CRS-207 Drug Asset Due Diligence Report 2026

This CRS-207 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 CRS-207 can convert its Live attenuated vaccine, Therapeutic vaccine profile and MSLN biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	CRS-207 (query alias: CRS-207)
Modality / target	Live attenuated vaccine, Therapeutic vaccine; MSLN; MSLN modulators
Highest global status	Phase 2
Originator	Johns Hopkins Bloomberg School of Public Health
Active developers	Johns Hopkins Bloomberg School of Public Health, Cerus Corp., Chugai Pharmaceutical Co., Ltd.

The MCP disease footprint includes Ovarian Cancer, Pancreatic Cancer, Peritoneal Neoplasms. 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
NCT05014776	Phase 2	Completed	17	Primary endpoint not disclosed in English source
NCT03190265	Phase 2	Completed	61	Primary endpoint not disclosed in English source
NCT03175172	Phase 2	Terminated	10	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

A Phase 2 Study of the Safety, Efficacy, and Immune Response of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma

Phase 2; n=17; evaluation: Not stated in English source. Reported fields: Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) = 0 Pts

Phase 2 Study of Epacadostat, Pembrolizumab, and CRS-207, With or Without Cyclophosphamide and GVAX Pancreas Vaccine in Patients With Metastatic Pancreas Cancer

Phase 2; n=41; evaluation: Not stated in English source. Reported fields: Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation = 0 Pts ; Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation = 0 Pts

A Randomized Phase 2 Study of the Safety, Efficacy, and Immune Response of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cyclophosphamide) in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma

Phase 2; n=61; evaluation: Not stated in English source. Reported fields: Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) = 2 Pts

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

CRS-207 addresses Ovarian Cancer, Pancreatic Cancer, Peritoneal Neoplasms. Commercial attractiveness rests on addressable patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Live attenuated vaccine, Therapeutic vaccine—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
2011-04-18	Aduro Licenses Cancer Immunotherapy from BioSante	Not disclosed	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 “Application of antisense oligonucleotide in preparation of medicine for treating esophageal cancer”. The milestone feed surfaced a patent-application signal described as “SYSTEMS AND METHODS FOR DETECTING CANCER VIA cfDNA SCREENING”.

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

Immunogenicity durability and clinically meaningful protection
Population selection, endpoint timing, and comparator relevance
Manufacturing consistency, distribution, and uptake

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