Broad pipeline with four assets in clinical development
AvenCell has a broad pipeline of product candidates in preclinical and clinical development for the treatment of hematologic malignancies.
AVC-201 is our lead allogeneic cell therapy program, combining our Universal switchable CAR-T technology with our TrueAllo™ platform to provide an “off-the-shelf” product for the treatment of relapsed/refractory AML.
To learn more about participating in our ongoing trials, please contact us.
AVC-201 is an investigational CD123-directed cell therapy targeting acute myeloid leukemia that utilizes AvenCell’s proprietary Universal Targeting platform, a regulatable CAR-T cell technology that can turn CAR-T cells “OFF” and “ON” by means of a separately infused Targeting Module. With AVC-201, AvenCell is aiming to create a solution to address the heterogeneity and aggressive nature of acute myeloid leukemia. CD123 is a target in acute myeloid leukemia and other hematologic malignancies, but its on-target off-tumor toxicity makes a conventional CD123-directed CAR very challenging.
AVC-201 is the first investigational cell therapy that utilizes AvenCell’s differentiated TruAllo™️ technology to provide a readily available “off-the-shelf” product engineered to fully overcome graft-versus-host disease as well as graft rejection by host T and NK cells and is therefore expected to drive persistent anti-leukemia effects.
AVC-201 is currently investigated in a first-in-human phase I dose escalation study of AVC-201 in patients with relapsed/refractory (R/R) and minimal residual desease (MRD+) AML, designed to assess safety and tolerability and identify a maximum tolerated dose (EudraCT 2022-501797-19-00, NCT05949125). Secondary and exploratory objectives include efficacy, biological activity, and PK.
AVC-201 is not approved for any indication in any geography and has not been demonstrated safe or effective for any use.
Undisclosed | Multiple Myeloma
AVC-203 is an investigational CD19-20 dual-targeted cell therapy for the treatment of B cell malignancies.
AVC-203 will be the second investigational cell therapy using AvenCell’s differentiated TruAllo™ technology to provide an “off-the-shelf” product engineered to overcome graft-versus-host disease as well as graft rejection by host T and NK cells. AVC-203 leverages the greater fitness of healthy donor T cells via improved gene editing and manufacturing processes to drive superior CAR-T expansion, compared with approved CAR-Ts, one of the strongest predictors of efficacy. It also leverages TruAllo™ technology to enable improved CAR-T persistence compared with first generation allogeneic technologies. Finally, CD19/CD20 dual targeting CAR-Ts show superior efficacy to currently approved single antigen CAR-Ts. By combining these advantages and through exhaustive preclinical testing, AVC-203 is designed to achieve superior efficacy compared to approved CAR-Ts while enabling immediate treatment and greater patient access at much lower cost and complexity.
AVC-203 will enter a first-in-human phase I study in patients with relapsed/refractory lymphoma in H2 2025.
AVC-203 is not approved for any indication in any geography and has not been demonstrated safe or effective for any use.
Heme/solid
AVC-201 is an investigational CD123-directed cell therapy targeting acute myeloid leukemia that utilizes AvenCell’s proprietary Universal Targeting platform, a regulatable CAR-T cell technology that can turn CAR-T cells “OFF” and “ON” by means of a separately infused Targeting Module. With AVC-201, AvenCell is aiming to create a solution to address the heterogeneity and aggressive nature of acute myeloid leukemia. CD123 is a target in acute myeloid leukemia and other hematologic malignancies, but its on-target off-tumor toxicity makes a conventional CD123-directed CAR very challenging.
AVC-201 is the first investigational cell therapy that utilizes AvenCell’s differentiated TruAllo™️ technology to provide a readily available “off-the-shelf” product engineered to fully overcome graft-versus-host disease as well as graft rejection by host T and NK cells and is therefore expected to drive persistent anti-leukemia effects.
AVC-201 is currently investigated in a first-in-human phase I dose escalation study of AVC-201 in patients with relapsed/refractory (R/R) and minimal residual desease (MRD+) AML, designed to assess safety and tolerability and identify a maximum tolerated dose (EudraCT 2022-501797-19-00, NCT05949125). Secondary and exploratory objectives include efficacy, biological activity, and PK.
AVC-201 is not approved for any indication in any geography and has not been demonstrated safe or effective for any use.
Undisclosed | Multiple Myeloma
AVC-203 is an investigational CD19-20 dual-targeted cell therapy for the treatment of B cell malignancies.
AVC-203 will be the second investigational cell therapy using AvenCell’s differentiated TruAllo™ technology to provide an “off-the-shelf” product engineered to overcome graft-versus-host disease as well as graft rejection by host T and NK cells. AVC-203 leverages the greater fitness of healthy donor T cells via improved gene editing and manufacturing processes to drive superior CAR-T expansion, compared with approved CAR-Ts, one of the strongest predictors of efficacy. It also leverages TruAllo™ technology to enable improved CAR-T persistence compared with first generation allogeneic technologies. Finally, CD19/CD20 dual targeting CAR-Ts show superior efficacy to currently approved single antigen CAR-Ts. By combining these advantages and through exhaustive preclinical testing, AVC-203 is designed to achieve superior efficacy compared to approved CAR-Ts while enabling immediate treatment and greater patient access at much lower cost and complexity.
AVC-203 will enter a first-in-human phase I study in patients with relapsed/refractory lymphoma in H2 2025.
AVC-203 is not approved for any indication in any geography and has not been demonstrated safe or effective for any use.
Heme/solid
AVC-201 is an investigational CD123-directed cell therapy targeting acute myeloid leukemia that utilizes AvenCell’s proprietary Universal Targeting platform, a regulatable CAR-T cell technology that can turn CAR-T cells “OFF” and “ON” by means of a separately infused Targeting Module. With AVC-201, AvenCell is aiming to create a solution to address the heterogeneity and aggressive nature of acute myeloid leukemia. CD123 is a target in acute myeloid leukemia and other hematologic malignancies, but its on-target off-tumor toxicity makes a conventional CD123-directed CAR very challenging.
AVC-201 is the first investigational cell therapy that utilizes AvenCell’s differentiated TruAllo™️ technology to provide a readily available “off-the-shelf” product engineered to fully overcome graft-versus-host disease as well as graft rejection by host T and NK cells and is therefore expected to drive persistent anti-leukemia effects.
AVC-201 is currently investigated in a first-in-human phase I dose escalation study of AVC-201 in patients with relapsed/refractory (R/R) and minimal residual desease (MRD+) AML, designed to assess safety and tolerability and identify a maximum tolerated dose (EudraCT 2022-501797-19-00, NCT05949125). Secondary and exploratory objectives include efficacy, biological activity, and PK.
AVC-201 is not approved for any indication in any geography and has not been demonstrated safe or effective for any use.
Undisclosed | Multiple Myeloma
AVC-203 is an investigational CD19-20 dual-targeted cell therapy for the treatment of B cell malignancies.
AVC-203 will be the second investigational cell therapy using AvenCell’s differentiated TruAllo™ technology to provide an “off-the-shelf” product engineered to overcome graft-versus-host disease as well as graft rejection by host T and NK cells. AVC-203 leverages the greater fitness of healthy donor T cells via improved gene editing and manufacturing processes to drive superior CAR-T expansion, compared with approved CAR-Ts, one of the strongest predictors of efficacy. It also leverages TruAllo™ technology to enable improved CAR-T persistence compared with first generation allogeneic technologies. Finally, CD19/CD20 dual targeting CAR-Ts show superior efficacy to currently approved single antigen CAR-Ts. By combining these advantages and through exhaustive preclinical testing, AVC-203 is designed to achieve superior efficacy compared to approved CAR-Ts while enabling immediate treatment and greater patient access at much lower cost and complexity.
AVC-203 will enter a first-in-human phase I study in patients with relapsed/refractory lymphoma in H2 2025.
AVC-203 is not approved for any indication in any geography and has not been demonstrated safe or effective for any use.
Heme/solid
VP, Clinical Operations
Susan is the Vice President, Clinical Operations for Avencell; she brings over 30 years of experience in Global Clinical Operations to AvenCell’s Clinical Operations team. Prior to joining Avencell, Susan had multiple senior level roles within the Biotech, Pharmaceutical and CRO organizations. Susan has experience in leading clinical operations teams to successful study execution and multiple global regulatory submissions. Susan is a graduate of the University of Wisconsin-Milwaukee with a Bachelor of Science in Medical Technology.
Chief Executive Officer
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