BioSpace Global Roundup: Rolling Submission for Sputnik V Begins in Europe


One week after its COVID-19 vaccine stood up to peer review, Russia has applied for a rolling review for authorization of its Sputnik V vaccine in Europe. Russian Direct Investment Fund said the application has been accepted for rolling review and it is now up to the agency to determine the timeline.

An interim analysis of Phase III data for the Russian-made vaccine that showed the preventative medicine generated an efficacy of 91.6% against the original strain of the virus. Among older patients above the age of 60, efficacy from Sputnik V was 91.8%. Russia’s Sputnik V vaccine is an adenoviral vector vaccine developed by Moscow’s Gamaleya Institute. The vaccine has been genetically modified to infect cells then make those cells manufacture spike proteins of SARS-CoV-2, the novel virus that causes COVID-19. Sputnik V uses two different vectors, which the Gamaleya Center said allows for a more effective defense against COVID-19. By deploying two different vectors, Sputnik V avoids a possible neutralizing effect and generates a durable and longer-lasting immune response, the Gamaleya Center said.

Elsewhere around the globe:

Aurora Science – Italy’s Aurora Science, an investment company, announced the €18.5 million financial support of InteRNA Technologies B.V., a Utrecht-based clinical-stage biotech company specialized in the development of a new generation of miRNA-based products targeting key processes in the initiation and progression of human diseases, with a focus on cancer. The funding will enable the clinical evaluation of the Company’s microRNA lead candidate, INT-1B3, in patients with advanced solid tumors, as well as the further development of other proprietary preclinical drug candidates in its pipeline.

Avacta Group – Avacta Group and Mologic, both based in the U.K., entered into partnership to accelerate to market Avacta’s AffiDX SARS-CoV-2 lateral flow rapid antigen test. Avacta will also support antigen testing in low and middle income countries 1 by providing access to Avacta’s spike antigen test through Mologic. The partnership will provide a faster route to market for Avacta’s rapid antigen test and also provides Avacta with additional manufacturing capacity through Mologic. The partnership between Avacta and Mologic also provides a framework agreement for the future development of a pipeline of tests in a range of disease areas. The possibility of combining Avacta’s spike antigen test with Mologic’s nucleocapsid antigen-based technology in a single lateral flow device is already being explored. A hybrid antigen test such as this is expected to be a world first and has the potential to deliver an extremely sensitive lateral flow coronavirus antigen test.

Signifier Medical Technologies – London -based Signifier announced eXciteOSA, its daytime intraoral neuromuscular stimulation device for treating mild obstructive sleep apnea and snoring, was cleared by the U.S. Food and Drug Administration. Signifier’s eXciteOSA is the first device used while awake that is intended to improve tongue muscle function. Used for only 20 minutes per day for a period of six weeks and then twice per week, the therapy is clinically proven to improve the quality of sleep by significantly reducing obstructive sleep apnea and snoring. Obstructive sleep apnea and snoring affect one in three people. If untreated, obstructive sleep apnea can lead to multiple complications, including hypertension, heart attack, glaucoma, diabetes, cancer and cognitive and behavioral disorders.

TISSIUM – France-based medtech TISSIUM has been named a French Tech 120 company for 2021. French Tech 120 is a growth-stage program by La French Tech, built to provide government-backed support for the 120 fastest growing companies in France. This is the second year in a row that TISSIUM has been selected. In 2021, TISSIUM is expanding its reach to increase its focus internationally, especially in the U.S., and it has recently added to its global leadership team to focus on partnerships and regulatory preparedness as a result.

Evolve Biologics – Based in Mississauga, Ontario, Evolve announced it has successfully completed its adult and pediatric Phase III clinical trial of PlasmaCap IG (Intravenous Immunoglobulin or “IVIG). PlasmaCap IG is an investigational IVIG replacement therapy for adult and pediatric patients with primary immune deficiency disease. There were no acute serious bacterial infections, meeting the primary study endpoint. The trial also met all of its secondary efficacy and safety endpoints. More than 98% of the infusions were completed without discontinuation or interruption, and 97% of all treatment-related adverse events reported were mild or moderate.

Affibody – Sweden’s Affibody and Netherlands-based Inmagene Biopharmaceuticals announced the FDA cleared its asset izokibep (ABY-035) for a Phase II study Ankylosing Spondylitis (AS), a subset of Axial Spondyloarthritis (axSpA). The study is a one-year double-blind controlled trial in approximately 300 patients with active Ankylosing Spondylitis. The trial will evaluate the efficacy, safety and tolerability of three different dosage regimens of izokibep as compared to placebo.

GENFIT – Based in France, GENFIT announced positive results from a Phase II study of elafibranor in patients with Primary Biliary Cholangitis (PBC) with incomplete response to ursodeoxycholic acid (UDCA) have been published in the Journal of Hepatology. These data show a clinically relevant improvement on the primary and composite biochemical endpoints, a positive trend on pruritus improvement, while maintaining a favorable tolerability profile, all of which are supportive of the conduct of ELATIVE, a longer term, larger scale pivotal Phase III study to evaluate elafibranor in patients with PBC. Elafibranor was granted Breakthrough Therapy designation by the FDA, as well as Orphan Drug designation by the FDA and the European Medicines Agency.

Vico Therapeutics – Netherlands-based Vico announced the European Commission granted orphan drug designation for VO659, its investigational antisense oligonucleotide therapy for the treatment of Spinocerebellar Ataxia (SCA). The orphan designation was based on a positive opinion from the EMA Committee for Orphan Medicinal Products (COMP). Vico previously received orphan drug designation for VO659 in Huntington Disease. Vico’s investigational RNA modulating therapy is designed to lower the mutant protein levels causing these neurodegenerative diseases.

Optibrium – U.K.-based Optibrium, a developer of software for drug discovery, secured a private equity investment from Kester Capital. The funding will accelerate the development of the business through organic growth and acquisition. Currently, more than 150 organizations worldwide deploy Optibrium’s technology in their research programs, including five of the top ten global pharmaceutical companies.

BioNTech – Germany’s BioNTech is boosting manufacturing of the mRNA COVID-19 vaccine it co-developed with Pfizer, in its Marburg facility. BioNTech plans to start the manufacturing of the drug substance based on the new manufacturing license granted from Darmstadt Regional Administrative Council for the amended facility in Marburg. BioNTech’s manufacturing facility in Marburg is a GMP-certified manufacturing facility.

Immunovia – Sweden-based Immunovia AB announced that its R&D and production departments in Lund, Sweden have been working at full speed to ensure the highest quality reagents and arrays are available for the final blind validation study of IMMray PanCan-d, its early-detection tool for pancreatic cancer.

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