Tillman Gerngross, Adagio CEO
Since the pandemic began in the spring of 2020, Tillman Gerngross has raised more than half a billion dollars for his startup Adagio and their promise to develop a so-called broadly neutralizing coronavirus antibody that could snare any variant.
When Omicron broke out over Thanksgiving, bringing a strain that threatened to evade widely-used antibody treatments from Eli Lilly and Regeneron, Adagio’s $ADGI soared 34% as Gerngross’ predictions appeared to come true. Early computational analyses suggested Adagio’s antibody, ADG20, currently in pivotal trials, should retain full efficacy against the variant.
Unlock this story instantly and join 125,500+ biopharma pros reading Endpoints daily — and it’s free.
Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.
Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).
When Bristol Myers Squibb celebrated the approval of ozanimod — branded Zeposia — in ulcerative colitis earlier this year, the company touted the first gastrointestinal indication for an S1P receptor modulator.
Now Pfizer wants to give the pharma rival a run for its money.
Pfizer is dropping $6.7 billion to acquire Arena Pharmaceuticals, whose lead drug, etrasimod, targets the sphingosine 1-phosphate receptor.
Unlock this story instantly and join 125,500+ biopharma pros reading Endpoints daily — and it’s free.
Rob Califf, the famous cardiologist from Duke University, is likely to return to the top of the FDA, this time under the Biden administration.
At his confirmation hearing Tuesday, Democrats and Republicans on the Senate health committee offered their support for Califf, with Chair Patty Murray (D-WA) stressing the need for an experienced leader, like Califf, who can ensure that science comes first.
A Boston-based provider of lab space is tripling its footprint with the addition of a West Coast campus.
SmartLabs, a company with labs in three different neighborhoods in the Boston area, will open a new research and manufacturing center that will be located in the heart of the South San Francisco biotech corridor. The site will support end-to-end drug development and include 500L manufacturing bioreactors that can support allogeneic and autologous cell therapies.
As the investments in cell and gene therapy manufacturing continue to grow across the world, Cincinnati Children’s Hospital and CTI Clinical Trial & Consulting Services have entered a $100 million agreement to produce clinical material locally.
The joint venture enables the hospital to work on its Translational Core Laboratory, which manufactures and tests services for cell and gene therapy trials. This will help address the global gene and cell therapy shortage and prevent the lack of capacity from getting in the way of new development. About 15 C&G therapy products have been approved by regulatory agencies across the globe, and a study from the Alliance for Regenerative Medicine predicts another 10 to 20 per year by 2025.
The drastic difference in efficacy for Merck’s Covid-19 pill between interim and final analyses — from a 50% relative reduction in hospitalizations and deaths at the interim to just 30% in the final results — had some worrying that the Pfizer pill’s early success for adults at high risk of hospitalization might also be more muted in the final results.
But that wasn’t the case early Tuesday as Pfizer said that final data available from the more than 2,200 high-risk patients enrolled in its trial confirmed prior results showing Paxlovid reduced the risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo. The company added:
Silviu Itescu, Mesoblast CEO
Novartis offered up $25 million in cash last November for the rights to Mesoblast’s potential cell therapy for Covid-19. But after a Phase III flunk, the Big Pharma’s now getting cold feet — and Mesoblast’s stock is suffering big time.
Mesoblast shares $MESO tanked more than 17% on Tuesday morning after announcing that Novartis has walked out on its partnership for remestemcel-L. And because the termination occurred before closing, Mesoblast missed out on upfront payments of $25 million cash and a $25 million equity investment.
Aamir Malik, Pfizer chief business innovation officer
Pfizer made a big splash in the M&A space Monday, announcing a $6.7 billion buyout of Arena Pharmaceuticals to chase Bristol Myers Squibb in the S1P race. But company execs suggested the company isn’t finished bringing on new assets.
In an investor call outlining the Arena acquisition, chief business innovation officer Aamir Malik took a moment to discuss Pfizer’s growth plans going forward. The strategy was made up of three pillars: advancing the internal pipeline, continuing to pursue outside opportunities and exploring the combination of technology and data to ‘accelerate’ growth.
Unlock this story instantly and join 125,500+ biopharma pros reading Endpoints daily — and it’s free.
Roche/Genentech CMO Levi Garraway
Breakthroughs in drug development have begun to unlock the potential of antibody-drug conjugates, therapies designed to better target proteins on tumor cells. Genentech’s Polivy has become an early winner in blood cancer, and now the drugmaker is revealing promising results in getting into patients even sooner.
A combination of Roche’s Polivy, an ADC targeting the CD79b protein on tumor cells, with Rituxan and the chemotherapy regimen R-CHOP cut the risk of disease progression or death over Rituxan-chemo alone by 27% in patients with first-line diffuse large B cell lymphoma, according to late-breaking data presented Tuesday at #ASH21.
https://endpts.com/adagio-raised-750m-for-an-antibody-against-future-variants-it-failed-against-omicron/
