Today, the European biotech sector is on the cusp of transforming to a product-selling industry with long-term sales revenues, partnerships and a growing significance in the global healthcare markets.
BIO-Europe Spring 2018, will once again be an engine for engaging with the right partners and expanding professional networks. Gathering in Amsterdam, The Netherlands, this year BIO-Europe Spring aims to build on last year’s success and numbers, which included: 1,425 companies; 2,521 delegates; 15,028 one-to-one meetings and 3,255 licensing opportunities.
An additional refreshing aspect of this year’s meeting is the number of panels being chaired by influential women in the sector, for instance: Phyllis Arthur, BIO; Barbara Freischem, European Biopharmaceutical Enterprises; Sofia Ioannidou, Edmond de Rothschild Investment Partners (EdRIP); Natasha Loder, The Economist; Evonne Sepsis, ESC Advisors; and Lisa Urquhart, EP Vantage.
The European sector is not just delivering near-to-market products and drug innovation but also driving biosimilar development, through new clinical trial and regulatory strategies. Cinfa Biotech GmbH, headquartered in Pamplona, Spain, with offices in Munich, Germany is committed to develop, manufacture and commercialize high-quality biosimilars for oncology and inflammatory diseases, addressing the growing need for affordable therapies on proven science, quality, safety and efficacy. BIO-Europe Spring is an excellent platform for Cinfa Biotech to meet potential partners and other members of the exciting life science community.
Cinfa Biotech’s lead product candidate is B12019, a biosimilar version of Neulasta® (pegfilgrastim) used to treat chemotherapy-induced neutropenia. The Marketing Authorisation Application (MAA) for B12019 has been accepted for review by EMA in September 2017. The clinical program of B12019 was based on scientific advice from EMA and included two studies, which confirmed the analytical and biofunctional similarity of B12019 and Neulasta® in highly sensitive clinical study settings.
Cinfa Biotech has attracted significant interest from companies for the commercialization of B12019 in Europe and is currently in advanced stages of licensing discussions for the European market. In parallel, the entry to the US market is in preparation. “Following our culture of expertise and cooperation, we welcome great ideas that have the potential to enhance patient access and create business opportunities. We have the structure, flexibility and entrepreneurial spirit to develop solutions tailored to the needs of our partners and customized for their markets,” said Dr. Ruediger Jankowsky, Managing Director of Cinfa Biotech GmbH.
One of the many European companies with a product in advanced clinical development with exciting clinical results is France-based ABIVAX S.A. (Euronext Paris:ABVX).
ABIVAXis an innovative biotechnology company targeting the immune system to develop treatments for infectious and inflammatory diseases as well as cancer. The company’s lead compound, ABX464, developed from its proprietary antiviral platform technology, is a first-in-class oral small antiviral molecule that blocks HIV replication through a unique mechanism of action combined with a strong anti-inflammatory effect. ABX464 is currently in Phase 2 clinical trials to provide a sustained viral remission or functional cure for patients with HIV/AIDS.
In May 2017, in a Phase 2a clinical trial, ABX464 demonstrated for the very first time that a therapeutic candidate could reduce HIV reservoirs in chronically infected HIV patients as measured by total HIV DNA detected in peripheral blood mononuclear cells (PBMCs)—an exciting finding that was confirmed with top-line results from the first cohort of a second Phase 2a trial, in September of 2018. The top-line results of the second cohort of this trial, which is treated for three months with ABX464, are expected for June 2018.
Following encouraging preclinical data on the molecule’s anti-inflammatory effect in the intestine, in November of 2017, ABIVAX started enrolling a Phase 2a “Proof-of-Concept” study with ABX464 in patients with moderate to severe ulcerative colitis. In the meantime, based on the safety package for ABX464, ABIVAX received the approval from the first EU countries for a one-year open-label extension of the trial. The company is expecting the top-line results from this clinical trial in September of 2018.
“We believe this is the perfect time to present ABIVAX to interested investors and potential partners from the life science industry given all the exciting advantages we have seen in our development pipeline over recent months,” said Prof. Hartmut Ehrlich, MD, CEO of ABIVAX. “BIO-Europe Spring for us is one of the most important partnering events during the year as it brings together life science decision makers and KOLs plus investors from all over the world and therefore provides the best platform for networking and business development conversations. As in previous years, we are very much looking forward to discussing our latest developments and achievements.”
Many other exciting European players are also looking for partners and licensing deals, for example, the gene therapy vector and biopharmaceutical protein specialistCEVEC Pharmaceuticals GmbH (Cologne, Germany).
CEVEC utilizes its proprietary CAP technology to meet the growing demand of efficient, reliable and scalable production of difficult to express proteins and viral vectors for gene therapy applications.
The increasing number of gene therapy-based discovery programs in the biotech and pharma industry is driving a greater need for the scalable production of gene therapy vectors. Many current systems, however, cannot keep up with the pace of production in terms of efficiency, costs of goods, safety and reproducibility. CEVEC’s CAP-GT platform of high density suspension cells, which are easily scalable and adaptable to all current bioreactor formats, overcomes these limitations. It comprises several specialized cell lines for an efficient and safe production of a broad spectrum of viral species including lentiviral (LV), adenovial (AV) and adeno-associated viral (AAV) vectors.
Recently the company introduced a new helper-free AAV packaging cell line for scalable, stable and continuous gene therapy vector production based on its CAP-GT technology, which eliminates the transient transfection step. This specific packaging cell line does not depend on the infection with helper viruses, such as adenovirus or herpes virus, making the production of AAVs easy, scalable and reproducible—comparable to the established protein or antibody manufacturing processes.
“The advantages in terms of safety and productivity plus the easy industrial scale-up of the newly introduced CAP-GT helper-free AAV packaging cell line create a unique position in gene therapy vector manufacturing with the clear goal to establish our CAP-GT technology as the industry standard for scalable viral vector production,” said Nico Scheer, CBO of CEVEC. “We are experiencing an increasing demand from the life science industry in our CAP technologies and BIO-Europe Spring for us provides the perfect platform to network with partners, industry executives and investors and to present our company, products and services, while discussing our strategy, also.”