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Vor Bio changes its priorities & Novo Nordisk Foundation injects €736M in European biotech

 

Good morning! Regulators are done watching AI from the sidelines. Yesterday, the EMA and FDA released joint guidance laying out ten principles for using AI in drug development. The aim: define “good practice” now, before AI use gets further ahead of oversight.

Why it matters: This is cross-Atlantic regulators signaling alignment, and when they agree, it tends to be a big deal, especially these days. With this new rulebook, AI tools will need to be high-quality, human-centric, compliant, and secure, with clear roles and limits inside R&D workflows.

Bottom line: As ethical, legal, and cybersecurity standards tighten, informal or black-box AI won’t fly for long in drug development.

Enjoy today’s read!

—Joachim E.

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SNAPSHOT

Vor Bio trashes lupus in favor of two lower competition autoimmune targets

trash can in front of the office

 

Why it matters: This refined approach positions Vor Bio as a late-stage immunology player targeting areas with significant unmet need and commercial potential while conserving capital through 2028.

Backstory: Vor Bio, formerly focused on cell therapy, in-licensed telitacicept from China-based Remegen in 2025. The drug has already shown strong safety and efficacy across multiple indications in China.

Big picture: The shift aligns Vor Bio with specialty biotech peers that have scaled by focusing on high-value, less crowded autoimmune niches. Lupus deprioritization reflects a maturing market with competing biologics like GSK’s Benlysta.

Zoom in: Myasthenia gravis is a well-defined pathophysiology and clinical endpoints, with global Phase III trials underway. The market is expected to grow to $7.6B by 2029, according to GlobalData. Additionally, Sjögren’s disease has no approved disease-modifying therapies, which makes it a high-upside, long-term play.

What’s next: Vor Bio is advancing a global Phase III MG program and preparing to initiate a global Phase III trial for Sjögren’s. The company expects to hit key milestones with existing capital through mid-2028. Novartis’s ianalumab may offer future competition in Sjögren’s, but telitacicept’s broader mechanism could offer differentiation.

SNIPPETS

What’s happening in biotech today?

🧬 HSV hero: Innovative Molecules, a Munich-based biotech company, has entered a €125 million partnership with Italian pharmaceutical firm Alfasigma to develop and commercialize adibelivir, a next-generation antiviral targeting Herpes Simplex Virus (HSV) encephalitis, a rare and life-threatening neurological condition. Under the deal, Alfasigma secures global rights to the injectable formulation of adibelivir and will handle its development, manufacturing, and commercialization, while Innovative Molecules retains rights to other formulations, including an oral version in Phase II trials for genital herpes.

🧫 Oncology upgrade: AstraZeneca has announced the acquisition of Boston-based Modella AI to enhance its oncology R&D capabilities through advanced AI integration, building on a prior collaboration initiated in July 2025. Although financial details were not disclosed, the acquisition aims to accelerate clinical development by embedding Modella’s foundational models and AI agents into AstraZeneca’s drug development processes. This move supports AstraZeneca’s broader strategy to reach $80 billion in total revenue by 2030, amid revenue declines from aging assets like Brilinta and Soliris.

👁️ Lesion shrinker: Ocugen has released preliminary Phase 2 data for its gene therapy candidate OCU410, showing promising results in treating geographic atrophy (GA) secondary to dry age-related macular degeneration. In a 12-month analysis of 23 patients, the medium dose of OCU410 reduced lesion growth by 54% compared to placebo, while the high dose showed a 36% reduction. The company attributes the lack of a clear dose-response to possible cohort imbalances or biological factors. Unlike current GA treatments from Apellis and Astellas, OCU410 targets multiple disease pathways beyond the complement system. Ocugen plans to complete Phase 2 reporting this quarter and begin Phase 3 trials by year-end, aiming for approval in 2028.

🎲 Payload play: QLi5 Therapeutics has raised €6.26 million in a funding round led by its Korean co-founder Qurient. The German biotech is advancing a platform that uses proteasome inhibitors (PIs) as novel antibody-drug conjugate (ADC) payloads, aiming to overcome the toxicity issues seen with first-generation PIs by enabling tumor-specific drug release. While early preclinical data has shown promise, the use of PIs as ADC payloads remains unproven clinically, positioning QLi5 in a nascent yet relatively untapped area of ADC development

🤝 ADC alliance: And still related to ADCs, Tahoe Therapeutics and Alloy Therapeutics have announced the formation of a jointly funded company to develop first-in-class ADCs targeting difficult-to-treat cancers. The new venture will advance two ADC programs aimed at novel tumor targets identified by Tahoe using its AI-driven Mosaic platform and large-scale single-cell data. The partnership combines Tahoe’s expertise in discovering tumor-selective targets with Alloy’s comprehensive capabilities in biologic drug engineering, ADC design, and company building through its 82VS venture studio.

SNAPSHOT

Novo Nordisk Foundation injects €736M to supercharge European biotech innovation

Made with Canon 5d Mark III and loved analog lens, Leica APO Macro Elmarit-R 2.8 100mm (Year: 1993)

 

Novo Nordisk Foundation is investing DKK 5.5 billion (€736 million) into the BioInnovation Institute (BII) from 2026 to 2035 to scale biotech and deep tech innovation across Europe.

Why it matters: The funding aims to close Europe’s gap between world-class research and market-ready solutions, creating companies, jobs, and new technologies.

Backstory: Since launching in 2018, BII has helped launch over 130 startups through its venture programs and contributed to a fourfold increase in Danish biotech VC investment.

Big picture: The initiative positions BII as a pan-European innovation leader, helping Europe better compete globally in life sciences.

Zoom in: BII will expand beyond Denmark while remaining anchored in Copenhagen. New focus areas such as AI and quantum tech will also be added to the priorities of the institute. Ongoing partnerships include work with the Gates Foundation, Ferring, and others.

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