VivoSim Releases Antibody Drug Conjugate (ADC) Data Showing Power to Detect ADC Toxicity and Guide Design of Safer ADCs
MWN-AI** Summary
VivoSim Labs, Inc. (Nasdaq: VIVS) made a significant announcement at the Society of Toxicology meeting in San Diego on March 24, 2026, regarding its validated NAMkind™ liver and intestine models for predicting toxicity in antibody drug conjugates (ADCs). With the increasing development of ADCs in oncology, VivoSim emphasizes the need for effective tools to distinguish between therapeutic effects and potential off-target toxicities. The NAMkind™ models demonstrate a strong correlation with clinical outcomes, as evidenced by their capacity to identify liver toxicity in ADCs like gemtuzumab ozogamicin, while also confirming low toxicity for others such as enfortumab vedotin.
The company highlighted the utility of these models in studying linker cleavage and target engagement, showcasing their effectiveness in predicting differential toxicity in drugs such as trastuzumab emtansine versus trastuzumab deruxtecan. Additionally, the NAMkind™ intestine model provides insights into specific antibody activities, payload effects, and overall ADC impact on epithelial cells.
Amar Sethi, Chief Scientific Officer at VivoSim, stated that these advances will support partners in optimizing lead candidates during early development stages, ultimately aiming for improved clinical success with minimal side effects. Keith Murphy, Executive Chairman, echoed this sentiment by reinforcing the models’ position at the forefront of biotechnological innovation.
VivoSim's NAMkind™ services are now accessible in the U.S., Europe, and regions including Korea and China, with the company actively expanding its capabilities to meet growing demands in preclinical safety testing. The anticipated regulatory shifts favoring non-animal testing methodologies, as indicated by the FDA's 2025 announcement, suggest a promising trajectory for VivoSim's initiatives and technologies in drug development.
MWN-AI** Analysis
VivoSim Labs, Inc. (Nasdaq: VIVS), has recently revealed exciting data at the Society of Toxicology meeting, highlighting its NAMkind™ liver and intestine models' ability to predict toxicity in antibody drug conjugates (ADCs). This innovation addresses a critical gap in the biomedical field, where determining the safety profiles of ADCs is essential, given their complex mechanisms aimed at delivering cytotoxic therapies for cancer treatment.
As investor sentiment traditionally magnifies post-announcements of breakthrough technologies, VivoSim’s validation of NAMkind™ models positions the company advantageously in the pharmaceutical market. With ADCs representing a rapidly growing segment within the oncology landscape, the capability to predict off-target toxicities meets an urgent industry need and enhances the potential success rate of drug candidates in clinical trials.
The clear correlation between the results from NAMkind™ models and actual clinical outcomes should provide confidence to investors. As the FDA increasingly moves towards favoring NAM over traditional animal testing methods, VivoSim stands to benefit from a shift in regulatory emphasis. The expansion of its services into key markets, including Europe and Asia, further enhances the company’s growth prospects and ability to meet global demand for innovative safety testing solutions.
From a strategic investment perspective, VivoSim appears to offer a compelling entry point. The ongoing need for safer ADCs aligns with the broader industry trend towards personalized medicine and reduced adverse effects, thus fostering investor interest. However, potential investors should remain cognizant of the inherent risks involved, such as technological adoption and regulatory shifts that can impact the timeline of profitability.
As VivoSim continues to scale its capacity to support development needs, maintaining a balanced approach to investment—factoring in both opportunity and risk—will be vital for those looking to capitalize on the momentum within the biotech sector.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
SAN DIEGO, March 24, 2026 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (Nasdaq: VIVS) (the “Company” or “VivoSim”), a provider of next-generation New Approach Methodologies (NAMs) for preclinical safety, today announced at the Society of Toxicology (“SOT”) meeting in San Diego, CA, that its NAMkind™ liver and NAMkind™ Intestine models have been validated for predicting toxicity and side effect profiles of antibody drug conjugates (ADCs).
When considering the hundreds of ADCs in development across the globe, the potential for off-target toxicity due to their common use in oncology to deliver cytotoxic payloads, and a lack of current available scientific solutions to separate anticancer activity from unwanted cytotoxicity, the Company believes that the use of NAMkind™ models becomes a powerful tool to use in conjunction with existing methods to select and improve the best ADC candidates for drug development.
Testing of approved ADC therapies in NAMkind™ models shows close correlation with clinical results
VivoSim NAMkind™ liver model was shown to clearly see the toxicity of liver toxic ADCs such as gemtuzumab ozogomicin and clearly showed drugs with low liver toxicity such as enfortumab vedotin as lacking liver toxicity. Issues of linker cleavage and target engagement can be studied, as differential toxicity between drugs like trastuzumab emtansine and trastuzumab deruxtecan were demonstrated with strong comparability to clinical outcomes.
NAMkind™ intestine models were also validated with ADCs and have the ability to detect differential effects such as antibody activity on epithelium, payload impact on epithelium, and overall ADC impact on epithelium. Permeability endpoints are sensitive to the exact chemical compound, be it ADC, antibody alone, or payload.
“These ADC toxicity results show a close correlation to clinical safety outcomes,” said Amar Sethi, Chief Scientific Officer at VivoSim. “We consider these models validated for ADC use and think that our partners may be able to screen out toxicities during lead candidate optimization or earlier stages, which may result in greater success in the clinic at eliminating cancers using drugs with limited side effect profiles,” he continued.
“With clearly demonstrated success in detecting differential toxicity in ADCs, our NAMkind models are now well-established at the cutting edge of the field,” said Keith Murphy, VivoSim’s Executive Chairman. “We continue to trailblaze into new modalities and empower our partners in new ways.”
NAMKind™ liver and small intestine toxicology services are now available in the US, Europe, and via local distributor engagement across Korea and China, with VivoSim continuing to scale capacity to support expanding global demand and urgent, real-world development needs.
About VivoSim Labs
VivoSim Labs, Inc. (“VivoSim” and the “Company”), is a pharmaceutical and biotechnology services company that is focused on providing testing of drugs and drug candidates in three-dimensional (“3D”) human tissue models of liver and intestine. The Company offers partners liver and intestinal toxicology insights using its new approach methodologies (“NAM”) models. The Company anticipates accelerated adoption of human tissue models following the U.S. Food and Drug Administration (“FDA”) announcement on April 10, 2025 to refine animal testing requirements in favor of these non-animal NAM methods. VivoSim Labs operates from San Diego, CA. Visit www.vivosim.ai.
Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Forward-looking statements include statements regarding NAMKind™, including the use of NAMkind™ models in conjunction with existing methods to select and improve the best ADC candidates for drug development and the Company’s models being well-established at the cutting edge of the field; VivoSim’s partners’ ability to screen out toxicities during lead candidate optimization or earlier stages, which may result in greater success in the clinic at eliminating cancers using drugs with limited side effect profiles; VivoSim’s ability to trailblaze into new modalities and empower their partners in new ways; and the Company’s scaling capacity to support expanding global demand and development needs. Such forward-looking statements are not guarantees of performance and actual actions or events could differ materially from those contained in such statements. These risks and uncertainties and other factors are identified and described in more detail in the Company’s filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on June 5, 2025, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on February 11, 2026. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events, or circumstances or to reflect the occurrence of unanticipated events.
Contact(s):
Investor Relations
info@vivosim.ai
VivoSim Labs, Inc.
FAQ**
How does VivoSim Labs Inc. (VIVS) plan to scale its NAMkind™ liver and intestine models to meet the growing global demand for preclinical safety testing in light of its recent validation at the Society of Toxicology meeting?
What specific challenges does VivoSim Labs Inc. (VIVS) anticipate in the adoption of its NAMkind™ models following the FDA's announcement to refine animal testing requirements, and how could this impact its business strategy?
Can VivoSim Labs Inc. (VIVS) provide insights on how its NAMkind™ models have improved the selection of antibody drug conjugates (ADCs) in clinical trials, particularly regarding off-target toxicity and side effect profiles?
In what ways does VivoSim Labs Inc. (VIVS) intend to expand its partnerships globally to leverage NAMkind™ technology, particularly in regions like Korea and China where local distributor engagement is active?
**MWN-AI FAQ is based on asking OpenAI questions about VivoSim Labs Inc. (NASDAQ: VIVS).
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