Companies from across the globe provide updates on their businesses and pipelines.
Valneva SE – Specialty vaccine company Valneva SE, based in France, announced a partnership with the government of the United Kingdom for its inactivated COVID-19 vaccine, VLA2001. Under the agreement, if vaccine development is successful, Valneva will provide the U.K. government with 60 million doses in the second half of 2021. The government then has options over 40 million doses in 2022 and a further 30 million to 90 million doses, in aggregate, across 2023 to 2025. Revenue from these options could amount to almost €900 million. Valneva’s inactivated SARS-CoV-2 vaccine is expected to have a two-dose regimen. UK government is also investing up-front in the scale up and development of the vaccine, with the investment being recouped against the vaccine supply under the partnership.
Celyad Oncology – Also based in France, Celyad Oncology SA entered into an Open Market Sale Agreement with Jefferies LLC. The company can sell American Depository Shares through Jefferies for up to 36 months. Celyad intends to use net proceeds from sales of ADSs for general corporate purposes, including but not limited to the research and development of company’s clinical and preclinical CAR T cell therapy candidates.
Havn Life Sciences – Vancouver-based Havn Life said its subsidiary, Havn Research, was granted a Section 56 exemption by Health Canada to obtain certain amounts of pure psilocybin for scientific purposes, specifically for the research and development of quality control methods. Havn Life intends to immediately begin work on experiments with the objective of developing a set of methods for the safe, standardized, quality-controlled production of medical compounds extracted from the Psilocybe spp. mushroom.
InflaRx – Germany-based InflaRx began the Phase III portion of its Phase II/III trial with IFX-1 in severe COVID-19 induced pneumonia. The primary endpoint will be 28-day all-cause mortality; key secondary endpoints will include assessment of organ support and disease improvement. An interim analysis is planned after enrollment of 180 patients, with a potential for an early stop for efficacy or futility.
AB Science – Protein kinase inhibitor-focused AB Science, based in Paris, presented results from its Phase IIb/III study evaluating its lead product, masitinib, in both progressive forms of multiple sclerosis. The study results demonstrate the efficacy of a therapeutic product in the treatment of patients suffering from both progressive forms of multiple sclerosis.
Mabion– Poland-based Mabion entered into a Memorandum of Understanding (MoU) with Australia’s Vaxine Pty Ltd. that outlines further agreements for the purpose of concluding a collaboration for the joint development, production and commercialization in the EU of Vaxine’s vaccine candidate against SARS-CoV-2, which is currently being evaluated in a Phase I clinical study. Upon completion of the prospective cooperation agreements, Mabion will become Vaxine’s partner to further develop, manufacture and commercialize the vaccine in the European Union, including Poland. Vaxine is developing Covax-19, a potential COVID-19 vaccine that is based on a synthetic spike protein produced using an insect cell-based manufacturing process.
Everest Medicine – China-based Everest Medicine announced top-line results from its Phase I clinical trial in China of taniborbactam (formerly VNRX-5133) in combination with cefepime for the treatment of infections caused by multi-drug resistant (MDR) pathogens. The study met its primary objective, demonstrating that the cefepime-taniborbactam combination treatment was safe and well tolerated among healthy Chinese volunteers with key pharmacokinetics parameters indicating no detectable signal of ethnic differences.
Polyganics – Medtech company Polyganics, which is based in The Netherlands, dosed its first patient in a study for ACTISEAL, the company’s liver and pancreas sealant patch. The trial will evaluate the seal’s efficacy in reducing fluid leakage following elective hepato-pancreato-biliary (HPB) surgery. Despite post-operative fluid leakage being one of the most common complications of HPB procedures, with potentially life-threatening consequences, there are currently no clinically effective treatment options available.
ERS Genomics Limited – Ireland’s ERS Genomics signed an agreement with Applied StemCell, Inc., a leading provider of stem cell, animal model, antibody discovery services and reagents.
GenSight Biologics – Based in France, GenSight submitted the Marketing Authorization Application for its lead product Lumevoq to the European Medicines Agency seeking approval for the treatment of patients with vision loss due to Leber Hereditary Optic Neuropathy (LHON) caused by mutation in the ND4 mitochondrial gene. This marks the first regulatory submission for GenSight. Lumevoq (Lenadogene nolparvovec) is a recombinant adeno-associated viral vector, serotype 2 (rAAV2/2), containing a cDNA encoding the human wild-type mitochondrial NADH dehydrogenase 4 protein (ND4), which has been specifically developed for the treatment of LHON associated with mutation in the ND4 gene. It received orphan drug designation status from the U.S. Food and Drug Administration. GenSight expects to submit the Biologics License Application to the FDA in the second half of 2021.
MediWound – The FDA accepted for review the BLA for Israel-based MediWound’s NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA assigned a Prescription Drug User Fee Act date of June 29, 2021. In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.
Capitainer – Sweden-based Capitainer signed a distribution deal with Speciality Diagnostix for Europe and Australia/New Zealand. The deal comes amid increasing interest driven by COVID-19 in Capitainer’s highly accurate qDBS dried blood spot sampling system. Capitainer’s qDBS system is designed to enable patients to collect their own volume defined dried blood spot at home. The patented smart chip ensures exact sample volumes of 10ul with low CV, independent of haematocrit.
