June 15, 2023

The need-to-know this morning

The FDA placed a partial clinical hold on studies involving a drug for ovarian cancer from Mersana Therapeutics. The action was taken due to the reporting of bleeding events, five of which were fatal, in patients enrolled in Mersana's studies.
Coherus Biosciences and Abbvie are working to settle a contract dispute over Coherus' recent launch of a low-cost copy of Abbvie's Humira.
Aldeyra Therapeutics said its treatment for allergic conjunctivitis achieved the goals of a late-stage clinical trial.
FDA advisers are meeting today to review and vote on the composition of Covid-19 vaccine boosters for the fall.

Genome editing

Verve and Lilly team up to CRISPR cardiovascular disease

Pushing to expand genome editing, which has shown dramatic benefits for some rare disorders, into more common diseases, Eli Lilly announced this morning that it has partnered with Verve Therapeutics on an early-stage effort to edit out cardiovascular disease.

Under the agreement, Lilly is paying $60 million up front and promising nearly $500 million more to work with Verve on a genome editing treatment targeting lipoprotein(a). Abbreviated Lp(a), it's a well-established risk factor for heart attack, stroke, and other cardiovascular problems, and approved drugs have little impact on its presence in the blood. The idea is to craft a one-time treatment that would cut off the production of Lp(a) in the liver, much like Verve's more advanced therapy targeting the protein PCSK-9.

Lilly's interest, albeit in a small-dollar deal, is co-sign of genome editing's potential in larger patient populations and an affirmation of Verve's approach to the field. The company, which executed a successful IPO in the middle of an industry downturn, is still waiting on the FDA to lift a clinical hold on the U.S. trial of its first medicine.

Obesity

AstraZeneca's plot to one-up Ozempic

AstraZeneca has missed out on the drug industry's obesity revolution. The company has a GLP-1-targeting medicine, an Ozempic competitor called Bydureon, but it's approved only for diabetes and saw its revenue fall 27% last year.

Now, instead of playing catch-up, the British drugmaker is trying to invent something that can do what today's blockbusters can't: keep weight off even after patients stop taking their medicine. Speaking to Bloomberg, AstraZeneca CEO Pascal Soriot acknowledged that "we don't know if it's possible." Gene therapy and genome editing allow for one-time treatments with lasting benefits, but the science — and desirability — of doing that for obesity remains unclear.

In the meantime, AstraZeneca is working with Regeneron Pharmaceuticals on a genetic approach to weight loss, following the latter company's discovery that rare mutations to a gene called GPR75 appear to protect people from developing obesity in the first place. That work remains in the earliest stages of development.

Personnel

Moderna's CMO is leaving for Amgen

Moderna Chief Medical Officer Paul Burton is leaving the company for Amgen just two years after replacing long-time top doctor Tal Zaks.

The news came via an Amgen internal memo circulated to reporters yesterday. Moderna has removed Burton from its website but did not disclose his departure, whether in a press release or filing with the SEC. In a statement to STAT, a Moderna spokesperson said: "We thank Paul for his contributions to Moderna and to global health and wish him well in his future endeavors."

Moderna has now turned over the majority of executive ranks since 2020, with only CEO Stéphane Bancel and President Stephen Hoge remaining. Burton's departure follows the single-day tenure of former Chief Financial Officer Jorge Gomez, who was fired in light of an internal investigation at his former employer. His predecessor left last year, and 2021 saw Moderna part ways with Zaks, its general counsel, and its chief commercial officer, who was fired after less than a year.

Financials

CRISPR is expensive

Which is perhaps why Editas Medicine, despite having $400 million in the bank, is raising another $125 million in a stock sale.

Editas, which has long lagged behind its rivals in genome editing, is likely taking advantage of some rare good news. Last week, the company presented some preliminary positive data on its genome-editing-based therapy for sickle cell disease, sending its stock price up about 20%. Seizing the moment, the company said yesterday it would mount a stock offering.

Editas, founded in 2014, is on its fourth CEO. Last year the company halted development on its most advanced CRISPR medicine, a treatment for a rare eye disease, and pivoted to sickle cell, where it is years behind a genome-editing treatment from partners CRISPR Therapeutics and Vertex Pharmaceuticals.

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