Entries by Georg Kääb

Novartis: Three deaths put CAR-T expansion into autoimmune diseases on hold

Novartis has paused eight clinical trials of its CD19 CAR-T therapy rap-cel after three patients died from a severe immune reaction. The studies are evaluating the therapy in autoimmune and neurological diseases including lupus, systemic sclerosis, myositis and multiple sclerosis. The move highlights the safety challenges of taking CAR-T beyond oncology into chronic immune-mediated diseases.

Heidelberg Pharma deepens ADC alliance with Huadong

German biotech Heidelberg Pharma and China-based Huadong Medicine are drawing ever closer: What began as a licensing partnership has developed into an alliance spanning capital investment, joint ADC development and clinical research. Now, up to six new targets are being added, making the partnership increasingly strategic.

Berlin-developed Ebola vaccine heads toward African trial

The Coalition for Epidemic Preparedness Innovations (CEPI) is providing Egyptian biopharmaceutical company Minapharm with up to $16.5 million (€14 million) to advance another vaccine candidate against Bundibugyo Ebola virus into clinical development. The candidate was developed by Minapharm’s Berlin-based subsidiary ProBioGen using its proprietary MVA-CR19 platform. A Phase I trial is planned in Africa, with the broader aim of helping the continent build the capacity to respond rapidly to emerging outbreaks.

Samanta Cimitan to (re)join Lonza from Celonic

Samanta Cimitan will join Lonza as Chief Commercial Officer (CCO), Senior Vice President and a member of the Extended Executive Committee on 1 January 2027. In the newly created role, she will lead Strategic Enterprise Account Management, Global Marketing and Commercial Excellence. She´s been with Lonza before her CEO role at Celonic for the last three years.

Moderna gives mRNA oncology a shot in the arm

A Phase III win for Moderna and Merck’s personalized mRNA cancer vaccine has reignited investor enthusiasm for mRNA — and put BioNTech back in the spotlight. But the data are more important than the stock rally: for the first time, a personalized mRNA cancer therapy has produced positive Phase III data in a major indication.

Europe withdraws Tavneos as AAV treatment and opens a gap for other complement inhibitors?

The European Commission has revoked the marketing authorization for Tavneos (avacopan) in ANCA-associated vasculitis, citing unreliable efficacy data from the pivotal ADVOCATE trial and serious liver safety concerns. The decision removes Europe’s only approved targeted therapy for the rare autoimmune disease – potentially opening the door for next-generation complement inhibitors.

Copenhagen-based Again acquires US Geno to connect AI-driven discovery with industrial biomanufacturing

The Copenhagen-based biomanufacturing company is acquiring Genomatica, bringing Geno’s computational biology and industrial biotech expertise into a platform designed to move from pathway discovery to commercial-scale production. The deal highlights a broader shift in industrial biotech: AI is moving beyond molecule design and into the engineering of how biology is manufactured.