Charlotte Fribert (CF), CEO of Toleranzia, and Niranjan Sardesai (NS), founder and CEO of Geneos Therapeutics, were among the delegates partaking in the future of advanced biologics conference (September 2023) that already tried out the innovation hub approach for real. In a brief interview, Helena Strigård gathered some of their thoughts.

The projects that your respective companies brought to the hub are quite different, tell us about them!

NS: “Geneos Therapeutics is developing individualized treatments for cancer based on our personalized therapeutic cancer vaccine (PTCV) platform. We use plasmid DNA to encode each patient’s cancer antigens and a non-viral delivery method to immunize patients with their personalized plasmid based PTCV. These treatments have to be manufactured individually for each cancer patient. We are interested in expanding our manufacturing network to support larger clinical trials. The NorthX Innovation Hub has extensive experience in E. coli-based microbial processing and manufacture of plasmid DNA under cGMP conditions. Therefore we engaged with NorthX to conduct a feasibility study to see if their platform process and testing methods could be used to manufacture representative DNA plasmids to Geneos’ specifications.”

Since we produce recombinant proteins in E. coli, we were interested in discussing Down Stream Processing (DSP) possibilities with them.”

CF: “Toleranzia develops drugs that use the immune system’s own intrinsic power to treat autoimmune orphan diseases. We turned to the NorthX Innovation Hub to benefit from their knowledge and experience in the development and manufacture of biologic drugs and more specifically in recombinant manufacturing processes. Since we produce recombinant proteins in E. coli, we were interested in discussing Down Stream Processing (DSP) possibilities with them.”

What was the first step, how did you get started?

NS: “Once the appropriate non-discosure agreements were in place between Geneos and NorthX, the two technical teams met and we established a scope of work for the feasibility study, following which we contracted with NorthX to conduct the manufacturing feasibility study. A detailed technical plan then was created, followed, and readily-adapted when needed, to guide the study to completion.”

A detailed technical plan then was created, followed, and readily-adapted when needed, to guide the study to completion.”

CF: “Getting started was straightforward also for us at Toleranzia. After an initial contact, we signed a two-way CDA and had a face-to-face brainstorming session to delineate the scope of the work. NorthX Innovation Hub presented several insightful and interesting process development ideas that could simplify our manufacturing process. This attracted us and increased our interest in moving forward with a collaboration. After that, it was pretty much “plug and play”.”

What is most important to you as you are looking to develop your project?

NS: “As Geneos Therapeutics a venture-backed biotech developing a novel treatment approach, but with limited resources, we are interested in partnering with CDMOs using a collaboration model. How can we collaborate to bring our respective strengths to the table and together move Geneos’ clinical programs forward in an efficient yet effective manner? We were impressed with NorthX’s facilities and capabilities, manufacturing knowledge and technical expertise, and the collaboration/partnering mindset of their team. This led us to initiate our collaboration and proved invaluable during our collaboration.”

Read more: Toleranzia completes GLP toxicology study

Where do you see your project develop from here?

CF: “The experiments conducted by NorthX Innovation Hub, gave us at Toleranzia new ideas which can be tested and potentially implemented in a second-generation manufacturing process to provide material for late-stage clinical development and with potential application in commercial manufacturing. This was a most valuable outcome for us!”

The experiments conducted by NorthX Innovation Hub, gave us at Toleranzia new ideas which can be tested and potentially implemented in a second-generation manufacturing process to provide material for late-stage clinical development and with potential application in commercial manufacturing.”

Photo of Charlotte Fribert and Niranjan Sardesai