| 01.25.22 | Pfizer, BioNTech test omicron-busting shot; Sier ra’s Gilead castoff wins big i n phase 3, heads for regulators

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This week's sponsor is Ajinomoto Bio-Pharma Services.

Today's Rundown

Pfizer, BioNTech launch trial for potential omicron-busting vaccine Sierra's bet on Gilead castoff pays off, teeing up FDA filing for rival to Incyte-Novartis cancer drug Moderna-partnered gene editor Metagenomi adds $175M to crown from Bayer, BMS and others to get into clinic, launch new biotechs 89bio, trying to rise from ashes of NASH failures, posts gains in disease severity, cardiovascular health in small data set AstraZeneca success torpedoes PCI's pivotal plan, crushing stock Leyden Labs, with license from J&J, secures $140M to stop viruses 'at the gate' with nasal spray Capricor will take DMD cell therapy to phase 3 with $30M from Nippon, as hunt continues for partners in other regions FDA bans Lilly, Regeneron antibody use in COVID-19 patients infected by omicron New research on tau's role in neurodegenerative diseases like Alzheimer's could inform new treatments From full-page newspaper ads to press events, hospitals say their pandemic pleas are reaching the public CAR-NK cell therapy extends survival in pancreatic cancer mouse model, CytoImmune plans 2022 trial FDA authorizes Mammoth Bio's high-throughput CRISPR test for COVID-19

Featured Story

Pfizer, BioNTech launch trial for potential omicron-busting vaccine

By Annalee Armstrong

Pfizer and BioNTech are launching a new clinical trial to test a potential omicron-busting COVID-19 vaccine. The new vaccine will be included in a three-cohort study that will also examine different regimens of the companies’ existing COVID-19 shot, Comirnaty.

This week's sponsor is Eurofins BioPharma Product Testing.

Sierra's bet on Gilead castoff pays off, teeing up FDA filing for rival to Incyte-Novartis cancer drug

By Nick Paul Taylor

Sierra Oncology’s bet on Gilead castoff momelotinib has paid off. Three years after picking up the drug at a knockdown price, Sierra has reported a clean sweep of phase 3 endpoints, positioning it to challenge Incyte and Novartis for a blockbuster blood cancer market and sending its stock up 43% to $22.

Moderna-partnered gene editor Metagenomi adds $175M to crown from Bayer, BMS and others to get into clinic, launch new biotechs

By Kyle LaHucik

Bayer and Moderna have already signaled confidence in Metagenomi's CRISPR gene editing. Now, Bristol Myers Squibb, Novo Nordisk and a crop of VC shops have also made a $175 million bet on the California biotech's platform.

89bio, trying to rise from ashes of NASH failures, posts gains in disease severity, cardiovascular health in small data set

By Annalee Armstrong

89bio is climbing over the rubble of fallen NASH treatments with new top-line data from a limited number of patients that show its candidate spurred improvements in disease severity based on several measures.

AstraZeneca success torpedoes PCI's pivotal plan, crushing stock

By Nick Paul Taylor

The shock waves caused by the success of AstraZeneca’s TOPAZ-1 clinical trial have reached Norway. After reviewing the results, PCI Biotech has decided to scrap its own pivotal advanced biliary tract cancer trial in the belief it may struggle to complete the study and win approval.

Leyden Labs, with license from J&J, secures $140M to stop viruses 'at the gate' with nasal spray

By Kyle LaHucik

Pandemic preparedness is a big buzzword these days in public health, and Leyden Labs wants to put the words into action with an intranasal spray to go after coronavirus variants, the flu and future viruses. The biotech has secured about $200 million to bankroll its mission.

Capricor will take DMD cell therapy to phase 3 with $30M from Nippon, as hunt continues for partners in other regions

By Kyle LaHucik

After showing its cell-based therapy slowed disease progression in Duchenne muscular dystrophy last September, Capricor Therapeutics is now ready to take the drug into a phase 3 trial with $30 million upfront from Nippon Shinyaku to help out.

FDA bans Lilly, Regeneron antibody use in COVID-19 patients infected by omicron

By Kevin Dunleavy

With the omicron variant accounting for more than 99% of COVID-19 infections in the U.S., the FDA has revised authorizations for the Eli Lilly and Regeneron antibodies, prohibiting their use in patients who have been infected with the variant.

New research on tau's role in neurodegenerative diseases like Alzheimer's could inform new treatments

By Kyle LaHucik

Tau proteins, when tangled inside of neurons, are central to neurodegenerative diseases like Alzheimer's and have been one of the leading targets among drug developers. Now, researchers say they've found new insight into the tau's role in such diseases and how the protein spreads throughout the brain.

From full-page newspaper ads to press events, hospitals say their pandemic pleas are reaching the public

By Dave Muoio

Although there's still room for improvement, health system leaders have "encouraging" anecdotal evidence that joint newspaper ads, op-eds and press conferences are successfully conveying the pandemic's severity to the general public. "Our most effective approach is when we join with other systems to present a united front," said Leigh Hamby, M.D., chief medical officer at Atlanta-based Piedmont Healthcare.

CAR-NK cell therapy extends survival in pancreatic cancer mouse model, CytoImmune plans 2022 trial

By Kyle LaHucik

Using natural killer cells from umbilical cords, City of Hope showed that a CAR-NK cell therapy was able to boost length of survival in a mouse model of pancreatic cancer using a freezing and thawing method. CytoImmune Therapeutics is slated to test the therapy in humans later this year.

FDA authorizes Mammoth Bio's high-throughput CRISPR test for COVID-19

By Conor Hale

While Mammoth has focused on tailoring its reagents to react with the coronavirus’s genome, Agilent has worked to deliver high-speed liquid handling hardware with its Bravo BenchCel DB workstation platform.