NANTES, France—Returning to its roots in a quest to develop companion diagnostic tests for rheumatoid arthritis (RA) therapies, gene expression biomarker firm TcLand Expression SA has signed a licensing agreement with Inserm Transfert, the private subsidiary and technology transfer office of the French National Institute of the Health and Medical Research (Inserm), for two patents covering gene expression signatures that may predict patient response to RA treatments.
Inserm spun off TcLand in 2002. Since then, most of the patents licensed to TcLand have come from Inserm, and TcLand has been developing and clinically validating gene-expression-based biomarkers for transplantation and companion diagnostic tests for use with autoimmune disease therapies. The licensing agreement with Inserm Transfert is the newest in a number of strategic collaborations that TcLand has with other organizations for the development of new biomarkers in RA, including the Vall d'Hebron University Hospital Research Institute in Spain and the Lyons Public Hospitals Group in France.
In this latest agreement, announced in early July, TcLand has global, exclusive access to two Inserm Transfert patents: the first, a method for predicting responsiveness to tumor necrosis factor (TNF)-blocking agents; and the second, a method for predicting the response to a treatment with the RA drug anakinra, an interleukin-1 receptor antagonist. Based on the methods protected by the two patents, TcLand intends to develop companion diagnostic tests for RA therapies.
Although the companies did not disclose financial terms of the agreement, TcLand CEO Alain Huriez estimates that the companion diagnostic tests the partners seek to develop could yield $60 million to $100 million in global sales on an annual basis, based on estimates that 70 million people worldwide suffer from the disabling disease.
"It is interesting to consider that much of the progress and talk about personalized medicine pertains to oncology, while the healthcare budget and expense for RA treatment is quite high," Huriez says. "But there is now some pressure and things are clearly moving now to where if the U.S. market can be provided with companion diagnostics, pharmas can improve the efficacy and cost-effectiveness of their drugs."
Pharmas may see this as an important part of their life cycle management strategies when they are developing new drugs, Huriez suggests.
"If these companies can show better efficacy and response, companion diagnostics may be very helpful in their life cycle management and product positioning," he explains. "This may also be very helpful for payors."
Inserm will conduct the research and patient data collection, while TcLand will work on clinical validation and regulatory approval. According to Inserm Transfert CEO CÈcile Tharaud, the deal is closely linked to a May 27 announcement that TcLand and its partners received nearly $585,000 in funding from the French National Research Agency for the company's companion diagnostic program in rheumatoid arthritis. The two-year project, titled "Predicting Responses to Anti-TNF alpha Therapy" (PRATT) will use state-of-the-art technology to develop a diagnostic test based on the measurement of gene expression in an easy-to-obtain, minimally invasive blood sample. The test will help to drive patient-centered therapy by identifying "responder" patients prior to treatment initiation; this will promote more effective treatments and enable "non-responder" patients to be fast-tracked to suitable alternative therapies.
"TcLand Expression is an Inserm spin-out and so we are particularly delighted to help consolidate its business activity, as we have done in the past and will no doubt continue to do in the future," Tharaud says. "The company is very well positioned in the field of biomarkers and personalized medicine—the strategic themes in this collaborative exploitation of Inserm's research work."
Inserm spun off TcLand in 2002. Since then, most of the patents licensed to TcLand have come from Inserm, and TcLand has been developing and clinically validating gene-expression-based biomarkers for transplantation and companion diagnostic tests for use with autoimmune disease therapies. The licensing agreement with Inserm Transfert is the newest in a number of strategic collaborations that TcLand has with other organizations for the development of new biomarkers in RA, including the Vall d'Hebron University Hospital Research Institute in Spain and the Lyons Public Hospitals Group in France.
In this latest agreement, announced in early July, TcLand has global, exclusive access to two Inserm Transfert patents: the first, a method for predicting responsiveness to tumor necrosis factor (TNF)-blocking agents; and the second, a method for predicting the response to a treatment with the RA drug anakinra, an interleukin-1 receptor antagonist. Based on the methods protected by the two patents, TcLand intends to develop companion diagnostic tests for RA therapies.
Although the companies did not disclose financial terms of the agreement, TcLand CEO Alain Huriez estimates that the companion diagnostic tests the partners seek to develop could yield $60 million to $100 million in global sales on an annual basis, based on estimates that 70 million people worldwide suffer from the disabling disease.
"It is interesting to consider that much of the progress and talk about personalized medicine pertains to oncology, while the healthcare budget and expense for RA treatment is quite high," Huriez says. "But there is now some pressure and things are clearly moving now to where if the U.S. market can be provided with companion diagnostics, pharmas can improve the efficacy and cost-effectiveness of their drugs."
Pharmas may see this as an important part of their life cycle management strategies when they are developing new drugs, Huriez suggests.
"If these companies can show better efficacy and response, companion diagnostics may be very helpful in their life cycle management and product positioning," he explains. "This may also be very helpful for payors."
Inserm will conduct the research and patient data collection, while TcLand will work on clinical validation and regulatory approval. According to Inserm Transfert CEO CÈcile Tharaud, the deal is closely linked to a May 27 announcement that TcLand and its partners received nearly $585,000 in funding from the French National Research Agency for the company's companion diagnostic program in rheumatoid arthritis. The two-year project, titled "Predicting Responses to Anti-TNF alpha Therapy" (PRATT) will use state-of-the-art technology to develop a diagnostic test based on the measurement of gene expression in an easy-to-obtain, minimally invasive blood sample. The test will help to drive patient-centered therapy by identifying "responder" patients prior to treatment initiation; this will promote more effective treatments and enable "non-responder" patients to be fast-tracked to suitable alternative therapies.
"TcLand Expression is an Inserm spin-out and so we are particularly delighted to help consolidate its business activity, as we have done in the past and will no doubt continue to do in the future," Tharaud says. "The company is very well positioned in the field of biomarkers and personalized medicine—the strategic themes in this collaborative exploitation of Inserm's research work."
