Oral presentation demonstrates that UniCAR-T-CD123 in rrAML is well tolerated with rapid recovery of hematopoiesis and encouraging early efficacy Poster presentation confirms re-activation and expansion of UniCAR-T cells during 2nd treatment cycle with Targeting Module TM123
Dresden, Germany, February 03, 2021. 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 ongoing
Robust expansion of UniCAR-T-CD123 in peripheral blood and bone marrow, comparable to conventional CD123-targeting CAR-T products
Rapid recovery of neutrophils after stop of treatment with targeting module TM123 in all treated patients
Encouraging 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.
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.
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 TCE 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, a T-cell engaging bispecific antibody (TCE) with binding specificity to CD33 in relapsed/refractory AML, and GEM3PSCA, a TCE 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.
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