Montpellier, October 25, 2023 – CYTEA BIO is pleased to report that it has completed a formal pre-IND consultation with FDA for CYT-102, the company’s lead product, consisting of monoclonal antibody armed donor NK cells, constructed using the proprietary Pin™ arming technology and designed for post-surgery treatment of glioblastoma multiforme (GBM), a devastating disease and the most common form of brain cancer.
FDA review has confirmed no red flags and no significant CMC, non-clinical or clinical impediments to completion of all pre-clinical activities and progression to first clinical studies. CYTEA BIO expects clinical studies to commence within about 15-18 months of closing a Series A investment round currently in progress.
The company has also completed an EMA “scientific advice” consultation with a similar outcome.
CYTEA BIO will also leverage CYT-102 for other oncology applications, and to utilize common manufacturing technologies for multiple additional products without further significant development efforts.
Alan Cookson, CEO of CYTEA BIO said: “These are important milestones for the company and for our unique Pin™ Platform which will greatly simplify the development, manufacture, and roll out of multiple product configurations. The use of normal allogeneic effector cell constructs using conventional ligands obviates the need for cell modification and secures common manufacturing methodologies for whole families of products. Regulators in the USA and Europe have recognized the potential of this approach and provided encouraging and helpful advice which will now enable the company to plan the completion all pre-clinical activities for the lead indication”.
