Genmab cuts early cancer projects to focus on Phase 3 trials

Genmab has decided to discontinue the development of three early-stage oncology projects in order to concentrate on its advanced-stage programs and key milestones. This strategic move includes halting the development of GEN1047 and GEN1056 for solid tumors, as well as GEN3017, which targets Hodgkin and non-Hodgkin lymphoma. Genmab's CEO, Jan van de Winkel, announced this decision during the company’s third-quarter earnings call. He explained that these programs did not meet the company's high internal standards for a truly differentiated therapeutic candidate.

Both GEN1047 and GEN3017 are bispecific antibodies that were being developed solely by Genmab. GEN1056, another antibody asset, is part of a collaboration with BioNTech focused on cancer immunotherapy, established in 2015. This partnership led to a Phase 1 trial initiated in 2022.

Additionally, Genmab has decided to abandon its plans to initiate Phase 3 studies for its antibody-drug conjugate (ADC) Tivdak in patients with previously treated head and neck cancer. Tivdak had received accelerated approval from the FDA for metastatic cervical cancer in 2021, and this was converted to a full approval earlier this year.

This strategic shift will allow Genmab to focus on maximizing the potential of its Phase 3 programs such as Epkinly, Rina-S, and acasunlimab. Genmab, along with its partner AbbVie, is testing Epkinly in Phase 3 trials for various B cell lymphomas. Epkinly has already received approval for specific forms of diffuse large B cell lymphoma and follicular lymphoma, achieving $82 million in sales in the third quarter.

Another focus of the company is its ADC Rina-S, which is undergoing a Phase 3 trial for platinum-resistant ovarian cancers. Genmab acquired Rina-S through its $1.8 billion purchase of ProfoundBio in April. At the time of the acquisition, van de Winkel indicated the need for evaluating and prioritizing both internal and newly acquired programs.

Furthermore, Genmab is advancing acasunlimab, a PD-L1x4-1BB bispecific antibody, into a Phase 3 trial for non-small cell lung cancer (NSCLC). This development is proceeding independently after BioNTech ended their collaboration in August.

In the earlier stages of its pipeline, Genmab is planning to share data from its Phase 2 study of the anti-CD38 monoclonal antibody GEN3014 with Johnson & Johnson later this year. Johnson & Johnson is expected to make a decision on whether to exercise its option for the drug in the first quarter of next year.

Overall, Genmab’s decision to cull certain early-stage assets reflects its commitment to advancing programs that meet its high standards for differentiation and therapeutic potential, ensuring a sharper focus on its most promising late-stage treatments.