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Trials |  |
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- | ivicentamab (GEN-3009) / Genmab
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas (clinicaltrials.gov) - Sep 13, 2023
P1/2, N=46, Terminated, Sponsor: Genmab
N=182 --> 46 | Trial completion date: Sep 2025 --> Jul 2023 | Recruiting --> Terminated | Trial primary completion date: Sep 2023 --> Nov 2022; Due to strategic evaluation of GEN3009 within context of Genmab's portfolio, decision not based on any safety or regulatory concerns.
- B-Cell Targeting Anti-CD37 Humanized Antibodies Engineered for Potent Effector Functions and Extended Plasma Half-Life (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_4105;
Taken together, the humanized and Fc-engineered anti-CD37 antibodies show potent effector functions, favorable pharmacokinetic properties and in vivo therapeutic efficacy. As such, the designed CD37 antibodies should be attractive modalities in targeted treatment of B cell malignancies, such as NHL, including lymphomas non-responding to anti-CD20 treatments, but also potentially for B-cell driven autoimmune disorders.
- NNV024 / Nordic Nanovector
NNV024, a Humanized Anti-CD37 Antibody with Enhanced ADCC and Extended Plasma Half-Life for the Treatment of B-Cell Malignancies (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_2185;
The anti-CD20 Abs rituximab and obinutuzumab as well as the anti-CD37 Ab, Duohexabody-CD37, were used for benchmarking. These encouraging preclinical results support further development of NNV024 as a potential therapeutic mAb candidate for the treatment of B-cell malignancies and B-cell driven autoimmune disorders.
- || ivicentamab (GEN-3009) / Genmab
Trial completion date, Trial primary completion date: First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas (clinicaltrials.gov) - Jul 6, 2022
P1/2, N=182, Recruiting, Sponsor: Genmab
These encouraging preclinical results support further development of NNV024 as a potential therapeutic mAb candidate for the treatment of B-cell malignancies and B-cell driven autoimmune disorders. Trial completion date: Apr 2025 --> Sep 2025 | Trial primary completion date: Dec 2023 --> Sep 2023
- ||| ivicentamab (GEN-3009) / Genmab
Enrollment change, Trial completion date, Trial primary completion date: First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas (clinicaltrials.gov) - Jan 3, 2022
P1/2, N=182, Recruiting, Sponsor: Genmab
Trial completion date: Apr 2025 --> Sep 2025 | Trial primary completion date: Dec 2023 --> Sep 2023 N=120 --> 182 | Trial completion date: May 2023 --> Apr 2025 | Trial primary completion date: Nov 2022 --> Dec 2023
- | GEN3009 / Genmab, AbbVie
Journal: DuoHexaBody-CD37, a novel biparatopic CD37 antibody with enhanced Fc-mediated hexamerization as a potential therapy for B-cell malignancies. (Pubmed Central) - Apr 14, 2021
Finally, potent anti-tumor activity in vivo was observed in cell line- and patient-derived xenograft models from different B-cell malignancy subtypes. These encouraging preclinical results suggest that DuoHexaBody-CD37 (GEN3009) may serve as a potential therapeutic antibody for the treatment of human B-cell malignancies.
- GEN3009 / Genmab
[VIRTUAL] DUOHEXABODY®-CD37 SHOWS POTENT ANTI-TUMOR ACTIVITY IN PRE-CLINICAL B-CELL LYMPHOMA MODELS IN VITRO AND IN VIVO () - May 16, 2020 - Abstract #EHA2020EHA_1345;
Non-clinical PK properties are as expected for a monomeric human IgG1 Ab. Clinical studies to explore the safety and efficacy of DuoHexaBody-CD37 (GEN3009) in patients with advanced NHL, including CLL are being planned.
- |||| ivicentamab (GEN-3009) / Genmab
New P1/2 trial: First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas (clinicaltrials.gov) - Apr 23, 2020
P1/2, N=120, Recruiting, Sponsor: Genmab