GT-103 Drug Asset Due Diligence Report 2026

This GT-103 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: 11 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 1

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: HOLD / OPTION

Decision memo

Preserve optionality until clinical differentiation, transaction economics, and freedom-to-operate are sufficiently de-risked.

The central underwriting question is whether GT-103 can convert its Monoclonal antibody profile and CFH biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	GT-103 (query alias: GT-103)
Modality / target	Monoclonal antibody; CFH; CFH inhibitors
Highest global status	Phase 1
Originator	Duke University
Active developers	Duke University

The MCP disease footprint includes Advanced Lung Non-Small Cell Carcinoma, Recurrent 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
NCT07017829	Phase 2	Recruiting	28	Primary endpoint not disclosed in English source
NCT05617313	Phase 2	Terminated	21	Primary endpoint not disclosed in English source
NCT04314089	Phase 1	Completed	31	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

1487 Results from a phase II study of GT103 in combination with pembrolizumab in refractory, metastatic non-small cell lung cancer

Phase 2; n=21; evaluation: Positive. Reported fields: Adverse Event: grade 3 lymphocyte decrease = 1 patient experienced grade 3 lymphocyte decrease

Safety and efficacy of complement factor H (CFH) inhibitor GT103 in advanced non-small cell lung cancer (NSCLC): Results of a phase Ib first in human dose escalation study.

Phase 1; n=31; evaluation: Positive. Reported fields: MTD = not reached Not Met; MTD = not reached Not Met

Results from a first-in-human phase 1B study of a complement factor H inhibitor (GT103) in patients with non-small cell lung cancer (NSCLC).

Phase 1; n=25; evaluation: Positive. Reported fields: SD = 24 %

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

GT-103 addresses Advanced Lung Non-Small Cell Carcinoma, Recurrent Non-Small Cell Lung Cancer. Commercial attractiveness rests on addressable 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 MCP screen returned matched transaction record(s) under the scope “target-level comparable: CFH.” Partner activity is a market-validation signal, but it does not establish net present value.

5. Transaction precedent and economics

Transaction-scope note: No direct asset-specific transaction was returned. The table below shows target-level comparable: CFH records as comparable precedents only.

Date	Transaction	Phase at deal	Disclosed economics
No matched asset or comparable transaction returned.

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

No asset-specific patent-application milestone appeared in the returned milestone slice. That absence is not a freedom-to-operate conclusion; a dedicated family, claim, ownership, expiry, and legal-status search remains mandatory before signing.

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

HOLD / OPTION