A roundup of some of the biggest pharma news from Belgium including Neuraxpharm’s new Belgian affiliate, Novalis Biotech’s investment in Rarity Bioscience, Catalent’s plasmid DNA manufacturing site and a recent study on the country’s clinical trial footprint.
Germany-based specialty pharma company focused on the treatment of central nervous system (CNS) disorders, Neuraxpharm, has announced the creation of Neuraxpharm Belgium to cover Belgium and Luxembourg, completing its presence in Benelux as it continues its expansion pathway in Europe.
Neuraxpharm’s expansion into Belgium adds an additional country to the growing list of more than 20 countries where Neuraxpharm is established. Neuraxpharm Belgium will be based in Brussels and will distribute and market prescription brand Buccolam(midazolam), which is indicated for the emergency treatment of children and adolescents with epileptic seizures, and Célocurine (suxamethonium chloride) available in hospitals, an adjuvant of general anesthesia, both of which are already available on the Belgian market.
Odimma partners with myNEO for the clinical development of personalized DNA-based cancer immunotherapy (flanders.bio)
France-based Odimma Therapeutics and Belgium-based myNEO have announced the expansion of their existing collaboration into a clinical trial collaboration agreement. The agreement combines Odimma’s synthetic DNA vaccine technology with myNEO’s data analysis platform for fast and accurate per-patient identification and selection of neoantigen targets predicted to elicit strong immune responses. The agreement covers a phase I and phase II clinical trial in solid tumors.
After combining Odimma’s DNA vaccine technology with neoantigens identified by myNEO and achieving promising pre-clinical results in mice last year, both companies decided to continue the successful collaboration into a clinical-stage program.
To further accelerate growth, Rarity Bioscience announces today a new strategic investment from Belgium-based Novalis Biotech. The investment is facilitated as an over-subscription of the recent round closed in November 2022. Apart from previous owner, that round also included Wallenberg Investments through Navigare Venture, now bringing the total investment round to EUR 3 million.
Novalis Biotech is an early-stage venture capital investor in technologies that revolutionise healthcare. The fund’s core competence lies in digitalization in the life sciences with a focus on “enabling technologies” within research and manufacturing technologies, genomics, bioinformatics, diagnostics, and personalised medicine.
The Rarity superRCA technology is a new method for mutation detection from liquid biopsies, published in Nature Communications. The technology demonstrates superior sensitivity that enables earlier detection of cancer relapse, potentially leading to earlier treatment. Compared to competing methods, the superRCA assays are analyzed using existing lab instruments, which reduces both the costs and adoption barriers for labs.
Mithra CDMO to collaborate wit VaRi Bioscience on the development of women’s health product (flanders.bio)
Mithra, specialised in women’s health, has announced a collaboration with VaRi Bioscience GmbH (“VaRi”), an innovative German biotech company focusing on novel drug delivery approaches in Female Health, for the development of an innovative vaginal ring in its CDMO based in Liège.
Under the terms of the collaboration, Mithra CDMO – Mithra’s R&D and manufacturing platform – will be responsible for the development of an innovative long-acting (3 months) estriol (E3)-based vaginal ring indicated for the treatment of vulvovaginal atrophy (VVA) for post-menopausal women requiring systemic anti-estrogenic therapy.
Catalent Completes Plasmid DNA Manufacturing Facility in Belgium (Company release)
Manufacturing giant, Catalent, has announced the opening of a new commercial-scale plasmid DNA (pDNA) manufacturing facility at its European center of excellence for cell therapies, in Gosselies, Belgium.
The state-of-the-art facility contains over 12,000 square feet (1,100 square meters) of development and manufacturing space across multiple cleanrooms for the dedicated production of CGMP-grade pDNA for clinical and commercial-phase supply. It has been designed to be EMA and FDA compliant to support customers with requirements for high-yielding processes at 50 and 300-liter fermentation scale. This will enable a wide range of batch sizes from milligram to multi gram scale.
At the new facility, Catalent will also produce a new range of ‘off-the-shelf’ plasmids to support cell and gene companies. These include adeno-associated virus (AAV) pHelper, which is available now, and Rep/Cap AAV2 and AAV5 plasmids, which will be available later this quarter. Rep/Cap AAV serotypes 1, 3, 6 and 10 will be available later this year.
The Japanese CDMO, Kaneka will be increasing its presence at its facility in Liège, Belgium to boost mRNA manufacturing capabilities.
Kaneka said in a press release that it plans to start operations sequentially from the end of 2023, as well as investing 2 billion yen, or around $15.4 million, and have five times the current production capacity at the site. The CDMO noted in its press release that while mRNA is currently being used in Covid-19 vaccines, it expects mRNA applications in other vaccines and products, and that demand will likely “increase dramatically.”
Belgium has been at the forefront of European clinical trials for more than 10 years with no less than 574 applications approved in 2021, 80 percent of them from biopharmaceutical companies.
At its annual Forum Clinical Trials, pharma.be presented the results of a recent study carried out by Deloitte on the footprint of clinical trials in Belgium. The speakers were then able to exchange their views on various issues relating to maintaining Belgium’s competitive position in a constantly changing European and global context.