Cirtuvivint Drug Asset Due Diligence Report 2026

This Cirtuvivint 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 Cirtuvivint can convert its Small molecule drug profile and CLK x DYRK biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Cirtuvivint (query alias: Cirtuvivint)
Modality / target	Small molecule drug; CLK x DYRK; CLK inhibitors, DYRK inhibitors
Highest global status	Phase 2
Originator	Biosplice Therapeutics, Inc.
Active developers	University of Colorado Denver, Biosplice Therapeutics, Inc., National Cancer Institute

The MCP disease footprint includes Soft Tissue Sarcoma, Small Cell Lung Cancer, Breast 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
NCT07155200	Phase 1/2	Recruiting	42	Primary endpoint not disclosed in English source
NCT07032285	Phase 2	Recruiting	25	Primary endpoint not disclosed in English source
NCT06856499	Phase 1	Recruiting	50	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

2744TiP - CIRTUSARC: A multicenter, open-label phase II trial of cirtuvivint as second-line therapy in selected advanced soft-tissue sarcomas

Phase 2; n=25; evaluation: Positive. Reported fields: PFS(3-month) = 70.0 % ( 50.9 - 84.4)

451O - Preliminary evidence of clinical activity from phase I and Ib trials of the CLK/DYRK inhibitor cirtuvivint (CIRT) in subjects with advanced solid tumors

Phase 1; n=65; evaluation: Positive. Reported fields: PSA30(in CRPC pts) = 3 Pts

CT112 - Initial results from a Phase 1 trial of a first-in-class pan-CDC-like kinase inhibitor (SM08502) with proof of mechanism in subjects with advanced solid tumors

Phase 1; n=19; evaluation: Positive. Reported fields: SAE = diarrhea (2/19 [10.5%])

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

Cirtuvivint addresses Soft Tissue Sarcoma, Small Cell Lung Cancer, Breast 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
2022-01-27	EPIC SCIENCES AND BIOSPLICE THERAPEUTICS ANNOUNCE PARTNERSHIP FOR METASTATIC CANCER TRIALS	Phase 1	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 “CLK2 inhibition as a radiation countermeasure”. The milestone feed surfaced a patent-application signal described as “Method for treating cancer by combining alkylating agent prodrug and cell cycle inhibitor”. The milestone feed surfaced a patent-application signal described as “Cancer methods”.

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