Pipeline

Broad pipeline with four assets in clinical development

Clinical and Pre‑Clinical Pipeline Overview

AvenCell has a broad pipeline of product candidates in preclinical and clinical development for the treatment of hematologic malignancies as well as solid tumors.

Our lead clinical program is AVC-101, a CD-123 directed autologous cell therapy for the treatment of relapsed/refractory AML. We have clearly demonstrated controllability of our Universal CAR-T Cells (UniCARs) and manageable toxicity.

 GEM3PSCA, a TCE with binding specificity to PSCA for the treatment of metastatic castrate-resistant prostate cancer as well as pancreatic, breast, bladder, renal and non-small cell lung cancer, are currently in Phase I studies. GEM3PSCA is globally partnered with Bristol-Myers Squibb.

To learn more about participating in our ongoing trials, please contact us.

Universal

AVC-101

AVC-101 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-101, 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-101 is currently investigated in a first-in-human phase I dose escalation study of AVC-101 in patients with relapsed/refractory acute myeloid leukemia (r/r AML) designed to assess safety and tolerability and identify a maximum tolerated dose (EudraCT 2019-001339-30, NCT04230265). Secondary and exploratory objectives include efficacy, biological activity, and PK. First encouraging results have been published and presented at scientific meetings (Wermke et al. 2021, Ehninger et al. 2021, Koedam et al. 2022, Ehninger et al. 2022).  

AVC-101 is not approved for any indication in any geography and has not been demonstrated safe or effective for any use.

AVC-102

AVC-102 is an investigational PSMA-directed cell therapy targeting prostate cancer and other PSMA-expressing solid cancers 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-102, AvenCell is aiming to create a solution to attack less differentiated solid tumor antigens, which are also expressed on non-malignant tissue. PSMA (prostate specific membrane antigen) is a target in prostate cancers, but also in several other solid tumors where it is expressed on tumor tissue and/or neo-vasculature. 

AVC-102 is currently investigated in a first-in-human phase I dose escalation study of AVC-102 in patients with relapsed/refractory prostate cancer designed to assess safety and tolerability and identify a maximum tolerated dose (EudraCT 2019­004211­32, NCT04633148). Secondary and exploratory objectives include efficacy, biological activity, and PK.

AVC-102 is not approved for any indication in any geography and has not been demonstrated safe or effective for any use.

Universal + Allogeneic

AVC-201

CD 123 | AML

AVC-202

Undisclosed | Multiple Myeloma

AVC-203

CD19/CD20* | DLBCL

Undisclosed Targets

Heme/solid

Bispecific

GEM3PSCA*

GEM3PSCA is an investigational PSCA-directed affinity-tailored T cell adaptor. The bispecific antibody binds to the CD3 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, breast, bladder and renal cancer as well as non-small cell lung cancer. The bi-specific antibody is characterized by high binding affinity to tumor antigens and lower affinity to the CD3 antigen on T 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.

GEM3PSCA is currently investigated in a first-in-human phase I dose escalation study in patients with relapsed/refractory urogenital tract cancer and pancreatic cancer to assess safety and tolerability and identify a maximum tolerated dose (NCT03927573). Secondary and exploratory objectives include efficacy, biological activity, and PK.

GEM3PSCA is globally partnered with BMS.

GEM3PSCA is not approved for any indication in any geography and has not been demonstrated safe or effective for any use.

*Partnered with BMS

Universal

AVC-101

AVC-101 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-101, 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-101 is currently investigated in a first-in-human phase I dose escalation study of AVC-101 in patients with relapsed/refractory acute myeloid leukemia (r/r AML) designed to assess safety and tolerability and identify a maximum tolerated dose (EudraCT 2019-001339-30, NCT04230265). Secondary and exploratory objectives include efficacy, biological activity, and PK. First encouraging results have been published and presented at scientific meetings (Wermke et al. 2021, Ehninger et al. 2021, Koedam et al. 2022, Ehninger et al. 2022).  

AVC-101 is not approved for any indication in any geography and has not been demonstrated safe or effective for any use.

AVC-102

AVC-102 is an investigational PSMA-directed cell therapy targeting prostate cancer and other PSMA-expressing solid cancers 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-102, AvenCell is aiming to create a solution to attack less differentiated solid tumor antigens, which are also expressed on non-malignant tissue. PSMA (prostate specific membrane antigen) is a target in prostate cancers, but also in several other solid tumors where it is expressed on tumor tissue and/or neo-vasculature. 

AVC-102 is currently investigated in a first-in-human phase I dose escalation study of AVC-102 in patients with relapsed/refractory prostate cancer designed to assess safety and tolerability and identify a maximum tolerated dose (EudraCT 2019­004211­32, NCT04633148). Secondary and exploratory objectives include efficacy, biological activity, and PK.

AVC-102 is not approved for any indication in any geography and has not been demonstrated safe or effective for any use.

Universal + Allogeneic

AVC-201

CD 123 | AML

AVC-202

Undisclosed | Multiple Myeloma

AVC-203

CD19/CD20* | DLBCL

Undisclosed Targets

Heme/solid

Bispecific

GEM3PSCA*

GEM3PSCA is an investigational PSCA-directed affinity-tailored T cell adaptor. The bispecific antibody binds to the CD3 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, breast, bladder and renal cancer as well as non-small cell lung cancer. The bi-specific antibody is characterized by high binding affinity to tumor antigens and lower affinity to the CD3 antigen on T 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.

GEM3PSCA is currently investigated in a first-in-human phase I dose escalation study in patients with relapsed/refractory urogenital tract cancer and pancreatic cancer to assess safety and tolerability and identify a maximum tolerated dose (NCT03927573). Secondary and exploratory objectives include efficacy, biological activity, and PK.

GEM3PSCA is globally partnered with BMS.

GEM3PSCA is not approved for any indication in any geography and has not been demonstrated safe or effective for any use.

*Partnered with BMS

Universal

AVC-101

AVC-101 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-101, 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-101 is currently investigated in a first-in-human phase I dose escalation study of AVC-101 in patients with relapsed/refractory acute myeloid leukemia (r/r AML) designed to assess safety and tolerability and identify a maximum tolerated dose (EudraCT 2019-001339-30, NCT04230265). Secondary and exploratory objectives include efficacy, biological activity, and PK. First encouraging results have been published and presented at scientific meetings (Wermke et al. 2021, Ehninger et al. 2021, Koedam et al. 2022, Ehninger et al. 2022).  

AVC-101 is not approved for any indication in any geography and has not been demonstrated safe or effective for any use.

AVC-102

AVC-102 is an investigational PSMA-directed cell therapy targeting prostate cancer and other PSMA-expressing solid cancers 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-102, AvenCell is aiming to create a solution to attack less differentiated solid tumor antigens, which are also expressed on non-malignant tissue. PSMA (prostate specific membrane antigen) is a target in prostate cancers, but also in several other solid tumors where it is expressed on tumor tissue and/or neo-vasculature. 

AVC-102 is currently investigated in a first-in-human phase I dose escalation study of AVC-102 in patients with relapsed/refractory prostate cancer designed to assess safety and tolerability and identify a maximum tolerated dose (EudraCT 2019­004211­32, NCT04633148). Secondary and exploratory objectives include efficacy, biological activity, and PK.

AVC-102 is not approved for any indication in any geography and has not been demonstrated safe or effective for any use.

Universal + Allogeneic

AVC-201

CD 123 | AML

AVC-202

Undisclosed | Multiple Myeloma

AVC-203

CD19/CD20* | DLBCL

Undisclosed

Heme/solid

Bispecific

GEM3PSCA*

GEM3PSCA is an investigational PSCA-directed affinity-tailored T cell adaptor. The bispecific antibody binds to the CD3 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, breast, bladder and renal cancer as well as non-small cell lung cancer. The bi-specific antibody is characterized by high binding affinity to tumor antigens and lower affinity to the CD3 antigen on T 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.

GEM3PSCA is currently investigated in a first-in-human phase I dose escalation study in patients with relapsed/refractory urogenital tract cancer and pancreatic cancer to assess safety and tolerability and identify a maximum tolerated dose (NCT03927573). Secondary and exploratory objectives include efficacy, biological activity, and PK.

GEM3PSCA is globally partnered with BMS.

GEM3PSCA is not approved for any indication in any geography and has not been demonstrated safe or effective for any use.

*Partnered with BMS

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Andrew Schiermeier, Ph.D.

Chief Executive Officer

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Want to discuss my work or a challenge you’re facing?  Leave your details and I’ll get back to you. Want to discuss my work or a challenge you’re facing?  Leave your details and I’ll get back to you. Want to discuss my work or a challenge you’re facing?  Leave your details and I’ll get back to you.