We now know Tome’s gene editing target

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Hello! Today we learn whether AI might help hasten the development of n-of-1 therapies (hint: not yet), explore why the FDA hasn’t offered Orange Book guidance on drug-device combinations, and talk about CRISPR. A lot.

The need-to-know this morning

• AC Immune has sold global licensing rights to an experimental immunotherapy for Alzheimer’s disease to the Japanese drugmaker Takeda. AC Immune received $100 million from Takeda for the therapy, called ACI-24.060, and is eligible for another $2.1 billion in future payments.
• Merck reported negative results from an interim analysis of a Phase 3 study involving the use of its experimental anti-TIGIT antibody as an adjuvant treatment for patients with high-risk melanoma.
• Cancer drug developer OnKure is going public via a reverse merger with Reneo Pharma.

AI might not yet help develop ‘n-of-1’ treatments

Can AI be used to help create “n-of-1” treatments for the rarest of genetic diseases? The jury’s still out, a new study suggests.

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