Nivolumab Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go
This Nivolumab Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.
Decision date: 15 July 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.
Approved
Highest phase
2015
Registered trials
3449
Result records
21
Matched deals
Executive recommendation: GO
Decision memo
Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.
The central underwriting question is whether Nivolumab can convert its Monoclonal antibody profile and PD-1 biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.
1. Asset identity and development status
| Asset | Nivolumab (query alias: nivolumab) |
|---|---|
| Modality / target | Monoclonal antibody; PD-1; PD-1 inhibitors |
| Highest global status | Approved |
| Originator | Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb Co. |
| Active developers | National Cancer Institute, Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb Co. |
The MCP disease footprint includes MSI-H/dMMR Rectal Cancer, PD-L1 positive Non-Small Cell Lung Cancer, Metastatic hepatocellular carcinoma. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.
2. Clinical program: design and endpoint audit
| Registry | Phase | Status | Enrollment | Lead primary endpoint |
|---|---|---|---|---|
| NCT07689175 | Phase 2 | Not yet recruiting | 60 | Disease control rate after immunotherapy nivolumab plus ipilimumab |
| NCT07694986 | Phase 2 | Recruiting | 30 | Safety Run-In: Maximum Tolerated Dose (MTD) |
| NCT07687875 | Phase 1 | Recruiting | 20 | Overall incidence of adverse events (AEs) |
The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.
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3. Clinical readouts: what is known
EON: A Single-arm Phase II Study of Etigilimab (OMP-313M32) in Combination With Checkpoint Inhibition (Nivolumab) in Patients With Platinum-resistant, Recurrent Epithelial Ovarian Cancer
Phase 2; n=23; evaluation: not stated. Reported fields: ORR = 15 percentage of participants (95% Confidence Interval, 3.2 - 37.9); -; -
Randomized Neoadjuvant Pilot Phase II Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination With Nivolumab vs. Nivolumab in Stage IIIB/C/D Melanoma Patients With an Integrated Imaging Biomarker
Phase 2; n=9; evaluation: not stated. Reported fields: Pathologic CR = 50 percentage of patients (95% Confidence Interval, 6.8 - 93.2); Pathologic CR = 75 percentage of patients (95% Confidence Interval, 19.4 - 99.4); -
PRIME-HCC: Preliminary Assessment of Safety and Bioactivity of the Ipilimumab and Nivolumab Combination Prior to Liver Resection (LR) in Hepatocellular Carcinoma (HCC)
Phase 1/2; n=33; evaluation: not stated. Reported fields: Delay to Surgery = 2 Participants ; -; -
These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.
4. Market and competitive position
Nivolumab addresses MSI-H/dMMR Rectal Cancer, PD-L1 positive Non-Small Cell Lung Cancer, Metastatic hepatocellular carcinoma. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Monoclonal antibody—must demonstrate a benefit large enough to offset class-specific safety and operational costs.
The strongest market-validation signal in this screen is partner behavior: 21 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.
5. Transaction precedent and economics
| Date | Transaction | Phase at deal | Disclosed economics |
|---|---|---|---|
| 2024-02-27 | 牵手再鼎，O药在国内想象空间还有多大？ | Approved | Financial terms not disclosed |
| 2024-02-22 | Immunocore announces clinical trial collaboration and supply agreement with Bristol Myers Squibb to evaluate IMC-F106C (PRAME HLA-A02) in combination with nivolumab in its registrational Phase 3 first-line advanced cutaneous melanoma trial | Phase 3 | Financial terms not disclosed |
| 2023-03-16 | BMS teams up with MD Anderson Cancer Center to carry out NEOSTAR trial, examining the efficacy of nivolumab combined with chemotherapy, as well as ipilimumab combined with nivolumab and chemotherapy, for NSCLC. | Approved | Financial terms not disclosed |
Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.
6. IP and freedom-to-operate screen
The milestone feed surfaced a patent-application signal described as “Application of dodecylamine medicine in improving curative effect of targeted PD-1/PD-L1 pathway immune checkpoint inhibitor and composition of dodecylamine medicine in improving curative effect of targeted PD-1/PD-L1 pathway immune checkpoint inhibitor”. The milestone feed surfaced a patent-application signal described as “Application of combination of OH2 oncolytic virus and PD-1 inhibitor in preparation of antitumor drugs”. The milestone feed surfaced a patent-application signal described as “Treatment of tumors by means of Anti-tigit antibody in combination with Anti-PD-1 antibody”.
The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights. Confirm that licensed patents, data and know-how track every granted territory and field.
7. Principal risks and diligence gates
- Class crowding and differentiation versus other PD-(L)1/VEGF agents
- Immune and anti-angiogenic safety, including bleeding and cardiovascular risk
- Biomarker strategy, indication selection, and head-to-head endpoint execution
Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.
8. Final go/no-go memorandum
GO
Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.
Required pre-signing gates: reproduce key efficacy analyses; complete an indication-specific safety review; run a full patent-family and freedom-to-operate search; model risk-adjusted economics by territory; and reconcile all rights, sublicenses and encumbrances.
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Data provenance: PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP; accessed 15 July 2026. Counts and status fields may change as source records update.
