Merck and Moderna cancer vaccine, Ionis, AstraZeneca: Readout

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Today, we look at how a China biotech crackdown could benefit Europe, what a rival drug failure might mean for Alnylam, the algorithm behind the Moderna-Merck cancer vaccine, and a landmark approval in pancreatic cancer.

RIP, Tim Curry. I shall mourn how humbly you buttle.

The need-to-know this morning

Moderna is raising $2 billion in convertible debt. The new financing comes one week after the Phase 3 success of its personalized cancer vaccine.

The power of the Moderna-Merck cancer vaccine may hinge on an algorithm

Moderna and Merck’s personalized cancer vaccine could become the first approved medicine whose genetic instructions are essentially written by an algorithm. For each patient, software analyzes thousands of tumor mutations and chooses 34 neoantigens to encode into a bespoke mRNA vaccine — a regulatory and computational experiment that some researchers now believe could be the treatment’s “secret sauce.”

That said, some skeptical Wall Street investors think that perhaps the personalization isn’t necessary at all, and that mRNA itself primes tumors to respond better to Keytruda. So what’s in that algorithm?

“I have no idea,” said Alex Rubinsteyn, a cancer vaccine expert at the University of North Carolina. “Everyone claims what they have is proprietary intelligence.”

U.S. crackdown on Chinese biotech could benefit Europe

A bipartisan bill aimed at limiting U.S. biotech ties with China could end up handing Europe a competitive advantage, executives from the Croatia-based CRO Optimapharm opine for STAT. The proposed Biotech Investment National Security Act, or BINSA, would broaden federal oversight of U.S. investment and dealmaking with Chinese biotech companies. However, Optimapharm’s argue, companies could simply route the drugs discovered in China through European sponsors — a strategy dubbed “Eurowashing.”

This potentially could shift licensing profits, tax revenue, and clinical development activity away from the U.S. Also, biotechs often default to crowded U.S., Australian, and Western European trial sites rather than considering faster and cheaper alternatives in Central and Eastern Europe. Whether BINSA passes or not, the executives say, companies should diversify their clinical trial strategies now before geopolitical tensions make those decisions for them.

A heart drug failure casts shadow over Alnylam

The European Society of Cardiology Congress in Munich could offer crucial clues about the future of Alnylam’s ATTR-CM franchise, STAT’s Adam Feuerstein writes. AstraZeneca and Ionis will reveal details on why their rival gene-silencing drug, eplontersen, failed a pivotal Phase 3 study.

The drug showed no cardiovascular benefit when added to widely used stabilizer drugs — which suggests that injectable gene silencers may not add much benefit to much to easier-to-use oral treatments.

This will matter for Alnylam’s blockbuster, Amvuttra, and especially next-generation nucresiran, now in Phase 3 testing. Alnylam says nucresiran’s greater potency and differently designed trial can succeed where eplontersen stumbled, but investors aren’t entirely convinced.

FDA approves landmark pancreatic cancer drug

The FDA has approved the buzzy pancreatic cancer drug made by Revolution Medicines. Rasonque is the first treatment to attack a genetic driver of pancreatic cancer — and what oncologists are calling the disease’s biggest therapeutic advance in decades.

In a pivotal trial, the RAS-targeting drug nearly doubled median survival to 13.2 months from 6.7 months with chemotherapy in previously treated patients. This establishes a new standard of care for a cancer with a dismal 8% five-year survival rate. The approval also caps a decades-long effort to drug the once-considered “undruggable” RAS proteins and transforms Revolution into a leader in targeted cancer medicines.

The drug will cost $39,800 per month and carries substantial skin and mouth toxicities, and patients eventually develop resistance. But it could potentially have benefits in other RAS-driven tumors, including lung and colorectal cancers.

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