TxCell SA , a biotechnology company developing innovative, cost-effective, personalized T-cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announced an amendment to the Ovasave collaboration option, development and license agreement (Ovasave Agreement) with Trizell Holding SA (Trizell).

In the agreement, TxCell will undertake a programme to bring forward the preparation of Ovasave for phase 3 development and commercialization, notably in the areas of process and manufacturing development. To finance this programme, Trizell will advance up to EUR 1.1 million in funding that was initially due after the future exercise of Trizell’s option to Ovasave.

In Trizell’s sole discretion it may finance a further EUR 4.3 million. TxCell has appointed the Cell Therapy Catapult, a leading cell therapy organization, to undertake the process and manufacturing development of TxCell’s ASTrIA product platform under TxCell’s leadership.

 Ovasave, TxCell’s lead product, is currently in a phase IIb clinical trial for refractory Crohn’s disease (CATS29 study – see release of Dec 4, 2014). Top line results of this study are expected at the end of 2016 / early 2017.

Initiating the programme detailed in the latest amendment to the agreement is intended to enable Ovasave to be moved seamlessly into phase III development following the ongoing phase IIb study.

It also aims to ensure that the phase III programme is performed with the same cost-effective manufacturing processes that will be used for future commercial products. In addition, the process will be designed and automated to allow it to be easily and economically upscaled in line with future demand. The programme allows other activities to be performed including formulation selection and any necessary pre-clinical studies.

TxCell will own all results and intellectual property generated, which can be used across TxCell’s ASTrIA product platform. TxCell will grant Trizell an exclusive license to use the results and IP specifically for Ovasave in IBD (Inflammatory Bowel Diseases) in line with the Ovasave agreement.

Trizell has initially committed EUR 1.1 million of funding to the phase III preparation programme and may, in its sole discretion, commit up to a further EUR 4.3 million. This funding will be offset against the potential total payments of up to EUR 76 million due to TxCell under the Ovasave agreement.

“This additional amendment to our agreement including the significant investments advanced by Trizell, is the latest important development for the Ovasave programme and for TxCell’s ASTrIA product platform. It provides further support for Ovasave to progress smoothly and rapidly to phase III and commercialization,” said Miguel Forte, senior vice president Clinical and Regulatory, TxCell.

 “Ovasave, TxCell’s lead personalized T-cell immunotherapy, offers the chance of a new therapeutic innovation for refractory Crohn’s disease patients who have no alternative treatment options. In addition to this, TxCell has a portfolio of further personalized T-cell immunotherapies from the ASTrIA product platform. This includes TxCell’s second product Col-Treg for refractory non-infectious uveitis, which is planned to start a placebo-controlled, dose-ranging clinical study mid-2015.”

Keith Thompson, chief executive officer of the Cell Therapy Catapult, said “The Cell Therapy Catapult is delighted to work with TxCell to undertake the process and manufacturing development of TxCell’s ASTrIA product platform and lead product Ovasave, an important potential treatment for refractory Crohn’s disease.”

“ Through the value of our offering as an international partner we will be able to add considerable cell therapy industry expertise to help TxCell develop cost-effective and scalable manufacturing processes that will be flexible for TxCell’s future requirements.”

The exclusive worldwide Ovasave license option agreement was signed by Ferring International Center (SA) (Ferring) and TxCell in December 2013. Its assignment to Trizell was announced on January 2, 2015.

Ferring and Trizell are both affiliates of the Dr Frederik Paulsen Foundation. Ferring secured the option from TxCell for EUR 3 million (of which EUR 2 million has been received by TxCell) and is the intended final commercializing party for Ovasave for the treatment of Inflammatory Bowel Disease (IBD), including Crohn's disease and ulcerative colitis. The agreement includes supplementary development, commercial and manufacturing milestone payments of up to EUR 73 million, plus royalties on future sales of Ovasave.

Trizell Holding SA is a company dedicated to advanced therapies, i.e. cellular and gene therapies. Ovasave will benefit from the additional focus and expertise that Trizell will supply. Ferring remains the intended final commercializing party.

The Cell Therapy Catapult is a centre of translational excellence for cell therapy and regenerative medicine. Its vision is for the UK to be a global leader in the development, delivery and commercialisation of cell therapy, making it a location for business start-up and growth.