Under the agreement, PharmaCell will provide consulting services on writing GMP-compliant documents for translating the CiMaas cell therapy processes into GMP (good manufacturing practice). Options have been taken on a full technology transfer trajectory to be started and executed at a later, unspecified date. A continuation option on a Phase I and possibly a Phase II clinical trial is also part of the agreement.
The company’s lead products are a dendritic cell vaccine that is almost ready to be validated and tested in clinical trials, and natural killer (NK) cells obtained from healthy donors that have proven in rodent studies to demonstrate anti-tumor activity.
Wilfred Germeraad, Chief Scientific Officer of CiMaas, told Outsourcing-Pharma.com that PharmaCell was selected because it’s a large CMO in Europe with several large customers experienced in the dendritic cell field, like Dendreon and ImmunoCellular Therapeutics.
“This secures us that they are experienced with dendritic cells, one of our key products. Secondly, PharmaCell has two state-of-the-art GMP facilities, one for small and one for larger clinical trials,” Germeraad said. “It is a wonderful opportunity to work together and it will immediately speed-up our work in translating the lab procedures into clinical products ready to be tested in patients with cancer.”
As far as the difficulties behind this scale up, Germeraad said: “Translation of the dendritic cell vaccine is feasible as PharmaCell will have experience with tech transfer of [dendritic cell] protocols. Their people will be trained under our supervision to be able to carry out our protocols. From the beginning we have designed our set-up with GMP in mind, so we can culture our cells without FCS [fetal calf serum], without viral transduction, without animal products in the process. This makes it all feasible.”
This year, CiMaas said it expects to optimize the production process and begin GMP documentation, while in 2016 the company will prepare GMP readiness for the two products and then in 2017 CiMaas expects to begin two Phase I/II trials.