Little more than two months after cutting a deal with Merck & Co. Inc. that could top $1 billion, Janux Therapeutics Inc. has closed on a $56 million series A. Janux is developing immunotherapies designed to trigger the immune system to kill specific tumors while leaving the healthy tissue safely alone. T-cell engagers bind to a tumor cell and use the patient’s T cells to eliminate the tumor.
The cost of newly FDA approved Pepaxto (melphalan flufenamide) from Oncopeptides AB is designed to put the therapy in the middle of the range compared to other multiple myeloma therapies, CEO Marty Duvall told BioWorld. “There are products well entrenched in that space,” he added.
With the FDA’s granting of emergency use authorization (EUA) to Johnson & Johnson (J&J), there is now a third vaccine – and the first requiring only a single shot – against COVID-19 for adult Americans. Though it packs less of an efficacy punch, the EUA allows J&J’s Ad26.COV2.S to join mRNA vaccines from Moderna Inc. and Pfizer Inc./Biontech SE as protection against the virus.
Roivant Sciences Ltd. is buying Silicon Therapeutics LLC for $450 million in Roivant equity plus regulatory and commercial milestone payments. The combination of Silicon’s computational physics platform for in silico design or optimizing small-molecule drugs with Roivant’s newly unveiled protein degradation platform will be powered by Roivant’s machine learning models.
Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C).
Asalyxa Bio Inc. has closed on an oversubscribed seed financing of more than $2 million designed to advance its lead candidate, ASX-100, into the clinic in acute respiratory distress syndrome.
Brainstorm Cell Therapeutics Inc. said FDA senior leadership told the company the level of clinical data in the Nurown (neurotrophic factor-producing mesenchymal stem cells) phase III trial in amyotrophic lateral sclerosis (ALS) does not provide the threshold of substantial evidence needed to support a BLA.
Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C). That’s cold but not nearly as cold as the mRNA-based vaccine’s emergency use authorization label calls for, which is storage in an ultra-cold freezer at temps of between -112 to -76 degrees Fahrenheit (-80 and -60 degrees Celsius).
Rigel Pharmaceuticals Inc. cut the biggest deal of the company’s life with its new collaboration with Eli Lilly and Co. that could be worth $960 million. The two will co-develop and commercialize Rigel’s R-552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases.
Excision Biotherapeutics Inc.’s CEO is specific when he talks about his company’s therapies and what they may achieve: a functional cure. “When you treat someone and they become cancer free, you can’t use the world ‘cured’ because the cancer may come back decades later,” Daniel Dornbusch told BioWorld. “But you can talk about a functional cure, meaning the cancer didn’t come back for a very long time. It’s functionally cured for maybe 10, 20 or 30 years."
