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CSL adding scalable stem cell gene therapy tech in $91m Calimmune buy

Dan Stanton

By Dan Stanton+

30-Aug-2017

Image: Pablo_K
Image: Pablo_K

CSL Behring will launch itself into the stem cell gene therapy through the acquisition of Calimmune, adding a preclinical candidate and two manufacturing efficiency technologies.

CSL Behring is set to pay $91m (€76m) upfront and up to $325m in milestone payments over the next eight years for Calimmune.

According to spokeswoman Natalie de Vane, the acquisition is the first step into the cell and gene therapy space for CSL with the addition of an ex vivo hematopoietic stem cell (HSC) gene therapy candidate and R&D facilities in Pasadena, California, and Sydney, Australia “a natural complement” to the firm’s protein-replacement business and its rare diseases focus.

We have been interested in the field for some time, and believe that Calimmune is an appropriate point of entry into this area for us, and a good strategic fit for our business and our longer-term strategic goals,” she told Biopharma-Reporter.

“Calimmune’s preclinical hematopoietic stem cell (HSC) gene therapy, CAL-H, for the treatment of sickle cell disease and β-thalassemia, aligns nicely with our deep expertise and leadership in haematology.”

Commercial manufacturing platforms

The deal also brings CSL the Select+ and Cytegrity platform technologies which de Vane told us have broad applications in other ex vivo stem cell gene therapies.

“[The platforms] have the potential to address some of the major challenges currently associated with the commercialisation of stem cell therapies, such as the ability to manufacture consistent, high-quality product, and to improve engraftment, patient to patient variability, efficacy and tolerability.”

The Select+ platform, for example, looks to reduce the required intensity of the conditioning chemotherapy currently used, which could make HSC therapy an outpatient procedure, while the Cytegrity tech looks to provide a scalable manufacturing platform with high batch-to-batch consistency.

“[This] would be a tremendous advantage as today lentiviral vectors are generally manufactured in small batches through a convoluted process,” she said.

The deal is expected to close in the next two weeks at which point CSL will hope to integrate the business with minimal disruption.

“Immediately after close, Louis Breton, Calimmune’s CEO, will report directly to our Chief Scientific Officer and R&D Director, Andrew Cuthbertson. Additionally, we will form a joint integration team focused on growing and building the Calimmune assets and technologies.”

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