Genmab halts phase 1/2 trial for oncology candidate GEN1160 amid broader strategic review

DENMARK—Danish pharmaceutical company Genmab has discontinued development of GEN1160, marking the second antibody-drug conjugate from its ProfoundBio acquisition to be dropped from its pipeline.

A company spokesperson confirmed to Fierce Biotech that the firm has halted a phase 1/2 trial evaluating the experimental therapy.

The decision stems from low patient enrollment in the clinical trial, aligning with Genmab’s broader strategy to prioritize its portfolio.

“This approach ensures we focus our resources on developing innovative antibody medicines with the greatest potential to make a meaningful impact for patients,” the spokesperson explained.

The discontinued trial had been testing GEN1160 in patients with renal cell carcinoma, nasopharyngeal carcinoma, and non-Hodgkin lymphoma.

GEN1160 now joins GEN1107 on Genmab’s list of discontinued assets from the April 2024 ProfoundBio acquisition.

The company terminated development of GEN1107, a solid tumor candidate, in September after phase 1/2 trial data revealed an unfavorable risk-benefit profile.

Despite these setbacks, Genmab continues advancing rinatabart sesutecan, known as Rina-S, which remains ProfoundBio’s flagship asset.

The company is pursuing the therapy for ovarian and endometrial cancers while also developing GEN1286 in solid tumors.

Enrollment is currently underway for a phase 1/2 trial testing GEN1286, previously called PRO1286, in patients with advanced solid tumors.

Rina-S faces competition from AbbVie’s Elahere, though the Chicago-based pharmaceutical company has launched legal action that could disrupt Genmab’s development timeline.

AbbVie filed a lawsuit in March alleging that ProfoundBio built its ADC technology using trade secrets stolen from a former AbbVie employee.

Genmab has pledged to “vigorously defend” itself against these allegations, pointing out that AbbVie has pursued similar legal action against several other companies, including Adcentrx, Alvotech, BeiGene, and Revance.

Rina-S has demonstrated promising clinical results, exceeding analyst expectations in May with a 50% unconfirmed response rate in advanced endometrial cancer.

This data has prompted Genmab to launch a phase 3 trial in the indication, which is scheduled to begin this month according to clinicaltrials.gov.

Additional phase 1/2 data released in October showed Rina-S achieved a 50% objective response rate, with two patients experiencing complete cancer remission.

While trimming its ProfoundBio assets, Genmab has simultaneously expanded its oncology pipeline through strategic acquisitions.

In late September, the company paid USD8 billion to acquire Netherlands-based biotech Merus and its bispecific antibody, petosemtamab.

The therapy previously achieved a 79% 12-month survival rate in phase 2 testing for patients with PD-L1–positive recurrent or metastatic head and neck squamous cell carcinoma, earning recognition from analysts for its best-in-disease profile.