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 |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
NL-201 is an investigational small molecule being developed for the treatment of solid tumors, including advanced solid tumors. It is studied in patients with relapsed or refractory cancer. The drug is currently in clinical development and is not approved by the FDA.
NL-201 is developed by Neurogene Inc., a biopharmaceutical company. Neurogene's stock is traded under the ticker symbol NGNE. The company is conducting clinical trials to evaluate the safety and efficacy of NL-201 in patients with solid tumors.
NL-201 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is no longer in active clinical trials.
NL-201 was studied in a Phase 1 clinical trial with the identifier NCT04659629. The trial evaluated NL-201 as a monotherapy and in combination with pembrolizumab in patients with relapsed or refractory cancer. The study enrolled 59 participants and has been completed.
No, NL-201 is not the same as pembrolizumab. NL-201 is an investigational small molecule developed by Neurogene Inc., while pembrolizumab is an approved immunotherapy drug. In the clinical trial NCT04659629, NL-201 was studied both alone and in combination with pembrolizumab.