Daily Snap - 10. October 2025

Author

Joachim Eeckhout
October 10, 2025

Good morning! The UK’s MHRA and the US FDA are joining forces to fast-track medical innovations, from AI in healthcare to advanced medical devices. This partnership aims to align regulations, speed up approvals, and help new technologies reach patients faster. As MHRA’s Lawrence Tallon put it, both countries share a single goal: ensuring patients benefit “quickly and safely from the latest medical innovations.” If there’s one thing we love at Biotech Snap, it’s when regulators find common ground across the Atlantic.

Enjoy today’s read!

—Joachim E.

SNIPPETS

What’s happening in biotech today?

💸COPD cash: Expedition Therapeutics has raised $165 million in a Series A funding round to advance its lead candidate, EXPD-101, a DPP1 inhibitor, into phase 2 clinical trials for chronic obstructive pulmonary disease (COPD). The round, announced on October 9, 2025, was led by Sofinnova Investments and Novo Holdings, with participation from several major investors, including Forbion and Sanofi Ventures. The Bay Area biotech, founded in 2024, had previously licensed ex-China rights to EXPD-101 from Fosun Pharma for $17 million upfront. In addition to COPD, Expedition plans to explore the drug's potential in other neutrophil-driven inflammatory diseases.

 🔗ADC upgrade: Catalent has signed a deal worth up to $10 million with Lisata Therapeutics to evaluate certepetide, a proprietary cyclic peptide, as a potential payload in antibody-drug conjugates (ADCs) for hard-to-treat diseases. Certepetide, which showed a positive survival trend in a phase 2b pancreatic cancer trial, enhances drug delivery through tumor tissue via protease-mediated cleavage and C-end Rule activation. Catalent aims to integrate this technology into its SMARTag ADC platform, advancing a new class of targeted bioconjugate therapies. Lisata will receive milestone payments and future sales royalties.

🏆 EP4 win: Ono Pharmaceutical's EP4 antagonist ONO-4578, developed in partnership with Bristol Myers Squibb, achieved its primary endpoint in a phase 2 trial by significantly improving progression-free survival in patients with HER2-negative unresectable advanced or recurrent gastric or gastroesophageal junction cancer. The study, conducted in Japan, South Korea, and Taiwan, tested ONO-4578 in combination with the PD-1 inhibitor Opdivo and chemotherapy. While detailed data were not disclosed, Ono plans to present the results at a future academic meeting. ONO-4578 targets immunosuppressive factors in the tumor microenvironment, and further trials, including a global colorectal cancer study, are ongoing.

📈 Cell scale up: The U.S. government, through the Advanced Research Projects Agency for Health (ARPA-H), is significantly investing in in vivo cell therapy research, signaling support for next-generation immunotherapies under the second Trump administration. The newly launched ImmunoVec received up to $40.7 million to develop DNA-delivering polymeric nanoparticles for treating autoimmune diseases. Other recipients include Kernal Bio and partners ($48 million) for mRNA-encoded CAR T-cell programs, Tessera Therapeutics ($41.3 million) for RNA-based gene editing, and Cytiva for CRISPR-based CAR-T therapies. These efforts aim to make cell therapies safer, more scalable, and accessible, despite recent industry layoffs and market challenges.

💥Cancer leap: Regeneron Pharmaceuticals has received FDA approval to expand the use of its cancer drug Libtayo for patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation, based on trial data showing a 68% reduction in disease recurrence or death compared to placebo. While this approval could eventually add $1 billion in annual sales and offers some positive momentum amid recent challenges, including a 40% stock drop, competition to its top-selling eye drug Eylea, and manufacturing setbacks, it lacks the broader impact some investors had anticipated. Regeneron is also pursuing approval for the expanded use in the EU by mid-2026.

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