Today, a brief rundown of news involving The Food and Drug Administration and AbbVie, as well as updates from Pfizer, Eli Lilly and GSK that you may have missed.
The Food and Drug Administration on Tuesday announced steps toward implementing “real-time clinical trials” to help speed up drug development. AstraZeneca and Amgen began two “proof of concept” studies in cancer to test out the initiative, through which they’ll report endpoints and safety signals to U.S. regulators as they happen. In a statement, Commissioner Martin Makary said the agency’s goal is to reduce the “lag time” that can delay regulatory decisions and eventually run “real-time, continuous trials across all phases of drug development.” — Ben Fidler
AbbVie has secured an option to acquire Kestrel Therapeutics, a startup developing a drug aimed at cancer-driving KRAS mutations, at an agreed-upon price. According to Kestrel, AbbVie will support funding of KST-6051, a drug that just began human testing and is designed to block multiple mutated forms of the KRAS protein. Should the program hit certain undisclosed milestones, AbbVie could buy the company afterwards in a deal worth as much as $1.45 billion. Kestrel claims its therapy is designed with a “differentated mechanism of action” than other, similar drugs, as it binds to KRAS in both “active” and “inactive” conformations. This distinction could make KST-6051 less toxic, the company said Tuesday. — Ben Fidler
Pfizer said its dual-acting antibody drug for multiple myeloma, Elrexfio, helped delay progression or death compared to standard therapy in a Phase 3 trial in people whose disease got worse after an initial treatment round. Pfizer didn’t disclose details, but said Elrexfio met the study’s main objective at an early data check and, at that point, most patients were still progression free. Trial investigators tested Elfrexio against a combination of Johnson & Johnson’s Darzalex, Bristol Myers Squibb’s Pomalyst and dexamethasone. A clearance would enable Elrexfio to be used on patients earlier in their disease course, where J&J’s competing bispecific Tecvayli was recently approved. Elfrexio is currently only available for use after at least four treatment lines. — Jonathan Gardner
Eli Lilly will work with startup Profluent to develop specialized enzymes that could be used to make gene editing drugs. Profluent is using artificial intelligence tools to create custom-designed “recombinases” — enzymes that can target specific areas of the genome and, when there, insert long stretches of DNA. Under the deal, Profluent will design these enzymes for multiple unnamed targets, and Lilly will receive an exclusive license to advance them afterwards. Lilly didn’t specify how much it’ll pay upfront to kickstart the deal, but Profluent is eligible to receive up to $2.25 billion overall. The alliance is the latest in a series of deals Lilly has struck in recent years to build up capabilities in genetic medicine. — Ben Fidler
GSK and Ionis Pharmaceuticals said Thursday that the FDA has accepted an application for bepirovirsen, an experimental drug they’ve been developing for chronic hepatitis B. The drug succeeded in two Phase 3 trials earlier this year, though the companies haven’t yet shared study details. Chronic hepatitis B infections are estimated to affect more than 250 million people worldwide and can lead to cirrhosis and liver cancer. GSK and Ionis believe bepirovirsen, an RNA-based medicine, can be a “functional cure” for those infections, with a six-month regimen pushing the virus down to undetectable levels. The FDA is scheduled to make an approval decision by Oct. 26. — Delilah Alvarado
