Date: 2015-02-02
Type of information: Termination of an agreement
Compound: OvaSave® (antigen-specific type 1 regulatory T (Ag-Treg) cell based immunotherapy)
Company: TxCell (France) Ferring International Center (Switzerland) Trizell Holding (Switzerland)
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Type agreement: development
licensing
Action mechanism: OvaSave® is an antigen-specific type 1 regulatory T (Ag-Treg) cell based immunotherapy. The Ag-Treg cells utilized in Ovasave® are isolated from whole blood of the patient, activated by the specific antigen, ovalbumin. The cloned Ag-Treg cells are expanded ex vivo before their reinjection into that same patient. The injected Ag-Treg cells home to sites of inflammation and are activated locally by the specific food antigen, ovalbumin.
Disease: inflammatory bowel diseases, including Crohn's disease and ulcerative colitis
Details: * On March 14, 2014, TxCell, a biotech developing personalized cell-based immunotherapies using antigen-specific regulatory T-cells (Ag-Tregs) for chronic inflammatory and autoimmune diseases, and Ferring International Center SA, a private biopharmaceutical with a global franchise in inflammatory bowel disease (IBD), have announced the signing of a collaboration, option, development and license agreement potentially worth up to € 76 million plus royalties subject to the achievement of milestones. In the agreement, TxCell has granted Ferring an option to acquire an exclusive worldwide license for the development, manufacture and marketing of TxCell’s lead candidate Ovasave® for the treatment of IBD, including Crohn's disease and ulcerative colitis.
TxCell will undertake a forthcoming phase IIb study with Ovasave® in refractory Crohn’s disease. Ferring will then be responsible for the conduct and funding of further development and commercialisation after the exercise of the option.
Financial terms: Initially, TxCell will receive €3 million for the acquisition of the option by Ferring, of which € 1 million was paid upon signature of the agreement and the remainder will be paid depending on the progress of the Ovasave® phase IIb trial planned to start in the second half of 2014. TxCell will also be eligible in the future in the event of the exercise of the option to development, commercial and manufacturing milestones and payments up to a total of € 73 million. TxCell will also receive tiered royalties up to double digits on future sales of Ovasave®.
Latest news: * On December 2, 2015 , TxCell announced that it has agreed with Trizell to terminate the agreement concerning Ovasave®. The agreement granted Trizell an exclusive option to in-license development and commercialization rights to Ovasave® in inflammatory bowel disease, including Crohn’s disease. TxCell has now regained full rights to Ovasave®. Following this reacquisition, TxCell now proposes to amend the CATS29 phase IIb trial for Ovasave®, currently underway in refractory Crohn’s disease patients. The primary endpoint of the trial (1 million cell dose vs placebo) is intended to be maintained. The dose exploring arms are however expected to be omitted. * On April 23, 2015, TxCell announced an amendment to the Ovasave® collaboration option, development and license agreement with Trizell Holding. In the agreement, TxCell will undertake a program 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 program, Trizell will advance up to € 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 € 4.3 million. TxCell has appointed the Cell Therapy Catapult, a leading cell therapy organizatio, 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. Top line results of this study are expected at the end of 2016 / early 2017. Initiating the program 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 program 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 program 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. * On January 2, 2015, TxCell announced a further enhancement to the development of its lead product Ovasave® for the treatment of Inflammatory Bowel Diseases (IBD), including Crohn's disease and ulcerative colitis. The collaboration, option, development and license agreement between TxCell and Ferring has been assigned to Trizell Holding SA, an affiliate member of the Dr Frederik Paulsen Foundation.
Following the amendments to the CATS29 trial, TxCell intends to recommence the trial in Q2 2016, with the drug product manufactured by MaSTherCell, a contract manufacturing organization. TxCell expects to complete recruitment in CATS29 at the end of 2017 and announce topline data by Q4 2017 or Q1 2018.
As a result of the new agreement, Trizell will be eligible to receive up to € 15 million in payments from TxCell, including € 2 million upfront. As TxCell was already paying all clinical development costs for Ovasave, the impact of regaining rights to the product on the TxCell short term financial outlook will be limited.
