Amivantamab-VMJM Drug Asset Due Diligence Report 2026

This Amivantamab-VMJM 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

137

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 Amivantamab-VMJM can convert its Bispecific antibody profile and EGFR x c-Met biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Amivantamab-VMJM (query alias: Amivantamab-VMJM)
Modality / target	Bispecific antibody; EGFR x c-Met; EGFR antagonists, c-Met inhibitors
Highest global status	Approved
Originator	Genmab BV, Janssen Biotech, Inc.
Active developers	Janssen Research & Development LLC, Johnson & Johnson (China) Investment Ltd., Janssen-Cilag International NV

The MCP disease footprint includes EGFR positive non-small cell lung cancer, EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer, EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer. 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
JPRN-jRCTs071250140	Phase 2	募集中	100	プロトコール治療開始後12カ月時点までのVTE発生割合
NCT07507188	Phase 2	Not yet recruiting	80	• scRNA-seq and/or spatial RNA sequencing analysis. Multiplex IHC and/or FACS analysis.
NCT07586202	Phase 2	Recruiting	68	Major Pathologic response (MPR)

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

Amivantamab Monotherapy in Chemorefractory <i>RAS</i> / <i>BRAF</i> Wild-Type Metastatic Colorectal Cancer: Results From OrigAMI-1, an Open-Label, Phase Ib/II Study

Phase 1/2; n=94; evaluation: Positive. Reported fields: -; ORR = 19.0 % ; ORR = 29.0 %

Real-world outcomes of amivantamab monotherapy in advanced EGFR-mutant non-small cell lung cancer.

Not Applicable; n=22; evaluation: Positive. Reported fields: DCR = 33.0 % ; DCR = 75.0 % ; DCR = 60.0 % ( 36.1 - 80.9)

Randomized phase II study of amivantamab + lazertinib versus afatinib in patients with uncommon/compound EGFR-mutated non-small cell lung cancer (WJOG17323L: AGEHA study).

Phase 2; n=70; evaluation: Positive. Reported fields: AE(Discontinuation) = 5.0 % ; AE(Discontinuation) = 10.0 %

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

Amivantamab-VMJM addresses EGFR positive non-small cell lung cancer, EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer, EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Bispecific 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: 2 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
2025-10-31	Yuhan promotes Leclaza+Rybrevant first-line lung cancer therapy with Janssen Korea	Approved	Financial terms not disclosed
2012-07-12	Genmab Enters Broad Collaboration with Janssen Biotech, Inc. for DuoBody Platform	Not disclosed	US$3.5M upfront; US$1,750.0M milestones

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 for reducing dermatologic adverse events in patients treated with EGFR/met bispecific antibodies”. The milestone feed surfaced a patent-application signal described as “Methods for reducing infusion-related reactions in patients treated with EGFR/met bispecific antibodies”. The milestone feed surfaced a patent-application signal described as “Treatment of locally advanced or metastatic EGFR-mutated non-small cell lung 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