BioSpace's Global Biopharma Roundup: May 9
BioNTech – Germany-based BioNTech acquired San Diego-based MabVax Therapeutics to bolster its portfolio with MVT-5873, MabVax’s lead candidate. MVT-5873 is a fully human IgG1 monoclonal antibody targeting sialyl Lewis A (sLea), an epitope expressed in pancreatic and other GI cancers that plays a role in tumor adhesion and metastasis formation. MVT-5873 is currently in Phase 1 clinical development in pancreatic cancer and has been tested in 35 patients with initial positive interim data announced in February 2018. In conjunction with the agreement, BioNTech has purchased MabVax Therapeutics’ infrastructure and laboratory equipment with the intention of establishing a research facility in San Diego. The location is advantageous for BioNTech’s planned U.S.-based clinical trials and will further support the production of the company’s investigational treatments. Financial terms were not disclosed.
SenzaGen – Sweden-based SenzaGen saw a boost ton International Asthma Day after the European Union invested in the development of an in-vitro test for respiratory sensitization. SenzaGen’s GARDair predicts whether chemical substances can cause allergic reactions in the airways. The test, which is based on Artificial Intelligence and Genomics, enables not only the development of safe products but also preventative measures. GARDair was launched in 2018 after it received funding from the EU research initiative Horizon 2020.
Mologic –Mologic completed the development of a next-generation ultra-sensitive lateral flow-based technology platform. The diagnostic program can be visually read and demonstrate up to a 1,000-fold improvement in sensitivity over current technology, the U.K.-based company said. The innovations at the core of the platform can be replicated for any protein or small molecule target with associated performance gains and represent a major advancement in the accuracy and application of commercial lateral flow assays for rapid diagnostic tests (RDTs) and support global efforts to eliminate high burden epidemics. With funding and support from the Bill & Melinda Gates Foundation, Mologic established the Centre for Advanced Rapid Diagnostics platform to deliver unprecedented improvements and innovation in lateral flow technology. During 2019, Mologic will open up the new technology platform to other partners through its services division thus ensuring it reaches applications that would benefit from ultra-sensitivity at the point of care, such as oncology and agriculture.
Akcea Therapeutics – This Boston-based company snagged marketing authorization from the European Commission for Waylivra as an adjunct to diet in adult patients with genetically confirmed FCS and at high risk for pancreatitis. As part of the conditional marketing authorization, Akcea and its parent company Ionis will conduct a non-interventional post-authorization safety study based on a Registry. Waylivra will launch first in Germany, then across Europe in 2020. FCS is caused by impaired function of the enzyme, lipoprotein lipase. It is estimated that there are between 3,000 to 5,000 people living with FCS worldwide, with approximately 1,000 people living with FCS in Europe.
Selexis SA – Switzerland-based Selexis will present cell line data from its collaboration with Berkeley Lights at the European Society of Animal Cell Technology (ESACT) 2019 Meeting. In an oral presentation, “Beacon CLD Platform, From Single Cell Productivity to Small Bioreactor,” Selexis scientists highlighted findings from the company’s integration of the Beacon Optofluidic Platform into the SUREtechnologyPlatform workflow. By combining Beacon with SUREtechnology’s advanced gene transfection technologies and Selexis’ proprietary clone prediction tool, Selexis scientists significantly reduced the time and effort in the development of high-performance research cell banks (RCBs) to just eight weeks. Iris Bodenmann of Selexis presented today as part of the Cell Culture Process Controls and Analytics track.
RedHill Biopharma – Specialty pharmaceutical company RedHill, with its headquarters in Israel, submitted a New Drug Application (NDA) to the FDA for Talicia (RHB-105) for the treatment of H. pylori infection. The NDA was submitted under the 505(b)(2) regulatory pathway. Talicia was granted Qualified Infectious Disease Product (QIDP) designation by the FDA and is eligible for six-month priority review of the NDA. The NDA for Talicia is supported by a clinical package including two positive Phase III studies in the U.S., along with two pharmacokinetic studies evaluating food effects and the comparative bioavailability of Talicia. It is estimated that H. pylori infection affects over 50 percent of the population worldwide3 and approximately 35 percent of the U.S. population, with an estimated 2.5 million patients treated annually in the U.S.
Follicum – Sweden-based Follicum secured a patient from the European Patent Office for its hair-growth formula for alopecia patients. The patent protects Follicum's peptides in Europe until 2032.