Hansa Biopharma Deploys Cradle’s AI Platform Across Discovery Pipeline

Hansa Biopharma AB announced a partnership with Cradle on October 1, 2026, deploying Cradle’s end-to-end platform across Hansa’s discovery pipeline to design, optimize, and advance novel therapeutic candidates. Cradle builds an AI-driven protein design and engineering platform for biologics. The companies said they aim to accelerate the development of new therapeutics for patients with severe autoimmune diseases, and the announcement states that Hansa is deploying the platform to develop novel immunomodulatory therapies in autoimmune disease. The announcement was datelined Lund, Sweden, and Amsterdam, the Netherlands.

Hansa, which describes itself as a pioneer in treatments for rare IgG-related immunologic conditions, said the collaboration reflects its continued strategic investment in AI-powered drug discovery as it builds the next generation of its pipeline. The company said Cradle’s track record of delivering results with leading biopharmaceutical companies made it a natural partner as Hansa expands its use of AI across new discovery programs. The announcement also characterizes the partnership as reflecting a broader shift toward unified AI platforms that combine candidate generation, optimization, and continuous learning from experimental data in a single workflow.

Hansa’s lead product, imlifidase, described in the announcement as a first-in-class enzyme, is commercially available in Europe under the brand name Idefirix and is presently in FDA review for highly sensitized patients awaiting kidney transplant, with a PDUFA date in December.

Why Hansa Selected Cradle

Sofia Järnum, VP Head of Research and Early Development at Hansa, said the company evaluated several AI models and vendors before selecting Cradle. She cited three capabilities Hansa regards as essential for next-generation protein engineering: end-to-end support across the discovery pipeline, from hit identification onward; multi-parameter optimization across complex engineering objectives; and active learning from Hansa’s own data to drive increasingly predictable outcomes.

In the joint announcement, which Cradle also published on its official blog the same day, Järnum said each of these capabilities accelerates Hansa’s lab-in-the-loop process, adding: “Cradle’s platform enables Hansa scientists to design and engineer better therapeutic candidates, faster and with greater probability of success.”

Cradle CEO and Co-Founder Stef van Grieken said the future of multimodality therapeutics engineering lies in empowering scientists with a platform that learns alongside them while they apply their own expertise to complex molecular challenges at scale. He said Cradle is excited to partner with Hansa on its mission to accelerate the discovery and development of novel therapeutics for patients suffering from rare and severe autoimmune disorders.

How Cradle’s Platform Works

Cradle describes its software on its platform page as optimizing multiple protein properties, including activity, stability, and expression, simultaneously rather than sequentially, balancing competing objectives in a single round. According to Cradle, the platform automatically builds a custom model after each experimental round, trained on public datasets, Cradle’s own wet-lab data, and the customer’s project results, and the company states that models trained on customer data remain private to that customer.

Cradle says the system runs tens of thousands of simulations to design experimental plates that balance exploiting known winning variants against exploring new possibilities. The platform includes tooling for hit identification from high-throughput screening and panning data and supports enzymes, peptides, and single- or multi-chain antibodies, according to the company. Cradle says its models are tested and validated continuously in its Amsterdam wet lab.

Cradle reports that customers achieve 2–12x speedups across more than 50 programs and that scientists consistently rate its AI-engineered protein candidates 8 out of 10. The Hansa announcement separately cites Cradle’s claim that customers report development timelines up to 18 months faster, suggesting that figure translates into significant R&D savings per clinical candidate.

Hansa’s Pipeline and Regulatory Milestones

Hansa’s pipeline page states that the company evaluates imlifidase and HNSA-5487 across a spectrum of potential disease areas and indications. For imlifidase, European commercialization in desensitization for kidney transplantation is ongoing based on a conditional approval from the European Commission, under which Hansa committed to a post-approval study; the page lists an EU Phase 3 PAES data readout among next anticipated milestones for mid-2026.

Beyond transplantation, Hansa is evaluating imlifidase for desensitization in gene therapy. A Phase 2 program in Crigler-Najjar syndrome partnered with Genethon is ongoing, with the page listing completion of enrollment in the second half of 2026 as the next milestone, while a Phase 1 program in Duchenne muscular dystrophy partnered with Sarepta Therapeutics is completed, with discussions regarding next steps ongoing. An investigator-initiated Phase 2 trial in autoimmune ANCA, sponsored by Dr. Adrian Schreiber and Dr. Philipp Enghard at Charité Universitätsmedizin in Berlin, has concluded its recruitment phase.

For HNSA-5487, which Hansa is developing for Guillain-Barré Syndrome, Phase 1 is completed and the page lists a clinical development plan agreed with the FDA in the first half of 2026. In the United States, the imlifidase Phase 3 study in kidney-transplant desensitization is completed, and Hansa lists a PDUFA date of December 19, 2026.