The BioPharm Brief: Targets, Technology, and Timing

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry.

What do cancer treatment, artificial intelligence, and obesity drug development have in common? All three are being pushed toward greater precision, whether that means targeting multiple tumor proteins, using AI to rethink drug discovery, or combining metabolic pathways in longer-acting therapies.

First, Akeso has dosed the first patient in a phase 2 trial evaluating AK146D1, a bispecific antibody-drug conjugate, in combination with ivonescimab for advanced breast cancer.

The study is evaluating the combination as a first-line treatment for patients with hormone receptor-positive, HER2-negative breast cancer and triple-negative breast cancer. AK146D1 is designed to simultaneously target TROP2 and Nectin-4, two proteins expressed on tumor cells. Akeso is positioning the program as part of an “IO2.0 plus ADC2.0” strategy, with the broader goal of combining next-generation ADCs with immuno-oncology therapies.

Next, AI is moving deeper into the drug discovery process.

Novo Nordisk and Amazon Web Services have announced a strategic partnership aimed at using artificial intelligence and cloud technologies to accelerate drug discovery and development.

The collaboration will use AWS tools including Amazon Bio Discovery, Amazon Bedrock, and Bedrock AgentCore. The companies have not yet disclosed specific timelines for AI-assisted drug programs to produce new therapies. The potential impact on drug development may take years to measure.

And finally, in obesity research, Ascletis is testing whether longer-acting peptide therapies can combine multiple metabolic pathways while reducing injection frequency. The company has initiated two phase 1 studies in the US, one evaluating ASC36, a once-monthly to once-quarterly amylin receptor agonist, and another evaluating ASC36_35FDC, a once-monthly fixed-dose combination of ASC36 with ASC35, a GLP-1 and GIP receptor dual agonist.

The combination is designed to target three pathways, amylin, GLP-1, and GIP, in a single injection that is designed to create a depot under the skin that gradually releases the drug over a month or longer. The phase 1 trials will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics following single and multiple ascending doses.

What happens next will depend on the data. Akeso’s phase 2 study, Novo Nordisk’s expanding use of AI, and Ascletis’ early clinical work will each have to show that these approaches can deliver meaningful results beyond the technology itself.

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Key takeaways:

• Akeso has begun Phase 2 testing of a bispecific ADC and ivonescimab combination in breast cancer.
• Novo Nordisk and AWS are expanding AI use across drug discovery and development.
• Ascletis has entered Phase 1 testing of longer-acting amylin and incretin therapies for obesity.