Good morning. As I’ve been watching the NBA finals, every commercial break has started to sound like this .
GSK buys maker of targeted cancer drugs for $10.6B
Nuvalent is the latest biotech to be subsumed in the recent wave of pharma acquisitions, my colleague Andrew Joseph reported this morning . The company has two drugs under review by the Food and Drug Administration that target genetic mutations found in lung cancer. Approval decisions on both are expected later this year.
The deal announced this morning will give GSK, which has focused on gynecologic cancers as well as multiple myeloma, a broader lung cancer portfolio. GSK is paying $124 per share for Cambridge, Mass.-based Nuvalent, a 26% premium to the biotech’s average share price over the last 30 days.
It’s also the largest transaction pursued by new GSK CEO Luke Miels since he took over the reins from Emma Walmsley at the start of the year.
Read more .
Gilead and Merck’s weekly HIV treatment worked
From STAT’s Jason Mast: Gilead and Merck said yesterday an experimental HIV pill successfully suppressed the virus when given just once per week in two large trials, paving the way for a new type of treatment.
The experimental medicine is part of a wave of longer-acting HIV drugs that public health experts hope will prove more convenient and accessible for patients than the daily pills long used to treat or prevent HIV. It combines Merck’s antiviral islatravir and Gilead’s antiviral lenacapavir. Lenacapavir is the active ingredient in Yeztugo, the widely celebrated drug that prevents HIV with just two injections every year.
The combination tablet came out of an unusual collaboration the two companies struck in 2021. Gilead is also working on other combinations with lenacapavir, alongside other next-generation antivirals, as part of its efforts to extend its multibillion-dollar HIV portfolio into the coming decades. And Merck last year started a Phase 3 trial on a once-monthly pill to prevent HIV.
Gilead and Merck’s lung cancer combo flopped
It was a busy night for these two companies. In addition to the aforementioned HIV study, Gilead and Merck announced the early shutdown of a Phase 3 study called EVOKE-03 that was evaluating Gilead’s Trodelvy plus Keytruda compared to Keytruda alone in patients with non-small cell lung cancer that express high levels of the PD-L1 protein.
The combination regimen failed to show a statistically significant improvement in progression-free survival, and an improvement of overall survival was deemed unlikely.
The negative study outcome is a setback for Gilead’s cancer aspirations. Trodelvy is an antibody that homes in on cancer cells that express a protein called TROP-2 on their surface. Once attached, a linker on the antibody releases cancer-killing chemotherapy directly to the tumor. The drug is approved for certain types of breast cancer, but has failed to show benefit in other types of cancer.
Merck will be less bothered by the failure of EVOKE-03 because it is developing, along with the Chinese biotech Kelun, a competing TROP-2-targeted antibody. That drug, called sac-TMT, cut the risk of tumor progression by 65% in patients with lung cancer, according to Phase 3 study results reported at the recent ASCO annual meeting.
AstraZeneca’s GLP-1 pill succeeds in mid-stage trials
Data released yesterday on AstraZeneca’s investigational GLP-1 pill suggest it may be competitive against other pills like Lilly’s Foundayo and Novo’s oral Ozempic.
In one Phase 2 trial, the drug, called elecoglipron, led patients with obesity to lose 11.2% of their weight after 36 weeks. (Eli Lilly’s pill Foundayo led to the same rate of weight loss in a Phase 3 study that lasted twice as long, but it’s hard to compare across trials in different phases.)
In a separate Phase 2 trial in people with diabetes, the drug helped patients lower their blood sugar and lose weight, by a greater magnitude than a comparator group taking oral Ozempic.
Read more .
Startup raises funds to develop ‘city RNAs’
From STAT’s Allison DeAngelis: City Therapeutics has raised $99.5 million in new funding — enough money to have five drug candidates in clinical trials, show off the prowess of its new technology, and set up the company for a potential IPO.
City, which was founded by former Alnylam Pharmaceuticals CEO John Maraganore, is developing what they hope will be the next generation of gene-silencing drugs. Maraganore and City’s CEO, Andy Orth, brought the first such medicines to market in the late 2010s. But the field has struggled to figure out a means of delivering RNA-muting molecules into organs and tissues beyond the liver, which has limited their reach. City was formed to develop diminutive “cleavage-inducing tiny RNAs,” or city RNAs.
The startup already has three drugs in clinical trials, and anticipates moving one or two additional candidates into human studies each year.
City hasn’t yet peeled back the curtain on city RNAs. The…
Read the full article at STAT News →
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