. As part of the multi-million-dollar collaboration, GQ Bio will lead the process development, which will take place at GQ Bio’s R&D facility in Germany, as well as contract research organizations. While the development of the manufacturing process is initially focused on PCRX-201, GQ Bio will be able to use the process for its entire HCAd platform including the lead candidate GQ-501.

 

PCRX-201, a HCAd expressing interleukin-1 receptor antagonist, was originally developed by GQ Bio for the treatment of osteoarthritis.  The product candidate was acquired by Flexion Therapeutics in 2017 and subsequently became part of the Pacira clinical pipeline after its acquisition of Flexion in 2021. It has been evaluated in a Phase 1a clinical trial with 72 knee osteoarthritis patients, which was recently presented at the Osteoarthritis Research Society International (OARSI) World Congress.  Intraarticular injection of PCRX-201 was well tolerated with no major adverse events across three dose levels with substantial reduction of knee pain across cohorts (Cohen et al 2023, OARSI World Congress, Denver, USA, Abstract O-2). Pacira plans to initiate a Phase 1b clinical trial in knee osteoarthritis patients with PCRX-201 in the last quarter of 2023. Furthermore, Pacira is investing in the development of a commercial-scale manufacturing process within this collaboration with GQ Bio.

Currently, there are more than 30 million knee osteoarthritis patients in the EU and US. In order to address markets of prevalent diseases such as osteoarthritis with gene therapy, a scalable manufacturing process as well as low manufacturing costs per dose allowing low selling prices for the final product are essential. Because HCAds enter joint cells very efficiently following intraarticular injection, only low doses are needed for local osteoarthritis therapy. Therefore, GQ Bio’s HCAd platform is ideally suited for the development of commercially viable gene therapies for osteoarthritis and other prevalent diseases.

“We are excited to start this collaboration with Pacira and are grateful for their confidence in our process development capabilities. This manufacturing process will be essential for the further development of PCRX-201, will be a crucial part of our HCAd platform and will be very important for the commercializability of gene therapies for prevalent diseases”, said Kilian Guse, CEO of GQ Bio.

“We believe PCRX-201 has the potential to be an important disease-modifying gene therapy for osteoarthritis.  We look forward to expanding our relationship with GQ Bio to ensure that we move forward with a commercially amenable process with a competitive cost of goods,” said Ron Ellis, DO, chief strategy officer of Pacira BioSciences.

About GQ Bio Therapeutics GmbH

GQ Bio is pioneering a high-capacity gene therapy vector platform (HCAd) that addresses some of the big challenges in the gene therapy field: Transfer of large and multiple genes with a single vector, highly efficient gene delivery (high transduction efficiency), and large-scale manufacturability. Based on its HCAd vector platform, GQ Bio develops transformative treatments for chronic, prevalent conditions such as osteoarthritis and intervertebral disc degeneration. GQ Bio is headquartered in Hamburg, Germany and has sites at Luckenwalde (greater Berlin area), Germany, as well as Eupen and Liège, Belgium.

 

 

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