Sanofi and GlaxoSmithKline (GSK) are in “advanced discussions” with the European Commission (EC) for the supply of up to 300 million doses of a COVID-19 vaccine. The vaccine candidate – developed by Sanofi in partnership with GSK – is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK’s established adjuvant technology. The doses would be manufactured in European countries including France, Belgium, Germany and Italy.
Intravacc, a Dutch viral and bacterial vaccine specialist, and Swiss CDMO, Celonic Group, have signed a research agreement to further design, develop and produce a COVID-19 vaccine. The vaccine will be based on an immunogenic Spike (S) protein of SARS-CoV-2 combined with Intravacc’s prorietary Outer Membrane Vesicle (OMV) technology. Earlier this year, Intravacc started working on the development of four candidate coronavirus vaccines based on three proprietary technologies: Vero cell, OMV and iBoost. For this specific joint vaccine development, Intravacc combines its safe and immunogenic OMV delivery platform with S-proteins expressed by Celonic Group’s industry-leading CHOvolution mammalian cell expression system, in order to generate a highly effective and balanced B and T cell response against SARS-CoV-2. Celonic Group will construct cell lines producing the S-protein in high quantities and develop a GMP production process. Preclinical studies will start shortly to select the best candidate protein for the vaccine. The collaboration aims to accelerate development of Intravacc’s COVID-19 OMV protein vaccine, which is expected to enter clinical testing in 2021. “Several studies have shown that OMVs have the ability to enhance the immune response and can be relatively easy formulated with target specific peptides and proteins,” said Intravcc CEO Dr Jan Groen. “This, combined with the fact they can be quickly scaled-up for manufacturing, makes it an ideal suited platform under the current circumstances where quantity and speed are critical” Dr Konstantin Matentzoglu, CEO of Celonic, added: “The novel vaccine has the potential to prevent morbidity and mortality of COVID-19. Together, we have an opportunity to make a difference in the lives of patients at this time of great need.”
The FDA has approved Roche’s Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients. The safety profile observed in the Tecentriq combination was consistent with the known safety profiles of the individual medicines. The supplemental Biologics License Application (sBLA) for Tecentriq was granted under priority review. The review was also conducted under Project Orbis, an initiative of the FDA Oncology Centre of Excellence that provides a framework for concurrent submission and review of oncology products among international partners. The approval is based on results from the Phase III IMspire150 study, in which the addition of Tecentriq to Cotellic and Zelboraf helped people live longer without disease worsening or death compared to placebo plus Cotellic and Zelboraf. “When receiving a cancer immunotherapy combined with targeted therapies, patients with BRAF V600 mutation-positive advanced melanoma were able to live for more than 15 months without their disease worsening,” said Levi Garraway, Genentech’s chief medical officer and head of Global Product Development. “Today’s FDA approval of this Tecentriq combination represents an important step forward for many patients living with advanced melanoma.”