Dresden, Germany, March 02, 2021. GEMoaB, a biopharmaceutical company focused on the development of next-generation immunotherapies for hard-to-treat cancers, today announced the publication of clinical data obtained from the ongoing Phase I study of their rapidly switchable UniCAR platform lead asset, UniCAR-T-CD123, in relapsed/refractory acute myeloid leukemia (rrAML), in the journal “Blood”.
The interim data of UniCAR-T-CD123 in rrAML, published online ahead of print as a letter in “Blood” (Wermke et al. 2021, https://doi.org/10.1182/blood.2020009759), demonstrate that UniCAR-T-CD123 in rrAML is well-tolerated with rapid recovery of hematopoiesis and encouraging early efficacy.
“The Blood publication nicely underpins the clinical advantages of our rapidly switchable UniCAR platform, which have also been recently presented at the 3rd EHA-EBMT CART-Cell Meeting,” said Prof. Dr. Gerhard Ehninger, Chief Medical Officer of GEMoaB. “We believe that the benefit-risk profile of UniCAR-T-CD123 obtained in rrAML promises to be highly differentiated, and while we are finishing up our Phase IA clinical study, we are looking forward to enter into the next phase of our clinical development program in this high unmet need indication.”
Phase I studies of UniCAR-T-CD123 for the treatment of rrAML and UniCAR-T-PSMA directed against CRPC and other PSMA-expressing late-stage solid tumors are ongoing.
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 through stopping TM infusion in case of side effects. 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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