BioSpace Global Roundup, April 16
Horizon Discovery – Cambridge, U.K.-based Horizon Discovery Group announced special commercial licensing terms to facilitate rapid access to its cGMP-compliant CHOSOURCE platform for the development or production of therapeutic proteins, diagnostic assay components or vaccines relating to COVID-19. The CHOSOURCE platform includes a gene-edited Glutamine Synthetase knockout Chinese Hamster Ovary K1 cell line, a well-established GS expression system recognized in the industry and by regulators as suitable for high yield biomanufacturing. The platform is already offered as a royalty-free alternative for the production of complex proteins and is empowering organizations from early stage start-ups to large pharmaceutical companies to drive efficiencies throughout development and production.
NeuClone -- Australia’s NeuClone Pharmaceuticals announced successful completion of monitoring visits and blood sampling for subjects in the Phase I clinical trial for its Stelara (ustekinumab) biosimilar candidate, NeuLara. Interim analysis indicates the safety and tolerability profiles were comparable between all three blinded treatment arms. The final clinical study report is anticipated in the third quarter of this year. NeuLara is being developed as a biosimilar of ustekinumab, an antibody targeting interleukin-12 and -23, approved under the brand name Stelara® to treat patients with plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
Bausch Health – Quebec-based Bausch Health Companies initiated a clinical trial program in Canada evaluating Virazole (Ribavirin for Inhalation Solution, USP) in combination with standard of care therapy to treat hospitalized adult patients with respiratory distress due to COVID-19. Because ribavirin is a synthetic nucleoside that works to stop viral replication, Virazole may be effective in reducing the severity of COVID-19 infection, the company said. Virazole is currently approved for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus (RSV). The initial study protocol is an open label, interventional trial that will evaluate the safety and efficacy of Virazole in hospitalized adult patients, aged 18 or older, who have tested positive for COVID-19, and as a result of their infection, have significant respiratory distress.
Myovant Sciences – Switzerland-based Myovant Sciences announced a new initiative to elevate conversations about menstrual health by sharing diverse, personal stories of real-life impact of menstrual stigma and symptoms. The program will be supported by The Moth, a nonprofit organization dedicated to building empathy in the world through the art and craft of true, personal storytelling. The initiative aims to shed light on the impact of menstrual stigma and symptoms by sharing women’s lived experiences. Myovant and HealthyWomen have partnered with The Moth to host a storytelling workshop for participating women. Those interested in sharing their stories are encouraged to visit FemaleForwardTogether.com for more information about how to apply.
GenSight Biologics – France’s GenSight announced the independent Data Safety Monitoring Board completed its second planned safety review of the ongoing PIONEER Phase I/II clinical trial of GS030, GenSight’s novel product combining gene therapy and optogenetics for the treatment of Retinitis Pigmentosa. The DSMB confirmed the absence of any safety issues for the second cohort of three subjects. GenSight expects to complete enrollment in the second half of 2020. In the context of COVID-19, this will have to be more precisely assessed as soon as possible. Early findings from the first two cohorts may be available in the course of 2020. Additionally, GenSight announced the completion of the pre-submission meeting with the European Medicines Agency (EMA) for the Company’s lead product Lumevoq (lenadogene nolparvovec). Lumevoq is the gene therapy developed by the company for the treatment of Leber Hereditary Optic Neuropathy (LHON), a rare blinding disease marked by sudden, irreversible vision loss.
RemeGen –China’s RemeGen received Fast Track designation from the U.S. Food and Drug Administration for RC18, a novel recombinant TACI-Fc (transmembrane activator and calcium modulator and cyclophilin ligand interactor) fusion protein, for the treatment of systemic lupus erythematosus (SLE). With its novel dual-target mechanism, RC18 shows statistically significant improvement for patients at multiple doses, the company said. The Fast Track designation for RC18 arrives on the heels of RemeGen's recently completed $100 million plus financing, led by Lilly Asia Ventures and Lake Bleu Capital.
RauCon – RauCon, which runs the pharma business development platform euroPLX, announced that the euroPLX 73 Vienna Pharma Partnering Conference has postponed the event until September due to the Austrian government’s conference ban until the end of June.
Halix -- Netherlands-based Halix BV joined a consortium of partners under the guidance of the University of Oxford, to provide GMP manufacturing services supporting the large scale production of a COVID-19 vaccine being developed by the University’s Jenner Institute The nCoV-19 vaccine is based on the Jenner Institute’s adenovirus vaccine vector technology, which was chosen as the most suitable candidate for a SARS-CoV-2 vaccine as it can generate a strong single dose immune response, and is not a replicating virus, so it cannot cause infection in the vaccinated individual.
LEO Pharma – Denmark’s LEO Pharma A/S signed a licensing agreement with Taiwan’s Oneness Biotech and Microbio Shanghai covering the development and commercialization of the novel atopic dermatitis and allergic asthma drug candidate, FB825. FB825 is a first-in-class drug candidate with a unique mechanism of action targeting the CεmX domain of the membrane bound IgE causing a depletion of mIgE positive B-cells.