BioSpace Global Roundup, June 18
Batavia Biosciences – France-based Batavia and Valneva Sweden AB, the Swedish subsidiary of Netherlands-based Valneva SE, entered into a collaboration to accelerate market-access of a low-cost inactivated polio vaccine (IPV). The IPV vaccine is based on the Sabin vaccine strains (sIPV), which Batavia has successfully obtained from the World Health Organization (WHO). Valneva will manufacture the sIPV vaccine for clinical trial purposes in its state-of-the-art GMP polio manufacturing facility operated under GAPIII polio containment in Solna, Sweden, using Batavia’s process. In return, Valneva will receive an upfront payment and monthly service fees.
CureVac – The Federal Republic of German is investing €300 million in CureVac to further development of the Company’s proprietary pipeline and mRNA platform technology and the expansion of business activities. Under the agreement, the Kreditanstalt für Wiederaufbau will hold a stake of around 23% in CureVac.
Mellon Medical – Dutch medtech company Mellon Medical signed an agreement with Netherlands-based Demcon to advance the Switch towards market introduction. The Switch is a (single patient use) precision surgical suturing device for abdominal wall closure, ideal for enabling the ‘small bites’ technique. This will reduce the risk of complications such as post-surgery incisional hernia, resulting in improved patient outcome and a substantial reduction of healthcare costs.
Affibody AB – Sweden’s Affibody AB completed its Phase I study investigating safety, tolerability, pharmacokinetics, and pharmacodynamics of its novel FcRn inhibitor ABY-039 (FcRn) in healthy volunteers. ABY-039 is a bivalent antibody-mimetic that targets the neonatal Fc receptor and that has shown potent lowering of plasma IgG titers and very long half-life in healthy volunteers. Its main competitor, efgartigimod, recently demonstrated the benefit of IgG lowering in patients with myasthenia gravis in Phase III. Due to tolerability observations in the Phase I study, Affibody terminated the program, which also brought to an end the company’s co-development agreement with Alexion for the asset. “In light of the successful development of efgartigimod, with a risk for a less than optimal product profile, and with note of a challenging target biology, including for instance the dual functionality of albumin and IgG binding, we will focus on other proprietary projects in our pipeline” David Bejker, chief executive officer of Affibody said in a statement.
In addition to the discontinuation of the ABY-039 study, Affibody announced positive top-line data from its 52-week trial investigating the novel bispecific IL-17A inhibitor ABY-035 in patients with moderate-to-severe psoriasis. The study showed that 88% of enrolled patients achieved 90% improvement of the baseline Psoriasis Area Severity Index (PASI) score after 12 weeks of treatment. Based on the clinical results in patients with moderate-to-severe psoriasis, the clinical development program of ABY-035 has been expanded to include further indications for development and commercialization.
eTheRNA Immunotherapies – Belgium’s eTheRNA Immunotherapies secured €34 million in a Series B funding round that was supported by existing investors LSP, PMV, Boehringer Ingelheim Venture Fund, Fund+ and Omega Funds. Proceeds of the financing will fund continued development and commercialization of proprietary mRNA technologies and a range of therapeutic products. eTheRNA’s TriMix platform is a core differentiating component in the company’s product programs and comprises three mRNAs encoding proteins that act together to significantly increase immune responses.
SOTIO – Czech Republic-based SOTIO announced it will present new preclinical data on SO-C101, an IL-15 superagonist currently being studied in a Phase I trial for the treatment of advanced solid tumors, in a virtual poster presentation at the 2020 American Association for Cancer Research virtual meeting next week.
OliX Pharmaceuticals – Korea’s OliX Pharmaceuticals signed an exclusive contract with LGC Biosearch Technologies Inc. (LGC), a contract development and manufacturing organization (CDMO) and part of the global life sciences tools company headquartered in London, to scale production of OliX’s OLX301D therapeutic candidate. Under the terms of the agreement, LGC will produce the active pharmaceutical ingredients for the preclinical and clinical study of OLX301D program, for the treatment of sub-retinal fibrosis and wet macular degeneration. The OLX301D program is a first-in-class treatment that may treat choroidal neovascularization and sub-retinal fibrosis in patients with wet macular degeneration.
BIA Separations -- Bio-chromatography development and manufacturing company BIA Separations, based in Slovenia, introduced its novel PrimaS ligand technology. The first application of PrimaS technology being made available is for mRNA purification addressing a rapidly growing interest in mRNA-based therapies. PrimaS is a key addition to the company‘s mRNA purification toolbox, including Oligo dT-18, C4-HLD and SDVB chemistries. The platform harnesses mRNA capturing and polishing strategies, including dsRNA impurity removal and mRNA sizing options. All technologies are easily scalable from lab to manufacturing, and are able to provide better product quality than traditional purification systems.
Ona Therapeutics – New portfolio therapeutics company Ona Therapeutics received an investment from Belgium-based Fund+, an investment firm focused on European life science companies. The financing will allow Ona Therapeutics to complete the pre-clinical development in a variety of tumor types and to move its lead candidate into first clinical studies in patients with metastatic cancer in 2023. Ona Therapeutics was spun-out of IRB Barcelona and ICREA.
Abivax – France’s Abivax received €5m in non-dilutive financing from Société Générale in the form of a loan guaranteed by the French state. This €5m loan will extend Abivax's cash runway into early 2021. Abivax CEO Hartmut Ehrlich said the funds will allow Abivax to maintain the rapid development pace of its ongoing and planned clinical study programs. Patient recruitment is progressing for its Phase IIb study ABX464 in ulcerative colitis and a Phase IIa study in rheumatoid arthritis. The company is also studying the asset in a Phase I/II study in hepatocellular carcinoma and will soon dose its first patient in a COVID-19 study. Abivax is already preparing for potential marketing authorizations and global commercialization of ABX464 for the treatment of high-risk COVID-19 patients.
Guerbet– Medical imaging company Guerbet, based in France, announced the approval of an additional indication for Lipiodol Ultra-Fluid by the China NMPA for use in Trans-Arterial Chemo-Embolization (cTACE) for intermediate-stage hepatocellular carcinoma in adult patients. Lipiodol Ultra-Fluid is used in Interventional Oncology for conventional trans-arterial chemoembolization. HCC is the most common primary liver cancer and the fourth biggest cause of death due to cancer worldwide. China represents more than 50% of all primary liver cancers globally.
Module Innovations – India’s Module Innovations received an infusion of $702,000 from CARB-X to develop a rapid diagnostic for drug-resistant urinary tract infections (UTI) infections. The diagnostic would also provide vital information on which antibiotics would be most effective against the superbug, including common uropathogens such as Escherichia coli, Klebsiella, Pseudomonas aeruginosa and Enterococci faecalis that often cause infection. The Indian company stands to receive an additional 2.5 million more if certain project milestones are met.
Staidson – Beijing-based Staidson and Madrid-based Pivotal, a CRO, launched a new collaboration to assess Staidson´s investigational product BDB-001, a monoclonal anti-C5a antibody, in progressive severe COVID-19 patients caused by SARS-CoV-2. BDB-001 specifically binds to C5a so that C5a loses its ability to bind to its receptors, thereby blocking its biological functions. The cumulative evidence to date suggests that complement C5a is a powerful inflammatory mediator involved in the progression of a wide variety of autoimmune and other immune-mediated diseases.
MEDIAN Technologies – France-based Median announced results of a preliminary retrospective study on the evaluation of the risk of recurrence for patients with primary liver cancer based on a non-invasive biomarker. The iBiopsy imaging biomarker discovery platform, which integrates advanced technologies in artificial intelligence has produced these results on one of the three indications on which it is positioned.