Genmab Halts Clinical Development of EGFR/c-MET Bispecific ADC GEN1286 Amid Portfolio Restructuring
Genmab
Differentiated Antibody Therapy Developer
Johnson & Johnson
Medical Device R&D and Manufacturer
PRO1286 is a bispecific EGFR x cMET ADC developed by Provention Bio. It consists of a bispecific human IgG1 antibody with fine-tuned affinity for EGFR and cMET, and Provention Bio's proprietary linker-drug sesutecan based on a topoisomerase 1 inhibitor.
On April 3, 2024, Genmab announced the acquisition of Provention Bio for $1.8 billion, simultaneously gaining access to multiple ADC drugs from Provention Bio, includingGEN1286. It was previously unclear whether Genmab was restricted from developing assets competing with the same target due to a conflict of interest related to the Rybrevant project, which was developed under its long-term discovery alliance with Johnson & Johnson. However, Genmab evidently determined it could proceed and initiated a Phase 1/2 solid tumor study for GEN1286 in November 2024. The reason for halting clinical recruitment this time remains unclear.
Before GEN1286 was shelved, Genmab had recently terminated two projects, GEN1160 and GEN1107. This means that among the pipeline acquired by Genmab for 1.8 billion, the only asset still under active development from Provention Bio is rinatabart sesutecan — an anti-FRα ADC currently in Phase 3 clinical trials.
On May 21, 2021, based on Phase 1 clinical data,FDA Approves Johnson & Johnson's EGFR/cMET Bispecific AntibodyRybrevant (generic name: amivantamab-vmjw),For the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) exon 20 insertion mutations, whose disease has progressed during or after platinum-based chemotherapy, this is the first approved inhibitor.The bispecific antibody targeting the EGFR/cMET-related pathway has also demonstrated the feasibility of its mechanism. Currently,Rybrevant has been approved for multiple indications.
And with the vigorous development of ADC,The competition for EGFR/cMET bispecific ADCs is also quite intense, with the submission of SIM0610 by Simcere.As many as 10 GFR/cMET bispecific ADCs have entered clinical trials.
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