DRESDEN, Germany, Feb. 3, 2021 /PRNewswire/ — GEMoaB, a biopharmaceutical company focused on the development of next-generation immunotherapies for hard-to-treat cancers, today announced interim data from the ongoing Phase I study of their lead asset UniCAR-T-CD123 in relapsed/refractory acute myeloid leukemia (rrAML) at the Virtual 3rd EHA-EBMT European CAR-T-Cell Meeting, which is held from February 04-06, 2021. The data are being presented as oral presentation by Dr. Martin Wermke, University Hospital Dresden, Germany (February 05, 12:20 CET) and as a poster presentation by Dr. Sabrina Kraus, University Hospital Würzburg, Germany (Abstract 68).
"These clinical results present a promising step forward as we continue to evaluate the safety and efficacy of UniCAR-T-CD123," said Professor Gerhard Ehninger, Chief Medical Officer of GEMoaB. "We are highly encouraged by the fact that UniCAR-T-CD123 has demonstrated a favorable safety and efficacy profile in rrAML. The clinical data nicely confirm our UniCAR key platform claims and provide the clinical proof of UniCAR’s rapid switch on/off and re-activation capability. We look forward to progressing our study and positioning UniCAR as a potentially superior cellular immunotherapy platform for patients with hard-to-treat advanced hematologic malignancies and solid tumors."
Data highlights for the oral presentation titled: "Proof-of-Concept for Rapidly Switchable Universal CAR-T Platform with UniCAR-T-CD123 in Relapsed/Refractory AML" include:
UniCAR-T-CD123 has been well tolerated to date with CRS (cytokine release syndrome) grade 1-2; no ICU admissions or dose limiting toxicities have been observed by the cut-off date; UniCAR-T-CD123 dose escalation is ongoingRobust expansion of UniCAR-T-CD123 in peripheral blood and bone marrow, comparable to conventional CD123-targeting CAR-T productsRapid recovery of neutrophils after stop of treatment with targeting module TM123 in all treated patientsEncouraging efficacy signals in the first 3 fully treated patients, with 1 PR (partial remission) and 2 CRi (complete remission with incomplete hematologic recovery) observed
The poster named "Re-activation of UniCAR-T-Cells with 2nd Cycle of Targeting Module TM123 in a Patient with Relapsed/Refractory AML" is summarizing data obtained on re-activation and re-expansion of UniCAR-T cells, leading to a CRi in the respective patient.
Both presentations will be available on the GEMoaB website following the congress.
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 bridging 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. Phase IA dose-finding studies of the first UniCAR assets UniCAR-T-CD123 in hematological malignancies and UniCAR-T-PSMA in solid tumors are 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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