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Morning! Today, we talk about some highly anticipated data from Summit Therapeutics that could show how its bispecific antibody drug outperformed Keytruda in a head-to-head lung cancer trial. Also, positive data from Lilly on its weekly insulin, and we explore amylin as a target for obesity.
Biotechs bet on amylin as the next obesity target
The first GLP-1 diabetes drug, Byetta, was developed by a company called Amylin Pharmaceuticals. The company, as evidenced by its name, was also interested in using amylin, a peptide hormone secreted by the pancreas along with insulin, as a target for weight-loss drugs. It abandoned that approach because it needed to be injected too often.
Now, the company — and nine others — believe that targeting amylin could offer advantages over GLP-1 drugs in the obesity space. This class of drugs might help preserve muscle mass, reduce nausea, and deliver longer-lasting weight loss.
At the front of the race, STAT’s Elaine Chen and Allison DeAngelis write, are Novo Nordisk and Eli Lilly — with Novo’s amylin candidate CagriSema nearing a Phase 3 readout. Other companies like Zealand Pharma are now developing standalone amylin drugs.
Summit Therapeutics’ big lung cancer readout
On Sunday, we’ll get new details on Summit Therapeutics’ buzzy bispecific immunotherapy. Top-line data indicated the drug outperformed Keytruda in a head-to-head Phase 3 study of patients with PD-L1 positive, advanced non-small cell lung cancer. But, as STAT’s Adam Feuerstein explains, plenty of questions remain.
The study on ivonescimab will be presented at the World Conference on Lung Cancer. The antibody targets two cancer-causing proteins: PD-1 and VEGF.
Lilly has more positive data on its weekly insulin
From STAT’s Elaine Chen: Eli Lilly this morning announced more positive results on its weekly insulin, called efsitora alfa, in type 2 diabetes patients.
In two Phase 3 trials, efsitora showed non-inferior A1C reductions versus two different daily insulins. When compared with patients on glargine, those on efsitora experienced about a 40% lower rate of dangerously low blood sugar, or hypoglycemic events. Meanwhile, when compared with degludec, efsitora showed a slightly higher rate of hypoglycemic events that Lilly said was not statistically significant.
This comes after Lilly earlier reported positive results from two other Phase 3 studies in type 2 diabetes patients. The company has yet to report results of a late-stage study in type 1 patients, though. The results of that trial will be key to follow to see if efsitora might be safer than a competing candidate from Novo Nordisk.
Novo’s weekly insulin, called icodec, has been shown in multiple trials to be as good as or superior to daily insulin products. But while the trials in type 2 patients did not show significant differences in hypoglycemic events between icodec and the daily insulins, the trial in type 1 patients showed that people on icodec did have significantly higher rates of hypoglycemia. The FDA recently rejected icodec as it had questions about its use in type 1 patients.
BioMarin’s big plans
From STAT’s Matthew Herper: Yesterday was BioMarin’s big investor day. What happened?
The company said it will save $500 million by better prioritizing research and development, and saving money across the board in manufacturing, procurement, and other areas, in addition to its previously announced layoffs of almost 400 people. “This was not outright cost-cutting, this was optimizing the business,” Chief Financial Officer Brian Mueller told STAT. “We actually think we’re better coming out of this.”
BioMarin also forecast eventual peak sales of Voxzogo, its treatment for achondroplasia, of $5 billion, triple the forecasts of Wall Street analysts. Mueller said that until yesterday, BioMarin had not provided enough detail to analysts to develop forecasts for the medicine’s use in future disorders. The company said its total annual sales will cross the $4 billion mark in 2027, and that by that time its profit margin will grow from 26% now to more than 40%.
Company shares shares slipped 1.9% yesterday. Akash Tewari, an analyst at Jefferies, called the plans “execution bets that will take years to play out” and that investors have been burned by BioMarin’s forecasts “in the recent past.”
Moderna’s experimental mpox vaccine shows promise
Moderna’s experimental mRNA-based mpox vaccine is more effective than the one that’s currently on the market developed by Jynneos, a new study shows. The animals that received Moderna’s vaccine developed milder disease, and developed fewer lesions after being infected with the virus.
Moderna’s inoculation targets four key poxvirus proteins, which could allow for quicker recoveries and reduced transmission. In contrast, the existing vaccines, such as the one from competitor Jynneos, use modified live viruses.
More reads
- UK regulator finds no suicidal thoughts link to diabetes, obesity drugs, Reuters
- BioAge files for IPO, plans pair of midstage obesity trials, FierceBiotech