Relatlimab Drug Asset Due Diligence Report 2026

This Relatlimab 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

Registered trials

Result records

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 Relatlimab can convert its Monoclonal antibody profile and LAG3 biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Relatlimab (query alias: Relatlimab)
Modality / target	Monoclonal antibody; LAG3; LAG3 inhibitors, ADCC, T lymphocytes stimulants
Highest global status	Approved
Originator	Bristol Myers Squibb Co.
Active developers	Bristol Myers Squibb Co., Ono Pharmaceutical Co., Ltd.

The MCP disease footprint includes Melanoma, Recurrent Lung Non-Squamous Non-Small Cell Carcinoma, Unresectable Melanoma. 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
NCT07504796	Phase 4	Recruiting	90	Progression Free Survival rate in patients randomized in Cohort B
NCT06999980	Phase 2	Recruiting	494	Pathological response rate
NCT06816927	Phase 2	Recruiting	92	Assess the safety of concomitantly administering nivolumab, relatlimab, RT, and TMZ in MGMT methylated patients by monitoring adverse events utilizing CTC Version 5.0 criteria

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

A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants With Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma

Phase 1/2; n=5; evaluation: not stated. Reported fields: Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A = 0 Participants ; Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A = 0 Participants ; -

Phase I/IIa dose finding study of triplet regimen of relatlimab (RELA) ipilimumab (IPI), and nivolumab (NIVO) in first-line therapy of metastatic melanoma (MM) (TRINITY).

Phase 1/2; n=33; evaluation: Positive. Reported fields: ORR = 59.0 %

Feasibility and efficacy of perioperative nivolumab with or without relatlimab for patients with potentially resectable hepatocellular carcinoma

Phase 2; n=30; evaluation: Positive. Reported fields: DFS(2-year) = 88.9 % ; DFS(2-year) = 73.3 %

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

Relatlimab addresses Melanoma, Recurrent Lung Non-Squamous Non-Small Cell Carcinoma, Unresectable Melanoma. 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: 1 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
2011-09-20	Bristol-Myers Squibb and Ono Enter into Strategic Agreement for Anti-PD-1 Antibody, BMS-936558/ONO-4538, and ORENCIA® (abatacept)	Approved	US$40.0M upfront

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 “Methods of treating multiple myeloma with BCMA inhibitors in combination with LAG3 inhibitors”. The milestone feed surfaced a patent-application signal described as “Treatment of cancer patients with tumor infiltrating lymphocyte therapies in combination with a LAG-3 inhibitor and a PD-1 inhibitor”. The milestone feed surfaced a patent-application signal described as “Combination therapy of a PD-1 antagonist and LAG3 antagonist and all-trans retinoic acid or a pharmaceutically acceptable salt thereof for treating patients with cancer”.

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