GeneQuine Biotherapeutics’ Gene Therapy Program for Treatment of Knee Osteoarthritis Acquired by Flexion Therapeutics

Knee osteoarthritis program developed by Hamburg-based gene therapy specialist GeneQuine Biotherapeutics acquired by Flexion Therapeutics for up to $64 million. Program holds potential to provide long-lasting pain relief and disease modification, and pending positive pre-clinical results is anticipated to enter clinical trials in 2019.

Hamburg, Germany, December 14, 2017 - GeneQuine Biotherapeutics GmbH today announced that Flexion Therapeutics, Inc. (Nasdaq: FLXN) has acquired the global rights to GQ-203 from GeneQuine. Flexion, a Burlington, MA-based specialty pharmaceutical company, is focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis (OA), a type of degenerative arthritis. GQ-203, now designated FX201 by Flexion, is a preclinical-stage, intra-articular therapeutic being developed for symptomatic pain relief and disease modification in patients with OA of the knee.

As part of the deal, GeneQuine will receive an upfront payment and is eligible to receive future payments for development and global regulatory approval milestones of in total up to $64 million.

GQ-203/FX201 is a locally administered gene therapy designed to express the anti-inflammatory protein interleukin-1 receptor antagonist (IL-1Ra) whenever inflammation is present within the joint. Inflammation is a known cause of pain, and chronic inflammation is thought to play a major role in the progression of OA. By persistently suppressing inflammation, FX201 may both reduce pain and modify the disease.

Kilian Guse, Chief Executive Officer of GeneQuine said: “We are very pleased that Flexion has taken over the development of GQ-203/FX201 and are confident that, given their deep expertise in OA drug development, they will be able to efficiently advance the program into the clinic and potentially to the market. Gene therapy was initially developed to treat rare genetic disease, and we are proud that we could – and will continue to – contribute to the trend in the field of applying this game-changing technology to common disorders such as OA.”

“We are excited to have successfully completed this transaction with GeneQuine for this innovative program, and look forward to advancing FX201 to the next stage of development” commented Michael Clayman, M.D., President and Chief Executive Officer of Flexion.

The GQ-203/FX201 technology was originally developed at Baylor College of Medicine, Houston, TX by GeneQuine’s co-founder Kilian Guse, PhD. GeneQuine was founded in 2012 with the venture capital funds High-Tech Gründerfonds, Bonn, Germany, and Innovationsstarter Fonds Hamburg, Hamburg, Germany, and has since pursued the preclinical development of the asset, demonstrating symptomatic and disease-modifying OA treatment in small and large animal models. GeneQuine will continue developing its IL-1Ra gene therapy programs for OA in veterinary species as well as focus on developing other gene therapies for musculoskeletal diseases.

Based on strong preclinical data, a single injection of GQ-203/FX201 could potentially enable expression of IL-1Ra in an osteoarthritic joint for a least a year. Initially, FX201 will be targeted towards a subpopulation of patients who confront aggressive OA of the knee and would be expected to differentially benefit from this therapy.

About GeneQuine Biotherapeutics GmbH

GeneQuine is a Hamburg, Germany-based biotech company focused on the development of innovative gene therapies. Based on a certain gene therapy vector technology, GeneQuine develops disease-modifying drugs for osteoarthritis in humans and animals in their lead programs. The technology was originally developed by the company’s co-founder Kilian Guse at Baylor College of Medicine, Houston, TX and licensed to GeneQuine.

Contact

Kilian Guse, CEO
kilian.guse@genequine.com

About High-Tech Gründerfonds

High-Tech Gründerfonds (HTGF) is Germany’s most active seed stage investor. With about EUR 830 million under management (EUR 272 million HTGF I, EUR 304 million HTGF II, EUR 254 million HTGFIII), HTGF provide financing for technology-driven companies active in a wide range of fields, including robotics, IoT and energy, Medtech and Biotech, chemicals and software. The seed financing provided is designed to enable start-ups to take their ideas through prototyping and to market launch. HTGF can provide up to EUR 3 million in total financing per company in follow-on financing rounds. Furthermore, start-ups benefit from HTGF’s team experience and expertise as well as the extensive network of investors, experts, managers and scouts. Investors in this public-private partnership include the German Federal Ministry of Economics and Energy, the KfW, Fraunhofer-Gesellschaft e.V. and numerous strategic corporate investors, including ALTANA, BASF, B.Braun, Robert Bosch, BÜFA, CEWE, Deutsche Post DHL, Drillisch AG, EVONIK, EWE AG, Haniel, Hettich, Knauf, Körber, LANXESS, media + more venture Beteiligungs GmbH & Co. KG, PHOENIX CONTACT, Postbank, QIAGEN, RWE Generation SE, SAP, Schufa, Schwarz Gruppe, STIHL, Thüga, Vector Informatik and WACKER.

Contact

Dr. Martin Pfister
Sen. Investment Manager
High-Tech Gründerfonds Management GmbH
Tel.: +49 228 823 00 100
m.pfister@htgf.de
www.high-tech-gruenderfonds.de/en

About Innovationsstarter Fonds Hamburg

The Innovationsstarter Fonds Hamburg provides venture capital to young and innovative companies with its place of business in Hamburg. The aim is to strengthen research and development activities. Open participation in limited liability companies can reach up to 1 million Euros. Investors are in equal shares the city of Hamburg and the European Regional Development Fund (EFRE). The management of the fund is the IFB Innovationsstarter GmbH which is a 100% owned subsidiary of the Hamburgischen Investitions- und Förderbank.

Contact

Gencer Sahin
Investment Manager
IFB Innovationsstarter GmbH
Tel.: +49 40 65 79 805 - 96
sahin@innovationsstarter.com
www.innovationsstarter.com

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