The BioPharm Brief: Gilead’s Oral IL-23R Bet, Roche’s Trispecific Deal, and Treasury’s Biotech Investment Proposal

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry. Today, we’re looking at two dealmaking stories and a proposed rule that could affect cross-border biotech investment.

First, Gilead Sciences has agreed to acquire Shanghai-based PepStar Therapeutics’ oral IL-23R inhibitor program for $1.275 billion upfront in cash. The lead candidate, HCXT-2001, is a macrocyclic peptide taken as a pill. It blocks the interleukin-23 receptor, a key driver of inflammation in immune-mediated diseases. HCXT-2001 is in a Phase 1 study in healthy adults, and inflammatory bowel disease is the target indication. Gilead said the program could be developed as a daily oral treatment, either alone or alongside its own oral integrin inhibitor, emvistegrast. The deal is expected to close in the fourth quarter.

Next, Zymeworks has licensed ZW209 to Roche in a deal worth up to $813 million, plus royalties. ZW209 is a trispecific T-cell engager. It binds DLL3, a protein found on most small cell lung cancer cells, and activates T cells through both CD3 and the co-stimulatory receptor CD28. That second signal is designed to help T cells survive and keep attacking tumors over time. A Phase 1 study in small cell lung cancer and other DLL3-expressing tumors is underway. Zymeworks will run the early trial with Roche, and Roche will fund it and lead later development.

And the US Department of the Treasury has proposed adding biotechnology to its Outbound Investment Security Program under the COINS Act. The rule would restrict certain US investments in biotech companies in China and other countries of concern. It covers areas such as biomanufacturing equipment, bioinformatics tools, and biological design and sequencing. The rule focuses on equity investments and joint ventures, and contractual arrangements are excepted unless they involve technology transfer. MassBio said it plans to submit comments, which are due December 7.

That’s today’s BioPharm Brief. For analysis and expert insights, please visit BioPharmInternational.com.

Key takeaways

• Oral peptides move into IBD: Gilead’s $1.275 billion upfront bet on HCXT-2001 shows big pharma’s appetite for oral alternatives to injectable IL-23 biologics.
• T-cell engagers add co-stimulation: ZW209 pairs DLL3 targeting with CD28 signaling to try to make T-cell responses more durable in small cell lung cancer.
• Cross-border biotech faces new scrutiny: Treasury’s proposal could reshape how US investors structure deals with Chinese biotechs, with comments due December 7.