AvenCell Therapeutics, Inc. today announced that it has dosed the first patient in a Phase IA study with AVC-201 for the treatment of relapsed/refractory Acute Myeloid Leukemia (AML) and other selected hematologic malignancies positive for CD123 (NCT05949125).
AVC-201 is the world’s first CRISPR-engineered switchable allogeneic CAR-T designed to fully avoid rejection by both the innate and adaptive host immune system. WATERTOWN, Mass., Feb. 6, 2024 /PRNewswire/ -- AvenCell Therapeutics, Inc., a leading clinical-stage cell therapy company focused on advancing both autologous and allogeneic switchable CAR-T cell therapies, today announced that it has dosed the first patient in a Phase IA study with AVC-201 for the treatment of relapsed/refractory Acute Myeloid Leukemia (AML) and other selected hematologic malignancies positive for CD123 (NCT05949125). AVC-201 is a CRISPR-engineered allogeneic switchable CAR-T candidate designed to target and eliminate cells expressing receptor CD123, which is known to be overexpressed in nearly all acute myeloid leukemias, and several other hematological malignancies. “Patients with AML with minimal residual disease or who progress after currently available treatment approaches generally have a very poor prognosis and limited options,” said Professor Martin Wermke, Head of the Early Clinical Trial Unit at the National Cancer Center Dresden, Germany. “AvenCell’s autologous switchable CAR-T therapy has already yielded highly promising early clinical results in AML treatment. AVC-201, a readily available donor-derived allogeneic cell product is expected to reach the patients in need much faster at substantially lower cost.” The phase 1 study, which includes up to 37 patients, will be conducted at multiple sites in Germany and the Netherlands. The primary objective of the trial is to assess the safety profile of AVC-201 and to determine the maximum tolerated dose. Secondary measures will include efficacy, safety, and CAR-T persistence. “We are excited to build on the safety and promising activity observed in our ongoing autologous switchable clinical study in AML (AVC-101) by now implementing what we believe is the most scientifically-compelling allogeneic technology in the industry,” said Andrew Schiermeier, AvenCell’s President & CEO. “We are the first company to combine a Switchable CAR-T with an off-the-shelf solution for broad applications across cancer and autoimmune indications. This modular approach allows for unparalleled future flexibility and reduction in cycle times, massive scaling of supply, and meaningful reductions in cost of goods, all of which will dramatically advance the field of cell therapy for patients.” About AVC-201 About AVC-201 Clinical Program About Acute Myeloid Leukemia (AML) About AvenCell Therapeutics AvenCell Therapeutics, Inc. was launched in 2021 by Blackstone Life Sciences, Cellex Cell Professionals, and Intellia Therapeutics, and incorporated the clinical-stage biopharmaceutical company GEMoaB GmbH. AvenCell is headquartered in Watertown, Massachusetts with additional R&D and manufacturing operations in Dresden, Germany. AvenCell Europe GmbH is sponsor of the AVC-201 study. For more information, visit www.avencell.com. Follow AvenCell on social media: LinkedIn. Forward-Looking Statements Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including AvenCell’s ability to initiate, progress or complete pre-clinical or clinical studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional pre-clinical or clinical studies; uncertainties relating to regulatory applications and related filing and approval timelines; risks related to AvenCell’s relationships and collaborations with third parties; risks related to the maintenance and protection of AvenCell’s intellectual property; risks related to the potential successful development and commercialization of AvenCell’s product candidates; and risks associated with AvenCell’s understanding of cell therapy and its application to the treatment of cancers. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to AvenCell, and AvenCell assumes no obligation and disclaims any intent to update any such forward-looking statements. Contact Logo - https://mma.prnewswire.com/media/2160029/AvenCell_Therapeutics_Logo.jpg View original content to download multimedia:https://www.prnewswire.com/news-releases/avencell-announces-first-patient-dosed-in-a-phase-ia-study-with-lead-product-candidate-avc-201-a-novel-allogeneic-cd123-directed-switchable-car-t-investigational-therapy-for-the-treatment-of-relapsedrefractory-acute-myeloid-leuk-302053495.html SOURCE AvenCell |