cancer
What Soon-Shiong says vs. what he's delivered
Patrick Soon-Shiong has spent years positioning himself as a visionary determined to crack pancreatic cancer. But the clinical evidence behind his claims remains remarkably thin, STAT’s Adam Feuerstein writes in his weekly Biotech Scorecard.
Revolution Medicines’ daraxonrasib is emerging as a genuine advance that could reshape treatment for advanced pancreatic cancer. But Soon-Shiong’s ImmunityBio has largely relied on dramatic anecdotes, promotional statements, and uncontrolled studies that fall far short of proving tangible survival benefits, Adam writes.
The company’s oft-cited claim that its multi-drug immunotherapy regimen doubled survival rests on comparisons to historical data rather than randomized evidence. And key portions of a Phase 2 trial have seemingly disappeared from public discussion without results having been reported.
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infectious disease
Enanta Pharmaceuticals advancing its RSV antiviral
Enanta Pharmaceuticals is pushing its RSV antiviral zelicapavir into late-stage development after a positive FDA meeting, the company said this morning. Enanta will be testing its experimental drug in pediatric patients this summer and in high-risk adults this fall, with data due next year.
The company is betting that zelicapavir — which targets the RSV nucleoprotein — could become the first approved antiviral treatment for RSV, a market it estimates could exceed $2 billion globally. Although there are several RSV vaccines on the market, antivirals are not typically used for the disease — but there’s certainly use for one.
The adult trial will focus on patients most vulnerable to severe outcomes, including those 75 and older and people with COPD or heart failure. The pediatric study will evaluate how quickly symptoms can resolve in children as young as 28 days old.
antibiotics
After FDA setback, GSK's oral antibiotic approved
Four years after an FDA rejection, GSK and Spero Therapeutics have won approval for Utebzi, the first oral carbapenem antibiotic for complicated urinary tract infections. The approval gives patients a potential at-home alternative to IV treatment. A Phase 3 study showed the pill performed similarly to infused carbapenem therapy in nearly 1,700 hospitalized patients.
The decision caps a long and occasionally rocky development path, FiercePharma notes. This included a complete response letter in 2022, and an SEC settlement involving former Spero executives accused of misleading investors about the drug’s efficacy. But it’s a long-awaited result after Spero and GSK’s $591 million licensing deal, along with federal support from BARDA. For GSK, Utebzi expands a growing anti-infectives franchise focused on drug-resistant infections.