Hamburg-based Evotec SE has secured a US$ 2.5 million grant from the Bill & Melinda Gates Foundation to advance its human induced pluripotent stem cell (iPSC)-derived teratogenicity platform. The funding also marks Evotec's entry into the foundation's prestigious Global Health Discovery Collaboratory (GHDC), a collaborative network of researchers and technology platforms dedicated to accelerating global health interventions.
The grant, announced on December 19, 2023, will provide GHDC member institutions with access to Evotec's innovative screening platform at no additional cost, potentially transforming how drug candidates are assessed for safety early in the development process.
Revolutionary Approach to Teratogenicity Testing
Teratogenicity—a drug's potential to cause developmental abnormalities in a fetus—represents a critical safety concern in pharmaceutical development. Traditional assessment methods typically occur late in the drug discovery process using animal models that are both time-consuming and expensive.
Evotec's platform addresses these limitations by leveraging human iPSC technology to create an in vitro, high-throughput screening system that can identify potential teratogenic effects much earlier in the development pipeline.
"Our high-throughput in vitro platform for teratogenicity testing in a human model holds potential to de-risk drug discovery programmes across many indications much earlier than with conventional in vivo methods and thereby improve the probability for a successful drug development," said Dr. Cord Dohrmann, Chief Scientific Officer of Evotec.
Addressing a Critical Public Health Concern
The importance of improved teratogenicity screening is underscored by current statistics. Between 40-80% of pregnant women in Western countries take prescription medications, creating significant risk for fetal exposure to potentially harmful compounds. Congenital anomalies resulting from teratogenic effects represent a major cause of infant mortality globally.
Evotec's platform aims to identify these risks earlier and more accurately than traditional methods, potentially saving significant development resources while creating safer medications.
Technical Innovation in Teratogenicity Assessment
The platform incorporates multiple human iPSC-based model systems representing tissues affected by teratogenic compounds. Using automated, high-throughput imaging and advanced immunostaining techniques, the system can rapidly assess compounds for potential developmental toxicity.
Validation studies have demonstrated high accuracy in distinguishing between known teratogens and non-teratogens. Evotec also plans to integrate artificial intelligence and machine learning capabilities with the platform to further enhance predictive capabilities.
Expanding Global Health Impact
By joining the GHDC network, Evotec's technology becomes available to a broader range of researchers working on treatments for diseases that disproportionately affect low and middle-income countries.
The GHDC consists of fifteen collaboratory platforms working together to accelerate discovery and translation of global health interventions. Evotec's addition brings specialized expertise in early safety assessment that could help advance promising drug candidates more efficiently.
Future Applications and Limitations
While the platform represents a significant advancement in early teratogenicity screening, Evotec notes that it does not replace regulatory requirements for later-stage in vivo studies. Rather, it serves as an early filter to identify potentially problematic compounds before significant resources are invested in their development.
The company envisions the technology being applied across multiple therapeutic areas, potentially transforming how drug safety is assessed throughout the pharmaceutical industry while supporting the specific global health initiatives championed by the Gates Foundation.
