VivoSim Labs Unveils New NAMkind™ Drug Toxicity Data at EUROTOX 2026, Demonstrating Predictive Superiority in Liver and Gastrointestinal Safety Across Small Molecules and ADCs
https://www.globenewswire.com/news-release/20...-adcs.html
SAN DIEGO, Sept. 16, 2026 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (NASDAQ: VIVS) (“VivoSim” or the “Company”) unveils new clinical benchmark data at the 58th Congress of the European Societies of Toxicology (EUROTOX 2026) in Vienna, Austria, demonstrating the ability of its NAMkind™ 3D human liver and intestinal platforms to predict drug toxicity across small molecules and increasingly complex therapies, including Antibody-Drug Conjugates (ADCs).
The new data strengthens VivoSim's positioning in the growing market for human-relevant predictive toxicology and New Approach Methodologies (NAMs), as pharmaceutical companies increasingly look for better ways to identify safety risks before drug candidates enter expensive human clinical trials.
Drug-induced liver injury (DILI) and gastrointestinal (GI) toxicity remain leading causes of drug candidate attrition, while ADC therapies introduce additional safety challenges involving payload toxicity, linker behavior and off-target exposure. VivoSim's EUROTOX findings demonstrate how its long-duration, primary human cell-based models can help identify and differentiate these risks earlier in development, successfully ranking clinical safety risks for small-molecule reference sets such as thiazolidinediones and NSAIDs, while deconvoluting complex structural toxicities in advanced ADC modalities.
NAMkind™ Targets Liver and GI Toxicity Before the Clinic
VivoSim's NAMkind™ Liver platform supports up to 28-day liver spheroid viability, while its intestinal models maintain barrier integrity for up to three weeks, allowing researchers to evaluate repeat-dose effects that shorter-duration laboratory assays may not capture.
In studies being presented at EUROTOX, VivoSim's repeat-dose testing framework successfully ranked clinical safety risks across small-molecule reference compounds while also distinguishing payload- and linker-dependent toxicities in ADCs. The NAMkind™ Liver platform ranked trastuzumab deruxtecan as significantly more hepatotoxic than trastuzumab emtansine in the presented testing. In the NAMkind™ Intestine model, transepithelial electrical resistance (TEER) identified mucosal barrier deterioration before overt tissue cytotoxicity, with human ileum tissue demonstrating greater sensitivity to ADC-induced toxicity than colon tissue.
The findings carry particular weight as ADC development expands across oncology and other therapeutic areas, sharpening demand for technologies capable of determining where toxicity originates and which component of a complex drug is responsible.
Moving Beyond Detecting Toxicity
The broader commercial opportunity for VivoSim goes beyond simply detecting whether a drug candidate is toxic: it lies in helping pharmaceutical developers understand why toxicity occurs and whether it is likely to matter in humans.
“As global regulators like the FDA accelerate the transition away from traditional animal testing, biopharma leaders are seeking predictive human tools that eliminate translational surprises before clinical entry,” said Keith Murphy, Executive Chairman of VivoSim Labs. “Our latest data presented at EUROTOX demonstrate that the NAMkind™ platform doesn't just evaluate traditional small molecules with exceptional fidelity, it successfully deconvolutes the complex safety liabilities of next-generation modalities like ADCs. By identifying payload and linker toxicities early, we provide our commercial partners with the actionable intelligence needed to save years of development and millions in potential clinical failure.”
“Predicting organ-specific toxicity requires capturing the biology of chronic, repeat-dose exposure,” said Amar Sethi, M.D., Ph.D., Chief Scientific Officer of VivoSim Labs. “With our extended-culture platforms, we observe micro-architectural and functional degradation that traditional short-term assays may miss. Whether ranking clinical DILI risk across small-molecule analogs or pinpointing why trastuzumab deruxtecan exhibits distinct hepatic and ileal liabilities compared to emtansine, our multi-endpoint profiling gives biopharma teams human-relevant translational signatures to optimize compound selection and de-risk pipelines.”
FDA NAM Momentum Adds to the Opportunity
The EUROTOX presentation arrives as regulators, including the U.S. Food and Drug Administration (FDA), continue advancing frameworks for New Approach Methodologies and human-relevant alternatives to traditional animal testing.
That regulatory shift does not represent an endorsement of VivoSim specifically, but it creates a potentially favorable industry backdrop for validated technologies capable of generating predictive human safety information before clinical development.
The opportunity extends beyond detecting toxicity. If broader validation and pharmaceutical adoption follow, NAMkind™ and VitroSense™ could become part of the decision layer between drug discovery and human clinical trials, helping pharmaceutical companies determine which programs deserve additional time and development capital.
For VivoSim investors, the EUROTOX data mark a meaningful validation point in the developing commercial thesis behind NAMkind™ using 3D human biology and predictive toxicology to help pharmaceutical companies identify safety liabilities earlier, select stronger drug candidates and reduce costly failures later in development.
VivoSim's demonstrated ability to evaluate both traditional small molecules and increasingly important complex modalities such as ADCs positions its NAMkind™ platform to broaden its applications across pharmaceutical R&D.
https://www.globenewswire.com/news-release/20...-adcs.html
SAN DIEGO, Sept. 16, 2026 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (NASDAQ: VIVS) (“VivoSim” or the “Company”) unveils new clinical benchmark data at the 58th Congress of the European Societies of Toxicology (EUROTOX 2026) in Vienna, Austria, demonstrating the ability of its NAMkind™ 3D human liver and intestinal platforms to predict drug toxicity across small molecules and increasingly complex therapies, including Antibody-Drug Conjugates (ADCs).
The new data strengthens VivoSim's positioning in the growing market for human-relevant predictive toxicology and New Approach Methodologies (NAMs), as pharmaceutical companies increasingly look for better ways to identify safety risks before drug candidates enter expensive human clinical trials.
Drug-induced liver injury (DILI) and gastrointestinal (GI) toxicity remain leading causes of drug candidate attrition, while ADC therapies introduce additional safety challenges involving payload toxicity, linker behavior and off-target exposure. VivoSim's EUROTOX findings demonstrate how its long-duration, primary human cell-based models can help identify and differentiate these risks earlier in development, successfully ranking clinical safety risks for small-molecule reference sets such as thiazolidinediones and NSAIDs, while deconvoluting complex structural toxicities in advanced ADC modalities.
NAMkind™ Targets Liver and GI Toxicity Before the Clinic
VivoSim's NAMkind™ Liver platform supports up to 28-day liver spheroid viability, while its intestinal models maintain barrier integrity for up to three weeks, allowing researchers to evaluate repeat-dose effects that shorter-duration laboratory assays may not capture.
In studies being presented at EUROTOX, VivoSim's repeat-dose testing framework successfully ranked clinical safety risks across small-molecule reference compounds while also distinguishing payload- and linker-dependent toxicities in ADCs. The NAMkind™ Liver platform ranked trastuzumab deruxtecan as significantly more hepatotoxic than trastuzumab emtansine in the presented testing. In the NAMkind™ Intestine model, transepithelial electrical resistance (TEER) identified mucosal barrier deterioration before overt tissue cytotoxicity, with human ileum tissue demonstrating greater sensitivity to ADC-induced toxicity than colon tissue.
The findings carry particular weight as ADC development expands across oncology and other therapeutic areas, sharpening demand for technologies capable of determining where toxicity originates and which component of a complex drug is responsible.
Moving Beyond Detecting Toxicity
The broader commercial opportunity for VivoSim goes beyond simply detecting whether a drug candidate is toxic: it lies in helping pharmaceutical developers understand why toxicity occurs and whether it is likely to matter in humans.
“As global regulators like the FDA accelerate the transition away from traditional animal testing, biopharma leaders are seeking predictive human tools that eliminate translational surprises before clinical entry,” said Keith Murphy, Executive Chairman of VivoSim Labs. “Our latest data presented at EUROTOX demonstrate that the NAMkind™ platform doesn't just evaluate traditional small molecules with exceptional fidelity, it successfully deconvolutes the complex safety liabilities of next-generation modalities like ADCs. By identifying payload and linker toxicities early, we provide our commercial partners with the actionable intelligence needed to save years of development and millions in potential clinical failure.”
“Predicting organ-specific toxicity requires capturing the biology of chronic, repeat-dose exposure,” said Amar Sethi, M.D., Ph.D., Chief Scientific Officer of VivoSim Labs. “With our extended-culture platforms, we observe micro-architectural and functional degradation that traditional short-term assays may miss. Whether ranking clinical DILI risk across small-molecule analogs or pinpointing why trastuzumab deruxtecan exhibits distinct hepatic and ileal liabilities compared to emtansine, our multi-endpoint profiling gives biopharma teams human-relevant translational signatures to optimize compound selection and de-risk pipelines.”
FDA NAM Momentum Adds to the Opportunity
The EUROTOX presentation arrives as regulators, including the U.S. Food and Drug Administration (FDA), continue advancing frameworks for New Approach Methodologies and human-relevant alternatives to traditional animal testing.
That regulatory shift does not represent an endorsement of VivoSim specifically, but it creates a potentially favorable industry backdrop for validated technologies capable of generating predictive human safety information before clinical development.
The opportunity extends beyond detecting toxicity. If broader validation and pharmaceutical adoption follow, NAMkind™ and VitroSense™ could become part of the decision layer between drug discovery and human clinical trials, helping pharmaceutical companies determine which programs deserve additional time and development capital.
For VivoSim investors, the EUROTOX data mark a meaningful validation point in the developing commercial thesis behind NAMkind™ using 3D human biology and predictive toxicology to help pharmaceutical companies identify safety liabilities earlier, select stronger drug candidates and reduce costly failures later in development.
VivoSim's demonstrated ability to evaluate both traditional small molecules and increasingly important complex modalities such as ADCs positions its NAMkind™ platform to broaden its applications across pharmaceutical R&D.
