Vactosertib Drug Asset Due Diligence Report 2026

This Vactosertib 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: 16 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 Vactosertib can convert its Small molecule drug profile and ALK5 biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Vactosertib (query alias: Vactosertib)
Modality / target	Small molecule drug; ALK5; ALK5 inhibitors
Highest global status	Phase 2
Originator	MedPacto, Inc.
Active developers	MSD Korea Co., Ltd., Merck & Co., Inc., MedPacto, Inc.

The MCP disease footprint includes Melanoma, Metastatic gastric adenocarcinoma, Colorectal 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
NCT06219733	Phase 2	Withdrawn	0	Primary endpoint not disclosed in English source
NCT06044311	Phase 2	Suspended	30	Primary endpoint not disclosed in English source
NCT05588648	Phase 1/2	Recruiting	48	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.

Reproduce the asset-to-trial workflow with PatSnap MCP

3. Clinical readouts: what is known

A Phase II Study of Preoperative Immunotherapy in Patients With Colorectal Cancer and Resectable Hepatic Metastases

Phase 2; n=6; evaluation: Not stated in English source. Reported fields: Proportion of Participants With Treatment-related, Adverse Events = 1.00 % ; Other (Not Including Serious) Adverse Events = 6 Pts

A 2-tiered, Phase 2, Rule-based, Intra-patient Dose Escalation Study to Investigate Safety and Feasibility of Vactosertib (TEW-7197) in the Treatment of Anemic Patients With Philadelphia Chromosome-negative MPNs (Ph-neg MPNs)

Phase 2; n=2; evaluation: Not stated in English source. Reported fields: Identify Dose Limiting Toxicities (DLTs) in Patients With MPN Enrolled on Tier 1 = 0 Count of DLTs ; Identify Dose Limiting Toxicities (DLTs) in Patients With MPN Enrolled on Tier 1 = 0 Count of DLTs

605 Vactosertib, a TGF-β signaling inhibitor, in combination with durvalumab increased mOS in ≥2L treatment of patients with PD-L1-positive advanced NSCLC

Phase 1/2; n=60; evaluation: Positive. Reported fields: Adverse Event: interstitial lung disease = 6.7% ; Adverse Event: interstitial lung disease = 6.7%

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

Vactosertib addresses Melanoma, Metastatic gastric adenocarcinoma, Colorectal Cancer. Commercial attractiveness rests on addressable patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Small molecule drug—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The MCP screen returned 1 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
2018-07-24	MedPacto partners with AstraZeneca to assess vactosertib and durvalumab combination 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 “Methods of identifying and treating an immune poor cancer”. The milestone feed surfaced a patent-application signal described as “Panels and methods for diagnosing and treating lung cancer”. The milestone feed surfaced a patent-application signal described as “TGF-beta inhibitors for use for treating resistant or unresponsive cancer in patients”.

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

Therapeutic index and off-target toxicity
Resistance biology and biomarker-defined patient selection
Differentiation from established and emerging standards

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