Selventa Therapeutic Diagnostic (TDx)

A Selventa Therapeutic Diagnostic (TDx) is a diagnostic test, specific to a given disease, that enables stratification of patients based on disease-driving mechanisms (Figure 1). Compared to a companion diagnostic (CDx) that is specifically associated with a drug, a Selventa TDx can predict response or non-response to a class of drugs or multiple classes of drugs. A TDx can be developed prior  to an exposure of patients to a drug, and in the absence of response data,  since it is based on a mechanistic understanding of the disease in individual patients. It can be used to investigate combination therapies and drive portfolio optimization.

Figure 1. Selventa discovers biomarker content for two different types of TDx based on disease-driving mechanisms. Selventa TDx can predict response or non-response to a single class of drugs (a single mechanism-based TDx; e.g. mechanism A) or multiple classes of drugs (a multi-mechanism-based TDx; e.g. mechanism A, B, C and D). If therapeutic opportunities for rheumatoid arthritis are used as an example to illustrate the figure, a single mechanism-based TDx could be based on TNF while multi-mechanism-based TDx could be based on multiple disease-driving mechanisms such as TNF, IL6, BAFF, JAK, IL17, etc.

 
For example, a TDx used at an investigational stage, can help our pharmaceutical partners to broadly look at their portfolio and appropriately select patients for TDx-guided decisions for their drug and diagnostic co-development:

 

  • Appropriate patient selection via a companion diagnostic (CDx) for optimal clinical trial design for one of more of their drugs

    • Each multi-mechanism-based TDx provides multiple CDx opportunities for a specific disease (Figure 2)

  • Development of novel molecular therapies in non-responders

  • Identification of combination treatments

  • Development of dual-targeted therapies

  • Assessment of overlapping or unique market opportunities

 

Ultimately, we anticipate that a Selventa TDx will provide the following advantages:

  • Inherently higher biomarker success rate due to mechanism-based discovery

  • Predictive biomarkers for precise, clear and successful Proof of Concept drug trials leading to a mandated diagnostic that guides therapy

  • Increased payer value by utilizing a diagnostic to identify the optimal therapy for the right patient

 

Figure 2. A multi-mechanism-based TDx can be investigationally used to identify sub-population of patients for multiple druggable mechanisms. Each component of this type of TDx potentially provides several CDx opportunities for a specific disease.