BioSpace Global Roundup, Oct. 29


Medtronic – Ireland-based Medtronic received regulatory approval from the U.S. Food and Drug Administration for the Abre venous self-expanding stent system. This device is indicated for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction, also known as deep venous obstruction. Symptoms of the disease include leg swelling, skin changes, leg ulcers, and pain. The FDA approval is based on data from the ABRE clinical study, that assessed the safety and effectiveness of the investigational Abre stent in 200 patients with iliofemoral venous outflow obstruction across the spectrum of deep venous obstruction including those with post thrombotic syndrome, non-thrombotic iliac vein lesions, and those who presented with an acute deep vein thrombosis.

Biophytis SA – France-based Biophytis SA announced it dosed the first patient in the Brazilin arm of its Phase II/III COVA study of sarconeos (BIO101) for the treatment of patients with COVID-19-related respiratory failure. The multinational trial is being conducted at 10 centers in Belgium, France, Brazil and in the U.S. The trial is assessing sarconeos (BIO101) in patients aged 45 and older, infected with SARS-CoV-2. It is designed to evaluate the efficacy and the safety of sarconeos as a treatment to prevent further deterioration in patients with COVID-19-related respiratory failure. The objective is to prevent them from being admitted to the intensive care unit and requiring ventilation.

Sensorion – Based in France, Sensorion signed an agreement with Novasep for the manufacturing of adeno-associated virus (AAV) vectors. The agreement covers the gene therapy program targeting OTOF (OTOF-GT), the gene encoding the otoferlin protein. Mutations in OTOF lead to severe or profound congenital hearing loss. OTOF-GT, the most advanced program, aims to restore the expression of Otoferlin in the inner hair cells of the ear where it plays an essential role in hearing. Under the terms of the agreement, Novasep will be in charge of developing and manufacturing (cell culture, AAV expression, purification, aseptic distribution and quality control) the two AAV vectors designed for the Sensorion OTOF-GT project and will supply Drug Product batches to support preclinical and clinical studies.

CN Bio – U.K.-based CN Bio, a 3D cell culture company, launched its Drug Metabolism and Safety Toxicity Testing Services. The new services will incorporate the company’s advanced Liver-on-Chip technology and expertise in the field to enable researchers to generate predictive and human-relevant data, improving the translatability from discovery to clinic, and accelerating new drugs to market.

Sobi -- Swedish Orphan Biovitrum AB, better known as Sobi, and Apellis Pharmaceuticals, Inc. announced a strategic collaboration to accelerate the advancement of systemic pegcetacoplan, a targeted C3 therapy, for the treatment of multiple rare diseases with high unmet need that impact more than 275,000 patients across the globe. Sobi will receive global co-development and exclusive ex-U.S. commercialization rights for systemic pegcetacoplan. Apellis retains U.S. commercialization rights. Apellis and Sobi plan to jointly advance the clinical development of systemic pegcetacoplan in five parallel registrational programs across hematology, nephrology, and neurology.

Gedea Biotech – Based in Sweden, Gedea Biotech received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with the NEFERTITI clinical study of its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV). Bacterial vaginosis is a vaginal infection with a prevalence of 10-30% in adult women.

NanoMab – London-based NanoMab Technology Limited signed an agreement with OncoBeta GmbH, a supplier of Tungsten-188/ Rhenium-188 generators for the production of high-energy beta emitting Rhenium-188, as well as a commercial stage medical device company specialized in innovative epidermal radioisotope therapies for non-melanoma skin cancers.

ProBioGen AG – Germany’s ProBioGen AG announced ImmunOs Therapeutics uses ProBioGen’s proprietary Pathway Modulator Technology, which is based on the stable expression of an optimized key-regulator enzyme acting on multiple pathways involved in cellular protein expression and protein secretion. Together with the DirectedLuck Transposase, ImmunOs will use the Pathway Modulator to increase the protein yield of selected candidates of their pipeline of novel complex recombinant proteins.

ATAI Life Sciences – Munich-based ATAI Life Sciences, which develops psychedelic and non-psychedelic compounds for various mental health indications, announced that Neuronasal Inc. has completed its pilot study intended to show nose to brain delivery of N-acetylcysteine (NAC) in healthy volunteers. Additionally, Neuronasal has been granted Investigational New Drug clearance by the FDA to continue Phase I clinical trial development in partnership with ATAI. Neuronasal's potentially ground-breaking proprietary treatment includes the intranasal delivery of low doses of N-acetylcysteine (NAC) to patients with acute mild traumatic brain injury (mTBI). NAC is a well-established compound that has been used safely for decades, mostly as a mucolytic and to treat acute paracetamol intoxication.

Orasis Pharmaceuticals – Israel’s Orasis Pharmaceuticals announced the initiation of NEAR-1 and NEAR-2 Phase III clinical studies in the U.S., evaluating its novel eye drop candidate designed to improve near vision for people with presbyopia. The NEAR-1 and NEAR-2 studies are multi-center, double-masked, parallel-group clinical trials in the U.S. enrolling approximately 600 participants with presbyopia to further evaluate the efficacy and safety of Orasis’ eye drop candidate.

Oxford Biodynamics – U.K.-based Oxford BioDynamics Plc signed a Human Material and Data Transfer Agreement with Oregon Health & Science University (OHSU) as part of its EpiSwitch COVID-19 disease severity test program. Under the terms of the agreement, samples from OHSU will be used to further the development of the company’s COVID-19 severity test, aimed at forecasting individuals’ risks of severe disease progression in advance, to inform risk mitigation decisions and help optimize acute and long-term treatment.

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