- Genezen and InterAct Therapeutics have announced a strategic manufacturing partnership to support the clinical development of IAT-S2, an AAV8-based gene therapy for breast cancer liver metastases.
- Genezen will provide AAV process development, scale-up and GMP manufacturing support for toxicology studies and clinical material for a planned Phase 1 trial.
Genezen, a gene therapy contract development and manufacturing organization (CDMO), has entered into a strategic manufacturing partnership with InterAct Therapeutics to advance the clinical development of IAT-S2, an AAV8-based therapy for breast cancer liver metastases (BCLM). The therapy is designed to target hepatocytes, modulate the liver microenvironment and suppress metastatic outgrowth.
IAT-S2 originated from research conducted by Dr. Isaac Chan, MD, PhD, at UT Southwestern Medical Center examining how metastatic breast cancer cells interact with healthy liver cells. InterAct Therapeutics is developing the program as a one-time, disease-modifying gene therapy intended to alter the tumor-liver microenvironment. The company said there are currently no specifically approved therapies targeting this microenvironment.
InterAct Therapeutics selected AAV8 as the delivery vector based in part on its ability to efficiently target hepatocytes. In preclinical studies, the company observed near elimination of liver metastases across five mouse models of liver metastasis. Following positive FDA INTERACT feedback, InterAct Therapeutics is preparing for IND-enabling studies.
Genezen will provide AAV process development, scale-up and GMP manufacturing expertise from its facility in Indianapolis. The work will support toxicology studies and production of clinical material for a planned Phase 1 trial as InterAct Therapeutics advances IAT-S2 toward an IND submission and first-in-human clinical development.
“This partnership is an important step toward translating a discovery that began in our lab into a potential therapy for patients.”
Dr. Isaac Chan, Chief Scientific Officer and Co-founder of InterAct Therapeutics
InterAct Therapeutics selected Genezen following an evaluation of manufacturing partners, citing its AAV experience, reputation, reliability and ability to support the program’s development timeline.
