Genmab's Endometrial Cancer Treatment Candidate Receives US FDA Breakthrough Therapy Designation

Genmab's endometrial cancer treatment candidate has received US FDA Breakthrough Therapy Designation. The company specializes in developing human and therapeutic antibodies for various diseases, including cancer, infectious diseases, and rheumatoid arthritis. Its net sales primarily come from royalties, research and development income, and other sources. The company has a portfolio of over 20 products in clinical development phase and 20 in preclinical development phase.

Genmab A/S (Nasdaq: GMAB), a Danish biotechnology company, has received a significant milestone in its quest to develop innovative antibody therapeutics. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to rinatabart sesutecan (Rina-S), an investigational folate receptor alpha (FRα)-directed, TOPO1-inhibitor antibody-drug conjugate (ADC), for the treatment of adult patients with recurrent or progressive endometrial cancer (EC) who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy [1].

The Breakthrough Therapy Designation aims to expedite the development and review of investigational medicines by the FDA for serious or life-threatening diseases where preliminary clinical evidence shows that a therapy may provide substantial improvements over available therapies. The designation was supported by previously published results from the endometrial cancer monotherapy dose expansion B2 cohort of the multi-part, Phase 1/2 RAINFOL™-01 trial (NCT05579366) [1].

Rina-S continues to be evaluated as a single-agent in patients with advanced EC in the Phase 1/2 RAINFOL™-01 trial and will be further evaluated in a planned Phase 3 trial. The company's Executive Vice President and Chief Development Officer, Judith Klimovsky, M.D., commented on the designation, "This Breakthrough Therapy Designation underscores the future potential of Rina-S as a treatment option for women diagnosed with advanced endometrial cancer, who face a poor prognosis after progressing on standard of care treatment" [1].

Genmab's portfolio includes over 20 products in clinical development and 20 in preclinical development phases, with a focus on antibody therapeutics for various diseases, including cancer, infectious diseases, and rheumatoid arthritis. The company's net sales primarily come from royalties, research and development income, and other sources.

The FDA's Breakthrough Therapy Designation for Rina-S is a significant step forward in Genmab's clinical development pipeline and highlights the company's commitment to advancing innovative antibody medicines for gynecologic cancers.

References:
[1] https://finance.yahoo.com/news/genmab-receives-fda-breakthrough-therapy-120000705.html