Daily Snap - 27. August 2025

Good morning! If you thought the Biosecure Act, passed last year to reduce the U.S. pharma industry's reliance on Chinese CROs, was enough to deter new initiatives, think again. In September, Chinese CRO ChemPartner is set to open a 12,000-square-foot research facility in Boston, providing its preclinical drug development services to the busiest biotech hub in North America. So much for keeping Chinese CROs at arm’s length—the competition is now setting up shop next door.

Enjoy today’s read!

—Joachim E.

SNIPPETS

What’s happening in biotech today?

🫁IPF hope:  Calluna Pharma has launched patient recruitment for its Phase II AURORA trial assessing CAL101, a monoclonal IgG1 antibody targeting the S100A4 DAMP protein, for idiopathic pulmonary fibrosis (IPF). Distinct among 110 global IPF drug programs, CAL101's novel mechanism selectively inhibits fibroblast activation and pro-fibrotic inflammation, showing promising preclinical efficacy and Phase I safety. The trial will enroll 150 patients randomized to receive monthly CAL101 or placebo infusions, with lung function (FVC) as the primary endpoint. Competing therapies targeting TGF-beta, LPA1, or CTGF face challenges such as adverse effects, receptor redundancy, or limited impact on underlying fibrosis mechanisms.

🧱Barrier buster: BioArctic has signed a license option agreement with Novartis, granting the Swiss pharmaceutical company access to its BrainTransporter platform, designed to deliver therapeutics across the blood-brain barrier for neurodegenerative diseases. Novartis will pay an upfront fee of $30M, with the total deal potentially reaching $802M, including milestone payments and royalties. The collaboration includes developing a drug candidate that combines the BrainTransporter with a proprietary Novartis antibody.

🤖 AI apothecary: Therna Biosciences has emerged from stealth with $10 million in seed funding led by AIX Ventures to develop AI-generated RNA medicines. The startup aims to address inefficiencies in RNA drug design by using a “lab-in-the-loop” platform that integrates generative AI models with experimental data. Backed by a strong scientific team and investor interest, Therna targets applications beyond vaccines, aiming to accelerate and de-risk RNA therapeutic development across multiple disease areas.

💊Oral slimshot: Eli Lilly has completed its clinical data package for orforglipron, an oral GLP-1 drug, following positive results from the phase 3 Attain-2 trial involving patients with obesity and Type 2 diabetes. The once-daily treatment met all primary and secondary endpoints, with the highest 36 mg dose yielding an average weight loss of 10.5% (22.9 pounds) and an A1C reduction of 1.8% over 72 weeks. Orforglipron also showed cardiovascular benefits and a tolerable safety profile. Coupled with earlier success in the Attain-1 trial, Lilly plans to seek global regulatory approval by year-end, aiming to position orforglipron as the first successful oral GLP-1 therapy.

🔗Bispecific boost: Akeso and Summit Therapeutics’ bispecific antibody ivonescimab has achieved a statistically significant and clinically meaningful overall survival (OS) benefit in the final analysis of the phase 3 HARMONi-A trial for EGFR-mutated, nonsquamous non-small cell lung cancer (NSCLC) patients who progressed after tyrosine kinase inhibitor therapy. This marks the first time the PD-1xVEGF-targeting drug has shown it can extend patient survival, reinforcing earlier findings of a 54% risk reduction in disease progression. The result bolsters prospects for the global HARMONi trial, which previously showed strong progression-free survival but fell short on OS significance in an interim analysis.

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