Human endogenous retrovirus (HERV) sequences comprise 8% of the total human genome DNA, and they entered the genome between 10 and 50 million years ago
HERVs are unique tumor targets that are overexpressed in more than 80% of solid tumors, but not in normal tissues
SunnyBay Biotech has developed therapeutics targeting the HERV-K supergroup of HERVs
Our approach for moving novel HERV-K therapeutic antibody-drug conjugates (ADCs), which reduce tumor growth, inhibit metastasis, and prolong survival in murine models of breast and lung cancers, from the lab into the clinic will be discussed
Overview of recent regulatory shifts (FDA Modernization Act 2.0, April 2025 FDA policy) enabling non-animal methods for oncology IND submissions.
Addressing tumor heterogeneity and efficacy challenges through isogenic iPSC-derived tumor models engineered with specific mutations (e.g., KRAS, TP53, EGFR) using CRISPR/Cas9, enabling precise assessment of variant effects.
Utilizing human induced pluripotent stem cells (iPSCs) for predictive toxicology (e.g., CARTOX assays) and disease modeling to enhance safety assessments and clinical trial efficiency, particularly in small molecule and antibody-based therapies.
Employing differentiated iPSC-derived healthy tissue models (e.g., cardiomyocytes, hepatocytes, neurons) to evaluate off-tumor/on-target toxicities in CAR-T therapies, mitigating risks of unintended tissue damage.
Operational considerations, validation strategies, and practical lessons from developing scalable iPSC biobanks supporting New Approach Methodologies (NAMs) in oncology drug development.
An overview of the FDA’s latest guidelines and requirements for DCTs, highlighting key aspects such as the integration of digital health technologies, remote monitoring, and the adherence to Good Clinical Practice (GCP) principles, as well as ensuring innovative trials maintain the highest standards of safety, efficacy, and data integrity.
Discussion of the FDA’s collaborative efforts with other regulatory bodies, promoting harmonized standards and facilitating global acceptance of DCT methodologies.
Adhering to the FDA’s comprehensive regulatory requirements so sponsors can navigate the complexities of DCTs and contribute to the evolution of clinical trials and the accelerated development of innovative medical treatments
