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Monday, November 7, 2022

NextCure discards antibody after candidate delivers no response in phase 2 cancer trial

 NextCure dropped one of its cancer antibodies after the therapy failed to make an impact in a phase 2 trial.

In a third-quarter earnings release, the Maryland-based biotech said it made the call to end development of the antibody, dubbed NC318, after reviewing data of the drug as monotherapy, including a phase 2 trial that had produced “no responses.” The phase 1/2 study was assessing the antibody for a range of cancers, including lung, breast, endometrial and solid tumors, according to ClinicalTrials.gov.

NextCure said it would continue to support Yale University’s phase 2 trial of the therapy in combination with Keytruda to treat advanced non-small cell lung cancer.

As recently as July, things were looking up for NC318. NextCure pointed to a research paper as evidence that it had made the right bet to pursue targeting Siglec-15 (S15) to restore immune cell function and anti-tumor responses in patients with cancer. S15 is a immunomodulatory target found on highly immunosuppressive cells called M2 macrophages in the tumor microenvironment and on certain tumor types including lung, ovarian and head and neck cancers.

At the time, the company pointed to preclinical research that showed NC318 blocked the negative effects of S15, leading NextCure to claim the antibody had “the potential to treat multiple cancer types.”

With NC318 now out of the picture, the company will prioritize NC410, which is undergoing a phase 1b/2 trial in combination with Keytruda in immune checkpoint refractory or naïve solid tumors. NC410 is designed to block immune suppression mediated by LAIR-1, an immunomodulatory receptor expressed on T cells and myeloid cells, including dendritic cells, a type of antigen-presenting cell.

These pipeline decisions are expected to add an extra 15 months to the company’s cash runway, allowing NextCure to fund its operating expenses into mid-2025.

The rest of the biotech’s pipeline consists of the monoclonal antibodies NC525, which is expected to enter the clinic in the first quarter of 2023, and NC762, which is undergoing a phase 1b expansion trial in solid tumors.

https://www.fiercebiotech.com/biotech/nextcure-discards-antibody-after-candidate-flunks-phase-2-cancer-trial

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