This section highlights FDA-related milestones and regulatory updates for drugs developed by NextCure (NXTC).
Over the past two years, NextCure has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LNCB74 and NC410. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
LNCB74 - FDA Regulatory Timeline and Events
LNCB74 is a drug developed by NextCure for the following indication: For treating multiple cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LNCB74
- Announced Date:
- March 6, 2025
- Indication:
- For treating multiple cancers.
Announcement
NextCure, Inc. provided a business update
AI Summary
NextCure, Inc. provided a business update alongside its full year 2024 financial results. The company highlighted significant progress in its antibody-drug conjugate (ADC) program, focusing on LNCB74 (B7-H4 ADC) as a potential treatment for multiple cancers. They successfully completed cohort 1 of the Phase 1 trial in February 2025 and plan to start additional backfill cohorts in the latter half of 2025. CEO Michael Richman explained that in 2024 the company reallocated resources to fast-track the ADC program, emphasizing the importance of these milestones in their development strategy.
NextCure also noted that its current cash resources, totaling approximately $68.6 million, are expected to fund operations into the second half of 2026. This update underscores the company’s commitment to advancing innovative cancer treatments through continued clinical progress.
Read Announcement - Drug:
- LNCB74
- Announced Date:
- January 10, 2025
- Indication:
- For treating multiple cancers.
Announcement
NextCure, Inc. announced the first patient has been dosed in its Phase 1 study of LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) as a therapeutic for treating multiple cancers.
AI Summary
NextCure, Inc. announced a major milestone in its cancer treatment research by dosing the first patient in its Phase 1 study of LNCB74. This new therapy is an antibody-drug conjugate (ADC) that specifically targets the B7-H4 protein found in various cancers. The Phase 1 trial is designed to evaluate the safety and tolerability of LNCB74, as well as its early signs of anti-tumor activity in patients with multiple cancer types.
The dosing marks the beginning of a crucial phase in the development of LNCB74, where researchers hope to demonstrate that this novel treatment option may improve outcomes for cancer patients. NextCure is excited about the potential of this ADC to pave the way for more effective therapies and to bring new hope to patients with limited treatment options.
Read Announcement- Drug:
- LNCB74
- Announced Date:
- December 10, 2024
- Indication:
- For treating multiple cancers.
Announcement
NextCure, Inc. announced that the U.S. Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) application for initiation of a Phase 1 clinical trial to evaluate LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) as a therapeutic for treating multiple cancers.
AI Summary
NextCure, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to begin a Phase 1 clinical trial for LNCB74. This new treatment is a B7-H4-targeting antibody‐drug conjugate (ADC) being developed to address multiple cancers. The trial will focus on evaluating the safety and potential effectiveness of LNCB74, following promising preclinical data that distinguishes it from other ADCs targeting B7-H4.
The acceptance of the IND marks an important milestone for NextCure, highlighting their commitment to advancing innovative cancer therapies. By launching this Phase 1 study, the company aims to improve treatment options for patients and strengthen its ADC program. The progress of LNCB74 into clinical development brings renewed hope for more effective cancer care in the future.
Read Announcement
NC410 - FDA Regulatory Timeline and Events
NC410 is a drug developed by NextCure for the following indication: In Combination with Pembrolizumab.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NC410
- Announced Date:
- September 16, 2024
- Indication:
- In Combination with Pembrolizumab
Announcement
NextCure, Inc. announced that clinical data from the Phase 1b portion of a Phase 1b/2 study evaluating NC410, a LAIR-2 fusion protein, in combination with pembrolizumab was presented at ESMO 2024.
AI Summary
NextCure, Inc. announced new clinical data at ESMO 2024 from the Phase 1b portion of its Phase 1b/2 study. The study evaluated NC410, a LAIR-2 fusion protein, in combination with pembrolizumab for treatment of ovarian cancer and colorectal cancer (CRC) patients. These patients included individuals who had not previously received immune checkpoint inhibitors as well as those with refractory disease.
The clinical results showed promising activity with durable responses in these hard-to-treat cancers. Trial investigators, including Emese Zsiros, M.D., Ph.D., and Eric S. Christenson, M.D., presented the Phase 1b data, noting partial responses and stable disease in the treated patients. NextCure plans to continue monitoring the patients and expects to provide further updates later this year.
Read Announcement
