Dresden, Germany, May 15, 2020. GEMoaB, a biopharmaceutical company focused on the development of next-generation immunotherapies for hard-to-treat cancers, today announced acceptance of three presentations on pre-clinical data for its proprietary universal CAR-T platform (UniCAR) targeting acute leukemia and solid tumors at the 2020 Virtual Annual Meeting of the American Association for Cancer Research (AACR II) being held from June 22-24.
CAR-T cell therapy holds great promise for treating a wide range of malignancies. Nevertheless, the CAR-T approach faces multiple challenges, including the risk of acute and long-term toxicities, a current lack of suitable targets, insufficient engraftment and persistence and a microenvironment hostile to CAR-T cells especially in solid tumors.
The AACR poster presentations highlight 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.
“At this year’s AACR meeting II, we are pleased to present important pre-clinical data from our rapidly switchable UniCAR platform,” said Armin Ehninger, Ph.D., Chief Scientific Officer of GEMoaB. “Our data suggest the opportunity to actively target CD123 in acute leukemias as well as PSMA and PD-L1 in solid tumors due to UniCAR’s rapid switch on/off capability. In solid tumor models, they also show potentially superior tumor penetration, expansion and persistence capabilities as well as a reduced risk of immunosuppression by the tumor microenvironment.”
The data further support the ongoing clinical 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 and ALL is ongoing. A Phase IA study with UniCAR-T-PSMA directed against CRPC and other PSMA-expressing late-stage solid tumors will be initiated by H2 2020.
GEMoaB’s poster presentations at AACR II:
Dietrich et al. Abstract No. 2209 / 14 – Rapidly switchable universal CAR-T cells with improved safety profile allow for active targeting of PD-L1 expressing solid tumors. – PO.IM02.06 – Combination Immunotherapies 2, June 22, 2020, 9:00 AM – 6:00 PM (EDT).
Cartellieri et al. Abstract No. 2176 / 8 – Using a PSMA-specific low-molecular-weight compound for prostate cancer treatment with rapidly switchable universal CAR-T cells: Overcoming the challenges of cellular immunotherapies in solid tumors. – PO.IM02.02 – Adoptive Cell Therapy 2, June 22, 2020, 9:00 AM – 6:00 PM (EDT).
Loff et al. Abstract No. 4232 / 6 – More than a bridging therapy: Targeting CD123 with rapidly switchable universal CAR-T cells for treatment of acute leukemia. – PO.CL06.02 – Adoptive Cell Therapy 4 / Combination Immunotherapies, June 22, 2020, 9:00 AM – 6:00 PM (EDT).
GEMoaB is a privately-owned, clinical-stage biopharmaceutical company that is aiming to become a globally leading 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. A Phase IA dose-finding study of the first UniCAR asset, UniCAR-T-CD123 for treatment of relapsed/refractory AML and ALL is ongoing, UniCAR-T-PSMA against CRPC and other PSMA-expressing late-stage solid tumors, is planned to be tested in a Phase IA study initiated by H2 2020.
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, 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.
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 more challenging cancers, including solid tumors. Standard 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 targeting modules (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’s platform of T-cell engaging bispecific antibodies (TCE) is characterized by high binding affinity to tumor antigens and lower affinity to the CD3 antigen on effector T-cells, preventing T-cell auto-activation in pre-clinical models. Safety and tolerability of the treatment are also increased by the relatively short serum half-life (60 min). The use of fully humanized antibodies reduces the risk of immunogenicity even in case of chronic dosing. Half-life extended TCEs are in pre-clinical development.
More information can be found at www.gemoab.com.
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