GEMoaB Announces Clinical Data Presentations on Their Lead Asset UniCAR-T-CD123 in relapsed/refractory AML at the Upcoming EHA-EBMT 3rd European CAR T-Cell Meeting

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DRESDEN, Germany, Jan. 7, 2021 /PRNewswire/ -- GEMoaB, a biopharmaceutical company focused on the development of next-generation immunotherapies for hard-to- treat cancers, today announced the acceptance of two presentations on clinical data from the ongoing Phase I study of their lead asset UniCAR-T-CD123 in relapsed/refractory acute myeloid leukemia (rrAML) at the 2021 EHA-EBMT 3rd European CAR T-Cell Meeting, being held from February 4-6. 

So far, CAR-T cell therapy in AML has been impacted by the lack of antigens differentially expressed on malignant blasts. Targeting CD123, which is also expressed on hematopoietic progenitor cells, with conventional CAR-T products has led to promising response rates but also to long-lasting aplasias, with the frequent need for subsequent allogeneic hematopoietic cell transplantation.

The Phase I data of UniCAR-T-CD123 in rrAML presented at the congress highlight the unique product profile of UniCAR-T-CD123 in heavily pretreated rrAML patients as well as the key features of GEMoaB's rapidly switchable universal CAR-T platform, UniCAR. The UniCAR platform promises an improved therapeutic window and increased efficacy and safety over conventional CAR-T therapies in hematological malignancies and solid tumors.

"We are pleased to present important clinical data for UniCAR-T-CD123, the lead asset of our rapidly switchable UniCAR platform, at the 2021 EBMT/EHA European CAR-T meeting", said Professor Gerhard Ehninger, Chief Medical Officer of GEMoaB. "Our data nicely support our UniCAR key platform claims and provide the clinical proof of UniCAR's rapid switch on/off and re-activation capability, potentially leading to a highly differentiated product for rrAML patients in need for better treatment options."

The clinical data further support the ongoing development of UniCAR in hematological malignancies and solid tumors. A Phase IA dose-finding study of the first UniCAR asset, UniCAR-T-CD123, for the treatment of relapsed/refractory AML, is ongoing. A Phase IA study with UniCAR-T-PSMA directed against CRPC and other PSMA-expressing late-stage solid tumors, has been initiated.

GEMoaB's presentations at the 3rd EHA/EBMT European CAR-T Meeting:

(1) Oral Presentation: ID33: Martin Wermke et al., "Proof-of-Concept for Rapidly Switchable Universal CAR-T Platform with UniCAR-T-CD123 in Relapsed/Refractory AML".

(2) Poster Presentation: AS-Cart-2021-00068: Sabrina Kraus et al., "Re-activation of UniCAR-T-Cells with 2nd Cycle of Targeting Module TM123 in a Patient with Relapsed/Refractory AML".

About the UniCAR-T-CD123 Phase IA 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-CD123 in up to 16 CD123 positive patients with relapsed/refractory AML. Its purpose is to determine the maximum tolerated dose (MTD) as well as Dose limiting toxicities (DLT) of the combined application of a single dose of UniCAR-T and the continuous infusion of TM123 over 25 days. Application follows post salvage therapy and lymphodepletion. The study also investigates response rates, response duration, 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 TM infusion. The study takes place at selected Phase I, Acute Leukemia and CAR-T experienced University centers in Germany. The study is supported by a grant from the German Federal Ministry for Education and Research (project "TurbiCAR"). 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.  

For further information please contact

Jana Fiebiger
[email protected]; Tel.: +49 351 4466-45012

Investor Contact

Michael Pehl
[email protected]; Tel.: +49 351 4466-45030

Forward-looking Statements This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results and matters discussed in the forward looking statements. Forward looking statements include statements concerning our plans, goals, future events and or other information that is not historical information.  The Company does not assume any liability whatsoever for forward-looking statements. The Company assumes that potential partners will perform and rely on their own independent analyses as the case may be. The Company will be under no obligation to update the Information.

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