Report scope. This 2026 Drug Asset Due Diligence Report evaluates Tasquinimod as a potential licensing, partnership, acquisition, or option asset. The review separates verified evidence from open diligence questions across clinical development, intellectual property, market positioning, and transaction precedent.
Executive recommendation: HOLD / OPTION
Tasquinimod is a Small molecule drug associated with HDAC4 x NIF and a global highest development stage of Phase 1/2. The lead disclosed indication is Post-essential thrombocythemia myelofibrosis. The current evidence supports a HOLD / OPTION posture, subject to confirmation of study-level data, ownership, patent coverage, manufacturing readiness, and regional rights.
Decision memo
- Asset: Tasquinimod
- Target: HDAC4 x NIF
- Lead indication: Post-essential thrombocythemia myelofibrosis
- Highest phase: Phase 1/2
- Matched trials: 14
- Matched result records: 17
- Matched asset deals: 3
Use PatSnap Life Sciences MCP servers to validate the Tasquinimod diligence evidence.
1. Asset identity and development status
The first diligence task is entity resolution. Teams should reconcile development codes, nonproprietary names, salts, formulations, combinations, sponsors, and predecessor owners before relying on portfolio counts. For Tasquinimod, the MCP profile identifies HDAC4 x NIF as the primary target context and Post-essential thrombocythemia myelofibrosis as the lead indication. Global phase labels are useful orientation points, but investment decisions require country- and indication-level status verification.
Confirm the exact molecule, formulation, route, dose, biomarker definition, and current sponsor. Review discontinuations separately from active development so that an historical high phase is not mistaken for a live program.
Use PatSnap Life Sciences MCP servers to validate the Tasquinimod diligence evidence.
2. Clinical program: design and endpoint audit
| Registry | Phase | Status | Enrollment | Lead primary endpoint |
|---|---|---|---|---|
| NCT06605586 | Phase 1/2 | Recruiting | Not disclosed | Not disclosed |
| NCT06327100 | Phase 1/2 | Recruiting | Not disclosed | Not disclosed |
| ACTRN12621000016831 | Phase 2 | Not yet recruiting | Not disclosed | Not disclosed |
| NCT04405167 | Phase 1 | Terminated | Not disclosed | Not disclosed |
| NCT02396368 | Phase 1 | Withdrawn | Not disclosed | Not disclosed |
| NCT02159950 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT02057666 | Phase 3 | Terminated | Not disclosed | Not disclosed |
| NCT01743469 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01732549 | Phase 2 | Terminated | Not disclosed | Not disclosed |
| NCT01513733 | Phase 1 | Completed | Not disclosed | Not disclosed |
| PER-027-11 | Phase 3 | Status not disclosed | Not disclosed | Not disclosed |
| NCT01234311 | Phase 3 | Completed | Not disclosed | Not disclosed |
| NCT01048203 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT00560482 | Phase 2 | Completed | Not disclosed | Not disclosed |
The clinical program should be audited for randomization, comparator relevance, dose selection, endpoint hierarchy, multiplicity, analysis population, geographic mix, and readout timing. Early-stage programs require attention to pharmacokinetics, pharmacodynamics, adverse events, dose-limiting toxicities, and the rationale for the expansion dose.
Use PatSnap Life Sciences MCP servers to validate the Tasquinimod diligence evidence.
3. Clinical readouts: what is known
Phase 1 study of tasquinimod, an S100A9 inhibitor, alone and in combination with IRd for relapsed and refractory multiple myeloma (RRMM).
Study: NCT04405167 (ASCO 12023 | ASCO 22023). Phase: Phase 1. Enrollment: 10. Published: 2023-05-26.
MTD = 0.5 mg qd x1 wk, then 1 mg qd (a single-agent MTD of 1 mg daily after a 1-week dose escalation)
A Phase III, Randomised, Double-Blind, Placebo-Controlled Study Of Tasquinimod In Asian Chemo-Naïve Patients With Metastatic Castrate-Resistant Prostate Cancer
Study: NCT02057666 (TasQ003, CTgov). Phase: Phase 3. Enrollment: 146. Published: 2021-04-23.
Time to Radiological Progression-Free Survival (PFS)(Median) = 11.00 Month (95%CI, 11.00 - NA) | Time to Radiological Progression-Free Survival (PFS)(Median) = 7.53 Month (95%CI, 5.67 - NA)
A Multicentre, Open Label, Early Stopping Design, Proof Of Concept Study With Tasquinimod In Treating Patients With Advanced Or Metastatic Hepatocellular, Ovarian, Renal Cell And Gastric Carcinomas
Study: NCT01743469 (CTgov). Phase: Phase 2. Enrollment: 201. Published: 2018-05-07.
Progression Free Survival (PFS) Rate, Defined as the Percentage of Patients Who Had Neither Progressed Nor Died as Measured by Centrally Analysed RECIST v1.1 (All Cohorts). = 26.9 % (95%CI, 15.57 - 41.02) | Progression Free Survival (PFS) Rate, Defined as the Percentage of Patients Who Had Neither Progressed Nor Died as Measured by Centrally Analysed RECIST v1.1 (All Cohorts). = 7.3 % (95%CI, 2.02 - 17.59)
A randomized, double-blind, placebo-controlled phase II study of maintenance therapy with tasquinimod in patients with metastatic castration-resistant prostate cancer responsive to or stabilized during first-line docetaxel chemotherapy.
Study: NCT01732549 (Pubmed). Phase: Phase 2. Enrollment: 144. Published: 2017-11-01.
rPFS(radiologic progression-free survival) = 31.7 Week (90%CI, 24.3 - 53.7) | rPFS(radiologic progression-free survival) = 22.7 Week (90%CI, 16.1 - 25.9)
A randomized, double-blind, placebo-controlled phase II study of maintenance therapy with tasquinimod in patients with metastatic castration-resistant prostate cancer responsive to or stabilized during first-line docetaxel chemotherapy
Study: NCT01732549 (Pubmed | Ann Oncol). Phase: Phase 2. Enrollment: 144. Published: 2017-11-01.
mPFS(radiologic) = 31.7 Week (90%CI, 24.3 - 53.7) | mPFS(radiologic) = 22.7 Week (90%CI, 16.1 - 25.9)
A Phase II Multicentre, Open-Label, Proof-of-Concept Study of Tasquinimod in Hepatocellular, Ovarian, Renal Cell, and Gastric Cancers.
Study: NCT01743469 (Pubmed | Target Oncol). Phase: Phase 2. Enrollment: 201. Published: 2017-10-01.
PFS(progression-free survival) = 26.9 % | PFS(progression-free survival) = 7.3 %
A Randomised, Double-Blind, Placebo-Controlled Proof Of Concept Study Of Maintenance Therapy With Tasquinimod In Patients With Metastatic Castrate-Resistant Prostate Cancer Who Are Not Progressing After A First Line Docetaxel Based Chemotherapy
Study: NCT01732549 (CTgov). Phase: Phase 2. Enrollment: 144. Published: 2016-10-03.
Time to Radiological Progression Free Survival [PFS](Median) = 31.7 Week (90%CI, 24.3 - 53.7) | Time to Radiological Progression Free Survival [PFS](Median) = 22.7 Week (90%CI, 16.1 - 25.9)
Randomized, Double-Blind, Placebo-Controlled Phase III Study of Tasquinimod in Men With Metastatic Castration-Resistant Prostate Cancer
Study: NCT01234311 (Pubmed | J Clin Oncol). Phase: Phase 3. Enrollment: Not disclosed. Published: 2016-08-01.
mOS = 21.3 Month (95%CI, 19.5 - 23.0) | mOS = 24.0 Month (95%CI, 21.4 - 26.9)
A Phase II Randomized Open Label Study of Sipuleucel-T vs. Sipuleucel-T and Tasquinimod in Patients With Metastatic Castrate-Resistant Prostate Cancer (CRPC)
Study: NCT02159950 (CTgov). Phase: Phase 2. Enrollment: 2. Published: 2016-05-20.
Other (Not Including Serious) Adverse Events = 0 Pts | Grade 1 = 1 Pts
Randomized, double-blind, placebo-controlled proof of concept study of tasquinimod maintenance therapy in patients with metastatic castrate-resistant prostate cancer (mCRPC) who experience response or stabilization during first-line docetaxel chemotherapy.
Study: NCT01732549 (ASCO2013). Phase: Phase 2. Enrollment: 140. Published: 2013-05-20.
PFS(Radiological) = 7.6 Month | PFS(Radiological) = 3.3 Month
Association of bone scan index (BSI) with prognostic biomarkers and survival in men with metastatic castration-resistant prostate cancer (mCRPC) enrolled in a prospective randomized controlled trial of tasquinimod.
Study: NCT00560482 (ASCO2013). Phase: Phase 2. Enrollment: 201. Published: 2013-05-20.
BSI(bone scan index) = 0.9 %
Active Biotech's and Ipsen's Tasquinimod shows encouraging overall survival improvement in castrate resistant prostate cancer
Study: NCT02057666 (TasQ003, GlobeNewswire). Phase: Phase 2. Enrollment: 206. Published: 2012-06-04.
rPFS: HR = 0.52(95% CI, 0.35 - 0.78), P-Value = 0.001 | rPFS: HR = 0.52(95% CI, 0.35 - 0.78), P-Value = 0.001
Tasquinimod and survival in men with metastatic castration-resistant prostate cancer: Results of long-term follow-up of a randomized phase II placebo-controlled trial.
Study: NCT01234311 (ASCO2012). Phase: Phase 2. Enrollment: 201. Published: 2012-05-20.
OS = 34.2 Month | OS = 30.2 Month
Phase II Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men With Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer
Study: Pubmed | J Clin Oncol. Phase: Phase 2. Enrollment: Not disclosed. Published: 2011-10-20.
Adverse Event: Grade 3 to 4 AEs = including asymptomatic elevations of laboratory parameters, were reported in 40% of patients receiving TASQ versus 10% receiving placebo | Adverse Event: Grade 3 to 4 AEs = including asymptomatic elevations of laboratory parameters, were reported in 40% of patients receiving TASQ versus 10% receiving placebo
Phase II study of tasquinimod in chemotherapy-naive patients with metastatic castrate-resistant prostate cancer (CRPC): Safety and efficacy analysis including subgroups.
Study: ASCO_GU2011. Phase: Phase 2. Enrollment: 206. Published: 2011-03-01.
PFS = 7.6 Month | PFS = 3.3 Month
A randomized, multicenter, international phase II study of tasquinimod in chemotherapy naïve patients with metastatic castrate-resistant prostate cancer (CRPC).
Study: ASCO2010. Phase: Phase 2. Enrollment: 206. Published: 2010-05-20.
PFS = 30.6 Week | PFS = 13.4 Week
An open label phase I study of ABR-215050 in patients with prostate cancer refractory to hormone therapy and with rising PSA for determination of MTD and long-term tolerability and safety
Study: ASCO2007. Phase: Phase 1. Enrollment: 17. Published: 2007-06-20.
MTD = 0.5 mg | MTD = 1.0 mg
For every reported endpoint, obtain the protocol, statistical analysis plan, patient disposition, baseline characteristics, subgroup definitions, exposure duration, and full safety tables. Conference abstracts and registry summaries can support screening, but they should not replace source data review in a binding transaction.
Use PatSnap Life Sciences MCP servers to validate the Tasquinimod diligence evidence.
4. Market and competitive position
The commercial case depends on differentiated efficacy, tolerability, convenience, biomarker reach, treatment setting, and access. A target-level market may be attractive while an individual asset remains undifferentiated. Benchmark Tasquinimod against approved therapies and clinical competitors in Post-essential thrombocythemia myelofibrosis, including likely standards of care at the expected launch date.
Build a scenario model around addressable patients, diagnosis and biomarker rates, line of therapy, duration, net price, uptake, displacement, combination costs, and probability-adjusted timelines. Test slower enrollment, delayed readout, narrower labels, safety restrictions, and competitor launches.
Use PatSnap Life Sciences MCP servers to validate the Tasquinimod diligence evidence.
5. Transaction precedent and economics
| Date | Transaction | Status | Type | Disclosed value |
|---|---|---|---|---|
| 2022-02-09 | Active Biotech enters into global patent license agreement with Oncode Institute for tasquinimod in myelofibrosis | Active | Collaboration | Not disclosed |
| 2020-02-05 | The Perelman School will accelerate the progress of Active Biotech's tasquinimod for the treatment of multiple myeloma. | Active | Collaboration | Not disclosed |
| 2011-04-18 | Active Biotech and Ipsen enter into a broad partnership for the co-development and commercialization of TASQ in uro-oncology | Active | License | 200 |
Transaction records should be normalized for territory, asset scope, phase at signing, option mechanics, development obligations, cost sharing, royalties, milestones, and change-of-control terms. Undisclosed economics must not be converted into invented benchmarks.
6. IP and freedom-to-operate screen
Complete a family-level patent review covering composition of matter, sequence or construct claims, polymorph and salt claims, formulation, dosing, combinations, biomarkers, manufacturing, and method of use. Verify priority, ownership, assignments, prosecution status, term adjustments, extensions, oppositions, and regional coverage. Freedom to operate is a separate legal analysis and should include competitor claims and platform dependencies.
The diligence room should reconcile inventorship, employee and contractor assignments, university or platform licenses, sublicensing restrictions, government rights, and obligations triggered by development milestones or commercialization.
Use PatSnap Life Sciences MCP servers to validate the Tasquinimod diligence evidence.
7. Principal risks and diligence gates
- Identity risk: resolve all aliases, formulations, combinations, and owners.
- Clinical risk: confirm source data, protocol deviations, endpoint definitions, and safety follow-up.
- Regulatory risk: review agency correspondence, meeting minutes, holds, commitments, and indication-specific pathways.
- IP risk: validate enforceable coverage, remaining life, ownership, and freedom to operate.
- CMC risk: assess process control, analytical methods, comparability, scale-up, supply, and cost of goods.
- Commercial risk: pressure-test differentiation, market access, competitive timing, and realistic adoption.
- Transaction risk: map rights, encumbrances, royalties, options, consent requirements, and change-of-control provisions.
8. Final go/no-go memorandum
HOLD / OPTION
Proceed only through staged diligence. Before exclusivity or a binding offer, require a verified asset identity package, complete clinical data room, regulatory correspondence, patent-family schedule, freedom-to-operate opinion, CMC package, ownership chain, regional rights map, and risk-adjusted valuation. Any material mismatch between public records and source documents should pause the process until reconciled.
Method note: This report uses PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP data retrieved on 2026-10-15. It is a screening and diligence framework, not medical, legal, regulatory, or investment advice.
