Pfizer partnered with BioNTech early in the pandemic and zeroed in to develop mRNA vaccines for other infectious diseases, beginning with influenza. GlaxoSmithKline is working with German mRNA specialist CureVac, while the executive chairman of Novartis recently announced that his company was considering an investment in the technology, too.
For Sanofi, buying Translate Bio follows the latest commitment to spend nearly USD 500 million a year on mRNA vaccine development through a new research unit that the French drugmaker intends to staff with 400 employees in the U.S. and France.
The Lexington, Massachusetts-based biotech is familiar to Sanofi, as the two companies have been partnered since 2018. Last year, they agreed to create an experimental coronavirus vaccine that, after some delay, is now in a Phase 1/2 clinical trial. Initial results are anticipated by the end of September.
Marinus hands over EU rights to Orion in USD 30 Million upfront deal for anti-seizure med
Marinus Pharmaceuticals has provided the European rights for antiseizure medicine ganaxolone to Orion in exchange for a USD 30 million upfront fee and milestones.
Radnor, Pennsylvania-based Marinus could receive up to USD 115 million later on in reimbursement, development, and commercialization milestone payments as well as royalties on sales. The upfront payment is subject to specific provisions related to some additional preclinical testing that Marinus will require to complete. This work is anticipated to wrap up in the first quarter of 2022.
The commercialization deal confers rights to Orion for ganaxolone in the European economic area, the U.K., and Switzerland for the oral and IV formulations of the therapy for the treatment of CDKL5 deficiency disorder (CDD), tuberous sclerosis complex, and refractory status epilepticus.
The deal will allow Orion for extensive commercial infrastructure across Europe and forte in rare neurological disorders, as per a statement by Marinus.
Marinus will pursue clinical development of the therapy and move it via the regulatory process in Europe. A filing in the region is foreseen by the end of the third quarter.
Orion, meanwhile, will take care of pricing and reimbursement approvals and commercialization in the particular regions. Ganaxolone is set to launch in mid-2022 so long as it secures approval to treat CDD patients.
With a novel fibroblast collaboration already working with Johnson & Johnson’s Janssen unit, Mestag Therapeutics is further linking arms with the healthcare giant through a USD 45 million seed financing.
The UK-based biotech extended its seed round to include Amsterdam investment firm Forbion alongside Google’s GV, Northpond Ventures, and founding backers SV Health Investors and J&J Innovation.
In May, Mestag inked a deal with Janssen under which the small biotech would look at fibroblast subpopulations across diseases. Fibroblasts are cells, which develop connective tissue and lead processes such as wound healing.
Janssen has the option for an exclusive license to develop and commercialize therapies directed against up to two targets through the deal. No financial terms were revealed.
A year-old Mestag has the funds to build a pipeline of antibodies and bring its single-cell approach toward the clinic.
Mestag is led by CEO Susan Hill, Ph.D., who was previously a chief business officer of retinal gene therapy biotech Gyroscope Therapeutics and CEO of Orbit Biomedical before that.
Fibroblasts are part of the platform fueling cell-based gene therapy biotech Castle Creek.
Moderna secures FDA fast track designation for respiratory syncytial virus vaccine
COVID-19 vaccine pioneer Moderna aims to develop one of the first mRNA-based vaccines against the respiratory syncytial virus (RSV). Now, the FDA has granted fast track designation for mRNA-1345, an experimental single-dose mRNA RSV vaccine in adults 60 and older.
Pfizer, Johnson & Johnson, GlaxoSmithKline, Novavax, and Bavarian Nordic are also developing RSV vaccines. None of those, however, use an mRNA platform.
According to the CDC, RSV generally causes mild cold-like symptoms but can lead to serious illness in infants and the elderly. In infants, RSV often leads to pneumonia and another type of respiratory tract infection known as bronchiolitis.
Moderna hopes to eventually secure regulatory approval to utilize the mRNA-1345 vaccine to protect the most vulnerable populations – young children and older adults, as stated by Stéphane Bancel, CEO of Moderna. The company currently has a Phase 1 study involving mRNA-1345 assessing its performance in younger adults, older adults, and children. The company presently has 11 vaccines for infectious diseases in human clinical trials. The pandemic has increased Moderna’s capacity to develop drugs independently and sharpened its focus on infectious diseases.
Moderna has secured fast track designation for other investigational therapies, including its COVID-19 vaccine, Zika vaccine candidate (mRNA-1893), methylmalonic acidemia (MMA) (mRNA-3704), and propionic acidemia (mRNA-3927) programs.
