GEMoaB Announces First Patient Dosed With the Affinity-Tailored T-Cell-adaptor GEM3PSCA in a Phase I Study in PSCA-positive Late-Stage Solid Tumors

DRESDEN, Germany I July 31, 2019 I GEMoaB GmbH, a biopharmaceutical company focused on the development of next generation immunotherapies for hard-to-treat cancers, today announced the dosing of the first patient in a Phase I open-label, dose escalation study of GEM3PSCA, an Affinity-Tailored Adapter for T-Cells (ATAC). The bispecific antibody binds to the CD3-Receptor on T-cells and prostate stem cell antigen (PSCA), differentially and broadly expressed in a variety of late stage solid tumors, such as castrate-resistant prostate cancer, pancreatic and breast cancer, bladder and renal cancer as well as non-small cell lung cancer. The ongoing execution of its clinical development plan reflects GEMoaB's strategy to position itself as a leading and fully integrated biotech company for long-term success, building on the strong science and R&D foundation of the company.

"In addition to moving forward with multiple pre-clinical assets of our earlier-stage portfolio this year, we are pleased to demonstrate the productivity of our proprietary next generation ATAC platform by advancing GEM3PSCA, our second internally discovered molecule, into the clinic. GEM3PSCA follows our ongoing Phase I study of our first ATAC asset GEM333 in CD33-positive relapsed/refractory AML," said Armin Ehninger, Ph.D., Chief Scientific Officer of GEMoaB. "Due to its unique molecular features, GEM3PSCA has the potential to balance efficacy and tolerability and benefit the large number of patients whose metastatic cancer is expressing PSCA. We look forward to conducting the early clinical work for GEM3PSCA in close cooperation with highly experienced academic clinical centers and are proud about our global GEM333 and GEM3PSCA partnerships with Celgene."

Purpose of the Phase I study is to evaluate safety, pharmacokinetics, pharmacodynamics and clinical activity of GEM3PSCA in patients with advanced solid tumors expressing PSCA. GEM3PSCA will be administered as a single agent dosed as a continuous infusion over 7-day cycles. Cohorts of patients will receive ascending doses of GEM3PSCA to determine the maximum tolerated dose (MTD) or optimal dose. Patients must have evidence of expression of the PSCA antigen from their tumor tissue, measured by immunohistochemistry, in order to be eligible for the study.

"We are excited to participate in the development of this novel approach to the immunologic treatment of solid tumors," said Prof. Dr. Ralf Bargou, Head of Comprehensive Cancer Center Mainfranken at the University Hospital Würzburg. "PSCA is a very promising target expressed in multiple late stage cancers that do not sufficiently benefit from currently existing targeted or immunotherapies. We are very motivated to provide our broad expertise in early clinical trial conduct and immuno-oncology and work closely with the GEMoaB team in order to rapidly obtain meaningful safety and efficacy results for GEM3PSCA."

About the Affinity-Tailored Adaptor for T-Cells (ATAC) platform

GEMoaB's platform of Affinity-Tailored Adaptors for T-Cells (ATAC) is characterized by high binding affinity to tumor antigens and lower affinity to the CD3 antigen on T-effector cells, preventing T-cell auto-activation in pre-clinical models. Safety and tolerability of the treatment are also increased by the relatively short (60 min) serum half-life. The use of fully humanized antibodies reduces the potential risk of immunogenicity even in case of chronic dosing. The first two clinical stage ATAC assets are GEM333 and GEM3PSCA. GEM333 is an ATAC with binding specificities to CD3 and CD33, currently in early clinical development in CD33 positive relapsed/refractory acute myeloid leukemia (for further information see https://clinicaltrials.gov/ct2/show/NCT03516760). GEM3PSCA is an ATAC with binding specificities to CD3 and PSCA, currently in early clinical development in multiple PSCA positive advanced solid tumors (for further information see https://clinicaltrials.gov/ct2/show/NCT03927573). GEM333 and GEM3PSCA are globally partnered with Celgene.

About GEMoaB GmbH

GEMoaB GmbH is a privately-owned, limited liability clinical-stage biopharmaceutical company that is focused on becoming a leading, fully integrated biopharmaceutical company. By focusing on its proprietary next generation ATAC, UniCAR and RevCAR platforms, the company intends to discover, develop, manufacture and commercialize next generation immunotherapies for the treatment of cancer patients with a high unmet medical need. GEMoaB works in close cooperation with its sister company Cellex GmbH, a global leader in the production of allogeneic and autologous cell products, which is responsible for manufacturing UniCAR and RevCAR.

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 lead 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.

SOURCE: GEMoaB

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