Givastomig Drug Asset Due Diligence Report 2026

This Givastomig 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: 18 September 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.

Phase 2

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: CONDITIONAL GO

Decision memo

Advance with milestone-based economics while efficacy durability, safety differentiation, patent scope, and market positioning are validated.

The central underwriting question is whether Givastomig can convert its Bispecific antibody profile and 4-1BB x CLDN18.2 biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Givastomig (query alias: Givastomig)
Modality / target	Bispecific antibody; 4-1BB x CLDN18.2; 4-1BB agonists, CLDN18.2 inhibitors
Highest global status	Phase 2
Originator	I-MAB Biopharma Co., Ltd.
Active developers	I-Mab Biopharma U.S. Ltd., I-MAB Biopharma (Shanghai) Co., Ltd., ABL Bio, Inc.

The MCP disease footprint includes Advanced cancer, Liver metastases, Adenocarcinoma of Esophagus. 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-jRCT2031250820	Phase 2	Recruiting	180	Primary endpoint not disclosed in English source
NCT07432295	Phase 2	Recruiting	180	Primary endpoint not disclosed in English source
NCT04900818	Phase 1	Recruiting	330	Primary endpoint not disclosed in English source

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

NovaBridge Presents Positive Givastomig Dose Expansion Data from the Phase 1b Combination Study in Patients with 1L Metastatic Gastric Cancer

Phase 1; n=54; evaluation: Positive. Reported fields: ORR = 77.0 % ; ORR = 73.0 %

A First-in-Human Study of Givastomig, a CLDN18.2 and 4-1BB Bispecific Antibody, as Monotherapy in Patients with CLDN18.2-Positive Advanced or Metastatic Solid Tumors

Not Applicable; n=75; evaluation: Positive. Reported fields: DLT = No DLT were reported up to 18 mg/kg

I-Mab Highlights Positive Givastomig Phase 1b Dose Escalation Data in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers at ESMO GI 2025

Phase 1; n=17; evaluation: Positive. Reported fields: DLT = No dose limiting toxicities (DLT) were observed ; DLT = No dose limiting toxicities (DLT) were observed

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

Givastomig addresses Advanced cancer, Liver metastases, Adenocarcinoma of Esophagus. Commercial attractiveness rests on addressable 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 MCP screen returned 3 matched transaction record(s) under the scope “asset-specific.” Partner activity is a market-validation signal, but it does not establish net present value.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2024-02-07	I-Mab Signs Agreement to Divest its Assets and Business Operations in China	Phase 3	Financial terms not disclosed
2021-11-02	Handok Pharmaceuticals acquired marketing rights of ABL001 in South Korea from ABL Bio	Phase 2	Financial terms not disclosed
2018-07-26	Transaction title not available in English source	Discovery	US$2.5M upfront; US$100.0M stated total

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 solid tumors using BI-specific antibodies”. The milestone feed surfaced a patent-application signal described as “Methods of treating cancers”. The milestone feed surfaced a patent-application signal described as “Immunotherapy for ox40 expressing 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.

7. Principal risks and diligence gates

Clinical differentiation versus current standards and pipeline competitors
Safety, dose optimization, and long-term tolerability
Patent scope, territorial rights, manufacturing, and commercial positioning

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

CONDITIONAL GO