| | | |   | Meghana here. Moderna seems to be on its way toward developing government-backed mRNA vaccines for highly infectious diseases, Seres Therapeutics is finally filing for an approval, and AstraZeneca sees two trial successes in breast cancer. | | | Moderna’s pending deadly virus deal with U.S. Moderna is about to make a deal with the U.S. Department of Defense to develop mRNA vaccines targeting biological threats like Ebola and Marburg virus, Bloomberg reports. Moderna scientists will work with University of Texas researchers to adapt the mRNA technology used for Covid-19 for other deadly viruses, in response to recent outbreaks in Zaire, Uganda and Sudan. Vaccines for these diseases are a top priority for U.S. pandemic preparedness, the U.S. Biomedical Advanced Research and Development Authority has said. Though Moderna hasn’t commented on this government contract, it has said earlier that it plans on advancing clinical studies of 15 vaccine programs targeting emerging or neglected infectious disease by 2025. Ebola has been a potential target for Moderna since well before its blockbuster success with Covid — having tested mRNA-based Ebola vaccines in animals back in 2018. But those studies did not, at the time, lead to human trials. | AstraZeneca’s double win in breast cancer Unlike its competitors, two drugs from AstraZeneca have just performed beautifully in treating breast cancer. A phase 3 trial for AKT inhibitor capivasterib, in combination with the hormone therapy Faslodex, showed significant progression-free survival over placebo, as well as “encouraging” early overall survival data. Though it hasn’t released the full data set yet, the company plans to submit it to regulators for approval, FierceBiotech writes. It’s almost a surprise, since a rival AKT inhibitor from Roche failed in a separate breast cancer trial. AstraZeneca also released phase 2 data for camizestrant, an oral selective estrogen receptor degrader, testing it against Faslodex in advanced forms of breast cancer. Both the low and higher doses of camizestrant beat the progression-free survival of Faslodex — which turned out to be a bit unexpected. Sanofi, for example, gave up recently on its own oral SERD after two failures in breast cancer. | The Current State of Digital Health in the Life Sciences MassBio's 2022 Digital Health Impact examines the convergence between digital health and the life sciences, the challenges facing its growth, and opportunities for collaboration. We will explore new strategies for therapeutics and digital health innovators to converge and ultimately deliver better outcomes for patients. Join MassBio on November 3 at the MassBioHub to explore this topic with keynote addresses, a panel discussion, and case studies. This is a hybrid event, register here. | After long last, Seres Therapeutics files a BLA The microbiome-altering therapies from Seres Therapeutics haven’t performed quite as hoped for, but the company is finally taking a significant step forward: The company has submitted a biologics license application with the FDA for SER-109, the company’s oral drug for C. difficile infections. It’ll receive a priority review, with an approval decision expected by April 26. Seres had a painful setback last year, when its ulcerative colitis candidate SER-287 failed in Phase 2. Even the performance of SER-109 hasn’t been pristine, with a 2016 study showing the drug didn’t work to reduce the risk of C. difficile infection, FierceBiotech writes. But data from a more recent trial showed that 79% of patients didn’t see recurrence of a C. difficile infection when given the drug, which is made of purified Firmicutes spores, compared to 53% in the placebo arm. | More reads - Using herpes virus vectors, Paul Peter Tak and Carl June team up to solve the CAR-T solid tumor challenge, Endpoints
- How the Covid pandemic has prepped the industry for a looming RSV and flu season, FierceBiotech
- It cost $38,398 for a single shot of a very old cancer drug, NPR
- FDA Adcomm returns mixed vote on GSK's CKD drug, BioSpace
| Thanks for reading! Until tomorrow,  | | | |
No comments