GEMoaB has apheresed the first patient in a Phase IA study with UniCAR-T-PSMA, the lead solid tumor product candidate from its proprietary UniCAR cellular immunotherapy platform. UniCAR-T-PSMA is investigated in late-stage, relapsed/refractory solid tumors expressing the PSMA antigen. The UniCAR platform has been designed to ensure excellent control over the universal CAR-T effector cell through a rapidly switchable on/off capability. This is combined with high flexibility to effectively target tumor antigens of choice by re-directing and activating UniCAR-T cells through soluble adapters termed Targeting Modules (TMs).

"The unique ability to rapidly switch on and off the UniCAR-T effector cells and thereby tightly control their activity – as we have now clinically validated in our ongoing UniCAR-T-CD123 study in AML – may help to overcome many of the limitations that conventional CAR-T therapies face when targeting less differentially expressed antigens, especially in solid tumors", said Prof. Dr. Gerhard Ehninger, GEMoaB's co-founder and Chief Medical Officer. "Our first UniCAR clinical study in solid tumors is of utmost importance for GEMoaB. We believe that the PSMA antigen is a great initial target as it is not only expressed on the tumor surface but also on the tumor neo-vasculature, allowing for a double attack of the malignant cells by UniCAR-T cells."

The Phase IA study includes patients with late-stage PSMA-positive relapsed/refractory solid tumors such as Castrate Resistant Prostate Cancer (CRPC), Non-small Cell Lung Cancer (NSCLC) or Triple Negative Breast Cancer (TNBC). It will examine the feasibility, safety and potential efficacy of the combined application of a single dose of UniCAR-T and the continuous infusion of the PSMA-specific TMpPSMA.

According to Prof. Dr. Ralf Bargou, Head of Comprehensive Cancer Center Mainfranken at the University Hospital Würzburg and coordinating investigator of this trial, the study could be an important step in the ongoing intensive research efforts to establish cellular immunotherapies as a key therapeutic pillar to improve patient outcomes in hard-to-treat solid tumor cancers.

"At our National Cancer Center in Würzburg we are focusing a significant amount of our ongoing research and clinical efforts on developing breakthrough immunologic treatments of solid tumors together with our partners", said Prof. Bargou. "PSMA is a very promising target expressed in multiple late-stage cancers that do not sufficiently benefit from currently existing therapies and the UniCAR platform provides many features to finally obtain meaningful safety and efficacy results for this innovative treatment modality. We are very much looking forward working closely with the GEMoaB team on this important study."