28-Jan-2021 - GeneQuine Biotherapeutics GmbH

Advance Gene Therapy Pipeline for Musculoskeletal Diseases

GeneQuine Biotherapeutics Secures more than €9 Million

GeneQuine Biotherapeutics GmbH, a biotech company focused on the development of gene therapy for musculoskeletal disorders, announced that it has raised €5.4 million in Series A financing and €3.65 million non-dilutive funding bringing the total amount raised to €9.05 million. The Series A investment round was led by Pacira BioSciences, Inc., a specialty pharmaceutical company and the leading provider of non-opioid pain management and regenerative health solutions, headquartered in Parsippany, NJ, USA. Other investors include High-Tech Gründerfonds, Bonn, Germany, who had previously invested in GeneQuine, as well as Noshaq SA, Liège, Belgium and Samum Vermögensverwaltungs GmbH, Hamburg, Germany. The non-dilutive funding consists of a convertible loan provided by Pacira BioSciences, Inc. and Samum Vermögensverwaltungs GmbH of in total €2.75 million and a grant by the investment bank of the state of Brandenburg (Germany) of €0.9 million.

The raised funds will be used to advance GeneQuine’s lead candidate GQ-303 for osteoarthritis (OA) to a phase 1 clinical trial, to develop new gene therapies for the treatment of intervertebral disc degeneration, to expand GeneQuine’s gene therapy vector platform and to grow the company’s operations. Last year, GeneQuine already expanded by hiring additional staff and setting up a subsidiary in Liège, Belgium. GeneQuine is headquartered in Hamburg, Germany, and operates an R&D site in Luckenwalde (greater Berlin area), Germany.

GeneQuine’s aim is to employ its gene therapy platform based on helper-dependent adenoviral (HDAd) vectors to turn tissues or organs that need to be treated into factories for local production of therapeutic proteins. Based on the concept of gene therapy, a single local injection should be sufficient to achieve multi-year protein production, avoiding the need for frequent drug administration as it is common for many conventional drugs.

GQ-303, currently at preclinical stage, is an HDAd vector expressing the protein proteoglycan 4 for local treatment of OA. Proteoglycan 4 (also known as lubricin) has been shown to have a dual mechanism of action in OA: 1) a biomechanical effect due to its lubricating properties, and 2) effects on molecular pathways leading to suppression of pain, inflammation and cartilage degeneration. Based on this unique mechanism of action, GQ-303 has the potential to be a symptomatic and disease-modifying therapeutic as demonstrated in several preclinical in vivo studies. GeneQuine is in advanced negotiations with a major contract manufacturing organization for production of GQ-303 for toxicology and clinical studies. Following production of GQ-303, GeneQuine will conduct pivotal toxicology studies in order to file an IND/clinical trial application. In 2017, GeneQuine’s then-lead gene therapy program, which is an HDAd vector expressing the protein interleukin-1 receptor antagonist (now called FX201) was acquired by the pharmaceutical company Flexion Therapeutics, Inc., Burlington, MA, USA.

In 2019, Flexion initiated a Phase 1 clinical trial in knee OA and has treated several patients with FX201 at two dose levels. As GQ-303 and FX201 are both HDAd vectors and are both injected intraarticularly for treatment of knee OA, GeneQuine considers most vector-related development risks for GQ-303 minimized. While both GQ-303 and FX201 are being developed for knee OA, GQ-303 will initially target a patient population that is thought to benefit most from the unique dual mechanism of action of proteoglycan 4.

GeneQuine is also developing HDAd-based gene therapies for treatment of intervertebral disc degeneration. Despite the tremendous unmet medical need in the treatment of intervertebral disc degeneration as one of the main causes for chronic low back pain, no disease-modifying medications are currently available. GeneQuine’s data suggest that local HDAd-mediated gene therapy has great potential in the development of a symptomatic and disease-modifying drug for this disease.

"We are very excited that we have raised this financing round, and are eager to put these funds to work to bring GQ-303 to the clinic, accelerate the development of gene therapy for intervertebral disc degeneration and build out our HDAd vector platform. We thank all the investors that participated in this financing round for their support. It is especially exciting to have Pacira as an investor on board given their expertise in clinical drug development in the musculoskeletal space", said Kilian Guse, CEO of GeneQuine.

"Our equity investment in GeneQuine represents a significant opportunity to participate in the development of what we believe is an exciting disease-modifying gene therapy for osteoarthritis. GeneQuine is conducting preclinical work to support the initiation of human studies in approximately two years. In addition to our confidence in this transaction as a sound investment, we enthusiastically look forward to the maturation of data and for further opportunity to participate in GeneQuine’s successful preclinical program and entry into the clinic. Importantly, this investment is consistent with our mission to advance innovative pain management and regenerative health solutions", said Ron Ellis, DO, senior vice president, corporate strategy and business development at Pacira.

"We are proud that we have attracted GeneQuine to Wallonia and that they set up a subsidiary in the region to advance their lead gene therapy program in collaboration with other local companies and academic partners in our life science ecosystem. GeneQuine develops unique gene therapies for treatment of musculoskeletal disorders and we look forward to seeing GeneQuine bring their lead candidate GQ-303 for osteoarthritis to clinical stage", said Gaetan Servais, CEO of Noshaq.

"GeneQuine is a great example of what we believe is a typical HTGF investment: An exciting technology at the very forefront of scientific development when we first invested in 2012 combined with a strong team that is capable of advancing gene therapy towards the clinic in a most efficient manner. We are looking forward, together with our co-investors and the know-how of Pacira, to supporting GeneQuine with the clinical translation of their promising pipeline", said Martin Pfister, principal at High-Tech Gründerfonds.

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