Initiation of First UniCAR Cellular Immunotherapy Study in Advanced Solid Tumors

GEMoaB Announces start of Phase IA Trial with Lead Solid Tumor Product Candidate from Rapidly Switchable Universal CAR-T Platform (UniCAR) in PSMA-expressing late-stage Malignancies

DRESDEN, Germany I December 3, 2020 I GEMoaB, a biopharmaceutical company focused on the development of next-generation immunotherapies for hard-to-treat cancers, today announced that it 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."

About the UniCAR-T-PSMA Study

This first-in-human phase I study is an open-label, non-randomized, dose-finding study designed to evaluate the safety and activity of UniCAR-T-PSMA in up to 16 patients with advanced relapsed/refractory, PSMA-positive solid tumors such as CRPC, NSCLC or TNBC. Its purpose is to determine the maximum tolerated dose (MTD), dose limiting toxicities (DLT) as well as the recommended Phase II dose for the combined application of a single dose of UniCAR-T and the continuous infusion of TMpPSMA over 25 days. The study will also investigate response rates, persistence of UniCAR-T cells over time as well as the ability to rapidly switch UniCAR-T cells on and off in case of side effects through stopping the TM infusion. The study will take place at selected Phase I and CAR-T experienced University centers in Germany. It is supported by a grant from the European Regional Development Fund (ERDF) provided through Saxony's Development Bank (SAB). To learn more about the trial, please visit clinicaltrials.gov.

About UniCAR

GEMoaB is developing a rapidly switchable universal CAR-T platform, UniCAR, to improve the therapeutic window and increase efficacy and safety of CAR-T cell therapies in challenging cancers, including acute leukemias and solid tumors. Conventional CAR-T cells depend on the presence and direct binding of cancer antigens for activation and proliferation. An inherent key feature of the UniCAR platform is a rapidly switchable on/off mechanism (less than 4 hours after interruption of TM supply) enabled by the short pharmacokinetic half-life and fast internalization of soluble adaptors termed TMs. These TMs provide the antigen-specificity to activate UniCAR gene-modified T-cells (UniCAR-T) and consist of a highly flexible antigen binding moiety, linked to a small peptide motif recognized by UniCAR-T.

About GEMoaB 

GEMoaB is a privately-owned, clinical-stage biopharmaceutical company that is aiming to become a fully integrated biopharmaceutical company. By advancing its proprietary UniCAR, RevCAR and ATAC platforms, the company will discover, develop, manufacture and commercialize next-generation immunotherapies for the treatment of cancer patients with a high unmet medical need. 

GEMoaB has a broad pipeline of product candidates in pre-clinical and clinical development for the treatment of hematological malignancies as well as solid tumors. Its clinical stage assets GEM333, an Affinity-Tailored Adaptor for T-Cells (ATAC) with binding specificity to CD33 in relapsed/refractory AML, and GEM3PSCA, an ATAC with binding specificity to PSCA for the treatment of castrate-resistant metastatic prostate cancer and other PSCA expressing late stage solid tumors, are currently investigated in Phase I studies and globally partnered with Bristol-Myers Squibb. A Phase IA dose-finding study of the first UniCAR asset in hematological malignancies, UniCAR-T-CD123 for treatment of relapsed/refractory AML, is currently recruiting patients.

Manufacturing expertise, capability and capacity are key for developing cellular immunotherapies for cancer patients. GEMoaB has established a preferred partnership with its sister company Cellex in Cologne, a world leader in manufacturing hematopoietic blood stem cell products and a leading European CMO for CAR-T cells, co-operating in that area with several large biotech companies. More information can be found at www.gemoab.com.  

SOURCE: GEMoaB

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