Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NL-201 · 1 trial · 2 indications
Evaluation of tolerability of NL-201 as measured by number of subjects with dose limiting toxicities (DLTs)
Evaluation of tolerability of NL-201 as measured by number of subjects with dose limiting toxicities (DLTs)
Evaluation of tolerability of NL-201 in combination with Pembrolizumab as measured by number of subjects with dose limiting toxicities (DLTs)
Evaluation of tolerability of NL-201 in combination with Pembrolizumab as measured by number of subjects with dose limiting toxicities (DLTs)
Rate of adverse events in patients with advanced solid tumors
Rate of adverse event grades in patients with advanced solid tumors
| Arm | Type | Description |
|---|---|---|
| Part 1: NL-201 Monotherapy Dose Escalation | EXPERIMENTAL | NL-201 given as monotherapy by intravenous administration testing ascending doses and two different schedules. |
| Part 2: NL201 Monotherapy Expansion Cohorts | EXPERIMENTAL | NL-201 given as monotherapy by intravenous administration in indication specific cohorts at a dose and schedule determined in Part 1. |
| Part 3: NL-201 in Combination with Pembrolizumab Dose Escalation | EXPERIMENTAL | NL-201, in combination with a set Pembrolizumab dose, testing ascending doses and two different schedules |
| Part 4: NL-201 in Combination with Pembrolizumab Expansion Cohorts | EXPERIMENTAL | NL-201 in combination with Pembrolizumab in indication specific cohorts at a dose and schedule determined in Part 3 |
| Name | Type | Description |
|---|---|---|
| NL-201 | DRUG | NL-201 is a de novo protein therapeutic. |
| Pembrolizumab Injection [Keytruda] | DRUG | A programmed death receptor-1 (PD-1)-blocking antibody |
Inclusion Criteria: * Patients with measurable disease * Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * At least 6 weeks from any prior nitrosurea or mitomycin C therapy; at least 4 weeks from any other prior chemotherapy or checkpoint inhibitor; at least 2 w...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
NL-201 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is being developed as a potential therapy for patients with relapsed or refractory cancer, both as a monotherapy and in combination with pembrolizumab. It has not been approved for any indication.
NL-201 targets IL-2 and IL-15, which are cytokines involved in immune system signaling. By engaging these cytokine pathways, NL-201 is designed to stimulate an anti-tumor immune response. It is a small molecule modality rather than a conventional antibody or recombinant cytokine therapy.
NL-201 is being developed by Neurogene Inc., which trades under the ticker NGNE. The company is advancing the asset as an oncology candidate. Neurogene is the sponsor responsible for the clinical development program evaluating NL-201 in patients with advanced solid tumors.
NL-201 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The Phase 1 program has been completed, with no trials currently active.
NL-201 has been evaluated in one clinical trial, NCT04659629, titled NL-201 Monotherapy and in Combination With Pembrolizumab in Patients With Relapsed or Refractory Cancer. This completed Phase 1 study enrolled 59 participants across the United States, Australia, and Canada in advanced solid tumor indications.