SOT 2025 Annual Meeting
Orlando — The SOT 2025 Annual Meeting took place from March 16th to 20th at the Orange County Convention Center, USA. This premier event gathered more than 5,000 distinguished toxicologists and 300 exhibitors from across the globe. With over 70 scientific sessions and more than 2,000 poster presentations, the conference served as a dynamic platform for cutting-edge research and innovation in toxicology.
Led by a team of distinguished toxicology experts, TriApex was thrilled to take part in this prestigious meeting, engaging in insightful discussions and building meaningful connections with industry leaders and peers. On March 18th, we proudly presented five scientific posters simultaneously, highlighting our latest research advancements in general toxicology and reproductive toxicology. These presentations underscored the company’s commitment to advancing scientific innovation in the field. Up next, we take a closer look at the key insights and findings from these five impactful studies.
Poster 1：Approaches to Improve Spontaneous Pregnancy Rates of Cynomolgus Monkeys Under Laboratory Conditions
This poster detailed a comprehensive study aimed at optimizing natural conception rates in cynomolgus monkeys. Key findings included:
Optimal Cohabitation Ratios: Our research highlighted that a 1:1 male-to-female ratio was most effective in enhancing pregnancy rates and mating efficiency, providing valuable insights for future studies.
Significant Pregnancy Rate Improvements: Through meticulous animal screening, appropriate male-to-female ratios, and timely cohabitation practices, we achieved a remarkable 86% pregnancy rate in one group, demonstrating the effectiveness of our targeted interventions.
Robust Data for Future Studies: The high pregnancy rates, non-abortion rates, and offspring survival rates achieved in our study provide a solid foundation for subsequent developmental and reproductive toxicity (DART) assessments, ensuring reliable and valid data.
Poster 2：Animal Welfare Enhancements for ePPND Studies
This poster focused on improving the welfare of NHPs during extended pre- and postnatal developmental (ePPND) toxicity studies. Key achievements included:
Reduced Cesarean Section Rates: The implementation of "channel cages" (patent for invention) significantly decreased the need for cesarean sections, with 85.7% of pregnancies resulting in natural births, thereby minimizing surgical interventions and associated risks.
Enhanced Animal Well-being: By introducing psychological comfort measures, restraint techniques, and enrichment activities, we observed reduced stress responses and increased cooperation from the animals, leading to healthier pregnancies and offspring.
Reliable Data from Well-being Conditions: Our enhanced welfare measures ensured that the data collected were not only accurate but also reflected the true biological responses, contributing to the reliability of our study outcomes.
TriApex has successfully identified and validated several effective measures to improve the pregnancy rates and animal welfare of laboratory cynomolgus monkey through professional research and practice, despite the ongoing challenge of achieving high pregnancy rates under laboratory conditions. This success is attributed to TriApex Laboratories Co., Ltd.'s robust supply chain (Kunming Biomed International, KBI) for cynomolgus monkeys and the extensive experience in supporting experiments with these primates in laboratory settings.
The establishment of the NHP DART research platform has launched a robust basis for various NHP studies, including ePPND studies. It not only guarantees reliable support but also highlights exceptional competitiveness in technology, resource integration, and research standardization, ultimately driving high-caliber research across related fields.
Our innovative approaches and significant findings in these areas are not only advancing scientific research but also setting new standards for ethical and efficient laboratory practices.
Poster 3：Immunogenicity-Mediated Abnormal Toxicokinetic Exposure and Toxicity Risk of Antibody-drug Conjugate
TriApex provided comprehensive analysis of antibody drug conjugate (ADC) to identify the underlying causes of abnormal Toxicokinetics (TK) exposure patterns observed in repeat-dose toxicity studies and to evaluate the associated safety risks.
TK Data Summay: Abnormal TK exposures were observed in ADC-treated animals in low-dose group, which showed elevated payload exposure levels and decreased total antibody and ADC exposure levels.
Immunogenicity Findings: All animals with abnormal TK showed high anti-drug antibodies (ADA) positivity rates and ADA titers increased progressively with repeated dosing.
Toxicity Risk: Abnormal animals may have other risks of toxicity compared with normal animals in the same group, such as hypersensitivity reactions (HSR).
In conclusion, TriApex poster share consideration on the influence of immunogenicity on the TK characteristics of ADCs. Immunogenicity-mediated abnormal toxicokinetic exposure is a significant factor affecting ADC safety in preclinical studies. Understanding the correlation between immunogenicity, TK exposure, and toxicity endpoints can enhance risk assessment for clinical development of ADCs.
Poster 4：The nonclinical safety evaluation of Bispecific Antibody-Drug Conjugates (BsAb-ADCs) in repeat-dose toxicity studies
The poster detailed a comprehensive methodology to assess the toxicological profiles of these dual-targeting therapeutics, providing essential insights and reference data to support both further research and clinical development.
The presentation summarized findings from both GLP-compliant toxicity studies and dose range-finding (DRF) investigations conducted in rodent and non-rodent models. Key observations included:
Off-Target Toxicity: The dual-target design of BsAb-ADCs resulted in unintended binding to non-target tissues, causing significant damage in organs such as the liver, kidneys, heart, and lungs.
Bone Marrow Suppression: Repeated dosing led to a noticeable decline in red blood cells, white blood cells, and platelets, indicating impaired hematopoietic function.
Immune and Neurological Effects: In non-human primate models, the activation of the immune system led to inflammatory responses and complement activation, contributing to neurotoxicity manifesting as seizures, tremors, and confusion.
Skin and Ocular Toxicity: Certain BsAb-ADCs induced local skin reactions and ocular adverse effects, with evidence of corneal damage.
To ensure a comprehensive safety evaluation of BsAb-ADCs, the TriApex team advocates a strategic framework that includes: first, a detailed analysis of both the parent drug and its metabolites to identify unexpected organ toxicities; second, determining the tissue-to-blood drug concentration ratio to gain critical insights into tissue delivery efficiency; third, an in-depth exploration of the relationships between the parent drug and its metabolites in various tissues to better understand the underlying mechanisms of toxicity; and finally, adopting a cost-effective approach for early pilot toxicity studies, thereby enabling the efficient use of tissue samples in subsequent GLP-compliant investigations.
In conclusion, the TriApex team underscored the importance of an integrated study design—one that combines pathological, toxicokinetic, and immunological assessments—to accurately predict and manage the complex toxicity profiles associated with BsAb-ADCs. They also emphasized that the design of such studies should be tailored to meet specific regulatory requirements and the unique characteristics of each candidate, ultimately ensuring robust and reliable safety assessments for future clinical applications.
Poster 5：TriApex’s Considerations for Detecting GalNAc-siRNA Concentrations in Liver and Kidney: Insights from Nonclinical Studies
TriApex provided comprehensive considerations for the non-clinical safety evaluation of detecting GalNAc-siRNA concentrations in Liver and Kidney. This poster summarized corresponding results of projects, showing that tissue detection was prioritized in dose range-finding (DRF) studies over GLP-compliant toxicity studies. AS(N-1)3’ and AS(N-2)3’ were identified as the primary metabolites across these studies, and drug concentrations in liver remained significantly higher than that in plasma, mostly in NHP studies. Drug concentration in liver may be lower than that in kidney especially in rat studies.
This poster also recommends comprehensive concentration analysis of GalNAc-siRNA candidates (including metabolites) in liver and kidney during nonclinical pilot toxicity studies, while the tissue samples were collected for potential testing in the follow-up GLP studies. This design has the following considerations:
Explain unexpected toxicity in organs.
Obtain tissue/blood drug concentration ratio so as to suggest the tissue delivery efficiency.
Explore the relationship between the parent drug and its metabolites in tissues.
Cost-effective to conduct determination in pilot toxicity studies.
In conclusion, TriApex poster share TriApex’s strategic framework for determining GalNAc-siRNA concentrations in liver and kidney during nonclinical evaluations, so as to provide interpretation of toxicity results and provide reference for the safety assessment of metabolites in clinical trials. However, Tri-Apex also believe that study design should be considered case by case depending on regulatory application needs and the actual situation.
Each TriApex poster highlights the team's expertise and scientific rigor in toxicology research and demonstrates our strong preclinical capabilities in toxicology. If you are interested in our posters you can download it at below. If you would like more information about our toxicology services, please contact us at bd@tri-apex.com.
Immunogenicity-Mediated Abnormal Toxicokinetic Exposure and Toxicity Risk of Antibody-drug Conjugate
Animal Welfare Enhancements for ePPND Studies
Approaches to Improve Spontaneous Pregnancy Rates of Cynomolgus Monkeys Under Laboratory Conditions
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