Evotec, Sernova Striving for Functional Diabetes Cure

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Two life sciences powerhouses are coming together to develop an off-the-shelf beta cell replacement therapy for insulin-dependent diabetes patients, which they hope will become a functional cure for both types of the disease.

This morning, Germany-based Evotec and Canada’s Sernova partnered to develop an implantable induced pluripotent stem cell (iPSC)-based beta cell replacement therapy that can be used with both type 1 and type 2 diabetes patients. The collaboration will harness the capabilities of Evotec’s QRbeta technology, which is used to produce iPSC-based beta cells in islet-like clusters, with Sernova’s proprietary Cell Pouch, an implantable and scalable medical device. Evotec’s islet-like clusters are functionally equivalent to primary human islets in their ability to normalize blood glucose levels using in vivo models over several months, the company said.

In previous studies assessing the Cell Pouch and primary donor islets, Sernova has seen long-lasting therapeutic results from its Phase I/II study. That trial saw sustained insulin independence in high-risk type 1 diabetes patients who previously required insulin injections for survival.

The trial, which was conducted at the University of Chicago, has shown significant promise, with at least one patient having become insulin-independent, Sernova Chief Executive Officer Philip Toleikis said Tuesday morning in a conference call. Sernova said that part of its research will include an evaluation of local immune protection technology in order to protect non-modified beta cells and avoid the requirement for immunosuppressive treatment.

“We believe this will immediately put Sernova at the forefront of diabetes treatment,” Toleikis said.

Under terms of the collaboration, Sernova acquired an exclusive global license to Evotec’s iPSC-based beta cells to pair with its Cell Pouch system. The two companies will work together to validate the combination in preclinical programs. If the combination enters the clinic,  Sernova will then have the right to secure an exclusive global license. Evotec will bolster the partnership with cell manufacturing through potential commercialization, in which case the companies will initiate a profit-sharing arrangement.

Cord Dohrmann, Evotec’s chief scientific officer, said his company had been looking for a potential partner like Sernova for some time. When he came across Sernova and the company’s Cell Pouch technology, Dohrmann said it “ticked all the boxes” and was a perfect fit for Evotec's iPSC-based beta cells. This morning, Dohrmann said the two companies will progress a “highly differentiated first-in-class beta cell therapy” into clinical development in order to bring a potential cure to insulin-dependent diabetics.

“At Evotec, we are really excited about this collaboration with Sernova. We are convinced they are the perfect match for Evotec’s expertise and experience,” Dohrmann said on the same call.

Like Evotec, Sernova had also been searching for a potential partner. Toleikis said his company looked at multiple iPSC cell technologies before partnering with Evotec on this collaboration.

“Evotec is an iPSC powerhouse having dedicated many years and substantial resources to developing high quality and stable stem cell technologies for multiple therapeutic applications. In every sense, both as a global strategic partner and as an iPSC expert, Evotec has exceeded all our expectations and we welcome them to join our advisory board,” Toleikis said.

Toleikis added that the joint iPSC beta-cell partnership completes the three pillars of its diabetes cell therapy platform. The Cell Pouch, coupled with Sernova’s recently acquired conformal coating immune protection technology, creates a total regenerative medicine cell therapy solution for insulin-dependent diabetes, he said.

Alongside the partnership, Evotec made an equity investment of €20 million (about $21.1 million) into Sernova. Dohrmann said the equity investment underlines the company’s strategic interest in the collaboration.

For Evotec, the partnership with Sernova is hot on the heels of an extension of its targeted protein degradation collaboration with Bristol Myers Squibb.

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