Johnson & Johnson Declines Option for Next-Gen CD38 Monoclonal Antibody GEN3014

Mar 11, 2025 16:50 CST Updated 16:50

Genmab

Differentiated Antibody Therapy Developer

Johnson & Johnson

Healthcare Product Manufacturers, Health Service Providers

On March 10 local time, Genmab A/S announced that Johnson & Johnson has decided not to exercise the option to obtain rights for development, manufacturing, and commercialization.HexaBody-CD38 (GEN3014) Global License.

Screenshot source: Corporate official website

GEN3014 is a next-generation CD38-specific IgG1 monoclonal antibody that combinesGenmab's proprietary HexaBody technology,Aimed at inducing anti-tumor activity through efficient CDC and other Fc-mediated effector functions.

Screenshot source: Company official website

June 2019,Genmab and Johnson & Johnson Reach Global Licensing and Option Agreement for GEN3014. Under the agreement, Genmab will completeGEN3014 NeedleCorrectMultiple Myeloma and Diffuse Large B-Cell LymphomaProof-of-concept study. Based on the results of the study, Johnson & Johnson may exercise its option and obtain rights for the development, manufacturing, and commercialization GEN3014 Global License.If choosing to continue development, Genmab will receive$150 millionOption Exercise Fee, and may receive up to$125 millionMilestone payments, as well as future sales royalties.

Genmab Initiates Phase I/II Open-Label Multicenter Trial（3014-01）`, aimed at evaluating`GEN3014 Safety and Preliminary Efficacy as a Single Agent in Patients with Relapsed or Refractory Multiple Myeloma and Other Hematologic Cancers.Part B of the Phase II expansion of the study evaluated intravenous injectionGEN3014AndSubcutaneous Injection of DaratumumabObjective Response Rate in Patients with Relapsed or Refractory Multiple Myeloma Who Have Not Received Anti-CD38 Antibody Treatment(Primary Endpoint)。

Preliminary data show, including 88 patients receiving the study treatment and 84 evaluable patients for response(42 participants in each group)，Intravenous InjectionGEN3014The ORR of the group was 55%.，Subcutaneous Injection of DaratumumabThe ORR of the group was 52%.; A very good partial remission rate for both (VGPR) 29% vs. 17%, respectively; complete response rate (CR) 7% vs. 2%, respectively.

Despite the initial GEN3014 The clinical data was encouraging and demonstrated strong clinical efficacy, but after a comprehensive evaluation of the data, market landscape, and product portfolio priorities, Johnson & Johnson opted to withdraw, and Genmab will also cease further development. GEN3014 Clinical Development.

Cover source: ZCool HaiLuo

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